Cosentyx Leads to Long-Term Improvement in AS Patients, Phase 3 Trial Shows
Results from a Phase 3 clinical trial show that treatment with Cosentyx (secukinumab) led to fast, significant, and sustained symptom improvement in patients with active ankylosing spondylitis (AS).
Improvements were particularly noticeable in patients who had never been treated with anti-TNF (tumor necrosis factor) therapies.
The study, “Efficacy, safety, and tolerability of secukinumab in patients with active ankylosing spondylitis: a randomized, double-blind phase 3 study, MEASURE 3,” was published in the journal Arthritis Research and Therapy.
Cosentyx is a human monoclonal antibody that works by inhibiting the pro-inflammatory cytokine, or immune protein, interleukin-17A, preventing exacerbated inflammation and immune reactions in chronic inflammatory diseases, such as ankylosing spondylitis.
The MEASURE 3 study (NCT02008916) is an international, 54-center trial evaluating the effectiveness and safety of Novartis’ Cosentyx in patients with ankylosing spondylitis who had never had anti-TNF therapy, or had an inadequate response or intolerance to it.
After a 10-week screening period, researchers randomized 226 adults to one of two Cosentyx dose groups (300 mg or 150 mg) or a placebo group.
Patients received three intraveneous infusions of Cosentyx or placebo at the start, week two, and week four. Those in the Cosentyx groups received one subcutaneous injection of their respective dose every four weeks until the end of the study.
Patients in the placebo group received one subcutaneous injection at weeks eight and 12. At week 16, patients were re-randomized to receive Cosentyx at either 300 mg or 150 mg every four weeks.
The trial’s primary objective was to determine the proportion of patients who met the Assessment of SpondyloArthritis International Society (ASAS 20) response, defined as an improvement of at least 20% in at least three of four main ASAS domains, with no more than 20% worsening in the remaining domains.
Additional endpoints included improvements in several parameters, such as changes in C-reactive protein levels — a blood marker of inflammation.
Intraveneous treatment with Cosentyx at a dose of 300 mg or 150 mg significantly increased the ASAS 20 response rate, compared with placebo (60.5%, 58.1%, and 36.8%, respectively).
Additionally, treatment with either Cosentyx dose improved all secondary endpoints, except ASAS partial remission in the 150 mg Cosentyx group, and were maintained up to 52 weeks.
The safety profile was consistent with previous studies, with infections accounting for the most common adverse event in the treatment group.
These results “reinforce the observation that secukinumab provides rapid, significant, and sustained improvement over 52 weeks in the signs and symptoms of active AS, regardless of prior experience with TNF inhibitors, with response rates that were highest in patients naïve to anti-TNF therapy,” the authors said.