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Orencia (abatacept)

Bristol-Myers Squibb · FDA-approved approved Verified Quality 81/100

Abatacept inhibits T-cell activation by binding CD80/CD86, blocking CD28 costimulatory interaction.

Abatacept (ORENCIA) is a selective T-cell costimulation modulator indicated for moderately to severely active rheumatoid arthritis in adults and polyarticular juvenile idiopathic arthritis and psoriatic arthritis in patients 2 years and older, as well as acute graft-versus-host disease prophylaxis in HSCT recipients. The drug exhibits linear pharmacokinetics with a half-life of 13-17 days intravenously and 14.3 days subcutaneously, reaching steady state by day 60 with intravenous dosing. Key safety concerns include increased risk of serious infections when combined with TNF antagonists or other biologic immunosuppressants, and interference with certain blood glucose monitoring systems during intravenous administration. ORENCIA represents an important therapeutic option for T-cell mediated inflammatory conditions with a well-characterized safety and efficacy profile when used as monotherapy.

At a glance

Generic nameabatacept
SponsorBristol-Myers Squibb
Drug classSelective T cell costimulation modulator
TargetCD80, CD86, CD28
Therapeutic areaImmunology
PhaseFDA-approved
First approval2005
Annual revenue3705

Mechanism of action

Abatacept is a selective costimulation modulator that inhibits T-cell activation by binding to CD80 and CD86 on antigen-presenting cells, thereby blocking their interaction with CD28 on T lymphocytes. This interaction normally provides a costimulatory signal necessary for full activation of T lymphocytes. Activated T lymphocytes are implicated in the pathogenesis of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriatic arthritis, and are found in the synovium of patients with these conditions. In vitro studies demonstrate that abatacept decreases T-cell proliferation and inhibits production of key cytokines including TNF-alpha, interferon-gamma, and interleukin-2. In animal models of arthritis, abatacept suppresses inflammation, decreases anti-collagen antibody production, and reduces antigen-specific interferon-gamma production. However, the relationship between these biological response markers and the clinical mechanisms by which ORENCIA exerts its therapeutic effects remains unknown.

Approved indications

Common side effects

Drug interactions

Key clinical trials

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
SEC EDGARRevenue + earnings