Annals of the rheumatic diseases
Abatacept; Adult; Antirheumatic Agents; Arthritis, Psoriatic; Double-Blind Method; Female; Humans; Immunocompromised Host; Male; Middle Aged; Pneumonia, Pneumocystis; Quality of Life; Treatment Outcome
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
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).
Orthopedics & Sports Medicine
Mease, Philip; Gottlieb, Alice B; van der Heijde, Désirée; FitzGerald, Oliver; Johnsen, Alyssa; Nys, Marleen; Banerjee, Subhashis; and Gladman, Dafna D, "Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis." (2017). Articles, Abstracts, and Reports. 1568.