Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial

BackgroundTo explore the effect of abatacept treatment on patient-reported outcomes (PROs) in psoriatic arthritis (PsA).MethodsPatients with PsA were randomised (1:1) to subcutaneous abatacept 125mg weekly/placebo for 24weeks with early escape (EE) to open-label abatacept (week 16). Adjusted mean changes from baseline to weeks 16 (all patients) and 24 (non-EE responders) in Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 (SF-36; physical and mental component summary and domains), Dermatology Life Quality Index and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were evaluated. Subpopulations were analysed by baseline C-reactive protein (CRP) level (> vsupper limit of normal [ULN]) and prior tumour necrosis factor inhibitor (TNFi) exposure. Proportions of patients reporting improvements minimal clinically important differences (MCIDs) andnormative values (NVs) in HAQ-DI, SF-36 and FACIT-F (week 16 before EE) were analysed.ResultsIn total population, numerically higher improvements in most PROs were reported with abatacept (n=213) versus placebo (n=211) at both time points (P>0.05). Higher proportions of abatacept versus placebo patients reported PRO improvements MCID andNV at week 16. At week 16, all PRO improvements were numerically greater (P>0.05) in patients with baseline CRP>ULN versus CRPULN (all significant [95% confidence interval] for abatacept vs placebo); improvements in SF-36 component summaries and FACIT-F were greater in TNFi-naive versus TNFi-exposed patients (abatacept > placebo). Week 24 subgroup data were difficult to interpret due to low patient numbers.ConclusionsAbatacept treatment improved PROs in patients with PsA versus placebo, with better results in elevated baseline CRP and TNFi-naive subpopulations.Trial registrationClinicalTrials.gov number, NCT01860976 (funded by Bristol-Myers Squibb); date of registration: 23 May 2013.