Proven combinations of medicines and the introduction of new anti-arthritis drugs have significantly improved the treatment of rheumatoid arthritis (RA), according to guidelines issued by the American College of Rheumatology and co-authored by physicians at the University of Alabama at Birmingham (UAB).
Lead author Kenneth Saag, M.D., M.Sc., a professor in the UAB Division of Clinical Immunology and Rheumatology, said the new guidelines update strategies for treating RA with the goal of preventing joint damage and disability.
The new recommendations do not strive to replace individualized medical decisions, Saag said. Instead, they are meant to guide rheumatologists and other health care workers toward the most updated recommendations. The last set of American College of Rheumatology RA treatment guidelines was published in 2002.
"The recommendations developed are not intended to be used in a 'cookbook' or prescriptive manner, or to limit a physician's clinical judgment," Saag said. "They provide guidance based on clinical evidence and expert panel input."
The recommendations focus on several classes of anti-arthritic drugs, including a potent group of agents called disease-modifying anti-rheumatic drugs (DMARDs). Newer genetically engineered DMARDs called biologics often work in combination with earlier therapies. Many anti-arthritic drugs are designed to stop damaging inflammation, and biologics work to interrupt the chain of events that leads to inflammation.
Newer biologics called anti-TNF agents adalimumab (Humira), etanercept (Enbrel) and infliximab (Remicade) prevent the production of an immunity protein that plays a role in inflammation.
Some of the key recommendations include:
-- Methotrexate or leflunomide therapy is recommended for most RA patients.
-- Anti-TNF agents etanercept, infliximab, or adalimumab along with methotrexate can be used in new or early RA cases with worsening and severe symptoms.
-- Doctors should not initiate or resume treatment with methotrexate, leflunomide, or biologics if RA patients have active bacterial infection, shingles (herpes-zoster), hepatitis B, hepatitis C and active or latent tuberculosis.
-- Doctors should not prescribe anti-TNF agents to patients with a history of heart failure, lymphoma or multiple sclerosis.
The full list of RA treatment recommendations is available at rheumatology by clicking on practice support, then guidelines.
University of Alabama at Birmingham
701 20th St. S, AB 1320
Birmingham, AL 35294-0113
United States
uab
View drug information on Enbrel; Humira; Remicade.
пятница, 7 октября 2011 г.
вторник, 4 октября 2011 г.
Study Results Suggest Oral Salmon Calcitonin Using Eligen(R) Drug Delivery Technology May Reduce Cartilage And Bone Degradation In Osteoarthritis
Emisphere Technologies, Inc. (OTCBB: EMIS) announced study results in which twice-daily oral salmon calcitonin using Emisphere's proprietary Eligen® Drug Delivery Technology significantly suppressed markers of cartilage and bone degradation versus placebo in men and women with osteoarthritis, the most common form of arthritis. The study, a Phase I, placebo-controlled, double-blind, double-dummy, randomized, gender-stratified clinical trial, was conducted on behalf of Emisphere's partner Novartis Pharma AG by Nordic Bioscience, and published online in the September 2009 issue of Osteoarthritis and Cartilage.
A total of 73 male and female subjects aged 57 to 75 years with painful osteoarthritis of the knee received twice-daily 0.6 mg or 0.8 mg doses of oral salmon calcitonin with the Eligen® Technology or placebo administered over 14 days. Doses of 0.8mg compared with 0.6mg produced significantly higher Cmax and AUC(0-4 hrs), of calcitonin, P=0.03. This resulted in significant reductions in CTX-I and CTX-II which are biochemical markers of bone degradation and of cartilage degradation, respectively. Gender had no observable influence on results. Oral sCT doses were well tolerated; 44 adverse events and no serious adverse events were reported in this study. For further details please consult the original publication which is available online (Karsdal MA et al; The effect of oral salmon calcitonin delivered with 5-CNAC on bone and cartilage degradation in osteoarthritic patients: a 14-day randomized study; Osteoarthritis and Cartilage; available online September 1, 2009).
"We are pleased that emerging data continue to indicate oral salmon calcitonin in combination with our absorption-enhancing Eligen® Technology may be a potential therapeutic option for women and men with osteoarthritis, which affects more than 20 million people in the United States," said Michael V. Novinski, President and Chief Executive Officer, Emisphere Technologies. "We look forward to further validating these results in the extensive ongoing Phase III clinical trial program."
Emisphere announced in June 2009 that recruitment had been completed for the planned second multi-center Phase III study exploring the safety and efficacy of oral salmon calcitonin using the Eligen® Technology to treat patients with osteoarthritis of the knee. Enrollment in the first Phase III trial for osteoarthritis was completed in September 2008.
Oral salmon calcitonin using Eligen® Technology is also being investigated in a Phase III study for osteoporosis being conducted by Novartis Pharma AG and Nordic Bioscience.
About Osteoarthritis
Osteoarthritis ("OA") is a clinical syndrome in which low-grade inflammation results in joint pain, caused by a wearing-away of cartilage that cushions the joints and the destruction or decrease of synovial fluid that lubricates those joints. As OA progresses, pain can result when the patient bears weight upon the joints, when walking or standing. OA affects nearly 21 million people in the United States, accounting for approximately 15 percent of visits to primary care physicians. It is estimated that 80 percent of the population will have radiographic evidence of OA by age 65.
Bone and cartilage degradation are normally tightly coupled in the pathogenesis of OA, indicating an optimal approach to counter the progression of OA may be to target both bone and cartilage degeneration. Recent preclinical experience and preliminary data from clinical settings suggest that calcitonin may have positive effects on both bone and cartilage.
Source
Emisphere Technologies, Inc.
A total of 73 male and female subjects aged 57 to 75 years with painful osteoarthritis of the knee received twice-daily 0.6 mg or 0.8 mg doses of oral salmon calcitonin with the Eligen® Technology or placebo administered over 14 days. Doses of 0.8mg compared with 0.6mg produced significantly higher Cmax and AUC(0-4 hrs), of calcitonin, P=0.03. This resulted in significant reductions in CTX-I and CTX-II which are biochemical markers of bone degradation and of cartilage degradation, respectively. Gender had no observable influence on results. Oral sCT doses were well tolerated; 44 adverse events and no serious adverse events were reported in this study. For further details please consult the original publication which is available online (Karsdal MA et al; The effect of oral salmon calcitonin delivered with 5-CNAC on bone and cartilage degradation in osteoarthritic patients: a 14-day randomized study; Osteoarthritis and Cartilage; available online September 1, 2009).
"We are pleased that emerging data continue to indicate oral salmon calcitonin in combination with our absorption-enhancing Eligen® Technology may be a potential therapeutic option for women and men with osteoarthritis, which affects more than 20 million people in the United States," said Michael V. Novinski, President and Chief Executive Officer, Emisphere Technologies. "We look forward to further validating these results in the extensive ongoing Phase III clinical trial program."
Emisphere announced in June 2009 that recruitment had been completed for the planned second multi-center Phase III study exploring the safety and efficacy of oral salmon calcitonin using the Eligen® Technology to treat patients with osteoarthritis of the knee. Enrollment in the first Phase III trial for osteoarthritis was completed in September 2008.
Oral salmon calcitonin using Eligen® Technology is also being investigated in a Phase III study for osteoporosis being conducted by Novartis Pharma AG and Nordic Bioscience.
About Osteoarthritis
Osteoarthritis ("OA") is a clinical syndrome in which low-grade inflammation results in joint pain, caused by a wearing-away of cartilage that cushions the joints and the destruction or decrease of synovial fluid that lubricates those joints. As OA progresses, pain can result when the patient bears weight upon the joints, when walking or standing. OA affects nearly 21 million people in the United States, accounting for approximately 15 percent of visits to primary care physicians. It is estimated that 80 percent of the population will have radiographic evidence of OA by age 65.
Bone and cartilage degradation are normally tightly coupled in the pathogenesis of OA, indicating an optimal approach to counter the progression of OA may be to target both bone and cartilage degeneration. Recent preclinical experience and preliminary data from clinical settings suggest that calcitonin may have positive effects on both bone and cartilage.
Source
Emisphere Technologies, Inc.
суббота, 1 октября 2011 г.
New Surgical Option For Wrist Arthritis
Breaking a fall, such as a tumble on the sidewalk, with your hands and wrists is everyone's natural reflex. But, if you fall hard enough, you'll often fracture your radius bone, or even one of the smaller wrist bones and wrist ligaments. Left untreated, these injuries could lead to disabling wrist arthritis.
For patients who develop wrist arthritis, a new surgical option known as OCRPRC (OsteoChondral Resurfacing in Proximal Row Carpectomy) is available at NewYork-Presbyterian Hospital/Columbia University Medical Center, where it is offered by one of the orthopedic surgeons who originally developed and described the technique -- Dr. Peter Tang. His research shows that the procedure reduces pain and improves hand function.
"I often see patients who had a wrist injury in the past who either did not seek medical attention or whose original injury was not diagnosed. As with most things in medicine, the earlier a diagnosis is made, the better the outcome. So if you continue to have pain after a month, you should make an appointment to see a hand surgeon for an evaluation," says Dr. Tang, who is an orthopedic hand surgeon at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of orthopedic surgery at Columbia University College of Physicians and Surgeons.
Because the biomechanics of the wrist is both delicate and complex, an alteration in the normal anatomy can lead to arthritis. Once disabling arthritis develops, surgery cannot simply fix the injured structure, but rather must remove the arthritis and improve wrist function. The two most common operations for wrist arthritis are a partial fusion of the small wrist bones (intercarpal fusion) and excision of the first row of carpal bones (proximal row carpectomy, or PRC). There are various reasons to choose one operation over the other, but PRC has a quicker recovery, may be better for older patients, gives equal grip strength to intercarpal fusion, and usually results in more wrist motion.
Once the three carpal bones are removed during the PRC procedure, the capitate bone becomes the point where the wrist articulates with the arm; as such, it is important that the arthritis has not progressed to the capitate bone.
For these patients whose arthritis has progressed, Dr. Tang has adapted a cartilage-grafting technique that is used effectively in sports medicine treatments for cartilage disorders in the knee, ankle and elbow. The results are promising, according to his study in the Journal of Hand Surgery, with improvement in grip strength and decrease in pain levels.
"The goal of this new procedure is to give the best possible outcome by improving the cartilage status of the capitate bone. Another plus is that we do not have to take the graft from another part of the body. Even though we take out the three carpal bones for arthritis, there is usually one area of the bones where we can find undamaged cartilage for grafting," says Dr. Tang.
The study followed eight patients who underwent osteochondral resurfacing over 18 months. Preoperatively, seven patients described their pain as moderate to severe, while postoperatively, seven patients described their pain as mild to no pain, and one patient described the pain as moderate. Preoperative grip strength increased from 62 percent of their healthy side to postoperatively, 71 percent. Preoperative Mayo wrist score improved from a score of 51, which rates as "poor," to a postoperative score of 68, which rates as "fair."
The Journal of Hand Surgery study is co-authored by Dr. Joseph E. Imbriglia who is clinical professor of orthopaedic surgery and director of the Hand and Upper Extremity Fellowship Program at the University of Pittsburgh School of Medicine, where Dr. Tang did his training. Interestingly, Dr. Imbriglia did both his orthopaedic residency and hand fellowship training at Columbia University College of Physicians and Surgeons.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit cumc.columbia.
NewYork Presbyterian Hospital
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments -- more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth in U.S.News & World Report's guide to "America's Best Hospitals," ranks first on New York magazine's "Best Hospitals" survey, has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital's mortality rates are among the lowest for heart attack and heart failure in the country, according to a 2007 U.S. Department of Health and Human Services (HHS) report card. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. For more information, visit nyp.
NewYork-Presbyterian Hospital
627 W 165th St., SB-621
New York
NY 10032
United States
nyp
For patients who develop wrist arthritis, a new surgical option known as OCRPRC (OsteoChondral Resurfacing in Proximal Row Carpectomy) is available at NewYork-Presbyterian Hospital/Columbia University Medical Center, where it is offered by one of the orthopedic surgeons who originally developed and described the technique -- Dr. Peter Tang. His research shows that the procedure reduces pain and improves hand function.
"I often see patients who had a wrist injury in the past who either did not seek medical attention or whose original injury was not diagnosed. As with most things in medicine, the earlier a diagnosis is made, the better the outcome. So if you continue to have pain after a month, you should make an appointment to see a hand surgeon for an evaluation," says Dr. Tang, who is an orthopedic hand surgeon at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of orthopedic surgery at Columbia University College of Physicians and Surgeons.
Because the biomechanics of the wrist is both delicate and complex, an alteration in the normal anatomy can lead to arthritis. Once disabling arthritis develops, surgery cannot simply fix the injured structure, but rather must remove the arthritis and improve wrist function. The two most common operations for wrist arthritis are a partial fusion of the small wrist bones (intercarpal fusion) and excision of the first row of carpal bones (proximal row carpectomy, or PRC). There are various reasons to choose one operation over the other, but PRC has a quicker recovery, may be better for older patients, gives equal grip strength to intercarpal fusion, and usually results in more wrist motion.
Once the three carpal bones are removed during the PRC procedure, the capitate bone becomes the point where the wrist articulates with the arm; as such, it is important that the arthritis has not progressed to the capitate bone.
For these patients whose arthritis has progressed, Dr. Tang has adapted a cartilage-grafting technique that is used effectively in sports medicine treatments for cartilage disorders in the knee, ankle and elbow. The results are promising, according to his study in the Journal of Hand Surgery, with improvement in grip strength and decrease in pain levels.
"The goal of this new procedure is to give the best possible outcome by improving the cartilage status of the capitate bone. Another plus is that we do not have to take the graft from another part of the body. Even though we take out the three carpal bones for arthritis, there is usually one area of the bones where we can find undamaged cartilage for grafting," says Dr. Tang.
The study followed eight patients who underwent osteochondral resurfacing over 18 months. Preoperatively, seven patients described their pain as moderate to severe, while postoperatively, seven patients described their pain as mild to no pain, and one patient described the pain as moderate. Preoperative grip strength increased from 62 percent of their healthy side to postoperatively, 71 percent. Preoperative Mayo wrist score improved from a score of 51, which rates as "poor," to a postoperative score of 68, which rates as "fair."
The Journal of Hand Surgery study is co-authored by Dr. Joseph E. Imbriglia who is clinical professor of orthopaedic surgery and director of the Hand and Upper Extremity Fellowship Program at the University of Pittsburgh School of Medicine, where Dr. Tang did his training. Interestingly, Dr. Imbriglia did both his orthopaedic residency and hand fellowship training at Columbia University College of Physicians and Surgeons.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit cumc.columbia.
NewYork Presbyterian Hospital
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments -- more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth in U.S.News & World Report's guide to "America's Best Hospitals," ranks first on New York magazine's "Best Hospitals" survey, has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital's mortality rates are among the lowest for heart attack and heart failure in the country, according to a 2007 U.S. Department of Health and Human Services (HHS) report card. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. For more information, visit nyp.
NewYork-Presbyterian Hospital
627 W 165th St., SB-621
New York
NY 10032
United States
nyp
среда, 28 сентября 2011 г.
Osteoarthritis Not Relieved By Knee Surgery
In what has been described as a landmark study, scientists in Canada have found that a routine knee operation undergone by many patients with
osteoarthritis does not relieve joint pain or improve knee function.
The study was the work of researchers at the The University of Western Ontario and Lawson Health Research Institute, both in London, Ontario,
Canada, and appears in the September 11th issue of the New England Journal of Medicine, NEJM.
The study was designed by the late Dr Sandy Kirkley, orthopaedic surgeon and arthroscopy specialist, and was coordinated by the Clinical Trials
Group of Robarts Research Institute. A research team comprising orthopaedic surgeons, rheumatologists and physiotherapists, carried out the study
at the Fowler Kennedy Sport Medicine Clinic at London Health Sciences Centre (LHSC).
Co-author Dr Brian Feagan, Clinical Trials Director at the Robarts Research Institute at Western, and a professor in the Departments of Medicine, and
Epidemiology and Biostatistics at Western's Schulich School of Medicine & Dentistry, said:
"This study provides definitive evidence that arthroscopic surgery provides no additional therapeutic value when added to physical therapy and
medication for patients with moderate osteoarthritis of the knee."
Ten per cent of Canadians, and 27 million Americans are living with osteoarthritis, the most common type of arthritis.
Arthroscopic surgery is a minimally invasive surgical operation where the surgeon makes a small incision and inserts an arthroscope (long tube with a
camera on the end and room to pass surgical instruments through as well) in the knee joint and them removes fragments of cartilage and smooths
down the surfaces of the joints.
For the study, which ran from 1999 to 2007, the researchers treated 178 male and female patients of average age 60 who came from the London
area and had moderate to severe arthritis of the knee.
The patients were randomly assigned to receive either surgical lavage and arthroscopic debridement together with optimized physical and medical
therapy (92 treatment group patients) or to receive physical and medical therapy without surgery (86 control group patients).
The patients then completed symptom assessment questionnaires at various points post-treatment, for up to two years. One
questionnaire was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and another questionnaire was the Short Form-36
(SF-36) Physical Component Summary score.
The total WOMAC score ranges from 0 to 2400, with higher scores meaning more severe symptoms. This was the primary outcome measure. The SF-36 Physical Component Summary score can range from 0 to 100, with the higher scores indicating better quality of life. This was part of the
secondary outcome measures.
The results showed that:
Of the 92 patients assigned to surgery, 6 did not have it.
All 86 patients in the control group had physical and medical therapy only, as planned.
After 2 years of follow up, the mean (plus or minus standard deviation) WOMAC score for the surgery group was 874 plus or minus 624,
compared with 897 plus or minus 583 for the control group.
The absolute difference between the surgery group WOMAC score minus the control group WOMAC score at 2 years was a statistically
insignificant -23 plus or minus 605 (95% confidence interval ranged from -208 to 161; P=0.22 after baseline and grade of severity
adjustments).
The SF-36 Physical Component Summary score for the surgery group was 37.0 plus or minus 11.4 and 37.2 plus or minus 10.6 for the control
group at 2 years.
The absolute difference in SF-36 Physical Component Summary scores in the surgery group minus the control group at 2 years was a statistically
insignificant -0.2 plus or minus 11.1 (95% confidence interval ranged from -3.6 to 3.2; P=0.93).
Analyses of WOMAC scores at interim visits and other secondary outcomes also failed to show better statistically significant results for the
surgery group.
The authors concluded that:
"Arthroscopic surgery for osteoarthritis of the knee provides no additional benefit to optimized physical and medical therapy. "
"Based on the available evidence, we believe that the resources currently allocated towards arthroscopic surgery for osteoarthritis would be better
directed elsewhere," they said.
In other words, at several stages during the 2 year follow up, the researchers found both patient groups experienced comparable improvements in
joint pain, stiffness, and function, but there was no significant benefit from surgery.
Co-author and orthopaedic surgeon Dr Bob Litchfield, who is also Medical Director of the Fowler Kennedy Sport Medicine Clinic, pointed out that the
study only looked at knee problems that were arthritis related :
"Although this study did not show a significant therapeutic benefit of arthroscopic debridement in this patient population, knee arthroscopy is still
beneficial in many other conditions affecting the knee, such as meniscal repair and resection, and ligament reconstruction."
Litchfield is also a professor in the Department of Surgery at Schulich Medicine & Dentistry and a scientist with the Lawson Health Research Institute.
"As surgeons, we need to know when things are working and when they're not. If this particular technique is not working for this subgroup of patients,
we better come up with something else that does," he added.
An earlier study (the "Moseley study") published in 2002 showing similar results was considered methodologically flawed and rejected by the medical
community and arthroscopic surgery is still routinely performed to treat joint pain and stiffness.
In 2006/2007, Ontario Health Insurance Plan (OHIP) spent 7.9 million dollars on this procedure alone, said the researchers in a press
statement.
"A Randomized Trial of Arthroscopic Surgery for Osteoarthritis of the Knee."
Kirkley, Alexandra, Birmingham, Trevor B., Litchfield, Robert B., Giffin, J. Robert, Willits, Kevin R., Wong, Cindy J., Feagan, Brian G., Donner, Allan,
Griffin, Sharon H., D'Ascanio, Linda M., Pope, Janet E., Fowler, Peter J.
N Engl J Med 2008 359: 1097-1107.
Volume 359, Number 11, pages 1097-1107, September 11, 2008.
Click here for Abstract.
Source: The University of Western Ontario, Journal abstract.
Written by: , PhD
osteoarthritis does not relieve joint pain or improve knee function.
The study was the work of researchers at the The University of Western Ontario and Lawson Health Research Institute, both in London, Ontario,
Canada, and appears in the September 11th issue of the New England Journal of Medicine, NEJM.
The study was designed by the late Dr Sandy Kirkley, orthopaedic surgeon and arthroscopy specialist, and was coordinated by the Clinical Trials
Group of Robarts Research Institute. A research team comprising orthopaedic surgeons, rheumatologists and physiotherapists, carried out the study
at the Fowler Kennedy Sport Medicine Clinic at London Health Sciences Centre (LHSC).
Co-author Dr Brian Feagan, Clinical Trials Director at the Robarts Research Institute at Western, and a professor in the Departments of Medicine, and
Epidemiology and Biostatistics at Western's Schulich School of Medicine & Dentistry, said:
"This study provides definitive evidence that arthroscopic surgery provides no additional therapeutic value when added to physical therapy and
medication for patients with moderate osteoarthritis of the knee."
Ten per cent of Canadians, and 27 million Americans are living with osteoarthritis, the most common type of arthritis.
Arthroscopic surgery is a minimally invasive surgical operation where the surgeon makes a small incision and inserts an arthroscope (long tube with a
camera on the end and room to pass surgical instruments through as well) in the knee joint and them removes fragments of cartilage and smooths
down the surfaces of the joints.
For the study, which ran from 1999 to 2007, the researchers treated 178 male and female patients of average age 60 who came from the London
area and had moderate to severe arthritis of the knee.
The patients were randomly assigned to receive either surgical lavage and arthroscopic debridement together with optimized physical and medical
therapy (92 treatment group patients) or to receive physical and medical therapy without surgery (86 control group patients).
The patients then completed symptom assessment questionnaires at various points post-treatment, for up to two years. One
questionnaire was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and another questionnaire was the Short Form-36
(SF-36) Physical Component Summary score.
The total WOMAC score ranges from 0 to 2400, with higher scores meaning more severe symptoms. This was the primary outcome measure. The SF-36 Physical Component Summary score can range from 0 to 100, with the higher scores indicating better quality of life. This was part of the
secondary outcome measures.
The results showed that:
Of the 92 patients assigned to surgery, 6 did not have it.
All 86 patients in the control group had physical and medical therapy only, as planned.
After 2 years of follow up, the mean (plus or minus standard deviation) WOMAC score for the surgery group was 874 plus or minus 624,
compared with 897 plus or minus 583 for the control group.
The absolute difference between the surgery group WOMAC score minus the control group WOMAC score at 2 years was a statistically
insignificant -23 plus or minus 605 (95% confidence interval ranged from -208 to 161; P=0.22 after baseline and grade of severity
adjustments).
The SF-36 Physical Component Summary score for the surgery group was 37.0 plus or minus 11.4 and 37.2 plus or minus 10.6 for the control
group at 2 years.
The absolute difference in SF-36 Physical Component Summary scores in the surgery group minus the control group at 2 years was a statistically
insignificant -0.2 plus or minus 11.1 (95% confidence interval ranged from -3.6 to 3.2; P=0.93).
Analyses of WOMAC scores at interim visits and other secondary outcomes also failed to show better statistically significant results for the
surgery group.
The authors concluded that:
"Arthroscopic surgery for osteoarthritis of the knee provides no additional benefit to optimized physical and medical therapy. "
"Based on the available evidence, we believe that the resources currently allocated towards arthroscopic surgery for osteoarthritis would be better
directed elsewhere," they said.
In other words, at several stages during the 2 year follow up, the researchers found both patient groups experienced comparable improvements in
joint pain, stiffness, and function, but there was no significant benefit from surgery.
Co-author and orthopaedic surgeon Dr Bob Litchfield, who is also Medical Director of the Fowler Kennedy Sport Medicine Clinic, pointed out that the
study only looked at knee problems that were arthritis related :
"Although this study did not show a significant therapeutic benefit of arthroscopic debridement in this patient population, knee arthroscopy is still
beneficial in many other conditions affecting the knee, such as meniscal repair and resection, and ligament reconstruction."
Litchfield is also a professor in the Department of Surgery at Schulich Medicine & Dentistry and a scientist with the Lawson Health Research Institute.
"As surgeons, we need to know when things are working and when they're not. If this particular technique is not working for this subgroup of patients,
we better come up with something else that does," he added.
An earlier study (the "Moseley study") published in 2002 showing similar results was considered methodologically flawed and rejected by the medical
community and arthroscopic surgery is still routinely performed to treat joint pain and stiffness.
In 2006/2007, Ontario Health Insurance Plan (OHIP) spent 7.9 million dollars on this procedure alone, said the researchers in a press
statement.
"A Randomized Trial of Arthroscopic Surgery for Osteoarthritis of the Knee."
Kirkley, Alexandra, Birmingham, Trevor B., Litchfield, Robert B., Giffin, J. Robert, Willits, Kevin R., Wong, Cindy J., Feagan, Brian G., Donner, Allan,
Griffin, Sharon H., D'Ascanio, Linda M., Pope, Janet E., Fowler, Peter J.
N Engl J Med 2008 359: 1097-1107.
Volume 359, Number 11, pages 1097-1107, September 11, 2008.
Click here for Abstract.
Source: The University of Western Ontario, Journal abstract.
Written by: , PhD
воскресенье, 25 сентября 2011 г.
Intelligent Therapies With Virtual Reality For The Psychological Treatment Of Patients Suffering From Fibromyalgia
Researchers of the Labpsictec at the Universitat Jaume I of Castellon (UJI) and the LahHuman Group at the Universidad Politecnica of Valencia (UPV) and the University of Valencia (UVEG) have developed a new therapy based on the use of mobile devices and virtual reality for the psychological treatment of patients suffering from fibromyalgia. This therapy is currently being validated by researchers of the UJI and the University of the Balearic Islands (UIB) with a group of 24 patients and it counts on the essential collaboration of the Rheumatology Department of the Hospital General of Castell??n, supervised by the medical doctor Belmonte.
Fibromyalgia is a complex and chonic pain syndrome which causes generalized pain and deep exhaustion, among other symptoms. It is a serious public health problem, more usual among adult women, and which causes significant negative psychologicla effects. In fact, 35% of affected patients suffer from depressive and anxious syndrome.
"Our aim is to achieve that woman patients learn strategies to face the pain which are an alternative to those they use and which are adaptive in order to improve their physical and mental state and their quality of life", points out Beatriz Rey, researcher of the LabHuman of the UPV.
The method developed by the researchers is made of three applications. The first one is an evaluation system of the chronic pain key factors through mobile devices. It is based on a commercial PDA and a made-to-measure device. The device monitors the degree of psysical activity (accelerometer) and communicates with the PDA via Bluethooth.
The PDA runs an application that offers some questions the patient has to answer three times a week: intensity of pain (on a scale from 0 to 10), intensity of fatigue (on a scale from 0 to 10) and mood (on a scale from 1 to 7; in this case, the application shows a series of emoticons). The answers to each three questions are stored in the PDA. When the user goes to the medical office, the PDA can be synchonized with the computer of the medical and the data can be stored in a server.
It has been designed a new version of the Virtual Reality system EMMA to induce positive emotions on woman patients that works together with this system. "The psychologist supervises the group sessions using a system of unique screen projection", points out Azucena Garc?a-Palacios researcher of the Labpsitec of the UJI.
Those sessions are carefully guided and use contents (texts, sounds, videos, music and images, etc) selected to induce positive emotions. The therapist is present during the session and guides its development. During each session, the system helps the woman patients to consider a feasible objective they must fulfil before taking part on the next one. Woman patients will follow a treatment of three weeks with two sessions a week for making an evaluation of the system.
The therapy also has an application of telepsychology (intelligent therapy) through mobile devices in order patients to continue the treatment out of the doctor's office, such as from home. "The application is run in the PDA and also allows watching videos on the screen. The videos are fragments of the treatment sessions with EMMA, which are used to induce positive emotions along sessions", points Rosa Ba?±os of the UVEG.
Source: Universitat Jaume I
Fibromyalgia is a complex and chonic pain syndrome which causes generalized pain and deep exhaustion, among other symptoms. It is a serious public health problem, more usual among adult women, and which causes significant negative psychologicla effects. In fact, 35% of affected patients suffer from depressive and anxious syndrome.
"Our aim is to achieve that woman patients learn strategies to face the pain which are an alternative to those they use and which are adaptive in order to improve their physical and mental state and their quality of life", points out Beatriz Rey, researcher of the LabHuman of the UPV.
The method developed by the researchers is made of three applications. The first one is an evaluation system of the chronic pain key factors through mobile devices. It is based on a commercial PDA and a made-to-measure device. The device monitors the degree of psysical activity (accelerometer) and communicates with the PDA via Bluethooth.
The PDA runs an application that offers some questions the patient has to answer three times a week: intensity of pain (on a scale from 0 to 10), intensity of fatigue (on a scale from 0 to 10) and mood (on a scale from 1 to 7; in this case, the application shows a series of emoticons). The answers to each three questions are stored in the PDA. When the user goes to the medical office, the PDA can be synchonized with the computer of the medical and the data can be stored in a server.
It has been designed a new version of the Virtual Reality system EMMA to induce positive emotions on woman patients that works together with this system. "The psychologist supervises the group sessions using a system of unique screen projection", points out Azucena Garc?a-Palacios researcher of the Labpsitec of the UJI.
Those sessions are carefully guided and use contents (texts, sounds, videos, music and images, etc) selected to induce positive emotions. The therapist is present during the session and guides its development. During each session, the system helps the woman patients to consider a feasible objective they must fulfil before taking part on the next one. Woman patients will follow a treatment of three weeks with two sessions a week for making an evaluation of the system.
The therapy also has an application of telepsychology (intelligent therapy) through mobile devices in order patients to continue the treatment out of the doctor's office, such as from home. "The application is run in the PDA and also allows watching videos on the screen. The videos are fragments of the treatment sessions with EMMA, which are used to induce positive emotions along sessions", points Rosa Ba?±os of the UVEG.
Source: Universitat Jaume I
четверг, 22 сентября 2011 г.
Results Of Golimumab Clinical Trial For Psoriatic Arthritis Symptoms
Patients with active psoriatic arthritis receiving monthly subcutaneous (SC) injections of golimumab (CNTO 148) experienced significant and sustained improvements in the joint and skin manifestations of the disease, according to findings from the largest Phase 3 biologic study ever completed in subjects with psoriatic arthritis. Findings presented at the American College of Rheumatology (ACR) Annual Scientific Meeting showed that at week 14 of the 405-patient study in subjects with active psoriatic arthritis, 51 percent of patients receiving golimumab 50 mg and 45 percent of patients receiving golimumab 100 mg experienced at least 20 percent improvement in arthritis signs and symptoms (ACR 20) compared with 9 percent of patients receiving placebo (P < 0.001 for both comparisons). Golimumab-treated patients maintained significant improvements in arthritis through week 24 and also showed substantial and sustained improvements in skin and nail psoriatic disease (as measured by a 75 percent reduction in Psoriasis Area and Severity Index [PASI 75] in patients with baseline body surface area with psoriasis of at least three percent, and the Nail Psoriasis Severity Index [NAPSI]).
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy.
"The availability of treatments that target TNF-alpha have dramatically changed rheumatologists' approach to the management of psoriatic arthritis, a potentially disabling inflammatory disease," said Arthur Kavanaugh, MD, Professor of Medicine, University of California, San Diego, School of Medicine, and lead study investigator. "These findings show golimumab to be promising in the treatment of multiple facets of the disease, namely the joints and skin, and support the utility of this anti-TNF-alpha treatment."
Joint and Psoriatic Improvements
Initial improvements as measured by ACR 20 at week 14 persisted through six months. At week 24, 52 percent and 61 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved ACR 20, compared with 12 percent of patients receiving placebo (P < 0.001). Significant improvements were observed in ACR 50 and ACR 70 measures at the same time points. At week 14, 30 percent and 28 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved ACR 50, compared with 2 percent of patients receiving placebo (P < 0.001). At week 24, the results persisted with 32 percent and 38 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieving ACR 50 as compared with four percent of patients receiving placebo (P < 0.001). ACR 70, a more stringent response criterion, was achieved at week 14 by 12 percent of patients receiving golimumab 50 mg and 17 percent receiving golimumab 100 mg, compared with 1 percent of patients receiving placebo (P < 0.001). At week 24, 19 percent of patients receiving golimumab 50 mg and 21 percent of patients receiving golimumab 100 mg achieved ACR 70 as compared with 1 percent of patients receiving placebo (P < 0.001).
Patients receiving both doses of golimumab also experienced improvements in enthesitis and dactylitis, two common disease manifestations causing pain and swelling. Enthesitis, an inflammation of a tendon, ligament or joint capsule insertion to the bone and dactylitis, a swelling of digits in the hands or feet, are estimated to affect more than one-third of people with psoriatic arthritis. At baseline, 78 percent (placebo group), 75 percent (golimumab 50 mg group) and 79 percent (golimumab 100 mg group) of study subjects presented with enthesitis (at least one tender body enthesitis site) as measured by the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) index modified for Psoriatic Arthritis; 34 percent (placebo group), 34 percent (golimumab 50 mg group) and 34 percent (golimumab 100 mg group) of subjects presented with dactylitis at baseline.
Both golimumab doses were significantly better than placebo in improvement of enthesitis as measured by percent change in the psoriatic arthritis modified MASES Index.
At week 14, the mean improvement in enthesitis was 44 percent among patients receiving golimumab 50 mg and 33 percent among patients receiving golimumab 100 mg, compared with a 19 percent worsening in patients receiving placebo (P < 0.001). At week 24, the mean improvements in enthesitis were 46 percent for patients receiving golimumab 50 mg and 52 percent among patients receiving golimumab 100 mg, compared with a 13 percent worsening in placebo patients (P < 0.001). The golimumab 100 mg dose significantly improved dactylitis measured by percent change in dactylitis score compared with placebo at week 14 (66 percent versus 5 percent; P = 0.009) and at week 24 (82 percent versus 28 percent; P < 0.001). There was a trend towards improvement in dactylitis for 50 mg golimumab dose at week 14 and 24 but the comparisons with placebo did not reach statistical significance.
In addition to improvements in joint symptoms, a substantial proportion of golimumab-treated patients experienced significant improvement in skin manifestations of the disease. Among a subset of the study population with at least three percent of body surface area involved by psoriasis at baseline, 40 percent and 58 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved PASI 75 at week 14, compared with 3 percent of patients receiving placebo (P < 0.001). At week 24, PASI 75 responses improved to 56 percent (golimumab 50 mg) and 66 percent (golimumab 100 mg), compared with 1 percent of placebo patients (P < 0.001). In additional analyses, patients receiving golimumab 50 mg and golimumab 100 also experienced improvements in nail psoriasis as measured by NAPSI and these improvements were sustained over time.
"These Phase 3 data show that once monthly subcutaneous administrations of golimumab 50 mg and golimumab 100 mg significantly improved articular and psoriatic manifestations in patients with psoriatic arthritis," said Jerome A. Boscia, MD, senior vice president, Clinical Research and Development, Centocor, Inc. "We are encouraged by these results and believe golimumab holds great promise as a new anti-TNF-alpha therapy for physicians and patients in need of additional therapeutic options."
Disease Activity and Physical Function Improvements
The majority of golimumab-treated patients in the study were classified as good or moderate responders as measured by the Disease Activity Score 28 (DAS28), which measures tender and swollen joints and overall disease activity including measurement of serum C-reactive protein (CRP) levels. After 14 weeks of treatment, 66 percent of patients receiving golimumab 50 mg were DAS28 responders, as were 67 percent of patients receiving the 100 mg dose, compared with 24 percent of patients receiving placebo (P < 0.001). At week 24, 64 percent and 78 percent of patients receiving golimumab 50 mg and 100 mg, respectively, were DAS28 responders, compared with 24 percent of patients receiving placebo (P < 0.001).
Patients receiving golimumab in the study also experienced significant improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ). At week 14, patients receiving golimumab 50 mg experienced a mean improvement of 0.31 and patients receiving golimumab 100 mg experienced a mean improvement of 0.38 in HAQ score, compared with an improvement of only 0.04 among placebo patients (P < 0.001). At week 24, the improvements were 0.33 and 0.39 in the respective treatment groups, compared with worsening in HAQ score of -0.01 among patients receiving placebo (P < 0.001). HAQ assesses the degree of difficulty a patient has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living). An improvement in HAQ of at least 0.3 indicates clinically meaningful improvement in physical function.
About the GO-REVEAL Trial
The Golimumab -- A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial involved 405 adults with psoriatic arthritis. Subjects with at least three swollen and tender joints and active psoriatic skin lesions of at least 2 cm in diameter were randomly assigned to receive SC injections of placebo or golimumab (50 or 100 mg) at weeks 0, 4, 8, 12, 16 and 20. At week 16, patients with inadequate arthritis response were switched to golimumab 50 mg (patients originally receiving placebo) or golimumab 100 mg (patients originally receiving golimumab 50 mg). The primary endpoint was ACR 20 response at week 14 for combined golimumab groups and individual golimumab dose groups versus placebo.
Through week 24, the placebo-controlled portion of the study, golimumab was generally well-tolerated, with two percent of golimumab-treated patients experiencing serious adverse events compared with six percent of patients in the placebo group. Injection site reactions occurred in five percent of patients receiving golimumab and three percent of patients receiving placebo. One case of prostate cancer and two cases of basal cell carcinoma were reported in golimumab-treated patients. There were no reports of tuberculosis or opportunistic infections through week 24.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting with joint pain and swelling that can lead to joint destruction and debilitation. It is frequently associated with inflamed, scaly, red patches of skin psoriasis and psoriasis nail involvement. Symptoms may include stiffness and tenderness of the joints and surrounding tissue and reduced range of motion. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected. Psoriasis affects an estimated two to three percent of the world's population, and approximately one out of three patients affected by psoriasis may develop psoriatic arthritis. Both men and women are equally affected by psoriatic arthritis, most commonly between the ages 30 and 50, in the peak of their productive years.
About Golimumab
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy. Golimumab targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha.
Centocor discovered golimumab and has exclusive marketing rights to the product in the United States. Schering-Plough has exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China where golimumab will be exclusively marketed by Xian-Janssen.
About Centocor
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.
The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary of Johnson & Johnson.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at sec/ or jnj/. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
About Schering-Plough
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is schering-plough/.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the potential of golimumab. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details and a discussion of risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in Schering-Plough's third quarter 2007 10-Q.
Source: Brian Kenney
Centocor, Inc.
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy.
"The availability of treatments that target TNF-alpha have dramatically changed rheumatologists' approach to the management of psoriatic arthritis, a potentially disabling inflammatory disease," said Arthur Kavanaugh, MD, Professor of Medicine, University of California, San Diego, School of Medicine, and lead study investigator. "These findings show golimumab to be promising in the treatment of multiple facets of the disease, namely the joints and skin, and support the utility of this anti-TNF-alpha treatment."
Joint and Psoriatic Improvements
Initial improvements as measured by ACR 20 at week 14 persisted through six months. At week 24, 52 percent and 61 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved ACR 20, compared with 12 percent of patients receiving placebo (P < 0.001). Significant improvements were observed in ACR 50 and ACR 70 measures at the same time points. At week 14, 30 percent and 28 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved ACR 50, compared with 2 percent of patients receiving placebo (P < 0.001). At week 24, the results persisted with 32 percent and 38 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieving ACR 50 as compared with four percent of patients receiving placebo (P < 0.001). ACR 70, a more stringent response criterion, was achieved at week 14 by 12 percent of patients receiving golimumab 50 mg and 17 percent receiving golimumab 100 mg, compared with 1 percent of patients receiving placebo (P < 0.001). At week 24, 19 percent of patients receiving golimumab 50 mg and 21 percent of patients receiving golimumab 100 mg achieved ACR 70 as compared with 1 percent of patients receiving placebo (P < 0.001).
Patients receiving both doses of golimumab also experienced improvements in enthesitis and dactylitis, two common disease manifestations causing pain and swelling. Enthesitis, an inflammation of a tendon, ligament or joint capsule insertion to the bone and dactylitis, a swelling of digits in the hands or feet, are estimated to affect more than one-third of people with psoriatic arthritis. At baseline, 78 percent (placebo group), 75 percent (golimumab 50 mg group) and 79 percent (golimumab 100 mg group) of study subjects presented with enthesitis (at least one tender body enthesitis site) as measured by the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) index modified for Psoriatic Arthritis; 34 percent (placebo group), 34 percent (golimumab 50 mg group) and 34 percent (golimumab 100 mg group) of subjects presented with dactylitis at baseline.
Both golimumab doses were significantly better than placebo in improvement of enthesitis as measured by percent change in the psoriatic arthritis modified MASES Index.
At week 14, the mean improvement in enthesitis was 44 percent among patients receiving golimumab 50 mg and 33 percent among patients receiving golimumab 100 mg, compared with a 19 percent worsening in patients receiving placebo (P < 0.001). At week 24, the mean improvements in enthesitis were 46 percent for patients receiving golimumab 50 mg and 52 percent among patients receiving golimumab 100 mg, compared with a 13 percent worsening in placebo patients (P < 0.001). The golimumab 100 mg dose significantly improved dactylitis measured by percent change in dactylitis score compared with placebo at week 14 (66 percent versus 5 percent; P = 0.009) and at week 24 (82 percent versus 28 percent; P < 0.001). There was a trend towards improvement in dactylitis for 50 mg golimumab dose at week 14 and 24 but the comparisons with placebo did not reach statistical significance.
In addition to improvements in joint symptoms, a substantial proportion of golimumab-treated patients experienced significant improvement in skin manifestations of the disease. Among a subset of the study population with at least three percent of body surface area involved by psoriasis at baseline, 40 percent and 58 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved PASI 75 at week 14, compared with 3 percent of patients receiving placebo (P < 0.001). At week 24, PASI 75 responses improved to 56 percent (golimumab 50 mg) and 66 percent (golimumab 100 mg), compared with 1 percent of placebo patients (P < 0.001). In additional analyses, patients receiving golimumab 50 mg and golimumab 100 also experienced improvements in nail psoriasis as measured by NAPSI and these improvements were sustained over time.
"These Phase 3 data show that once monthly subcutaneous administrations of golimumab 50 mg and golimumab 100 mg significantly improved articular and psoriatic manifestations in patients with psoriatic arthritis," said Jerome A. Boscia, MD, senior vice president, Clinical Research and Development, Centocor, Inc. "We are encouraged by these results and believe golimumab holds great promise as a new anti-TNF-alpha therapy for physicians and patients in need of additional therapeutic options."
Disease Activity and Physical Function Improvements
The majority of golimumab-treated patients in the study were classified as good or moderate responders as measured by the Disease Activity Score 28 (DAS28), which measures tender and swollen joints and overall disease activity including measurement of serum C-reactive protein (CRP) levels. After 14 weeks of treatment, 66 percent of patients receiving golimumab 50 mg were DAS28 responders, as were 67 percent of patients receiving the 100 mg dose, compared with 24 percent of patients receiving placebo (P < 0.001). At week 24, 64 percent and 78 percent of patients receiving golimumab 50 mg and 100 mg, respectively, were DAS28 responders, compared with 24 percent of patients receiving placebo (P < 0.001).
Patients receiving golimumab in the study also experienced significant improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ). At week 14, patients receiving golimumab 50 mg experienced a mean improvement of 0.31 and patients receiving golimumab 100 mg experienced a mean improvement of 0.38 in HAQ score, compared with an improvement of only 0.04 among placebo patients (P < 0.001). At week 24, the improvements were 0.33 and 0.39 in the respective treatment groups, compared with worsening in HAQ score of -0.01 among patients receiving placebo (P < 0.001). HAQ assesses the degree of difficulty a patient has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living). An improvement in HAQ of at least 0.3 indicates clinically meaningful improvement in physical function.
About the GO-REVEAL Trial
The Golimumab -- A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial involved 405 adults with psoriatic arthritis. Subjects with at least three swollen and tender joints and active psoriatic skin lesions of at least 2 cm in diameter were randomly assigned to receive SC injections of placebo or golimumab (50 or 100 mg) at weeks 0, 4, 8, 12, 16 and 20. At week 16, patients with inadequate arthritis response were switched to golimumab 50 mg (patients originally receiving placebo) or golimumab 100 mg (patients originally receiving golimumab 50 mg). The primary endpoint was ACR 20 response at week 14 for combined golimumab groups and individual golimumab dose groups versus placebo.
Through week 24, the placebo-controlled portion of the study, golimumab was generally well-tolerated, with two percent of golimumab-treated patients experiencing serious adverse events compared with six percent of patients in the placebo group. Injection site reactions occurred in five percent of patients receiving golimumab and three percent of patients receiving placebo. One case of prostate cancer and two cases of basal cell carcinoma were reported in golimumab-treated patients. There were no reports of tuberculosis or opportunistic infections through week 24.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting with joint pain and swelling that can lead to joint destruction and debilitation. It is frequently associated with inflamed, scaly, red patches of skin psoriasis and psoriasis nail involvement. Symptoms may include stiffness and tenderness of the joints and surrounding tissue and reduced range of motion. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected. Psoriasis affects an estimated two to three percent of the world's population, and approximately one out of three patients affected by psoriasis may develop psoriatic arthritis. Both men and women are equally affected by psoriatic arthritis, most commonly between the ages 30 and 50, in the peak of their productive years.
About Golimumab
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy. Golimumab targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha.
Centocor discovered golimumab and has exclusive marketing rights to the product in the United States. Schering-Plough has exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China where golimumab will be exclusively marketed by Xian-Janssen.
About Centocor
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.
The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary of Johnson & Johnson.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at sec/ or jnj/. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
About Schering-Plough
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is schering-plough/.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the potential of golimumab. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details and a discussion of risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in Schering-Plough's third quarter 2007 10-Q.
Source: Brian Kenney
Centocor, Inc.
понедельник, 19 сентября 2011 г.
Sixty years young: Arthritis Care Awareness Week 2007
Nine million Britons, including 12,000 children, currently live with
arthritis, the country's biggest single cause of physical disability,
and, as the population ages, that figure can only rise.
In 2025, the number of over-85s is predicted to have mushroomed by
two-thirds, placing the health service under unprecedented strain.
In commemorating its Diamond Jubilee this year, Arthritis Care - the
biggest voluntary organisation dedicated to supporting people with
arthritis - is readying itself for another sixty years in the frontline
of very real challenge.
'There was no NHS when Arthritis Care was founded in 1947. It worked to
help people to understand arthritis, to alleviate the pain, isolation,
and disability it caused, and to support them towards self-management of
what is a long-term and as-yet incurable condition,' said Neil
Betteridge, Arthritis Care's chief executive.
'Today, we have almost come full circle. There is an NHS but there is
still no cure for arthritis. And there is a worrying new sense that
people with arthritis are once again on their own - there is much talk
of healthcare rationing, the postcode lottery, and cutbacks to the
health professions who serve people with arthritis.'
'At the same time, the speed of health service reform means that
Arthritis Care is no less vital to people with arthritis in 2007 than it
was sixty years ago. People still need support, and signposting to
services, and they need more help than ever in getting their voices
heard.'
The message of this year's Arthritis Care Awareness Week is therefore
Much done; much still to do.
'Today we can look back with pride on many achievements, particularly
Arthritis Care's pioneering of self-management training, its
campaigning, its award winning information, and its development of
services for children and young people with arthritis. But we cannot
afford to slacken now - we must keep campaigning for equal access to NHS
care and treatment, keep championing the rights of people with
arthritis, and be vigilant in our efforts to ensure that rheumatology is
not a Cinderella service in future, but one designed to cope with
increasing demands,' said Neil Betteridge.
Arthritis Care was founded in 1947 by Arthur Mainwaring Bowen as the
British Rheumatic Association. Aged 25, and an undergraduate at
Aberystwyth University, 'Waring' as he was known, had developed
inflammation in his foot which spread to his spine. It was ankylosing
spondylitis, a form of arthritis five times more common in men than
women.
His widow Helen says: 'Waring was always very conscious of the isolation
felt by people in his position and this is what led him to form an
association for people with rheumatism. When I look at how many people
have benefited from Arthritis Care, I'm very glad he did.'
People like the many callers to Arthritis Care's free helplines, or this
40 year old man who wrote in:
'I was looking up your web site about arthritis. I was badly bullied as
a child and had my feet stamped on a few times and now after thirty
years I am suffering from osteoarthritis in my big toes. I am in pain
all the time and need a walking stick to help support me as I walk, as
they have the habit of locking up and I can fall down. I am waiting to
see an Orthopaedic Surgeon and god knows when that will be, and I am
getting sick of waiting as the thought of cutting my feet off has
crossed my mind a few times in the last few years. I can't do the things
I love to do like work and hill walking now as I am in too much pain.'
arthritiscare.uk
arthritis, the country's biggest single cause of physical disability,
and, as the population ages, that figure can only rise.
In 2025, the number of over-85s is predicted to have mushroomed by
two-thirds, placing the health service under unprecedented strain.
In commemorating its Diamond Jubilee this year, Arthritis Care - the
biggest voluntary organisation dedicated to supporting people with
arthritis - is readying itself for another sixty years in the frontline
of very real challenge.
'There was no NHS when Arthritis Care was founded in 1947. It worked to
help people to understand arthritis, to alleviate the pain, isolation,
and disability it caused, and to support them towards self-management of
what is a long-term and as-yet incurable condition,' said Neil
Betteridge, Arthritis Care's chief executive.
'Today, we have almost come full circle. There is an NHS but there is
still no cure for arthritis. And there is a worrying new sense that
people with arthritis are once again on their own - there is much talk
of healthcare rationing, the postcode lottery, and cutbacks to the
health professions who serve people with arthritis.'
'At the same time, the speed of health service reform means that
Arthritis Care is no less vital to people with arthritis in 2007 than it
was sixty years ago. People still need support, and signposting to
services, and they need more help than ever in getting their voices
heard.'
The message of this year's Arthritis Care Awareness Week is therefore
Much done; much still to do.
'Today we can look back with pride on many achievements, particularly
Arthritis Care's pioneering of self-management training, its
campaigning, its award winning information, and its development of
services for children and young people with arthritis. But we cannot
afford to slacken now - we must keep campaigning for equal access to NHS
care and treatment, keep championing the rights of people with
arthritis, and be vigilant in our efforts to ensure that rheumatology is
not a Cinderella service in future, but one designed to cope with
increasing demands,' said Neil Betteridge.
Arthritis Care was founded in 1947 by Arthur Mainwaring Bowen as the
British Rheumatic Association. Aged 25, and an undergraduate at
Aberystwyth University, 'Waring' as he was known, had developed
inflammation in his foot which spread to his spine. It was ankylosing
spondylitis, a form of arthritis five times more common in men than
women.
His widow Helen says: 'Waring was always very conscious of the isolation
felt by people in his position and this is what led him to form an
association for people with rheumatism. When I look at how many people
have benefited from Arthritis Care, I'm very glad he did.'
People like the many callers to Arthritis Care's free helplines, or this
40 year old man who wrote in:
'I was looking up your web site about arthritis. I was badly bullied as
a child and had my feet stamped on a few times and now after thirty
years I am suffering from osteoarthritis in my big toes. I am in pain
all the time and need a walking stick to help support me as I walk, as
they have the habit of locking up and I can fall down. I am waiting to
see an Orthopaedic Surgeon and god knows when that will be, and I am
getting sick of waiting as the thought of cutting my feet off has
crossed my mind a few times in the last few years. I can't do the things
I love to do like work and hill walking now as I am in too much pain.'
arthritiscare.uk
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