Bio-Naïve Patients with Psoriasis Show Greater Efficacy After Using Guselkumab

Bio-naïve individuals with psoriasis and those without comorbidities may see distinctly positive responses to guselkumab therapy in terms of efficacy and safety, new findings suggest, supporting early implementation of guselkumab in patients with recent-onset psoriasis.1

This new research was authored by investigators such as Yayoi Tada, from the Department of Dermatology at Teikyo University in Japan. Tada and colleagues set out to evaluate guselkumab’s real-world safety and effectiveness among Japanese patients with psoriasis, conducting a multicenter study using a single-arm, prospective, post-marketing surveillance trial design.

“We, therefore, conducted a prospective, post-marketing, surveillance study of guselkumab in Japanese patients with PsV, PsA, GPP, or EP,” 1,2 Tada and colleagues wrote. “The interim results at week 20 of treatment were reported previously. This paper reports the real-world safety and effectiveness of guselkumab up to 52 weeks, focusing on the impact of patient factors on responses to treatment.”

Trial Design and Findings

The investigative team looked at Japanese patients with diagnoses of psoriasis vulgaris (PsV), erythrodermic psoriasis (EP), psoriatic arthritis (PsA), or generalized pustular psoriasis (GPP), involving them as subjects within 14 days of their first guselkumab administration. This was done provided the participants had begun therapy in the timeframe between May 2018 - October 2020 at participating institutions.

The team observed each of these individuals for 52 weeks following their initial guselkumab injection or until the point of treatment cessation. Subcutaneous administration of guselkumab was provided for subjects at a dosage of 100 mg, with each provided with the medication at the 0 and 4-week marks followed by every 8 weeks, subsequently.

At each patient's registration, the investigators recorded their baseline characteristics, highlighting such elements as their condition's severity, their psoriasis type, medical histories, and comorbid conditions. Throughout the observation period, they would gather data on guselkumab therapy, concurrent treatments, and safety signals.

Using several measures, the investigators looked at guselkumab's efficacy. These included clinical global impressions (CGI) as determined by treating physicians, the Psoriasis Area and Severity Index (PASI; range 0–72, with higher scores suggesting greater severity), the Dermatology Life Quality Index (DLQI; range 0–30, with higher scores suggesting greater impairment), the patient global assessment of disease activity (PtGA), and the Disease Activity Score 28 (DAS28) based on C-reactive protein (CRP).

All throughout the investigation, the research team carried out safety assessments regarding adverse events (AEs), adverse drug reactions (ADRs), serious AEs, and serious ADRs. The team highlighted the definition of ADRs as AEs for which a causal association with guselkumab could not be excluded by those investigating the drug or by study sponsors.

Key safety concerns included serious infections, severe hypersensitivity reactions, malignancy, neutrophil count reduction, and major adverse cardiovascular events.

The investigators' safety assessment included 416 individuals, among whom 310 reported PsV. In their effectiveness analysis, the population was comprised of 251 individuals, with 236 reporting PsV or PsA. Among those involved in the PsV arm, males made up 71.3%, with the group showing a median age of 58 years and a median disease duration of 11.5 years.

The presence of comorbidities was highlighted among in 50.0% of participants, with prior biologic therapy being noted among 41.3%.1 The analysis demonstrated that 8.4% of subjects experienced 49 ADRs, and 2.9% reported 13 serious ADRs. The investigative team further noted that 3.4% were shown to have 16 AEs that resulted in cessation of treatment.

Among the 236 subjects with PsV or PsA in the efficacy assessment, the team found that PASI response rates at the 52-week mark were as follows: PASI 75 was achieved by 69.9% of individuals, PASI 90 by 54.5%, and PASI 100 by 32.5%.1 Among those who were shown to be biologic-naïve, consistently higher PASI 75 and PASI 90 response rates were highlighted compared to individuals with prior biologic exposure.

“In conclusion, this prospective, post-marketing, surveillance study demonstrated that guselkumab was well-tolerated and effective in Japanese patients with psoriasis in a real-world setting,” they concluded.1 “No new safety concerns were identified.”

References

1. Tada Y, Sugiura Y, Kamishima M, Takahashi S, Tanaka Y, Masuda J, et al. Real-world safety and effectiveness of guselkumab in patients with psoriasis: A post-marketing surveillance study through up to week 52 in Japan. J Dermatol. 2025; 00: 1–16. https://doi.org/10.1111/1346-8138.17710.

2. Tada Y, Sugiura Y, Kamishima M, Tanaka Y, Tsuchiya H, Masuda J, et al. Safety and effectiveness of guselkumab in Japanese patients with psoriasis: 20-week interim analysis of a postmarketing surveillance study. J Dermatol. 2024; 51: 779–790.