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Orencia (Abatacept) - 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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Media Articles Related to Orencia (Abatacept)

New Knees in Rheumatoid Arthritis: Cure or Time Machine? (CME/CE)
Source: MedPage Today Rheumatology [2015.07.22]
(MedPage Today) -- Total knee arthroplasty may help RA patients return to a less disabled lifestyle.

How effective is total knee replacement in patients with rheumatoid arthritis?
Source: Arthritis / Rheumatology News From Medical News Today [2015.07.21]
Studies that have assessed the effects of total knee replacement on quality of life are scarce and have been almost exclusively limited to patients with osteoarthritis, even though rheumatoid...

Drug for Rheumatoid Arthritis May Also Help Ease Vitiligo
Source: MedicineNet Arthritis Specialty [2015.06.25]
Title: Drug for Rheumatoid Arthritis May Also Help Ease Vitiligo
Category: Health News
Created: 6/24/2015 12:00:00 AM
Last Editorial Review: 6/25/2015 12:00:00 AM

Rheumatoid Arthritis Early Symptoms and Signs
Source: MedicineNet Juvenile Arthritis Specialty [2015.06.17]
Title: Rheumatoid Arthritis Early Symptoms and Signs
Category: Diseases and Conditions
Created: 6/24/2013 12:00:00 AM
Last Editorial Review: 6/17/2015 12:00:00 AM

Positive results from Phase 3 study evaluating Cimzia in DMARD-naïve rheumatoid arthritis patients
Source: Arthritis / Rheumatology News From Medical News Today [2015.06.16]
UCB has announced data that may in the future offer alternative care options for rheumatoid arthritis (RA) patients who have not been treated with disease-modifying anti-rheumatic drugs...

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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). [2012]
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.

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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 term.

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

Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination With Methotrexate in Adults With Very Early Rheumatoid Arthritis (RA) [Recruiting]
The primary purpose of the protocol is to show that Abatacept can induce remission after 12 months of treatment and then maintained remission following 6 months of drug withdrawal.

Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis [Recruiting]
Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause swelling of the arteries in the head, neck, upper body, and arms. TAK specifically affects the aorta, the largest blood vessel in the body, and its branches. Therapies are available to improve the symptoms of GCA and TAK, but relapse often occurs, and better treatments are needed. Abatacept is a drug that interacts with certain cells in the body that are involved with GCA and TAK. This study will evaluate the effectiveness of abatacept in treating GCA and TAK and preventing disease relapse.

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.

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Reports of Suspected Orencia (Abatacept) Side Effects

Drug Ineffective (115)Headache (87)Fatigue (83)Nausea (62)Pneumonia (59)Dyspnoea (50)Circumstance or Information Capable of Leading TO Medication Error (49)Diarrhoea (49)Incorrect Storage of Drug (47)Interstitial Lung Disease (45)more >>

Page last updated: 2015-07-22

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