On 17 November 2020, Novartis registered a Phase III psoriatic arthritis (PsA) clinical trial of its IL-17 inhibitor Cosentyx (secukinumab) compared against Johnson & Johnson’s Stelara (ustekinumab). The 28-week study is expected to be completed in 310 subjects who have failed treatment with a tumor necrosis factor (TNF) inhibitor, and the study’s primary endpoint is the Health Assessment Questionnaire-Disability Index (HAQ-DI). With the plethora of biologic therapies available, post-marketing head-to-head clinical trials are a critical method through which prescribers can compare drugs directly against one another. The registration of this trial demonstrates Novartis’ continued efforts to solidify its position in an increasingly crowded market.
Although Novartis has committed significant resources towards marketing Cosentyx, the last few years have brought bad news to the brand from head-to-head comparator trials in the rheumatology space. This latest trial in PsA comes one year after the news that Cosentyx failed to demonstrate statistically significant improvement compared with AbbVie’s TNF-inhibitor Humira (adalimumab) in the Phase III EXCEED Trial (NCT02745080), sponsored by Novartis themselves. The company had hoped Cosentyx would demonstrate statistically significant superiority measures in terms of its primary endpoint, the American College of Rheumatology score of 20% improvement (ACR20), a measure that would have made them serious contenders for first-line therapies especially given the 2019 EULAR guideline revisions. The change in the primary endpoint is likely a reflection of Novartis’ desire to avoid a repeat performance in this trial, focusing on a quality of life measure instead of clinical improvement.
After the TNF-inhibitors, J&J’s Stelara is a PsA market leader and incredibly popular with dermatologists, who work closely with PsA patients and their rheumatologists to manage both aspects of their disease. Cosentyx, which was approved in PsA in 2015, was a fast rising star in the PsA disease space for several years. However, success in this latest trial is critical to ensure its future in the field. Although Cosentyx had an advantage by being first-in-class, Eli Lilly’s Taltz is right on its heels with several positive head-to-head results in tow.