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Journal article
The effect of secukinumab on patient-reported outcomes in patients with active psoriatic arthritis in a randomised phase 3 trial
The Lancet. Rheumatology, v 4(3), pp E208-E219
01 Mar 2022
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Abstract
Background The phase 3 FUTURE 5 trial (NCT02404350) showed the clinical and radiographical efficacy of secukinumab in patients with psoriatic arthritis. This analysis aimed to assess the effect of secukinumab on patient-reported outcomes (PROs).
Methods FUTURE 5 was a phase 3, multicentre, parallel-group randomised trial in which patients who were 18 years old or older, met the classification criteria for psoriatic arthritis at screening, and had symptoms of moderate-to-severe psoriatic arthritis for at least 6 months were randomly assigned to receive secukinumab 300 mg, 150 mg, 150 mg no loading dose (NL), or placebo weekly from baseline to week 4 and every 4 weeks thereafter. The prespecified PROs of the FUTURE 5 trial were assessed first in the overall population. We report mean changes from baseline and the proportion of patients reporting improvements equal to or more than the minimum clinically important differences (MCIDs) and scores equal to or more than the normative values for patient global assessments (PtGA) of disease activity; psoriasis and arthritis visual analogue scale (VAS) scores; pain VAS; Health Assessment Questionnaire Disability Index (HAQ-DI); 36-item Short Form Health Survey (SF-36); Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F); and quality of life questionnaires. Patients were then stratified and assessed according to their tumour necrosis factor (TNF) inhibitor status (TNF-naive and TNF-inadequate responder [TNF-IR] populations) as a post-hoc analysis.
Findings Patients in all secukinumab groups reported significant least-squares mean changes from placebo at week 16 in all PROs except SF-36 mental component summary (MCS), irrespective of TNF inhibitor use. These included PtGA (300 mg difference vs placebo -12.2 [95% CI -16.3 to -8.1], 150 mg -8.22 [-12.4 to -4.1], 150 mg NL -8.3 [-12.5 to -4.2]; all p<0.0001), pain VAS (300 mg -14.3 [-18.3 to -10.2], 150 mg -11.5 [-15.6 to -7.5], 150 mg NL -11.3 [-15.3 to -7.2]; all p<0.0001), HAQ-DI (300 mg -0.33 [-0.42 to -0.24], 150 mg -0.23 [-0.32 to -0.14], 150 mg NL -0.24 [-0.33 to -0.15]; all p<0.0001), and FACIT-F (300 mg 4.8 [3.2 to 6.4], 150 mg 4.2 [2.6 to 5.8], 150 mg NL 3.5 [1.9 to 5.1]; all p<0.0001). Similarly, the proportion of patients with improvements equal to or better than MCID at week 16 was higher in the secukinumab group compared with the placebo group for most PROs except SF-36 (MCS), regardless of TNF inhibitor use.
Interpretation Secukinumab resulted in early, statistically significant, clinically meaningful, sustained improvements in PROs across all doses compared with placebo in patients with active psoriatic arthritis. These improvements were seen irrespective of previous TNF inhibitor use, in a post-hoc analysis. These results indicate that secukinumab provides comprehensive improvement for patients with psoriatic arthritis, regardless of previous therapy. Copyright (C) 2022 Elsevier Ltd. All rights reserved.
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Details
- Title
- The effect of secukinumab on patient-reported outcomes in patients with active psoriatic arthritis in a randomised phase 3 trial
- Creators
- Vibeke Strand - Stanford UniversityGurjit S. Kaeley - Florida CollegeMartin J. Bergman - Drexel UniversityDafna D. Gladman - Toronto Western HospitalLaura C. Coates - Nuffield Orthopaedic CentreBintu Sherif - RTI Health SolutionsPeter Hur - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USABhumik Parikh - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USAIsabelle Gilloteau - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USAPhilip J. Mease - University of Washington
- Publication Details
- The Lancet. Rheumatology, v 4(3), pp E208-E219
- Publisher
- Elsevier
- Number of pages
- 12
- Grant note
- Novartis
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Medicine (Graduate)
- Web of Science ID
- WOS:000763005800020
- Scopus ID
- 2-s2.0-85124883171
- Other Identifier
- 991019168068804721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Rheumatology