Study Finds Secukinumab Improves Quality of Life for Patients with Psoriasis

Boston—Psoriatic arthritis (PsA) is associated with progressive pain, fatigue, disability, structural damage, and reduced health-related quality of life (HRQoL). Interluekin-17A (IL-17A) antagonists are developing as a potential treatment option for PsA. Secukinumab is an IL-17A that has demonstrated a rapid and sustained efficacy in subjects with PsA.

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Secukinumab was recently approved in early 2015 for the treatment of plaque psoriasis; however, prior to the approval, a study on the effect of secukinumab for PsA was presented at the ACR/ARHP meeting during a poster session titled Secukinumab, an Anti-Interleukin-17A Monoclonal Antibody, Improves Physical Function, Quality of Life, and Work Productivity in Patients with Active Psoriatic Arthritis: Results from a Phase 3, Randomized, Controlled Trial.

FUTURE 1 was a phase 3, double-blind, multicenter, parallel-group, placebo-randomized, controlled trial that examined treatment impact with secukinumab over 52 weeks in patients with PsA. A total of 606 patients were randomized to receive intravenous (IV) secukinumab 10 mg/kg followed by subcutaneous (SC) secukinumab 150 mg or 75 mg or placebo.

Participants were included in the study if they were ≥18 years of age fulfilling the Classification of Psoriatic Arthritis criteria with active disease defined as ≥3 tender joints and ≥3 swollen joints despite previous treatment with nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs, or tumor necrosis factor inhibitors. The patients had moderate-to-severe physical function impairment, fatigue levels, and impaired HRQoL at baseline.

The primary end point was the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response at week 24. Patient-reported outcomes included Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 Health Survey (SF-36), EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D), Psoriatic Arthritis Quality of Life (PsAQoL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), and Work Productivity and Activity Impairment-General Health.

A total of 505 patients (85%) completed 52 weeks of treatment. ACR20 responses at 24 weeks were significantly higher in patients receiving secukinumab 10 mg/kg IV and 150 mg SC (50.5%) compared with placebo (17.3%; P<.001). Improvements were observed by week 1 and sustained through week 52. In both groups receiving secukinumab (10 mg/kg IV and 150 mg SC; 10 mg/kg IV and 75 mg SC), HAQ-DI and SF-36 scores were significantly improved compared with placebo.

Improvements in EQ-5D, SF-36, and FACIT-Fatigue by week 24 were also reported in the secukinumab 10 mg/kg IV and 150 mg SC group compared with patients receiving placebo. During the same time period, patients in the secukinumab 10 mg/kg IV and 75 mg SC group demonstrated improvements in EQ-5D and PsAQoL. Mean changes from baseline in HAQ-DI, SF-36, and FACIT-Fatigue scores exceeded minimum clinically important differences for the secukinumab 10 mg/kg IV and 150 mg SC group.

Patients receiving secukinumab reported clinically meaningful changes across all 8 SF-36 domain scores at week 24, indicating improvements in social and emotional well-being, and pain, fatigue, and physical function.

This was the first phase 3 trial to demonstrate that selective IL-17A inhibition improves physical function, fatigue, HRQoL, and work productivity in patients with active PsA, according to the authors.—Kerri Fitzgerald

The research was funded by Novartis Pharma AG, Basel, Switzerland.