Background Psoriatic arthritis (PsA) has a significant negative impact on patients' (pts) health-related quality of life (HRQoL). Secukinumab improved the signs and symptoms of active PsA in the randomized, double-blind, placebo (PBO)-controlled phase 3 FUTURE 2 study (NCT01752634).1
Objectives To investigate the effect of secukinumab through Week (Wk) 24 on patient-reported outcomes (PROs) in the FUTURE 2 study.
Methods 397 adults with active PsA were randomized to subcutaneous (s.c.) secukinumab (300, 150 or 75 mg) or placebo (PBO) at baseline, Wks 1, 2, 3 and 4, and every 4 wks thereafter. At Wk 16, PBO non-responders were switched to secukinumab 300 or 150 mg (1:1). From Wk 24, all pts initially randomized to PBO received secukinumab 300 or 150 mg (1:1). PROs were assessed using the following instruments: Short Form-36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS); Health Assessment Questionnaire-Disability Index (HAQ-DI); Psoriatic Arthritis Quality of Life (PsAQoL); Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) and Work Productivity and Activity Impairment Questionnaire (WPAI-GH). SF-36 PCS and HAQ-DI were secondary study endpoints that were included in a hierarchical testing analysis to adjust for multiplicity at Wk 24. The other PROs were exploratory endpoints. Statistical analyses used a mixed-effect model repeated measures method.
Results At baseline, dose groups were comparable with respect to demographics and disease activity; subjects had moderate to severe physical impairment and fatigue levels, and impaired HRQoL. At Wk 24, secukinumab 300 and 150 mg improved SF-36 PCS scores vs PBO (P<0.01) and HAQ-DI (P<0.01 for 300 mg) (Table). In exploratory analyses, secukinumab also improved FACIT-F and PsAQoL scores (Table), as well as aspects of work productivity, as assessed by WPAI, vs PBO at Wk 24.
Conclusions In pts with active PsA, secukinumab had a positive effect in terms of improving quality of life and reducing fatigue and the impact of disease on work productivity.
McInnes IB, et al. Presented at ACR 2014; L1
Acknowledgements Medical writing support was provided by Jessica Breen and Rachel Mason at Seren Communications (Tytherington, UK), and was funded by Novartis.
Disclosure of Interest P. Rahman Consultant for: Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer, and Roche. Consultant to pharmaceutical companies dealing with biologic agents in rheumatology, V. Strand Consultant for: AbbVie, Afferent, Amgen, Biogen Idec, Bioventus, BMS, Carbylan, Celgene, Celltrion, CORRONA, Crescendo, Genentech/Roche, GSK, Hospira, Iroko, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, SKK, Takeda, UCB, and Vertex, I. McInnes Consultant for: Novartis, Amgen, Janssen, BMS, Pfizer, UCB, Abbvie, Celgene, and Lilly, H. Marzo-Ortega Consultant for: Abbvie, Celgene, Janssen, MSD, Pfizer, and UCB, E. Dokoupilová: None declared, M. Churchill: None declared, S. Kandala Employee of: Novartis, L. Pricop Shareholder of: Novartis, Employee of: Novartis, S. Mpofu Shareholder of: Novartis, Employee of: Novartis