Achieves primary end point in both phase-3 studies in patients with moderate-to-severe plaque Psoriasis
Sun Pharma announces late-breaking data from two pivotal phase III clinical trials (reSURFACE 1 and 2). It achieved the primary endpoint with tildrakizumab, an investigational IL-23p19 inhibitor, in patients with moderate-to-severe plaque psoriasis at the 25th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria.
The phase III data results through week 28 are being presented for the first time as part of the “Late Breaking News” Session at the premier European dermatology conference. Tildrakizumab clinical trials included over 1,800 patients from more than 200 clinical trial sites worldwide.
In the trials, an average of 63 per cent of patients achieved 75 per cent of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12 after only two injections, and 77 per cent achieved 75 per cent skin clearance after 28 weeks and three injections of the 100 mg dose of tildrakizumab (64 per cent and 80 per cent in reSURFACE1, 61 per cent and 74 per cent in reSURFACE2). Similarly, an average of 57 per cent and 66 percent 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.
Those receiving the 200 mg dose also saw an average of 64 per cent and 78 per cent of patients achieving PASI 75 at weeks 12 and 28 respectively. Also, 59 per cent and 69 per cent of the patients had PGA score of “clear” or “minimal” at weeks 12 and 28 respectively.
The data showed that a higher number of patients on tildrakizumab achieved PASI 90 and 100 compared to placebo and etanercept. An average of 37 per cent and 36 per cent of patients achieved PASI 90 at week 12 with the 100 mg dose and 200 mg dose respectively which increased to 54 per cent and 59 per cent at week 28. Correspondingly, an average of 13 per cent on tildrakizumab achieved PASI 100 at week 12 regardless of dose with an increase to 24 per cent for the 100 mg dose and 30 per cent for the 200 mg dose at week 28.
The overall safety profile of tildrakizumab in both phase III clinical trials was consistent with the safety data observed in previously reported studies. The incidences of severe infections, malignancies, and extended major cardiovascular events were low and similar across treatment groups (1-3 per cent).
EP News Bureau