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

Abstract

Background: To explore the effect of abatacept treatment on patient-reported outcomes (PROs) in psoriatic arthritis (PsA).

Methods: Patients 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.

Results: In 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.

Conclusions: Abatacept treatment improved PROs in patients with PsA versus placebo, with better results in elevated baseline CRP and TNFi-naïve subpopulations.

Trial registration: ClinicalTrials.gov number, NCT01860976 (funded by Bristol-Myers Squibb); date of registration: 23 May 2013.

Keywords: DMARDs (biologic); Outcomes research; Patient perspective; Psoriatic arthritis.

Conflict of interest statement

Ethics approval and consent to participate

The study was conducted in accordance with the Declaration of Helsinki, International Conference on Harmonisation Guidelines for Good Clinical Practice and local regulations. Schulman Associates Institutional Review Board or Independent Ethics Committees approved the protocol, consent form and any other written information provided to patients or their legal representatives.

Consent for publication

Not applicable.

Competing interests

VS reports receiving consulting fees from AbbVie, Amgen Corporation, AstraZeneca, Biogen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Corrona, Crescendo/Myriad Genetics, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi and UCB. EA, TL, AJ, SB and HAA are employees of Bristol-Myers Squibb and report holding stock in Bristol-Myers Squibb. PJM reports receiving consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Janssen, Lilly, Merck, Novartis, Pfizer, Sun, UCB and Zynerba; and speaker fees from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer and UCB.

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Figures

Fig. 1

HAQ-DI (a), FACIT-F (b), DLQI (c) change from baseline (weeks 16 and 24, overall population). *Statistically significant difference. Dotted lines represent MCID (HAQ-DI: ≥ − 0.35; FACIT-F: ≥ − 4.0). CI confidence interval, DLQI Dermatology Life Quality Index, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue scale, HAQ-DI Health Assessment Questionnaire-Disability Index, MCID minimal clinically important difference, NA not applicable, SE standard error

Fig. 2

SF-36 PCS and MCS change from baseline (weeks 16 and 24, overall population). *Statistically significant difference. Dotted line represents MCID (≥ 2.5). CI confidence interval, MCID minimal clinically important difference, MCS mental component summary, PCS physical component summary, SE standard error, SF-36 Short Form-36

Fig. 3

Abatacept/placebo SF-36 domain scores (baseline, weeks 16, 24) versus normative population (a, overall; b, CRP > ULN). Normative values for SF-36 individual domains were defined based on matching the age/gender distribution of this protocol population to US 1999 norms in patients without chronic disease or arthritis [20, 34]: PF and RP 81.9, BP 69.7, GH 70.4, VT 59.3, SF 84.4, RE 87.8, MH 75.6. A/G age/gender, BP bodily pain, CRP C-reactive protein, GH general health, MH mental health, PF physical function, RE role–emotional, RP role–physical, SF social function, SF-36 Short-Form 36, ULN upper limit of normal, VT vitality

Fig. 4

Rates of PRO improvements ≥ MCID (a) or ≥ normative values (b) at week 16 (overall population). *Statistically significant difference. MCID values: HAQ-DI ≥ − 0.35, SF-36 PCS ≥ 2.5, SF-36 MCS ≥ 2.5, FACIT-F ≥ − 4.0 and SF-36 domains ≥5.0. Normative values: HAQ-DI ≥ 0.5, SF-36 PCS ≥ 50, SF-36 MCS ≥ 50 and FACIT-F ≥ 40.1. CI confidence interval, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue scale, HAQ-DI Health Assessment Questionnaire-Disability Index, MCID minimal clinically important difference, MCS mental component summary, PCS physical component summary, PRO patient-reported outcome, SF-36 Short Form-36

Fig. 5

SF-36 domain score changes from baseline for CRP > ULN population: weeks 16 (a) and 24 (b). *Statistically significant difference. BP bodily pain, CI confidence interval, CRP C-reactive protein, GH general health, MH mental health, PF physical function, RE role–emotional, RP role–physical, SE standard error, SF social function, SF-36 Short Form-36, VT vitality