Boehringer Ingelheim announced results from a phase III study, confirming that Cyltezo is equivalent to Humira, with no clinically meaningful differences in efficacy, safety, and immunogenicity in people with moderate-to-severe chronic plaque psoriasis.1 The 16-week data was presented at the European Association of Dermatology and Venereology Annual Meeting (EADV 2018) in Paris.
“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,” said Kay Tetzlaff, vice president and medical head of therapeutic area biosimilars at Boehringer Ingelheim. “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.”
In the phase III study (NCT 02850965), 318 patients between 18 and 78 years of age with moderate-to-severe chronic plaque psoriasis, who had not previously received treatment with one or more biologic, were randomized to receive Cyltezo or Humira at 80 mg on day 1, 40 mg on day 7 and 40 mg every other week thereafter.
The primary endpoint, which measured the proportion of patients achieving a 75 percent reduction in PASI (Psoriasis Area and Severity Index) at week 16, was met. The 24-week data from this study are expected to be presented next year.
These clinical data in the psoriasis population continue to build on the strong existing analytical, pharmacological, non-clinical similarity data as well as the clinically similar data in the rheumatoid arthritis population, which were used to support the approval of Cyltezo by the U.S. FDA. In addition, Boehringer Ingelheim is conducting a clinical trial to demonstrate the interchangeability between Cyltezo and Humira.
This is the first study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar.
Citrate-free Cyltezo is not commercially available in the U.S. at this time. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie in the U.S.
1 Menter A, et al. Biosimilar BI 695501 and Adalimumab Reference Product have Similar Efficacy and Safety in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: 16-week Results from a Phase III Study. Abstract presented at European Association of Dermatology and Venereology Annual Meeting (EADV 2018), Paris, September 12-16 2018.
Filed Under: Drug Discovery