Sotyktu(deucravacitinib)

Sotyktu (deucravacitinib) is a drug developed by Bristol-Myers Squibb Company (NDA 214958). It is indicated for the treatment of plaque psoriasis, which affects 80-90% of psoriasis patients, with 20% experiencing moderate to severe forms. The International Birth Date for Sotyktu was 09 September 2022.

In clinical trials, Sotyktu achieved statistical significance for co-primary endpoints, including sPGA 0/1 and PASI 75 response rates. At Week 16, sPGA 0/1 response rates were 53.6%, and PASI 75 response rates were 44% (USA). Nominal significance for co-primary endpoints was also achieved when compared to Apremilast. Statistically significant differences were observed in PSSD Symptom and Sign scores and DLQI in favor of deucravacitinib versus placebo, and nominal significant differences were observed between deucravacitinib and Apremilast for PRO and HRQoL measures. However, statistical significance was not achieved for fingernail psoriasis scores (PGA-F 0/1) or palmoplantar psoriasis scores (pp-PGA) versus apremilast.

Safety findings include MACE incidence rates of 0.2% and 0.6%, and extended MACE incidence rates of 0.3% and 0.7%. The incidence rate of AEs in SOC “Psychiatric Disorders” was 9.3/100 P-Y and 9.7/100 P-Y. VTE incidence was 0.1%, and peripheral arterial events incidence was 0.1% and 0.2%. Serious CV events EAIR was 1.2/100 P-Y. A total of 15 pregnancies were reported during the clinical program.