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The reSURFACE 1 (64-week) and reSURFACE 2 (52-week) trials were conducted as randomized, double-blinded, parallel-group, placebo-controlled phase 3 trials.
Over a span of 5 years, Tildrakizumab exhibited a positive safety profile in psoriasis patients, characterized by low occurrence rates of severe infections, malignancies, and major adverse cardiovascular events. These rates were found to be similar to those observed in the psoriasis reference registries.
The reSURFACE 1 (64-week) and reSURFACE 2 (52-week) trials were conducted as randomized, double-blinded, parallel-group, placebo-controlled phase 3 trials. The objective of this study was to examine the safety data spanning 5 years from the reSURFACE 1/2 phase 3 trials in terms of events per 100 person-years of exposure, along with determining the number needed to harm (NNH) for the incidence of a single adverse event of special interest (AESI).
A pooled analysis was performed using data from 2 randomized controlled trials involving 1800 individuals having moderate-to-severe plaque psoriasis. The Psoriasis Longitudinal Assessment and Registry (PSOLAR) served as the safety reference data for calculating the NNH.
The rates of AESI observed with Tildrakizumab were in line with the rates noted in the PSOLAR data. The NNH for severe infection occurrence over one year was 412 for 200 mg Tildrakizumab, and was negative for 100 mg Tildrakizumab because of reduced rates in the reSURFACE trials.
For malignancy, the NNH over one year was 990 with 100 mg Tildrakizumab (negative for 200 mg Tildrakizumab), and for major adverse cardiovascular events, the NNH over one year was 355 with 200 mg Tildrakizumab (negative for 100 mg Tildrakizumab).
Over 5 years, Tildrakizumab showed positive safety results with minimal AESI occurrences, aligning with PSOLAR data. This led to notably high or negative NNH for Tildrakizumab-associated AESI, because of lower event rates.
Journal of Dermatological Treatment
Five-year safety of Tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest
Alexander Egeberg et al.
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