Objective To evaluate the effect of secukinumab on patient-reported outcomes (PROs) in subjects with active psoriatic arthritis (PsA) in the FUTURE 1 study.
Methods Subjects were randomised 1:1:1 to receive intravenous (i.v.) secukinumab 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous secukinumab 150 or 75 mg every 4 weeks or matching placebo until week 24.
Results At week 24, subjects receiving secukinumab i.v.→150 mg or i.v.→75 mg reported greater least squares mean changes from baseline than those receiving placebo in patient global assessment of disease activity (−20.6 and −20.0 vs −7.4, respectively), patient assessment of pain (−20.8 and −20.4 vs −6.7), psoriatic arthritis quality of life (−3.5 and −3.2 vs −0.4), Dermatology Life Quality Index (−8.8 and −7.9 vs 0.7); p<0.0001 vs placebo for both secukinumab groups for above PROs and Functional Assessment of Chronic Illness Therapy-Fatigue (6.74 (p<0.05 vs placebo) and 6.03 vs 4.00); all of which well exceeded minimum clinically important differences.
Conclusions In subjects with PsA, secukinumab treatment resulted in clinically meaningful improvements in global disease activity, pain, generic and disease-specific measures of health-related quality of life and fatigue.
Trial registration number NCT01392326; Results.
- Psoriatic Arthritis
- Quality Indicators
- Patient perspective
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Handling editor Tore K Kvien
Parts of the patient-reported outcome data from the FUTURE 1 trial were previously presented at the American College of Rheumatology (ACR) annual meeting, 15–19 November 2014, Boston, Massachusetts, USA
Contributors All authors had access to the data, contributed to its interpretation and collaborated in the development of the manuscript. All authors critically reviewed and provided feedback on subsequent versions. All authors made the decision to submit the manuscript for publication and vouch for the accuracy and completeness of the data and fidelity of this report to the study protocol.
Funding The study was sponsored by Novartis Pharma AG, Basel, Switzerland and designed by the scientific steering committee and Novartis personnel. Medical writing support was funded by Novartis.
Competing interests VS has received consulting fees from Abbvie, Amgen, Bristol-Myers Squibb, Celgene, Genentech/Roche, Janssen, Lilly, Merck, Novartis, Pfizer and UCB. PM has received research grants, consultation fees and/or speaking fees from Abbvie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB. LG has received lecture/consultancy honoraria from Abbvie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Novartis, Pfizer, Roche and UCB. FvdB has received speaker or consultancy fees from Abbvie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer and UCB. JZ, LP and SM are employees of Novartis.
Ethics approval The study protocol was approved by the institutional review board or ethics committees at each centre.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The study protocol can be made available on request.