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.
Media Articles Related to Orencia (Abatacept)
Abatacept, Adalimumab Equal Head-to-Head for RA at 2 Years
Source: Medscape Medical News Headlines [2013.06.14]
The first head-to-head comparison of 2 biologics showed comparable efficacy for the 2 commonly used drugs.
Medscape Medical News
In Rheumatoid Arthritis, Abatacept As Effective As Adalimumab, With Fewer Injection Site Reactions
Source: Health News from Medical News Today [2013.06.14]
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). AMPLE, the first two-year head-to-head biologics trial, was comprised of 646 biologic-naÃƒÂ¯ve patients with active rheumatoid arthritis (RA) equally randomised to either ABA or ADA, with a stable dose of methotrexate (MTX). 79.2% (252 of 318) ABA patients and 74.7% (245 of 328) ADA patients completed the trial...
Drug Discontinuations Rampant in Rheumatoid Arthritis
Source: Medscape Medical News Headlines [2013.06.15]
In the modern era of biologics, up to one third of patients with rheumatoid arthritis still discontinue therapy within a year, most often because of lack of efficacy.
Medscape Medical News
The Impact Of Rheumatoid Arthritis On Joint Replacement Surgery Outcomes
Source: Health News from Medical News Today [2013.06.15]
Two new studies by researchers at Hospital for Special Surgery have shed light on joint replacement outcomes in patients with rheumatoid arthritis (RA). One study overturns the common belief that RA patients have worse outcomes after a total knee replacement (TKR) than patients who undergo the operation for osteoarthritis. The other study demonstrates that RA patients who undergo a total hip replacement were as likely to have significant improvements in function and pain as patients with osteoarthritis (OA), even though they did not do as well...
Roche's RoActemra® (Tocilizumab) Shows Long-Term Efficacy In Monotherapy And Also Benefits In Early Rheumatoid Arthritis
Source: Health News from Medical News Today [2013.06.14]
Roche (SIX: RO, ROG; OTCQX: RHHBY) have announced data from two phase III studies using RoActemra in patients with rheumatoid arthritis (RA): the long-term extension (LTE) follow up of the AMBITION study demonstrated long-term efficacy of RoActemra without methotrexate (MTX); and the FUNCTION study showed the clinical benefits of the medicine, alone or in combination with MTX, when used to treat patients with early RA.1,2 These studies are being presented at the 2013 European League Against Rheumatism (EULAR) Congress...
Published Studies Related to Orencia (Abatacept)
Evaluation of abatacept administered subcutaneously in adults with active
rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity,
efficacy and safety (phase Iiib ALLOW study). 
rheumatoid arthritis despite methotrexate in a phase III trial... CONCLUSIONS: Overall immunogenicity to SC abatacept is low, consistent with
Model-based determination of abatacept exposure in support of the recommended dose for Japanese rheumatoid arthritis patients. [2011.12]
The objective of this study was to provide support for a body weight-tiered dosing regimen by characterizing abatacept pharmacokinetics (PK) and the relationship between exposure and the ACR20 (American College of Rheumatology criteria for 20% improvement) response in Japanese patients with rheumatoid arthritis (RA)...
Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial. [2011.10]
OBJECTIVE: To evaluate abatacept treatment over 3 years in patients with rheumatoid arthritis (RA) refractory to methotrexate (MTX)... CONCLUSION: In MTX-inadequate responders with RA, abatacept provided consistent safety and sustained efficacy over 3 years. The data suggest an increasing inhibitory disease-modifying effect on radiographic progression.
Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. [2011.10]
OBJECTIVE: To compare the efficacy and safety of subcutaneous (SC) and intravenous (IV) abatacept... CONCLUSION: SC abatacept provides efficacy and safety comparable with that of IV abatacept, with low immunogenicity and high retention rates, consistent with the established IV abatacept profile. Rates of injection site reactions were low. SC abatacept will provide additional treatment options, such as an alternative route of administration, for patients with RA. Copyright (c) 2011 by the American College of Rheumatology.
Co-stimulation modulation with abatacept in patients with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled trial. [2011.07.30]
BACKGROUND: The immunopathogenesis of type 1 diabetes mellitus is associated with T-cell autoimmunity. To be fully active, immune T cells need a co-stimulatory signal in addition to the main antigen-driven signal. Abatacept modulates co-stimulation and prevents full T-cell activation. We evaluated the effect of abatacept in recent-onset type 1 diabetes... INTERPRETATION: Co-stimulation modulation with abatacept slowed reduction in beta-cell function over 2 years. The beneficial effect suggests that T-cell activation still occurs around the time of clinical diagnosis of type 1 diabetes. Yet, despite continued administration of abatacept over 24 months, the decrease in beta-cell function with abatacept was parallel to that with placebo after 6 months of treatment, causing us to speculate that T-cell activation lessens with time. Further observation will establish whether the beneficial effect continues after cessation of abatacept infusions. FUNDING: US National Institutes of Health. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Clinical Trials Related to Orencia (Abatacept)
Efficacy, Pharmacokinetics, Safety and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japan [Recruiting]
The purpose of this study is to assess the efficacy of abatacept after subcutaneous
administration and intravenous administration in Japanese active rheumatoid arthritis (RA)
subjects with inadequate response to methotrexate (MTX), and on background MTX in the short
Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, MA Facility of Bristol-Myers Squibb [Not yet recruiting]
The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667)
drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers
Squibb are comparable in healthy subjects
Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis [Not yet recruiting]
This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related
genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis [Not yet recruiting]
The purpose of this study is to evaluate Orencia (abatacept) for treatment of lupus
nephritis when used on a background of Cellcept (mycophenolate) and prednisone
Abatacept in the Treatment of Uveitis [Recruiting]
Reports of Suspected Orencia (Abatacept) Side Effects
Drug Ineffective (115),
Circumstance or Information Capable of Leading TO Medication Error (49),
Incorrect Storage of Drug (47),
Interstitial Lung Disease (45), more >>
Page last updated: 2013-06-15