Phase III trial of Cyltezo meets endpoint in plaque psoriasis.- Boehringer.

Boehringer announced results from a phase III study, confirming that Cyltezo (adalimumab biosimilar) is equivalent to Humira, with no clinically meaningful differences in efficacy, safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis. 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 FDA. In addition, Boehringer 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. The 16-week data was presented at the European Association of Dermatology and Venereology Annual Meeting (EADV 2018) in Paris.