At the 2017 annual meeting of the American College of Rheumatology (ACR) and the Association of Rheumatology Health Professionals (ARHP), researchers presented late-breaking evidence that two dose levels of subcutaneous secukinumab inhibit structural damage in patients with psoriatic arthritis (PsA).
Philip J. Mease, MD, of the Swedish Medical Center and University of Washington, both in Seattle, along with his co-authors, presented primary results of the ongoing FUTURE 5 trial. The randomized, double-blind, placebo-controlled, parallel-group phase III study is assessing the safety and efficacy (including radiographic inhibition of structural damage) of subcutaneous secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, at doses of 300 mg and 150 mg.
The study included 996 patients at least 18 years of age who met the Classification Criteria for Psoriatic Arthritis and had symptoms of moderate to severe PsA. The sample was randomized to subcutaneous secukinumab 300 mg with loading dose (LD), 150 mg with LD, 150 mg without LD, or placebo. The groups were well balanced for demographics, disease history, and background characteristics.
All groups received secukinumab or placebo at baseline; at weeks 1, 2, 3, and 4; then every four weeks. At week 16, placebo non-responders were switched to secukinumab 300 mg or 150 mg; all remaining placebo patients were switched at week 24. Of the 996 patients who were randomized, 66 (6.9%) discontinued by week 24, most (n = 37) from the placebo group. The most common reason for discontinuation was patient/guardian decision, followed by adverse events (AEs).
At week 24, all secukinumab dose groups experienced significantly inhibited radiographic structural progression. All secukinumab doses were significantly superior to placebo, but secukinumab 300 mg had higher response rates than both 150 mg doses, and the 150 mg with LD group had better responses than the 150 mg without LD groups.
The most commonly reported AEs were consistent with previous trials and were mostly associated with an upper respiratory tract infection. No deaths, systemic fungal infections, tuberculosis infections, or major adverse cardiac events were reported.