Abatacept

(Orencia®)

Orencia®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 250 mg Injection (subcutaneous; 50 mg/0.4 mL, 87.5 mg/0.7 mL, 125 mg/mL)
Drug ClassSelective T cell costimulation modulators
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA)
  • Indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA)
  • Indicated for the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA)
  • Indicated for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched
  • or 1 allele-mismatched unrelated donor.

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Summary
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  • This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
  • Abatacept effectively delays the onset of full-blown rheumatoid arthritis (RA) in at-risk individuals and shows efficacy in reducing disease-related physical limitations; it achieves radiographic non-progression in psoriatic arthritis (PsA) patients, though it is less effective than tumor necrosis factor (TNF) and IL inhibitors for this outcome.
  • Compared to TNF inhibitors, abatacept’s efficacy in RA and PsA is not affected by BMI, whereas TNF inhibitors’ effectiveness is BMI-dependent; interleukin (IL) inhibitors inhibitors, unaffected by body mass index (BMI), also outperform abatacept in preventing radiographic progression in PsA.
  • Abatacept demonstrates comparable DeltaDAS28 efficacy to adalimumab, certolizumab, etanercept, rituximab, and tofacitinib, showing over a 70% probability of statistical significance against control by Week 6.
  • Abatacept demonstrated an acceptable safety profile in PsA and RA patients, with limited significant safety differences compared to other biologic disease-modifying anti-rheumatic drugs (bDMARDs).
  • Specific safety data for abatacept in Pediatric Rheumatic Diseases (PiRD) is limited in the reviewed studies.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Orencia (abatacept) Prescribing Information.2024Bristol-Myers Squibb, Princeton, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines