Boehringer Ingelheim’s Cyltezo achieves clinical equivalence to Humira in Phase 3 psoriasis trial

German pharmaceutical giant Boehringer Ingelheim has announced a significant milestone in the treatment of moderate-to-severe chronic plaque psoriasis. Their drug, Cyltezo, a biosimilar to AbbVie’s renowned psoriasis medication Humira (Adalimumab), has demonstrated clinical equivalence in a pivotal phase 3 trial, known as NCT 02850965.

The trial successfully met its primary endpoint, which was the proportion of patients achieving at least a 75% reduction in the Psoriasis Area and Severity Index (PASI) by week 16. A total of 318 patients, aged between 18 and 78, who had not previously been treated with biologic drugs for their condition, participated in the trial. Patients were randomized to receive either Cyltezo or Humira, following a regimen of 80mg on day 1, 40mg on day 7, and then 40mg bi-weekly.

Cyltezo showed no clinically meaningful differences in efficacy, safety, or immunogenicity compared to Humira, confirming its potential as a valuable treatment option for patients with chronic plaque psoriasis. This result is significant, considering Humira’s approval for various autoimmune conditions in multiple countries, including rheumatoid arthritis and Crohn’s disease.

Kay Tetzlaff, Vice President and Medical Head of Therapeutic Area Biosimilars at Boehringer Ingelheim, emphasized the importance of these findings. “This phase III study builds on recent evidence that demonstrates Cyltezo is equivalent to Humira for the treatment of moderately-to-severely active rheumatoid arthritis. These data reinforce the robust body of evidence that Boehringer Ingelheim is collecting to provide safe and effective treatment options that will contribute to the quality and sustainability of healthcare systems,” Tetzlaff remarked.

The success of the NCT 02850965 trial not only underscores Cyltezo’s clinical equivalence but also consolidates its standing based on existing analytical, pharmacological, and non-clinical data. This comprehensive data collection supported Cyltezo’s approval by the US Food and Drug Administration (FDA) and marks it as a strong contender in the biosimilar market, potentially making treatment more accessible and sustainable.

The results from the phase 3 trial are promising for the future of biosimilar treatments in managing complex autoimmune diseases. As Cyltezo continues to show comparable effectiveness to Humira, it may become a key player in expanding treatment options, reducing healthcare costs, and improving patient outcomes across various therapeutic categories.