Data Show Efficacy of Secukinumab in Multiple Aspects of Ankylosing Spondylitis After 5 Years

At the annual meeting, researchers led by Xenofon Baraliakos, MD, of the Ruhr-University of Bochum in Germany, presented long-term, end-of-study findings from the phase III MEASURE 1 extension trial, which is evaluating the safety and efficacy of secukinumab (SEC) in patients with ankylosing spondylitis (AS). The researchers examined signs and symptoms, physical function, and objective markers of inflammation through five years. They found sustained efficacy, which improved with dose escalation, and the treatment was well tolerated.

SEC is a fully human monoclonal IgG1 antibody that selectively neutralizes interleukin-17A. It is the only biologic disease-modifying anti-rheumatic drug approved by the U.S. Food and Drug Administration for use in AS, other than tumor necrosis factor inhibitors.

In the MEASURE 1 study, researchers initially randomized patients to receive placebo or intravenous SEC 10 mg/kg at baseline and at weeks two and four, followed by subcutaneous SEC 150 mg or 75 mg every four weeks thereafter. Then, based on Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at week 16, the researchers took patients re-randomized those taking placebo to receive SEC 150 mg or 75 mg at week 16 (non-responders) or week 24 (responders).

After the initial trial of two years, 274 patients entered the three-year extension study, which assessed outcomes at week 260. Results reported included all patients in the extension trial, including those who switched from placebo.

Overall, 108 of 128 patients (84.4%) who received SEC 150 mg and 122 of 146 patients (83.6%) who received SEC 75 mg completed 260 weeks of treatment. Sustained improvements were noted in outcome assessments, including ASAS and the Bath Ankylosing Spondylitis Disease Activity Index. Eighty-two patients (56.2%) who had been receiving SEC 75 mg received dose escalation to 150 mg after week 168, and their outcome assessments improved. In addition, the researchers noted, SEC was well tolerated, and the treatment’s safety profile was consistent over the entire study period.

The study concluded that SEC provided sustained efficacy in signs and symptoms, physical function, and objective markers of inflammation for patients with AS through five years. Dose escalation from 75 mg to 150 mg provided improved efficacy. Finally, SEC was well tolerated over the long term, with a similar safety profile as previously reported.