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Orencia (abatacept)
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 name | abatacept |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Selective T cell costimulation modulator |
| Target | CD80, CD86, CD28 |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2005 |
| Annual revenue | 3705 |
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
- Juvenile idiopathic arthritis
- Rheumatoid arthritis
Common side effects
- headache
- upper respiratory tract infection
- nasopharyngitis
- nausea
- upper respiratory tract infection
- bronchitis
- herpes zoster
- pneumonia
- localized infection
- bronchitis
Drug interactions
- TNF antagonists
- Other biologic RA therapy (anakinra), other biologic PsA therapy, JAK inhibitors
- Blood glucose monitoring systems using GDH-PQQ test strips
Key clinical trials
- Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma (PHASE1)
- Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases (PHASE1,PHASE2)
- Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation (PHASE2)
- Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis (PHASE3)
- Treatment Tapering in JIA With Inactive Disease (PHASE3)
- Study of COYA 302 for the Treatment of ALS (PHASE2)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- Treatment of Antibody-Mediated Rejection (ABMR) With CarBel (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |