The Food and Drug Administration has approved tildrakizumab, an interleukin-23 antagonist, for the treatment of moderate to severe plaque psoriasis in adults who are eligible for systemic therapy or phototherapy, according to a statement from Sun Pharma.
Tildrakizumab is administered at a dose of 100 mg, subcutaneously, at weeks 0 and 4, then every 12 weeks. Approval is based on data from two phase 3, identically designed clinical trials, reSURFACE1 and reSURFACE2 . Both studies were multicenter, randomized, double-blind, and placebo controlled. In the studies, 926 patients received tildrakizumab (616 patients) or placebo (310 patients).
Both studies demonstrated the effectiveness of tildrakizumab compared with placebo, based on Psoriasis Area and Sensitivity Index (PASI 75) responses and a Physician’s Global Assessment (PGA) score of clear or minimal at week 12 after receiving two doses. At week 12, 64% and 61% of those on tildrakizumab had achieved a PASI 75 score, compared with 6% of those on placebo; 58% and 55% of those on tildrakizumab had a PGA score of 0 or 1 (clear or minimal), compared with 7% and 4% of those on placebo.
The effectiveness of tildrakizumab extended beyond 12 weeks, with 74% of patients achieving a PASI 75 at 28 weeks after three doses. This percentage grew to 84% at week 64 in patients who continued treatment. Similar results were observed with PGA scores, with 69% of patients who had a PGA score of 0 or 1 at 12 weeks maintaining that score at week 28.
Tildrakizumab has been associated with serious side effects, including serious allergic reactions including skin rash, swelling of the face and mouth, trouble breathing, and chest tightness. It may also increase patient susceptibility to infection. It is approved with a Medication Guide for patients, explaining the potential risks associated with treatment.
Tildrakizumab will be marketed as Ilumya .
Sun Pharma is working with the FDA on postapproval commitments, and once that has been completed, they will have a better idea of when it will become available, according to a spokesperson for the manufacturer. The cost is not yet available.