Abatacept

(Orencia®)

Orencia®

Drug updated on 9/4/2024

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

  • For the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
  • For the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).
  • For the treatment of adult patients with active psoriatic arthritis (PsA).
  • 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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  • Orencia (abatacept) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA); for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA); for the treatment of adult patients with active psoriatic arthritis (PsA); and 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.
  • This summary is based on the review of 26 systematic review(s)/meta-analysis(es). [1-26]
  • Glucocorticoid Withdrawal: After one year, the odds ratios for discontinuing glucocorticoid use were 2.19 for TNF-inhibitors, 2.46 for tocilizumab, and 1.73 for abatacept. Compared to TNF-inhibitors, adjusted hazard ratios were 1.1 for abatacept and 1.30 for tocilizumab.
  • Remission Rates After Tapering: Remission rates varied from 14-28% when targeted monotherapy was stopped, with higher remission rates up to 72% observed in dose reduction studies. Early RA trials showed remission rates of 27-72%, while established RA trials showed 14-20%.
  • RA-Associated Interstitial Lung Disease (ILD): No significant changes in FVC, FEV1, and DLCO were observed with ncs-DMARD treatment, except in the rituximab subgroup, which showed significant FVC improvement.
  • Efficacy in Rheumatoid Arthritis: Abatacept demonstrated higher ACR 20/50/70/90 response rates compared to placebo, conventional synthetic DMARDs, and other biologic DMARDs.
  • Adverse Events: Abatacept-treated patients had fewer adverse events compared to other b/tsDMARDs; no significant differences in adverse events between bDMARDs, including abatacept, were noted.
  • Serious Adverse Events: Abatacept demonstrated lower relative rates of serious adverse events in JIA compared to other biologics, and fewer serious adverse events in trials compared to TNFi and JAK inhibitors.
  • Infections: Abatacept was associated with lower infection rates compared to other biologics.
  • Population Types and Subgroup Considerations: Specific population types and subgroups include patients with RA (including those with RA-associated ILD, endothelial dysfunction, or subclinical atherosclerosis), JIA (both systemic and non-systemic), PsA, and lupus nephritis. Relevant findings highlight higher remission rates in early RA compared to established RA after treatment tapering, significant FVC improvement in RA-associated ILD with rituximab, greater net benefit of abatacept in systemic JIA, and a lower risk of cardiovascular events with abatacept in RA patients compared to TNFi.

Product Monograph / Prescribing Information

Document TitleYearSource
Orencia (abatacept) Prescribing Information.2023Bristol-Myers Squibb Company, Princeton, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Oral glucocorticoid use in patients with rheumatoid arthritis initiating TNF-inhibitors, tocilizumab or abatacept: Results from the international TOCERRA and PANABA observational collaborative studies.2024Joint Bone Spine
The Gap in Knowledge about Tapering Targeted Therapy being used as Monotherapy in Rheumatoid Arthritis: A Systematic Review.2024Current Rheumatology Reviews
Efficacy of non-conventional synthetic DMARDs for patients with rheumatoid arthritis-associated interstitial lung disease: A systematic review and meta-analysis.2023RMD Open
Analysis of efficacy and safety of abatacept for rheumatoid arthritis: Systematic review and meta-analysis.2023Clinical and Experimental Rheumatology
Changes of anti-citrullinated peptide antibodies titers after biologic treatment in patients with rheumatoid arthritis: A systematic literature review and retrospective study.2023Clinical and Experimental Rheumatology
Prevention of rheumatoid arthritis: A systematic literature review of preventive strategies in at-risk individuals.2023Autoimmunity Reviews
Biologic disease-modifying antirheumatic drugs for preventing radiographic progression in psoriatic arthritis: A systematic review and network meta-analysis.2023Pharmaceutics
Efficacy and safety of novel biologics in the treatment of lupus nephritis based on registered clinical trials: A systematic review and network meta-analysis.2023Clinical and Experimental Medicine
Safety of biological therapy in patients with rheumatoid arthritis in administrative health databases: A systematic review and meta-analysis.2022Frontiers in Pharmacology
Targeted systemic therapies for psoriatic arthritis: A systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes.2022RMD Open
Impact of using concomitant conventional DMARDs on adherence to biologic DMARD treatment in rheumatoid arthritis: Multi-centre, population-based cohort study.2021Seminars in Arthritis and Rheumatism
Model-based meta-analysis compares DAS28 rheumatoid arthritis treatment effects and suggests an expedited trial design for early clinical development.2021Clinical Pharmacology and Therapeutics
Most appropriate conventional disease-modifying antirheumatic drug to combine with different advanced therapies in rheumatoid arthritis: A systematic literature review with meta-analysis.2021Arthritis Care & Research
Reduction of biologics in rheumatoid arthritis: A systematic review and meta-analysis.2021Rheumatology International
The benefit-risk balance for biological agents in juvenile idiopathic arthritis: A meta-analysis of randomized clinical trials.2020Rheumatology
Comparative efficacy and safety of current therapies for early rheumatoid arthritis: A systematic literature review and network meta-analysis.2020Clinical and Experimental Rheumatology
Pharmacological treatment of psoriatic arthritis: A systematic literature research for the 2019 update of the EULAR recommendations for the management of psoriatic arthritis.2020Annals of Rheumatic Diseases
Safety of synthetic and biological DMARDs: A systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis.2020Annals of Rheumatic Diseases
Efficacy of pharmacological treatment in rheumatoid arthritis: A systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis.2020Annals of Rheumatic Diseases
Prognostic factors of good response to DMARDs in psoriatic arthritis: A narrative review.2020Expert Review of Clinical Pharmacology
Biological DMARD efficacy in psoriatic arthritis: A systematic literature review and meta-analysis on articular, enthesitis, dactylitis, skin and functional outcomes.2020Clinical and Experimental Rheumatology
Presence of anti-cyclic citrullinated peptide antibodies is associated with better treatment response to abatacept but not to TNF inhibitors in patients with rheumatoid arthritis: A meta-analysis.2020Clinical and Experimental Rheumatology
Efficacy and safety of biologics in psoriatic arthritis: A systematic literature review and network meta-analysis.2020BMJ
The effect of non-TNF-targeted biologics on vascular dysfunction in rheumatoid arthritis: A systematic literature review.2019Autoimmunity Reviews
Comparison of adverse events of biologicals for treatment of juvenile idiopathic arthritis: A systematic review.2019Expert Opinion on Drug Safety
Comparative efficacy and safety of targeted DMARDs for active psoriatic arthritis during induction therapy: A systematic review and network meta-analysis.2019Seminars in Arthritis and Rheumatism

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