- Secukinumab (Cosentyx) ± loading dose reduced signs and symptoms of ankylosing spondylitis (AS) but failed to achieve the primary efficacy endpoint at 16 weeks because of an unexpectedly high placebo effect.
- Secukinumab showed sustained responses over the course of a non-placebo-controlled maintenance phase lasting 88 more weeks.
Why this matters
- Clinicians should consider prescribing secukinumab because of its sustained reduction in signs and symptoms of AS.
- Randomized, placebo-controlled, phase 3 MEASURE-4 trial (n=350) of self-administered subcutaneous secukinumab consisting of 3 groups: secukinumab 150 mg with 150 mg loading dose (load group), secukinumab without loading dose (no-load group), or placebo.
- Patients were dosed weekly until week 4, and thereafter every 4 weeks until 104 weeks.
- At 16 weeks, placebo group was converted to open-label 150 mg no-load secukinumab.
- Primary outcome was ≥20% improvement on the Assessment of SpondyloArthritis International Society criteria (ASAS20) at 16 weeks.
- Funding: Novartis Pharma AG.
- No differences in primary outcome at week 16 for secukinumab load group (59.5%), no-load group (61.5%), and placebo group (47%; P=.057 and .054, respectively).
- Sustained ASAS20 responses observed at week 104 (74% of 150-mg group and 77.5% of no-load group).
- No new safety signals emerged.
- High placebo effect.