Guselkumab: Mid‐term effectiveness, drug survival, and safety in real clinical practice

Abstract

Guselkumab is a fully human immunoglobulin-G1-lambda (IgG1λ) monoclonal antibody that binds selectively to the p19 subunit of interleukin 23. Few series of real clinical practice that reflect the use of guselkumab have been published so far, including the measure of survival at more than 52 weeks. An observational, longitudinal, retrospective study of real clinical practice of patients with moderate to severe psoriasis receiving treatment with guselkumab 100 mg subcutaneous every 8 weeks in five tertiary hospitals in Andalusia (Spain) was carried out. A total of 87 patients were included in this study. Disease severity and treatment response was assessed by PASI, BSA, VAS pruritus, and DLQI at baseline and after 4, 12, 24, 36, 52, and 76 weeks. Data are presented as mean ± SD for continuous variables, and number and percentage for categorical variables. To determine the differences between visits in PASI, BSA, VAS pruritus, and DLQI a Wilcoxon matched-pairs test was performed. The survival of guselkumab was calculated using Kaplan-Meier survival analysis. Our population presented with a mean age of 49.9 years, 60.9% of them were male, had a mean PSO evolution of 20.4 (9.5) years. A total of 79.3% were obese or presented with overweight and had several comorbidities (dyslipidemia 28.7%, arterial hypertension 23% and 20% diabetes among others). At baseline their disease parameters were: PASI = 14.6 (7.2), BSA = 22.3 (16.6), VAS pruritus = 6.0 (2), and DLQI = 15.8 (5). After 52 weeks their disease improved to PASI = 0.9 (1.1), BSA = 1.0 (1.8), VAS pruritus = 0.47 (0.88), and DLQI = 1.54 (2.50). The percentage of patients who achieved PASI 75, 90, and 100 at 52 weeks was 90.3%, 71%, and 51.6%, respectively. The patients evaluated at week 76 (n = 3) reached PASI 0, BSA 0, and DLQI 0. After 93.4 weeks (1 year, 9 months, and 14 days), the overall survival rate was 94% (4 events were reported). A total of four patients discontinue to AE or lack of efficacy after 76 weeks. Guselkumab showed excellent results in the control of psoriasis in the mid-term with an elevated number of patients maintaining treatment after 52 to 76 weeks and a good safety profile.

Real‐world evidence from the non‐interventional, prospective, German multicentre PERSIST study of patients with psoriasis after 1 year of treatment with guselkumab

“…The improvement in the mean DLQI score aligns with findings from other RWE studies of guselkumab. 22,23,28 A similar proportion of patients in PERSIST achieved a DLQI score of 0-1 at W52 as in VOYAGE 1 (62.5%) at W48. 12 Overall, guselkumabtreated patients reported improvements in HRQoL, demonstrating its effectiveness even in a population that has received previous biologic therapies.…”

Long-Term Efficacy and Safety of Guselkumab for Moderate to Severe Psoriasis: A 3-Year Real-Life Retrospective Study

“…An overall survival of 94% after 93.4 weeks of treatment with guselkumab was reported by Ruiz-Villaverde et al in an observational, longitudinal retrospective study as well. 25 …”

Real‐world drug survival of guselkumab, ixekizumab and secukinumab for psoriasis

“…A recently published retrospective study with 87 patients treated with guselkumab found an overall survival of 94% at 93Á4 weeks. 4 Another study found an overall 12-month drug survival rate of 84% for secukinumab and 87% for ixekizumab, with no significant differences between them. 5 Our study is limited by the small sample size and short follow-up period for guselkumab, but we have provided encouraging data supporting its efficacy and safety in real-world settings.…”

“…The number of patients with psoriasis treated with biologics increased dramatically in France between 2008 and 2016 (+1100% for adalimumab and +800% for ustekinumab). 4 Furthermore, the decline in phototherapy use should increase in the future as new TTs are expected to become available for the treatment of other dermatoses (e.g. vitiligo, alopecia areata, cutaneous Tcell lymphoma and graft-versus-host disease).…”