Background: Guselkumab has been shown to be safe and effective for the treatment of psoriasis in numerous randomized clinical trials and real-life studies. Real life data on treatment up to 4 years are lacking. Objectives: The present study aims to estimate the drug survival DS, effectiveness, and safety of guselkumab over a period of 208 weeks (w). Methods: We included all consecutive patients with psoriasis or psoriatic arthritis receiving at least 1 dose of guselkumab. Effectiveness was evaluated according to the achievement of PASI100, 90 and <=3. DS was evaluated according to Kaplan-Meyer curve. Results: In atotal of 202 patients theeanPASI decreased from 10.88 (SD 5.76) at baseline to 0.48 at 208w. PASI100 showed an increasing response, the outcome was achieved in 30%, and 64.71% of patients at 16W, and 208W, respectively. For PASI90 and<=3 we found a similar trend. 208w of treatment, the estimated DS was 68.5% on observed cases. Being Super Responders (SRs) according to our (p=0.005) and the GUIDE definition (p<0.001), along with cardiovascular comorbidities reduced the risk of drug interruption. In our population none of the baseline characteristics showed a clear impact on the effectiveness of guselkumab. Considering both SR definitions, in our cohort being a SRs is associated with better response in the long-term when considering PASI100 and 90 in both linear and multivariate analysis. Conclusions: Our study confirms the good effectiveness and favorable safety profile of guselkumab in a real-world setting up to four years.
Drug survival, effectiveness, and safety of guselkumab for moderate-to-severe psoriasis for up to 4 years
Mastorino, Luca
First
;Ortoncelli, Michela;Stroppiana, Elena;Astrua, Chiara;Fiasconaro, Chiara;Liao, Yingying;Gallo, Giuseppe;Quaglino, Pietro;Ribero, Simone
2025-01-01
Abstract
Background: Guselkumab has been shown to be safe and effective for the treatment of psoriasis in numerous randomized clinical trials and real-life studies. Real life data on treatment up to 4 years are lacking. Objectives: The present study aims to estimate the drug survival DS, effectiveness, and safety of guselkumab over a period of 208 weeks (w). Methods: We included all consecutive patients with psoriasis or psoriatic arthritis receiving at least 1 dose of guselkumab. Effectiveness was evaluated according to the achievement of PASI100, 90 and <=3. DS was evaluated according to Kaplan-Meyer curve. Results: In atotal of 202 patients theeanPASI decreased from 10.88 (SD 5.76) at baseline to 0.48 at 208w. PASI100 showed an increasing response, the outcome was achieved in 30%, and 64.71% of patients at 16W, and 208W, respectively. For PASI90 and<=3 we found a similar trend. 208w of treatment, the estimated DS was 68.5% on observed cases. Being Super Responders (SRs) according to our (p=0.005) and the GUIDE definition (p<0.001), along with cardiovascular comorbidities reduced the risk of drug interruption. In our population none of the baseline characteristics showed a clear impact on the effectiveness of guselkumab. Considering both SR definitions, in our cohort being a SRs is associated with better response in the long-term when considering PASI100 and 90 in both linear and multivariate analysis. Conclusions: Our study confirms the good effectiveness and favorable safety profile of guselkumab in a real-world setting up to four years.
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