Tildrakizumab for the treatment of moderate-to-severe psoriasis: a 52-week, real-world Portuguese multicentric study.

Background: Real-world evidence plays a pivotal role in validating the efficacy of biologic drugs beyond the controlled environment of randomized trials. This study aimed to evaluate the effectiveness of tildrakizumab in treating moderate-to-severe psoriasis within a real-world setting over a 52-week period in Portugal.
Methods: This multicentric, prospective, observational study included adult patients with moderate-to-severe psoriasis. All participants received tildrakizumab 100 mg at weeks 0 and 4, followed by a maintenance dose every 12 weeks, and were monitored for 52 weeks. Primary endpoints were determined based on Psoriasis Area and Severity Index (PASI) assessments at baseline, 16 (±2) weeks, 28 (±2) weeks and 52 (±2) weeks.
Results: A total of 54 patients were enrolled in the study (56% men, mean age of 50.3 ± 14.4 years). Half of the sample ( n =27) had no prior experience with biologic treatments. About 74% of patients ( n =40) presented at least one comorbidity during the study, with psoriatic arthritis being the most prevalent (29.6%). By week 52, there was a significant decrease in the mean PASI from 17.8±10.3 at baseline to 1.3±1.9 ( p <0.001), indicating an overall improvement of 93%. By week 52, more than 85% of patients attained PASI ≤5, more than 80% reached PASI ≤3, and nearly 60% achieved PASI ≤1. Infections were observed in 9.3% of patients, and one patient required hospitalization (1.9%). The cumulative proportion of patients continuing treatment at 52 weeks was 88.9%.
Conclusions: This study demonstrates that tildrakizumab is an effective and safe agent for the treatment of moderate-to-severe psoriasis in a diverse, real-world setting.
Competing Interests: Disclosure and potential conflicts of interest: TT has received consultancy and/or speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Amgen, Almirall, Arena Pharmaceuticals, Biocad, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Fresenius-Kabi, Janssen, LEO Pharma, Eli Lilly, MSD, Mylan, Novartis, Pfizer, Samsung-Bioepis, Sanofi-Genzyme, Sandoz and UCB. He is also Associate Editor for Drugs in Context. PV has received consultancy and/or speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Boehringer Ingelheim, Janssen, Leo, Lilly, Novartis, Pfizer, Sanofi and Sandoz. PM-B has received honoraria for acting as a consultant and/or speaker for AbbVie, Pfizer, Janssen, LEO Pharma, Novartis, Sanofi, Teva, Bayer and L’Oreal. SM has no conflicts to disclose. MH has received consultancy and/or speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Janssen, LEO Pharma, Novartis, Pfizer and Sanofi-Genzyme. PF has received honoraria for acting as a consultant and/or speaker for AbbVie, Janssen, LEO Pharma, Eli Lilly, Novartis and Pfizer. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2024/02/dic.2023-12-5-COI.pdf
(Copyright © 2024 Torres T, Varela P, Mendes Bastos P, Magina S, Henrique M, Ferreira P.)