Phase II study of BI 655066 shows superiority over Stelara (ustekinumab) for psoriasis- Boehringer Ingelheim

New results from a Phase II head-to-head psoriasis study showed superior efficacy of Boehringer Ingelheim's investigational biologic compound BI 655066, an IL-23 inhibitor, over ustekinumab (Stelara). After nine months, 69% of patients with moderate-to-severe plaque psoriasis maintained clear or almost clear skin (PASI 90) with BI 655066 in the higher dose group compared to 30% of patients on ustekinumab. Patients also achieved this skin clearance significantly faster (approximately 8 weeks versus approximately 16 weeks) and for more than 2 months longer (more than 32 weeks versus 24 weeks) than those on ustekinumab. In addition, completely clear skin (PASI 100) was maintained after 9 months in nearly triple the percentage of patients on BI 655066 compared with ustekinumab (43 versus 15%).

Primary endpoint results showed nearly double the percentage of patients with moderate-to-severe plaque psoriasis achieved clear or almost clear skin (PASI 90) after 12 weeks of treatment with BI 655066, compared to ustekinumab (77.1 versus 40%). The new data further demonstrate that BI 655066 has similar safety and tolerability to ustekinumab, regardless of dose, with no serious drug-related side-effects. The most common side effects were runny nose, sore throat, and headache.

See- K Papp et al. 2015. "Onset and duration of clinical response following treatment with a selective IL-23p19 inhibitor (BI 655066) compared with ustekinumab in patients with moderate-to-severe chronic plaque psoriasis". 24th European Academy of Dermatology and Venereology (EADV) congress, Copenhagen, Denmark, 7–11 October 2015 [Presentation].