Novartis Launches Head-to-head Clinical Trial for Secukinumab and Biosimilar

Novartis has initiated a head-to-head clinical trial of Cosentyx (secukinumab) versus proposed biosimilar adalimumab for patients with ankylosing spondylitis (AS).

The trial, SURPASS, is the first head-to-head clinical comparison in AS investigating the superiority of secukinumab for slowing spinal bone damage versus proposed biosimilar adalimumab.

In part of its rheumatology program for secukinumab, Novartis is also currently recruiting for the EXCEED trial, a head-to-head clinical comparison of brand Cosentyx versus adalimumab (Humira) for psoriatic arthritis (PsA). It is the first large double-blinded head-to-head trial comparing the 2 therapies for PsA, based on improvement of ACR 20 scores at 52 weeks of treatment.

Secukinumab is the first targeted biologic IL-17A inhibitor, functioning by blocking the primary cytokine involved in entheses inflammation in spondyloarthritis — which plays a big role in autoimmune diseases PsA and AS.

Approximately 40% of PsA patients will develop irreversible joint damage and permanent physical deformity, according to Novartis, and irreversible spinal fusion is association with cases of increased levels of IL-17A in patients with AS.

As the first and only fully human IL-17A inhibitor approved to treat AS, PsA, and psoriasis, secukinumab has shown rapid and sustained efficacy and a consistent safety profile, according to Novartis. It is currently approved in the US as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic or phototherapy.

It is also approved in more than 80 countries for the treatment of plaque psoriasis, and another 70-plus countries for the treatment of AS and PsA.

Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer of Novartis, noted that secukinumab’s clinical efficacy and safety is already backed by its use in more than 125,000 patients.

“Many patients living with PsA and AS cannot enjoy a normal life as they are experiencing persistent pain and fatigue, and are at risk of long-term mobility loss,” Narasimhan said. “These patients deserve the best treatment possible and we are hopeful that the EXCEED and SURPASS trials will provide valuable answers for doctors and patients in their decision making."

Robert Landewe, MD, PhD, Professor of Rheumatology in the Amsterdam Rheumatology and Clinical Immunology Center & the Zuyderland Medical Center, Heerlen, the Netherlands, said the EXCEED and SURPASS trials are addressing important clinical questions “solving residual uncertainty for patients with PsA and AS.”

He advocated for the opportunistic data to come from comparative studies.

"Head-to-head trials deliver the most robust data helping to advance clinical practice and are key to clinical decision making,” Landewe said. “In this case, these data would add to the body of evidence to underline the benefit of different biologic pathways for physicians."