Abstract
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 125 mg weekly/placebo for 24 weeks 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 (> vs ≤ upper limit of normal [ULN]) and prior tumour necrosis factor inhibitor (TNFi) exposure. Proportions of patients reporting improvements ≥ minimal clinically important differences (MCIDs) and ≥ normative 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 and ≥ NV at week 16. At week 16, all PRO improvements were numerically greater (P > 0.05) in patients with baseline CRP > ULN versus CRP ≤ ULN (all significant [95% confidence interval] for abatacept vs placebo); improvements in SF-36 component summaries and FACIT-F were greater in TNFi-naïve 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-naïve subpopulations.Trial registrationClinicalTrials.gov number, NCT01860976 (funded by Bristol-Myers Squibb); date of registration: 23 May 2013.
Highlights
To explore the effect of abatacept treatment on patient-reported outcomes (PROs) in psoriatic arthritis (PsA)
Patient-reported outcomes Health Assessment Questionnaire-Disability Index (HAQ-DI) [4, 7], Short Form-36 (SF-36) physical component summary (PCS), mental component summary (MCS) and individual domain scores [5, 6], Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F) [3] and Dermatology Life Quality Index (DLQI) [2] scores were assessed at weeks 16 and 24 in the overall population and in patient subpopulations by baseline C-reactive protein (CRP) (> or ≤ upper limits of normal (ULN), defined as 3 mg/L) and prior tumour necrosis factor inhibitor (TNFi) use
In TNFi-exposed abatacept-treated patients, improvements exceeded Minimal clinically important difference (MCID) in SF-36 PCS scores (Table 1). These analyses demonstrated that abatacept treatment generally improved PROs in patients with active PsA in the phase 3 Active pSoriaTic aRthritis rAndomizEd triAl (ASTRAEA) trial, in those who were TNFi-naïve and/or with elevated CRP at baseline
Summary
To explore the effect of abatacept treatment on patient-reported outcomes (PROs) in psoriatic arthritis (PsA). Healthrelated quality of life (HRQoL) can vary greatly according to a patient’s specific symptoms; assessing treatment effects using patient-reported outcomes (PROs) is important in PsA [2,3,4,5,6]. In the phase 3 Active pSoriaTic aRthritis rAndomizEd triAl (ASTRAEA, NCT01860976), subcutaneous (SC) abatacept 125 mg weekly significantly increased the proportion of patients achieving ≥ 20% improvement in the American College of Rheumatology criteria (ACR20) compared with placebo at week 24 (primary endpoint: 39.4% vs 22.3%; P < 0.001) and was well tolerated in patients with active PsA [10]. A numerically higher proportion of patients with HAQ-DI responses (reductions from baseline ≥ 0.35) was evident with abatacept versus placebo (P > 0.05). Due to the hierarchical testing procedure employed, it was not possible to attribute significance to endpoints ranked below HAQDI responses in the hierarchical testing [10]
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