Antirheumatic Drug Is Effective as Long-Term Treatment for AS
Secukinumab is an effective and safe long-term treatment for ankylosing spondylitis (AS), according to final results of the 5-year, phase 3 MEASURE 1 extension trial presented at the ACR/ARHP Annual Meeting.
Other than anti-tumor necrosis factor (anti-TNF), secukinumab—a fully human monoclonal antibody that selectively neutralizes IL-17A—is the only approved biological disease-modifying antirheumatic drug for the treatment of AS.
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“Not all patients respond adequately to existing anti-TNF therapies or sometimes have contraindications to such agents,” Alan Kivitz, MD, CPI, president of Altoona Arthritis & Osteoporosis Center in Duncansville, Pennsylvania, and co-investigator on the trial, told Rheumatology Consultant. “Having another MOA is important to provide patients with other options.”
For the extension trial, Kivitz and colleagues sought to show whether secukinumab efficacy would continue and not abate over time. In addition, the researchers wanted to ensure no occurrence of new or increasing safety signals.
The participants were randomly assigned to receive 150 mg/kg intravenous secukinumab at baseline, 2 weeks, and 4 weeks, followed by either 75 mg or 150 mg subcutaneous secukinumab 4 weeks after, or matched placebo.
Based on Assessment of SpondyloArthritis International Society (ASAS) response criteria at 16 weeks, participants who received placebo were re-randomized to either 150 mg or 75 mg subcutaneous secukinumab at 16 weeks (non-responders) or 24 weeks (responders).
Overall, 84.4% (108/128) and 83.6% (122/146) of all participants who received 150 mg and 75 mg secukinumab—including those who switched from placebo—completed 260 weeks of treatment.
The researchers found that improvements in ASAS20, ASAS40, BASDAI50, and other efficacy outcomes were sustained through 260 weeks. Additionally, participants who had their secukinumab dosage increased from 75 mg to 150 mg saw an improvement in ASAS40, ASAS PR, ASAS 5/6, and BASDAI50 responses.
Secukinumab was well-tolerated throughout the entire treatment period, with no new safety signals identified.
Adverse events of special interest included superficial fungal infections and inflammatory bowel disease—either new onset or exacerbation of preexisting disease, according to Kivitz.
“We will likely see increasing use of secukinumab in AS patients and see it used before anti-TNF agents,” Kivitz said.
He added: “Current trials are underway to better understand optimal dosing strategies as well as direct head-to-head comparison with a TNF inhibitor.”
Baraliakos X, Braun J, Deodhar AA, et al. Long-term evaluation of secukinumab in ankylosing spondylitis: 5 year efficacy and safety results from a phase 3 trial. Paper presented at: 2018 ACR/ARHP Annual meeting; October 19-24, 2018; Chicago IL. https://acrabstracts.org/abstract/long-term-evaluation-of-secukinumab-in-ankylosing-spondylitis-5-year-efficacy-and-safety-results-from-a-phase-3-trial/. Accessed November 19, 2018.