Novartis has announced the initiation of SURPASS, a head-to-head clinical trial of Cosentyx (secukinumab) versus proposed biosimilar adalimumab in ankylosing spondylitis (AS). SURPASS is the first head-to-head clinical trial in AS investigating superiority of Cosentyx in slowing spinal bone damage versus proposed biosimilar adalimumab. SURPASS is currently recruiting patients, with the 'first patient first visit' already achieved in November 2017.
SURPASS and EXCEED are part of a larger rheumatology program for Cosentyx. EXCEED is a head-to-head clinical trial of Cosentyx versus Humira (adalimumab) in psoriatic arthritis (PsA), which is already recruiting. EXCEED is the first large double-blinded head-to-head clinical trial versus Humira in PsA investigating superiority of Cosentyx on ACR 20 at 52 weeks as the primary endpoint.
"The EXCEED and SURPASS head-to-head trials are addressing important clinical questions solving residual uncertainty for patients with PsA and AS," said Dr. Robert Landewé, Professor of Rheumatology in the Amsterdam Rheumatology and Clinical Immunology Center & the Zuyderland Medical Center, Heerlen, the Netherlands. "Head-to-head trials deliver the most robust data helping to advance clinical practice and are key to clinical decision making. In this case, these data would add to the body of evidence to underline the benefit of different biologic pathways for physicians."
"Cosentyx is backed by strong clinical efficacy and safety data and already has supported more than 125,000 patients worldwide," said Vas Narasimhan, global head, drug development and Chief medical officer, Novartis. "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. 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."
Cosentyx is the first targeted biologic that specifically inhibits IL-17A, cornerstone cytokine involved in the inflammation of entheses in spondyloarthritis, which plays a major role in PsA and AS. Both conditions are debilitating autoimmune diseases with a high risk of mobility loss. Approximately 40 percent of PsA patients will develop irreversible joint damage and permanent physical deformity. For AS patients, inflammation of the sacroiliac joints and new bone formation of the spine is associated with increased levels of IL-17A, with severe cases progressing to irreversible spinal fusion.
Cosentyx is the first and only fully human IL-17A inhibitor approved to treat AS, PsA and psoriasis. It has demonstrated rapid and sustained efficacy as well as a consistently favorable safety profile, including injection site pain at rates similar to placebo. To date, Cosentyx has been used by more than 125,000 patients worldwide.