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THU0433 Secukinumab Improves Physical Function, Quality of Life, Fatigue and Work Productivity in Patients with Active Psoriatic Arthritis in Future 2, A Phase 3 Trial
  1. P. Rahman1,
  2. V. Strand2,
  3. I.B. McInnes3,
  4. H. Marzo-Ortega4,
  5. E. Dokoupilová5,
  6. M. Churchill6,
  7. S. Kandala7,
  8. L. Pricop8,
  9. S. Mpofu9
  1. 1Memorial University, St John's, Canada
  2. 2Stanford University, Stanford, United States
  3. 3University of Glasgow, Glasgow
  4. 4University of Leeds, Leeds, United Kingdom
  5. 5Medical Plus, Uherské Hradiště, Czech Republic
  6. 6Arthritis Center of Nebraska, Lincoln, United States
  7. 7Novartis Healthcare Pvt Ltd, Hyderabad, India
  8. 8Novartis Pharmaceuticals Corporation, East Hanover, United States
  9. 9Novartis Pharma AG, Basel, Switzerland

Abstract

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.

References

  1. 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

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