Efficacy and Safety of Tildrakizumab for Treatment of Moderate-to-Severe Scalp Psoriasis in Patients with Obesity Over 52 Weeks

INTRODUCTION: Obesity contributes to inflammation and may decrease psoriasis treatment efficacy. We investigated whether obesity affects the efficacy and safety of tildrakizumab, an anti-interleukin-23 p19 antibody approved for the treatment of adults with moderate-to-severe plaque psoriasis, for scalp psoriasis treatment. METHODS: ). Efficacy outcomes included an Investigator Global Assessment (IGA) modified 2011 (scalp) (IGA mod 2011 [scalp]) score of "clear"/"almost clear" (0/1) with a ≥ 2-point reduction (IGA mod 2011 [scalp] response), ≥ 90% improvement in Psoriasis Scalp Severity Index (PSSI) score (PSSI 90 response), ≥ 4-point reduction in Scalp Itch-Numeric Rating Scale (Scalp Itch-NRS response; among patients scoring ≥ 4 at baseline), and percent change from baseline (%CFB) in affected scalp surface area (SSA). Safety was assessed from adverse events. The analysis was not prospectively powered to detect differences between subgroups. RESULTS: In the intention-to-treat population, 56/117 (47.9%) patients randomized to tildrakizumab and 57/114 (50.0%) to placebo had obesity (modified intention-to-treat population: tildrakizumab, 43/89 [48.3%]; placebo, 40/82 [48.8%]). At Week 16, significantly more patients treated with tildrakizumab versus those receiving placebo achieved IGA mod 2011 (scalp) (obesity, 21/43 [48.8%] versus 4/40 [10.0%], p = 0.0002; no obesity, 23/46 [50.0%] versus 2/42 [4.8%], p < 0.0001) and PSSI 90 responses (obesity, 27/43 [62.8%] versus 4/40 [10.0%], p < 0.0001; no obesity, 27/46 [58.7%] versus 0/42 [0.0%], p < 0.0001). Treatment effect was also maintained for Scalp Itch-NRS response (p < 0.0001) and mean %CFB in affected SSA (no statistical testing), regardless of obesity status. Results in patients treated with tildrakizumab were similar through Week 52. No new safety signals were identified. CONCLUSIONS: No statistically significant differences in efficacy or safety were observed between patients with and without obesity. GOV IDENTIFIER: NCT03897088.