ORENCIA SUMMARY
ORENCIA® (abatacept) is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA is supplied as a sterile, white, preservative-free, lyophilized powder for parenteral administration. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the solution of ORENCIA is clear, colorless to pale yellow, with a pH range of 7.0 to 8.0. Each single-use vial of ORENCIA provides 250 mg abatacept, 500 mg maltose, 17.2 mg monobasic sodium phosphate, and 14.6 mg sodium chloride for administration.
ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists.
ORENCIA should not be administered concomitantly with TNF antagonists. ORENCIA is not recommended for use concomitantly with anakinra.
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NEWS HIGHLIGHTSMedia Articles Related to Orencia (Abatacept)
ACR: Abatacept Efficacy in RA Lasts for Two Years (CME/CE)
Source: MedPage Today Rheumatology [2009.10.23]
PHILADELPHIA (MedPage Today) -- Abatacept (Orencia) is effective against clinical symptoms and joint erosion in early rheumatoid arthritis for at least two years, researchers said here.
Judgement In Favour Of NICE On Judicial Review Of Abatacept For Rheumatoid Arthritis Guidance
Source: Arthritis / Rheumatology News From Medical News Today [2009.11.10]
The High Court has ruled in favour of NICE by dismissing the application from Bristol Myers Squibb (BMS), the manufacturer of abatacept, for a judicial review of the NICE guidance on the use of abatacept for the treatment of rheumatoid arthritis. In April 2008, NICE published final guidance which did not recommend abatacept as a treatment option for people with rheumatoid arthritis.
Adeona Announces Publication Of Results Of 160 Patient Phase 2 Clinical Trial Of Oral DnaJP1 For Rheumatoid Arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2009.11.15]
Adeona Pharmaceuticals, Inc. (AMEX: AEN) announced the publication in the journal Arthritis & Rheumatism of results of a 160-patient, six-month, double-blind, placebo-controlled Phase 2 clinical trial using the company's oral dnaJP1 for the treatment of rheumatoid arthritis (RA). The results of the study were originally presented at the 2008 American College of Rheumatology Annual Meeting. The study was sponsored by the National Institutes of Health (NIH).
How Rheumatoid Arthritis Spreads
Source: MedicineNet Rheumatoid Arthritis Specialty [2009.11.10]
Title: How Rheumatoid Arthritis Spreads
Category: Health News
Created: 11/10/2009 9:50:00 AM
Last Editorial Review: 11/10/2009 9:50:12 AM
Rheumatoid Arthritis Treatment Doesn't Promote Cancer (HealthDay)
Source: Y! Health Arthritis News [2009.10.29]
HealthDay - THURSDAY, Oct. 29 (HealthDay News) -- Treatment with tumor
necrosis factor (TNF) blockers doesn't increase rheumatoid arthritis
patients' risk of cancer, new research has found.
Published Studies Related to Orencia (Abatacept)
Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended phase IIB study. [2009.04]
OBJECTIVE: To evaluate the safety and efficacy of abatacept plus methotrexate (MTX) over 5 years in patients with rheumatoid arthritis... CONCLUSION: Abatacept maintained the efficacy observed at Year 1 over 5 years of treatment, and demonstrated consistent safety and tolerability. These data, along with relatively high retention rates, support the longterm clinical benefit provided by selective T cell costimulation modulation. Clinical trial registry: ClinicalTrials.gov; clinical trial registration number: NCT00254293.
Abatacept: a T-cell co-stimulation modulator for the treatment of rheumatoid arthritis. [2008.11]
Rheumatoid arthritis (RA) is a debilitating autoimmune disease that has traditionally been treated with disease-modifying anti-rheumatic drugs (DMARDs). In the European Union (EU), patients who fail to respond to traditional DMARDs may receive tumor necrosis factor-alpha (TNF-alpha) antagonists... Taken together, these data suggest that selective co-stimulation modulation with abatacept may be a viable option for patients who are refractory to both traditional therapies and TNF-alpha antagonists.
Abatacept: a T-cell co-stimulation modulator for the treatment of rheumatoid arthritis. [2008.08.01]
Rheumatoid arthritis (RA) is a debilitating autoimmune disease that has traditionally been treated with disease-modifying anti-rheumatic drugs (DMARDs). In the European Union (EU), patients who fail to respond to traditional DMARDs may receive tumor necrosis factor-alpha (TNF-alpha) antagonists... Taken together, these data suggest that selective co-stimulation modulation with abatacept may be a viable option for patients who are refractory to both traditional therapies and TNF-alpha antagonists.
Abatacept inhibits progression of structural damage in rheumatoid arthritis: results from the long-term extension of the AIM trial. [2008.08]
OBJECTIVE: Assess the effect of abatacept on progression of structural damage over 2 years in patients with rheumatoid arthritis who had an inadequate response to methotrexate... CONCLUSIONS: Abatacept has a sustained effect that inhibits progression of structural damage. Furthermore, the mean change in radiographic progression in patients treated with abatacept for 2 years was significantly lower in year 2 versus year 1, suggesting that abatacept may have an increasing disease-modifying effect on structural damage over time.
Treatment impact on estimated medical expenditure and job loss likelihood in rheumatoid arthritis: re-examining quality of life outcomes from a randomized placebo-controlled clinical trial with abatacept. [2008.07]
OBJECTIVES: Quality of life (QoL) improvement is important to demonstrate in RA clinical trials, but can be abstract. More meaningful measures of QoL include medical expenditure and job loss, aspects that have marked importance for RA patients, physicians and society. We re-examined previous positive QoL findings for abatacept over placebo by converting existing QoL measures into estimated medical expenditure and estimated likelihood of job loss... CONCLUSIONS: QoL changes provided greater reduction in medical expenditure and likelihood of an inability to work. The strong effect sizes obtained for all significant analyses suggest that the results are clinically meaningful. Moreover, given the nature of the variables, results should also be meaningful for patients, physicians, employers and health care insurance entities. Limitations are discussed regarding using estimated outcomes rather than analysis of actual outcomes.
Clinical Trials Related to Orencia (Abatacept)
Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers [Completed]
Study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is being developed for the treatment of Rheumatoid Arthritis and which can affect the immune system.
A Study of Abatacept in Patients With Active Ulcerative Colitis [Recruiting]
The purpose of this clinical research study is to learn if abatacept can improve signs and
symptoms of active ulcerative colitis in patients who have not had an adequate response to
other therapies. The safety of this treatment will also be studied
Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy [Active, not recruiting]
The purpose of this study is to learn if Abatacept will provide clinical efficacy to subjects who have failed an anti-TNF therapy. The safety of this treatment will also be studied.
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis [Recruiting]
The purpose of this clinical research study is to learn if abatacept treatment of patients
with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and steroids as
part of this study will control the nephritis despite a protocol-defined steroid taper; the
endpoint is a "complete renal response", a composite including normalization of renal
function (or stable normal function if function was normal at study entry) plus
disappearance of protein and cells/casts from the urinary sediment. The safety of this
treatment will also be studied
Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After SC Administration to Subjects With RA [Active, not recruiting]
The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.
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