During the 27th European Academy of Dermatology and Venerology (EADV) Congress in September, data was presented on the efficacy of BMS-986165, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for treating plaque psoriasis. Additionally, research was presented on the bioequivalence of Cyltezo (adalimumab-adbm) to adalimumab.
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Phase 2 Study Results for BMS-986165
BMS-986165 is an oral, selective tyrosine kinase 2 (TYK2) inhibitor being investigated for treating patients with moderate to severe plaque psoriasis.1 At EADV Congress, researchers presented data from the IM011-011 trial, a multi-center, randomized, double-blind, placebo-controlled, parallel group phase 2 study.
The trial evaluated the clinical efficacy and safety of BMS-986165 in patients (N=267) with moderate to severe psoriasis. Patients received 3 mg BMS-986165 (n=44) every other day, 3 mg BMS-986165 every day (n=44), 3 mg BMS-986165 twice daily (n=45), 6 mg BMS-986165 twice daily (n=45), 12 mg BMS-986165 every day (n=44) or placebo (n=45). The primary endpoint was Psoriasis Area and Severity Index (PASI) 75 at Week 12. Key secondary endpoints were attaining the PASI 90 and PASI 100, as well as Dermatology Life Quality Index (DLQI).
At Week 12, PASI 75 and PASI 90 were achieved in 67–75% of patients treated with 3 mg or more BMS-986165 compared with 7% of placebo-treated patients. Patients experienced treatment efficacy regardless of whether they had prior exposure to a biologic therapy. Data showed a favorable risk-benefit profile, with diarrhea, headache, nasopharyngitis, nausea and upper respiratory tract infections being the most common adverse events reported.