Treatment with secukinumab in patients with active ankylosing spondylitis (AS), particularly patients naïve to antitumor necrosis factor therapy, is associated with rapid, significant, and sustained improvement in signs and symptoms of the disease over 52 weeks, according to the results of a recent randomized, double-blind, double-dummy, placebo-controlled, 3-year, phase 3 study (MEASURE 3; ClinicalTrials.gov identifier: NCT02008916) published in Arthritis Research & Therapy.
A total of 226 patients age ≥18 with moderate to severe AS were randomly assigned to treatment with intravenous (IV) secukinumab 10 mg/kg at baseline, week 2, and 4 (loading regimen), followed by subcutaneous (SC) secukinumab 300 mg (n=76) or secukinumab 150 mg (n=74) beginning at week 8, or matched placebo. Placebo-treated participants were re-randomized to SC secukinumab 300 mg or 150 mg at week 16.
The primary endpoint of the study was the Assessment of SpondyloArthritis International Society criteria for 20% improvement (ASAS20) in response rate at week 16 in the secukinumab 300-mg and 150-mg groups vs placebo. Secondary endpoints included improvements in ASAS40, ASAS 5/6, Bath Ankylosing Spondylitis Disease Activity Index, and ASAS partial remission responses, along with change in high-sensitivity C-reactive protein levels from baseline.
The ASAS20 response rate was significantly greater at week 16 in the secukinumab 300-mg (60.5%; P <.01) and 150-mg (58.1%; P <.05) groups vs placebo (36.8%). At week 16, all secondary endpoints, other than ASAS partial remission in the secukinumab 150-mg group, were met.
Infections, including candidiasis, were reported more often in the secukinumab treatment groups than in the placebo group. In secukinumab-treated patients, pooled incidence rates of Candida infections and grade 3 to 4 neutropenia were 1.8% for both of these adverse events.
The investigators concluded that both the 300-mg and 150-mg doses of secukinumab are efficacious and well tolerated in patients with active AS. The usability of prefilled syringes and the acceptability of the liquid-in-vial formulation that delivered IV loading doses were confirmed.
Pavelka K, Kivitz A, Dokoupilova E, et al. Efficacy, safety, and tolerability of secukinumab in patients with active ankylosing spondylitis: a randomized, double-blind phase 3 study, MEASURE 3. Arthritis Res Ther. 2017;19(1):285.