ABSTRACT
Background
Real-world data for guselkumab, the first interleukin-23 inhibitor approved to treat moderate-to-severe psoriasis, are scarce. This study represents the first 60-week, real-life, multicenter, retrospective experience to investigate the effectiveness, safety, tolerability, and drug retention of guselkumab in psoriatic patients.
Research design and methods
Clinical information was collected at baseline and at weeks 12, 24, 36, 48, and 60.
Results
The mean baseline Psoriasis Activity Severity Index (PASI) reduced from 14.2 to 3.1 at week 12 and decreased to around 0 at weeks 36, 48, and 60. PASI 75, PASI 90, and PASI 100 were 100%, 96.8%, and 83.9% at week 60, respectively. Multiple logistic regression analysis showed that neither body mass index >30, smoking, ≥3 comorbidities, difficult-to-treat areas, nor a failure to ≥2 prior biologic treatments significantly influenced PASI reduction (p > 0.05).
Conclusions
Our findings confirm guselkumab as an appropriate therapeutic option in routine clinical practice, especially when dealing with complex patients with comorbidities or previous failure to biologic treatments.
Funding
This paper was not funded.
Acknowledgments
English-language editing was provided by Melanie Gatt (PhD), an independent medical writer, on behalf of Health Publishing & Services Srl.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
A reviewer on this manuscript has disclosed that they are an employee of the Mount Sinai Hospital System and have received research funds from AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Janssen/Johnson & Johnson, Leo Pharmaceuticals, Medimmune/AstraZeneca, Novartis, Pfizer, Sciderm, Valeant and ViDac. They are also a consultant for Allergan, Aqua, Boehringer-Ingelheim, LEO Pharma, Menlo, Mitsubishi, Promius and Theravance. Another reviewer on this manuscript has disclosed that they are a speaker and adviser for Janssen, AbbVie, Amgen, Eli Lilly, Leo, Novartis, Pfizer, Sun, Ortho and Union Chimique Belge. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.
Author contributions
F Bardazzi, F Viviani and F Filippi conceived and designed the study, recruited patients and were involved in data acquisition and were involved in the analysis and interpretation of the data; Y Merli conceived and designed the study; VG di Lernia, F Peccerillo, A Conti, C Lasagni, M Tabanelli, S D’Adamio, S di Nuzzo and C Cortellazzi recruited patients and were involved in data acquisition.