Atul A. Deodhar
CHICAGO — Research presented at the ACR/ARHP 2018 Annual Meeting showed that secukinumab, a treatment for ankylosing spondylitis, was effective against multiple features of the disease over 5 years.
Results of the phase 3 trial — which is a 3-year extension of the MEASURE 1 trial — also showed that the safety profile of secukinumab (Cosentyx, Novartis) remained consistent.
“Secukinumab, a fully human monoclonal antibody that inhibits interleukin-17A, is the only other class of biologic that is approved for the treatment of AS other than anti-tumor necrosis factor agents,” Atul A. Deodhar, MD, professor of medicine and medical director at the Oregon Health and Science University, told Healio. “The main finding here was that secukinumab was shown to provide sustained efficacy across multiple domains, including signs and symptoms, physical function, and objective markers of inflammation, together with a favorable and consistent safety profile through 5 years of treatment in patients with AS.”
During the initial phase of the MEASURE 1 trial, 290 patients with AS were randomly assigned to receive placebo or 10 mg/kg of IV secukinumab at baseline, week 2 and week 4, followed by 150-mg or 75-mg doses of subcutaneous secukinumab every 4 weeks thereafter. Based on the Assessment in Ankylosing Spondylitis (ASAS) response at week 16, patients in the placebo arm could switch to receive 150 mg or 75 mg of secukinumab.
After 2 years, 274 patients were enrolled in the 3-year extension trial. During the extension trial, dose escalation from 75 mg to 150 mg of secukinumab was allowed.
Efficacy outcomes were assessed through week 260. The outcomes were based on several disease activity measurements, including a 20% ASAS response (ASAS20), a 40% ASAS response (ASAS40), and a 50% or greater improvement in the Bath ankylosing spondylitis disease activity index (BASDAI50).
Overall, 84.4% of patients who received 150 mg of secukinumab and 83.6% of those who received 75 mg of secukinumab completed 260 weeks of treatment. Efficacy outcomes were sustained throughout the trial, with 65.2% of patients receiving 150 mg of secukinumab and 54.4% receiving 75 mg of secukinumab achieving ASAS20/40 index responses, as well as 63.4% of patients receiving 150 mg and 56.3% receiving 75 mg achieving BASDAI50.
After 168 weeks, 56.2% of patients receiving 75 mg of secukinumab had their dosage increased to 150 mg. These patients also had improvements in ASAS responses.
Secukinumab had a favorable safety profile, with incidence rates of 0.1 per 100 patient-years for ulcerative colitis, 0.5 per 100 patient-years for malignant/unspecified tumors, 0.6 per 100 patient-years for Chron’s disease and 1.8 per 100 patient-years for uveitis.
“These data provide reassurance to clinicians on the effectiveness secukinumab for the long-term treatment of patients with this chronic disorder,” Deodhar said. – by Erin Michael
Baraliakos, X, et al. Abstract L13. Presented at: ACR/ARHP Annual Meeting, Oct. 20-24, 2018; Chicago.
Disclosure: Deodhar reports associations with AbbVie, Eli Lilly and Company, Janssen, Novartis, Pfizer, UCB and SUN Pharma.