Real-World Effectiveness and Safety of Tildrakizumab in Patients With Moderate-to-Severe Psoriasis: Week 28 Interim Analysis of a Phase 4 Study

August 2023 | Volume 22 | Issue 8 | 754 | Copyright © August 2023


Published online July 25, 2023

Jayme Heim MSN FNP-BCa, J. Gabriel Vasquez MDa, Brad Schenkel MSb, Neal Bhatia MDc

aWest Michigan Dermatology, Grandville, MI
bSun Pharmaceutical Industries, Inc., Princeton, NJ
cTherapeutics Clinical Research, San Diego, CA



Effectiveness
Patients experienced significant improvement in disease severity by multiple measures as early as week 4, with further improvements by week 28. The PASI score decreased from a mean ± SD of 11.6 ± 7.1 (median, 10.5; range, 2.7 to 33.8) at baseline to 6.5 ± 5.1 at week 4 (mean percent improvement, 45.3%; P<0.001) and to 1.8 ± 3.0 at week 28 (mean percent improvement, 82.1%; P<0.001; Figure 1A–B). At week 28, the PASI 75 response rate was 76.9%, the PASI 90 response rate was 55.8%, and the PASI 100 response rate was 21.2% (Figure 1C–E). 

Mean ± SD BSA decreased from 14.5 ± 11.5 at baseline to 11.6 ± 10.6 at week 4 (mean percent improvement, 21.6%) and further decreased to 2.9 ± 6.4 by week 28 (mean percent improvement, 73.1%; both P<0.001; Figure 2A–C). The mean ± SD sPGA was 3.2 ± 0.6 at baseline and decreased to 2.1 ± 0.7 by week 4 (mean percent improvement, 33.9%; P< 0.001) and to 1.2 ± 0.9 by week 28 (mean percent improvement, 61.7%; P<0.001; Figure 3A–C). The mean (± SD) calculated sPGA x BSA decreased from 47.0 ± 41.5 at baseline to 26.0 ± 26.2 at week 4 (mean percent improvement, 43.9%; P<0.001) and to 6.8 ± 20.3 at week 28 (mean percent improvement, 80.1%; P<0.001; Figure 4A–C).