Novartis' Secukinumab Narrowly Misses End Point in Trial Against Adalimumab

Novartis Friday announced results from a head-to-head trial of its secukinumab (Cosentyx) versus adalimumab in patients with active psoriatic arthritis (PsA), saying its therapy missed statistical significance for its primary end point.

The interleukin-17 (IL-17) inhibitor is already approved to treat ankylosing spondylitis, PsA, and plaque psoriasis.

Although secukinumab missed showing superiority for American College of Rheumatology criteria for 20% improvement (ACR20) at week 52, the company said it showed numerical superiority.

In the EXCEED trial comparing secukinumab to adalimumab, PsA-specific end points were seen in a pre-specified sensitivity analysis. No new safety signals were detected, with results showing a consistent and favorable safety profile for secukinumab, similar to previous trials.

EXCEED, the first double-blinded head-to-head clinical trial evaluating secukinumab at a dose of 300 mg versus adalimumab at a dose of 40 mg, is a 52-week, multicenter, randomized, double-blind, active control, Phase 3b trial evaluating the efficacy of secukinumab compared with adalimumab in over 800 patients with active PsA who are naïve to biologics.

Secukinumab was administered at baseline, weeks 1-4, and then every 4 weeks until week 48. Adalimumab 40 mg was administered at baseline, and then every 2 weeks until week 50.

Secukinumab has less frequent dosing than adalimumab, which won’t face biosimilar competition until 2023, although other therapies, such as oral agents as well as other injectable competitors are waiting in line.

“These data will be welcomed by patients and clinicians to guide clinical decision making and highlight secukinumab as a viable option as a first-line biologic for the treatment of psoriatic arthritis,” says Iain McInnes, a professor of rheumatology at the University of Glasgow and an investigator in the secukinumab clinical trial program.

“EXCEED is the first ever monotherapy head-to-head trial with a primary end point in psoriatic arthritis specific to joints.” said Eric Hughes, global development unit head, Immunology, Hepatology & Dermatology. “We will assess the EXCEED data in their totality and we view the results as confirming our vision of Cosentyx becoming standard of care in psoriatic arthritis.”

Detailed data will be presented at a future scientific congress.