Results from a Phase 3 study of Cyltezo (adalimumab-adbm; Boehringer Ingelheim) showed that the biosimilar was clinically equivalent to Humira (adalimumab; AbbVie) in patients with moderate-to-severe chronic plaque psoriasis. The data was presented at the European Association of Dermatology and Venereology Annual Meeting (EADV 2018) in Paris.
The Phase 3 study (N=318) enrolled patients aged 18 to 78 years with moderate-to-severe chronic plaque psoriasis who had not previously received treatment with ≥1 biologic. Patients were randomized to either Cyltezo or Humira at 80mg on day 1, 40mg on day 7, and 40mg every other week thereafter. The study’s primary endpoint, the proportion of patients achieving a 75% reduction in Psoriasis Area and Severity Index (PASI) at week 16, was met, demonstrating that Cyltezo was clinically equivalent to Humira.
Data from week 24 are anticipated to be announced next year. In addition, the Company is currently conducting the VOLTAIRE-X trial to demonstrate the interchangeability between Humira and Cyltezo.
Cyltezo, a recombinant tumor necrosis factor (TNF) blocker, is the first adalimumab biosimilar to be FDA-approved. It is indicated to treat various chronic inflammatory diseases, including plaque psoriasis, rheumatoid arthritis, and ulcerative colitis. It is currently not commercially available in the US.
For more information call (800) 542-6257 or visit Cyltezo.com.