Tildrakizumab (Sun Pharma), an investigational interleukin (IL)-23p19 inhibitor, has achieved its primary endpoint in two pivotal phase 3 studies (reSURFACE 1 and 2) involving patients with moderate-to-severe plaque psoriasis. An average of 63% of patients showed 75% skin clearance (Psoriasis Area Sensitivity Index [PASI] 75) by week 12 after two injections of tildrakizumab 100 mg, and 77% showed PASI 75 after 28 weeks and three injections.
Similarly, an average of 57% and 66% of patients had a Physician’s Global Assessment (PGA) score of “clear” or “minimal” with the 100-mg dose at weeks 12 and 28, respectively. In addition, 64% and 78% of patients treated with a 200-mg dose of tildrakizumab achieved PASI 75 at weeks 12 and 28, respectively, and 59% and 69% had PGA scores of “clear” or “minimal” at those time points.
The data further showed that a higher number of patients receiving tildrakizumab achieved PASI 90 and PASI 100 compared with placebo and etanercept. An average of 37% and 36% of patients treated with tildrakizumab achieved PASI 90 at week 12 with the 100-mg and 200-mg doses, respectively, which increased to 54% and 59% at week 28. Moreover, an average of 13% of those receiving tildrakizumab achieved PASI 100 at week 12 regardless of the dose, with increases to 24% for the 100 mg-dose and to 30% for the 200-mg dose at week 28.
In both trials, the rates of severe infections, malignancies, and extended major cardiovascular events (MACE) were low and similar across treatment groups (1% to 3%).
Tildrakizumab is an investigational humanized, anti–IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23.
Source: Sun Pharma; October 1, 2016.