Abatacept (marketed as Orencia) is a fusion protein composed of an immunoglobulin fused to the extracellular domain of CTLA-4, a molecule capable of binding B7. Abatacept is a selective costimulation modulator as it inhibits the costimulation of T cells. It was developed by Bristol-Myers-Squibb and is licensed in the United States for the treatment of rheumatoid arthritis in the case of inadequate response to anti-TNFa therapy.
A drug approved for the treatment of rheumatoid arthritis may also turn out to be the first targeted therapy for one of the most common forms of kidney disease, a condition that almost inevitably leads to kidney failure.
In the U.S., there are nearly 300,000 children with juvenile arthritis and other rheumatic illnesses according to estimates from the American College of Rheumatology (ACR). For pediatric patients with systemic juvenile idiopathic arthritis (JIA), effective treatment for this disabling disease is imperative.
Vanderbilt's Eskind Diabetes Clinic has been selected to examine the ability of the drug abatacept to prevent type 1 diabetes (T1D). As part of the TrialNet consortium, Vanderbilt will be one of 14 North American sites observing the effects of the drug in people at high risk to develop T1D.
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined 9 biotechnologically produced drugs for the treatment of adults with rheumatoid arthritis in whom prior pharmacological treatment had failed.
The European League Against Rheumatism has released updated recommendations for the management of RA. According to this latest guidance, treatment with disease-modifying anti-rheumatic drugs should be initiated as soon as a diagnosis of RA is made, with the aim of reaching a target of remission or low disease activity in every patient.
Data from AMPLE presented at EULAR 2013, the Annual Congress of the European League Against Rheumatism, demonstrate comparable efficacy and similar safety profiles between subcutaneous abatacept (ABA) and adalimumab (ADA).
The University of Cincinnati will lead a $5.2 million national trial studying removal of both corticosteroids and common immunosuppression treatments from the post-transplant drug regimen for kidney transplant patients.
Rheumatoid arthritis patients treated with biologic response modifiers for at least 6 months do not have a greater risk for malignancy than those given other disease-modifying drugs or placebo, conclude US and Spanish researchers.
Data from one of the few head-to-head trials in rheumatoid arthritis (RA) presented today at EULAR 2012, the Annual Congress of the European League Against Rheumatism, demonstrates that at one year, 64.8% of patients receiving abatacept (Orencia) and 63.4% of patients receiving adalimumab (Humira) achieved ACR20.
Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the company's biologics manufacturing facility in Devens, Massachusetts for commercial production of ORENCIA.
A trend toward more aggressive treatment in patients just starting to develop rheumatoid arthritis is among the most important changes in treatment guidelines for the disease, according to updated American College of Rheumatology recommendations published today in the journal Arthritis Care & Research. The trend may proceed from emerging opinions that joint damage caused by RA is irreversible, and that early, intensive therapy better preserves physical function, quality of life and capacity to work.
A new study shows that kids with juvenile idiopathic arthritis develop cancer four times more often than children without the disease, but the treatments they receive - including biologic treatments like Enbrel - may not explain their increased risk. If confirmed, researchers say the findings should ease fears that biologic treatments known as TNF inhibitors cause cancer in children and young adults.
Bristol-Myers Squibb Company and Ono Pharmaceutical Co., Ltd., today announced an agreement to expand Bristol-Myers Squibb's territorial rights to develop and commercialize the anti-PD-1 antibody known as BMS-936558/ONO-4538, and to create a strategic alliance for the co-development and co-commercialization of ORENCIA in Japan.
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a subcutaneous formulation of ORENCIA (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis.
The American College of Rheumatology has developed new guidelines for starting and monitoring treatments for children with juvenile idiopathic arthritis. These are the first JIA guidelines endorsed by the ACR, with the goal of broad acceptance within the rheumatology community.
In a previous study, rheumatoid arthritis (RA) patients who failed to respond to methotrexate were shown to experience positive results with fostamatinib disodium (R788), an oral spleen tyrosine kinase (Syk) inhibitor that is thought to block immune cell signaling involved with bone and cartilage destruction. In the current study, RA patients who failed to respond to biologic agents were studied.
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the subcutaneous formulation of ORENCIA® (abatacept), a treatment for adult patients with moderate to severe rheumatoid arthritis (RA) administered through an injection into the skin. Bristol-Myers Squibb submitted the sBLA to the FDA for the subcutaneous formulation of ORENCIA and received confirmation of its receipt on October 4, 2010.
Results from a 12-month multi-center clinical trial did not show therapeutic benefit of abatacept over placebo in patients with non-life threatening systemic lupus erythematosus (SLE). Abatacept failed to prevent new disease flares in SLE patients tapered from corticosteroids in an analysis where mild, moderate and severe disease flares were evaluated together. Full details of the phase IIb clinical trial are published in the October issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology (ACR).
Bristol-Myers Squibb Company has today announced that on 1 July 2010 the European Commission approved a new indication for ORENCIA® (abatacept), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a TNF-alpha inhibitor.
BioTrends is pleased to announce the fielding of a new syndicated report, LaunchTrends®: ACTEMRA. Roche, Inc. announced that they received FDA approval for Actemra (generic name: tocilizumab) on January 8th. This represents the first IL-6 receptor inhibitor agent approved for Rheumatoid Arthritis (RA); Actemra is approved for adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF antagonist therapies. Actemra represents the fourth IV Infusion product in the RA Market and the first infusion product with monthly maintenance dosing.