Effectiveness and safety of guselkumab for the treatment of psoriasis in real‐world settings at 24 weeks: A retrospective, observational, multicentre study by the Spanish Psoriasis Group

Abstract

Data on the effectiveness and safety of a drug in real‐world clinical practice complement the evidence from clinical trials, which are carried out in a different setting. Little has been published on the effectiveness and safety of guselkumab in the treatment of psoriasis in clinical practice. The ojective of this study was to assess the effectiveness and safety of guselkumab at 24 weeks in patients with moderate to severe plaque psoriasis in routine clinical practice. A retrospective, multicentre study of adult patients with moderate to severe plaque psoriasis treated with guselkumab for at least 24 weeks was carried out in Spain. We studied 343 patients, 249 of whom were followed for 24 weeks. By week 24, the mean (SD) psoriasis area severity index (PASI) had decreased from 11.1 (7.3) to 1.7 (2.8) (−9.3; [−10.2;‐8.4]), 85.9% of the patients had achieved PASI score of 4 or less and 77.9% a PASI score of 2 or less. In terms of relative PASI response, 59.4% of the patients achieved a PASI‐90 response and 49.0% a PASI‐100 response. On multivariate analysis, two factors reduced the probability of a PASI of 2 or less at 24 weeks: a BMI ≥30 (OR, 0.44; 95% CI, 0.22–0.88) and a greater previous exposure to biologic therapy (OR, 0.69; 95% CI, [0.56–0.84]). Adverse events were rare (9.9%) and led to withdrawal from treatment in only nine patients (2.6%) by the end of the follow‐up period. The results of this study confirm the high efficacy and safety of guselkumab indicated by the clinical trial data. In clinical practice, the absolute PASI score appears to be a better marker of response to treatment than the relative value.

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

“…Our results in terms of efficacy are lower than those reported in the NAVIGATE study but comparable with other GUS series in real clinical practice. In our cohort, 72% of the patients studied achieved PASI <3 at week 24, data similar to the 77.9% reported in the Spanish series of the psoriasis group 11 or in the Fougerousse series, with 40.2% of patients achieving PASI-90 at week 16. 8 The safety profile was reasonable, with a 5.5% rate of adverse events, none of which led to GUS discontinuation.…”

“…The Spanish series, which does not describe this subgroup in depth, and the Fourgerousse series, which does, but with a shorter follow-up time. 8,11 Both series contain younger patients (mean age: 48.3 and 45.5 respectively vs 52). In Fourgerousse series, UTK to GUS transition was carried out in 35% of the patients studied.…”

“…Regarding the dosing regime, 70% of our patients did not receive an induction dose, a much higher percentage than the 5.5% or 10% reported in previous series. 10,11 Moreover, in 38.8% of our patients the dosing regime was optimized by increasing the administration interval. This is also higher than the 14.6% previously reported.…”

Efficacy of Tildrakizumab Across Different Body Weights in Moderate-to-Severe Psoriasis Over 5 Years: Pooled Analyses from the reSURFACE Pivotal Studies

“…Recent real-world evidence suggests that an obese or overweight status might lead to decreased efficacy, even in IL-23p19 inhibitors (i.e. guselkumab, risankizumab) [49][50][51][52]. In clinical trials, however, this was not the case [53,54].…”

Switch from ustekinumab to guselkumab in patients with psoriasis in real clinical practice using the “minimal disease activity” parameter

“…The interleukin (IL)-23/Th17 axis is crucial in the pathogenesis of psoriasis, and the selective inhibition of IL-23 with guselkumab has shown to be highly effective in patients with inadequate response to IL-12/ IL-23 blockade with ustekinumab. 1,2 Hence, we aimed to address the effectiveness of guselkumab in real-life cohorts, dealing with more complicated patients (e.g., multiple comorbidities, common previous biologic failure) previously treated with ustekinumab.…”