Efficacy and Safety of Abatacept, a T-cell Modulator, in a Randomised, Double-blind, Placebo-controlled, Phase III Study in Psoriatic Arthritis

Authors

Philip Mease
Alice Gottlieb, New York Medical CollegeFollow
D van der Heijde
O FitzGerald
A Johnsen
M Nys
S Banerjee
D Gladman

Journal Title

Annals of the Rheumatic Diseases

First Page

1550

Last Page

1558

Document Type

Article

Publication Date

9-1-2017

Department

Dermatology

Abstract

OBJECTIVES: To assess the efficacy and safety of abatacept, a selective T-cell costimulation modulator, in a phase III study in psoriatic arthritis (PsA). METHODS: This study randomised patients (1:1) with active PsA (~60% with prior exposure to a tumour necrosis factor inhibitor) to blinded weekly subcutaneous abatacept 125 mg (n=213) or placebo (n=211) for 24 weeks, followed by open-label subcutaneous abatacept. Patients without >/=20% improvement in joint counts at week 16 were switched to open-label abatacept. The primary end point was the proportion of patients with >/=20% improvement in the American College of Rheumatology (ACR20) criteria at week 24. RESULTS: Abatacept significantly increased ACR20 response versus placebo at week 24 (39.4% vs 22.3%; p/=0.35) at week 24, this was not statistically significant (31.0% vs 23.7%; p=0.097). The benefits of abatacept were seen in ACR20 responses regardless of tumour necrosis factor inhibitor exposure and in other musculoskeletal manifestations, but significance could not be attributed due to ranking below Health Assessment Questionnaire-Disability Index response in hierarchical testing. However, the benefit on psoriasis lesions was modest. Efficacy was maintained or improved up to week 52. Abatacept was well tolerated with no new safety signals. CONCLUSIONS: Abatacept treatment of PsA in this phase III study achieved its primary end point, ACR20 response, showed beneficial trends overall in musculoskeletal manifestations and was well tolerated. There was only a modest impact on psoriasis lesions. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov number, NCT01860976 (funded by Bristol-Myers Squibb).

Recommended Citation

Mease, P., Gottlieb, A., van der Heijde, D., FitzGerald, O., Johnsen, A., Nys, M., Banerjee, S., & Gladman, D. (2017). Efficacy and Safety of Abatacept, a T-cell Modulator, in a Randomised, Double-blind, Placebo-controlled, Phase III Study in Psoriatic Arthritis. Annals of the Rheumatic Diseases, 76 (9), 1550-1558. https://doi.org/10.1136/annrheumdis-2016-210724

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License