Dermatology (Basel, Switzerland) · 2024
Time to Loss of Disease Control following Guselkumab Withdrawal in Relation to Initial Speed of Response: A post hoc Analysis of the VOYAGE 2 Trial.
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Kirby Brian, Chiricozzi Andrea, Gorecki Patricia, Buyze Jozefien, Parker Raphaelle, Wegner Sven, Puig Lluis
Аннотация
BACKGROUND: Psoriasis is a chronic inflammatory skin disorder typically requiring lifelong treatment. As such, patients may occasionally need treatment breaks. Understanding factors predicting maintenance of disease control during treatment breaks could improve long-term disease management. This post hoc analysis of data from the phase 3 VOYAGE 2 clinical trial evaluates how initial speed of response to guselkumab treatment affects time to loss of disease control following treatment withdrawal and identifies baseline characteristics corresponding with maintenance of disease control.
METHODS: Patients with moderate-to-severe plaque psoriasis were assigned to treatment withdrawal following achievement of a Psoriasis Area and Severity Index (PASI) 90 response after two or four guselkumab doses. Loss of disease control was defined as time to PASI ≥3 and was assessed using Kaplan-Meier analysis. The relationship between baseline characteristics and maintenance of response was evaluated using a Cox proportional hazards model.
RESULTS: Of patients who were randomized to placebo and switched to guselkumab at week 16, 149/248 (60%) achieved PASI90 after two guselkumab doses (week 28). Of patients who were randomized to guselkumab, 377/496 (76%) had a PASI90 response after four guselkumab doses (week 28), of whom 182 were then re-randomized to withdrawal. Of these, 131 had achieved PASI90 after two guselkumab doses (week 12) and 51 had achieved PASI90 after four guselkumab doses (week 28). Maintenance of disease control following guselkumab withdrawal was longer in patients who achieved PASI90 after two versus four guselkumab doses. Lower body mass index, biologic-naïve status, and shorter disease duration at baseline corresponded with a longer time to PASI ≥3 following withdrawal.
CONCLUSION: Faster initial response to guselkumab resulted in longer maintenance of disease control after treatment withdrawal. These findings may be used to inform personalized dosing strategies with guselkumab, which may increase patient compliance to treatment and improve long-term treatment outcomes.
METHODS: Patients with moderate-to-severe plaque psoriasis were assigned to treatment withdrawal following achievement of a Psoriasis Area and Severity Index (PASI) 90 response after two or four guselkumab doses. Loss of disease control was defined as time to PASI ≥3 and was assessed using Kaplan-Meier analysis. The relationship between baseline characteristics and maintenance of response was evaluated using a Cox proportional hazards model.
RESULTS: Of patients who were randomized to placebo and switched to guselkumab at week 16, 149/248 (60%) achieved PASI90 after two guselkumab doses (week 28). Of patients who were randomized to guselkumab, 377/496 (76%) had a PASI90 response after four guselkumab doses (week 28), of whom 182 were then re-randomized to withdrawal. Of these, 131 had achieved PASI90 after two guselkumab doses (week 12) and 51 had achieved PASI90 after four guselkumab doses (week 28). Maintenance of disease control following guselkumab withdrawal was longer in patients who achieved PASI90 after two versus four guselkumab doses. Lower body mass index, biologic-naïve status, and shorter disease duration at baseline corresponded with a longer time to PASI ≥3 following withdrawal.
CONCLUSION: Faster initial response to guselkumab resulted in longer maintenance of disease control after treatment withdrawal. These findings may be used to inform personalized dosing strategies with guselkumab, which may increase patient compliance to treatment and improve long-term treatment outcomes.