Tildrakizumab for moderate-to-severe plaque psoriasis with scalp involvement: Results from a phase IIIb trial

A multicenter, randomized, double-blind, placebo-controlled, phase IIIb trial (NCT03897088) is evaluating the safety and efficacy of tildrakizumab, an anti-interleukin (IL)-23 p19 monoclonal antibody, for the treatment of adult patients with moderate-to-severe plaque psoriasis with scalp involvement.¹ Week 16 results from this trial were published in the Journal of the American Academy of Dermatology by Gebauer et al.¹

The primary endpoint was met; more patients in the tildrakizumab 100 mg arm (n = 89) compared with those in the placebo arm (n = 82) achieved an Investigator Global Assessment modified 2011 of the scalp (IGA mod 2011 [scalp]) response at Week 16 (49.4% vs 7.3%; p <0.00001).

Tildrakizumab was also associated with higher rates of a ≥90% improvement from baseline Psoriasis Scalp Severity Index (PSSI) score vs placebo at Week 12 (48.3% vs 2.4%; p <0.00001) and Week 16 (60.7% vs 4.9%; p <0.00001), indicating substantial clinical efficacy in reducing scalp psoriasis severity. 

Tildrakizumab was well tolerated with no new safety signals, no discontinuations due to adverse events, and no deaths reported through Week 16.