Ustekinumab to guselkumab transitions: A series of 54 patients emulating the navigate trial in real life

Abstract

NAVIGATE clinical trial demonstrated a higher rate of Psoriasis Assesment Severity Index (PASI)90 response in patients treated with guselkumab when compared to ustekinumab and an improved response in those who switched from ustekinumab to guselkumab due to partial response. The objective of the study is to describe ustekinumab to guselkumab switching in clinical practice. Observational, multicentric, descriptive study including 54 psoriasis patients who switched to guselkumab after treatment with ustekinumab from March 2019 to February 2021. Mean basal PASI with ustekinumab (16.7) was higher than with guselkumab (7.2). Up to 49.01% of patients were able to reach PASI90 with ustekinumab and up to 21.56% had a less frequent dosage regime vs. summary of product characteristics. Main reason to start guselkumab was a loss of ustekinumab cutaneous or articular response (82.36%) but up to 17.64% were switched in order to increase dosage regime efficiency. Six months after starting guselkumab, the absolute PASI was lower than 2 in 72% of patients and 38.5% of them were treated with a reduced dosage regime. Guselkumab doses used by our cohort were 19.5% lower than the expected according to the summary of product characteristics. No adverse events reported. There is no real-world evidence regarding patients who switched from ustekinumab to guselkumab. A short paragraph in the article by Fougerousse et al, reported 63 patients with a mean basal PASI of 5.3 and similar efficacy rate at week 16 to NAVIGATE. Our study adds practical information regarding efficacy, safety and efficiency through dose optimization in a real-world cohort.

Real‐life effectiveness and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: A 104‐week multicenter retrospective study – IL PSO (ITALIAN LANDSCAPE PSORIASIS)

“…Our retrospective study is one of the largest real‐life studies on guselkumab use in patients who failed ustekinumab, with a population of 233 patients. Our study confirmed data from both clinical trials and real‐life studies on the effectiveness of guselkumab in daily clinical practice in patients affected by moderate‐to‐severe plaque psoriasis with previous exposure to ustekinumab 12,14,16,17 . Compared with the Phase 3 clinical trial NAVIGATE, 12 which evaluated the effectiveness of guselkumab in patients with inadequate response to ustekinumab in 135 patients, our cohort was larger at baseline.…”

“…Our study confirmed data from both clinical trials and real-life studies on the effectiveness of guselkumab in daily clinical practice in patients affected by moderate-to-severe plaque psoriasis with previous exposure to ustekinumab. 12,14,16,17 Compared with the Phase 3 clinical trial NAVIGATE, 12 which evaluated the effectiveness of guselkumab in patients with inadequate response to ustekinumab in 135 patients, our cohort was larger at baseline. Our population was slightly older (with a mean age of 54.27 years vs. 44.2 years), with a lower BMI (27.56 vs. 30.3) and also included patients with previous exposure to anti-IL-17 drugs.…”

“…These findings are consistent with other real-life studies which evaluated the effectiveness of guselkumab in a cohort of multi-failure patients (including patients with previous exposure to anti-IL-17 drugs). 14,16,17,27,28 Guselkumab, along with other anti-IL-23 drugs, could also represent a valid therapeutic option in patients who failed several biologics.…”

“…Moreover, despite drug antibodies being associated with ustekinumab failure, the results of both clinical trials and real‐life experiences have shown that guselkumab effectiveness is not influenced by previous exposure to ustekinumab. These studies had limitations of short follow‐up and limited sample size 14–16 …”

“…These studies had limitations of short follow-up and limited sample size. [14][15][16] Our multicentric retrospective study aimed to assess the effectiveness and safety of guselkumab in 233 patients who received this drug after failing therapy with ustekinumab.…”