medwireNews: Results of the phase III MEASURE 3 trial provide additional support for secukinumab as a treatment option for patients with ankylosing spondylitis (AS).
Karel Pavelka (Charles University, Prague, Czech Republic) and co-investigators found that the 74 patients with moderate-to-severe AS who were randomly assigned to receive secukinumab at a maintenance dose of 150 mg and the 76 who were given a maintenance dose of 300 mg were significantly more likely to achieve at least a 20% improvement in Assessment of SpondyloArthritis international Society score (ASAS20 response) at week 16 than the 76 patients in the placebo group, with rates of 58.1% and 60.5% versus 36.8%. Differences between the groups were observed from week 1.
The interleukin-17A inhibitor was given as an intravenous loading dose of 10 mg/kg at baseline and at weeks 2 and 4, followed by self-administered subcutaneous maintenance treatment every 4 weeks in the form of prefilled syringes. All patients reported successful self-injection of secukinumab.
Patients in the 150 mg and 300 mg secukinumab groups also had significantly higher ASAS40 response rates at week 16 than those receiving placebo (40.5 and 42.1 vs 21.1%), as well as significantly greater decreases from baseline in high-sensitivity C-reactive protein levels.
Pavelka and colleagues note that the efficacy of secukinumab was maintained for up to a year of treatment, with respective ASAS20 and ASAS40 response rates of 58.1% and 40.5% in the 150 mg group, and 68.4% and 53.9% in the 300 mg group at 1 year.
In prespecified subgroup analyses, the improvements in efficacy endpoints occurred regardless of prior exposure to anti-tumor necrosis factor (TNF) therapy, but response rates were numerically higher among patients who were TNF inhibitor-naïve.
The incidence of adverse events (AEs) during the 16-week randomized phase was comparable among patients in the 150 mg, 300 mg, and placebo groups, with rates of 45.9%, 44.7%, and 44.0%, respectively. Similarly, a corresponding 0.0%, 1.3%, and 1.3% of patients experienced serious AEs.
“The safety profile of secukinumab in this study was consistent with that observed in previous trials of secukinumab in patients with active AS and other indications, including psoriatic arthritis,” write the study authors in Arthritis Research & Therapy.
Furthermore, rates of AEs and serious AEs were lower than those observed in the MEASURE 1 or MEASURE 2 studies, despite the use of a higher dose of secukinumab in MEASURE 3, “suggesting that secukinumab 300 mg is as well-tolerated as the currently approved 150 mg dose,” they continue.
And the team concludes that secukinumab may address an “unmet medical need [that] persists due to primary and secondary treatment failure and intolerance, which has been well-documented in a substantial proportion of patients with AS.”
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