Subcutaneous Secukinumab Provides Sustained Inhibition of Radiographic Progression in Patients with Active Psoriatic Arthritis: 52-Week Results from a Phase 3 Study[690]

According to 52-week study results presented at the annual meeting, subcutaneous secukinumab (SEC) provided sustained inhibition of radiographic progression in patients with active psoriatic arthritis. The phase III study, led by Philip J. Mease, MD, of the University of Washington in Seattle, also found sustained or improved clinical responses, as well as a safety profile consistent with previous reports.

SEC is a fully human monoclonal IgG1 antibody that selectively targets interleukin-17A. In the FUTURE 5 study, the treatment significantly improved signs and symptoms of PsA and inhibited radiographic progression versus placebo at week 24. At the 2018 annual conference of American College of Rheumatology/Association of Rheumatology Health Professionals, the team reported on radiographic progression, additional efficacy endpoints, and safety through 52 weeks.

The researchers randomized 996 patients with active PsA into four groups: subcutaneous (SC) SEC 300 mg with loading dosage (LD) (n = 222), SC SEC 150 mg with LD (n = 220), 150 mg SC SEC without LD (n = 222), or placebo (n = 332). All patients received SEC or placebo at baseline and at weeks 1, 2, 3, and 4, then every 4 weeks. Patients in the placebo group were switched to SEC 300 mg or 150 mg at week 16 or 24.

To determine radiographic progression, two blinded researchers (plus adjudicator if necessary) assessed mean changes in van der Heijde–modified total Sharp score for PsA, based on hand/wrist/foot radiographs obtained at baseline and weeks 16, 24, and 52. In addition, researchers considered American College of Rheumatology 20/50 Criteria, Psoriasis Area and Severity Index 75 score, and whether dactylitis and enthesitis resolved.

About 90% of patients completed 52 weeks of treatment, and inhibition of radiographic progression was sustained through 52 weeks. Clinical responses also were sustained or improved through 52 weeks. Exposure-adjusted incidence rates of selected AEs were serious infections (1.6), Candida infections (2.2), Crohn’s disease (0.2), ulcerative colitis (0.1), major adverse cardiovascular event (0.2), and malignant/unspecified tumors (0.5). Therefore, the safety profile in this study was similar to results previously reported.