ABSTRACT
Background: Limited information is available from real-life studies evaluating the long-term efficacy and drug retention of ustekinumab.
Research design and methods: Data from 378 patients with moderate-severe psoriasis were retrospectively analyzed. Over 8 years, disease severity and treatment response were evaluated using the PASI score. Predictors of PASI response were evaluated by logistic regression. Ustekinumab retention rate was calculated by the Kaplan–Meier method.
Results: Over the 8 years, >80% of patients achieved a PASI score of <3 and PASI 75, 90 and 100 response was achieved in 76.2%, 61.9% and 57.1% of patients, respectively. Predictor variables for improved PASI response (after 2 years) were HLA-C*06-POS patients, female gender and BMI <30 Kg/M2. The 2-year retention rate was 81% and 59% after 8 years with mean retention rate of 5.4 years. Improved retention rate was observed in patients positive for the HLA-C*06 allele (3.7 vs. 2.5 years, p = 0.005) and female gender (3.7 vs. 3.3 years, p = 0.06), with no significant difference observed in other patient groups. Ustekinumab was generally well tolerated without evidence of cumulative toxicity or organ toxicity.
Conclusion: The long-term use of ustekinumab was observed to be effective and safe in patients with moderate-severe chronic psoriasis in a real world-setting.
Author Contributions
MG, LB, MT were involved in the conception and design of the study; MG, LB, MT, SD, DS, PL, AM MG, MT, recruited patients and data acquisition; MG, MT, and CGE were involved in the analysis and interpretation of the data; all authors contributed to drafting the paper/revising it critically for intellectual content and approved the final version of the manuscript to be published.
Declaration of interest
L Bianchi has served as speaker and as consultant for Abbvie, Novartis, Janssen-Cilag, Pfizer, UCB, and Leo-Pharma outside the submitted work. The authors have no other 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 apart from those disclosed.
Reviewer Disclosures
Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.
Supplementary Material
Supplemental data for the article can be accessed here.