CONFERENCE UPDATE: EADV 2025
Profiling guselkumab super responders in Chinese patients with moderate-to-severe psoriasis: Insights from a phase 4 RCT post-hoc analysis
Psoriasis is a chronic, immune-mediated inflammatory skin disease.1 The advent of highly effective biologics has transformed disease management, shifting treatment goals toward achieving near-complete or complete skin clearance.1 Guselkumab, a fully human monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), is approved for the treatment of moderate-to-severe psoriasis.1 At the EADV Congress 2025, Professor Zheng Min from The Second Affiliated Hospital Zhejiang University in China, presented results from a post-hoc analysis of a phase 4 randomized clinical trial (RCT), offering new insights into predictors of exceptional clinical response to guselkumab in Chinese patients.1
In the global phase 3 VOYAGE 1 and 2 studies, 40.8% of patients receiving guselkumab achieved a “super response”, defined as Psoriasis Area and Severity (PASI) 0 at both week 20 and week 28.1 A recent trial in China further affirmed its effectiveness and favorable tolerability in Chinese patients with moderate-to-severe psoriasis.1 However, the characteristics of super responders (SRes) in this population remain unclear.1 This post-hoc analysis therefore examined the proportion of patients who achieved super response and compared the baseline characteristics of guselkumab-treated SRes and non-super responders (non-SRes) in the Chinese post-approval commitment (PAC) study.1
The randomized, double-blind, placebo-controlled phase 4 trial was conducted across 26 sites in China.1 Eligible adults with moderate-to-severe plaque psoriasis had an Investigator’s Global Assessment (IGA) score of ≥3, a PASI score of ≥12, and body surface area (BSA) involvement of ≥10%, and were eligible for either systemic therapy or phototherapy.1 At baseline, patients were randomized 2:1 to receive guselkumab 100mg or placebo, with placebo patients crossing over to guselkumab treatment at week 16.1 Both groups received subcutaneous injection according to a predefined dosing schedule and were followed up for 48 weeks, with an additional safety follow-up until week 56.1
The post-hoc analysis assessed the proportion of guselkumab-treated patients achieving super response (PASI 100) at both week 20 and week 28, and compared the baseline demographics and disease characteristics between SRes and non-SRes.1 Patients with missing PASI assessments at either week 20 or 28 were classified as non-SRes.1 Among the 217 patients assigned to the guselkumab group, 53.6% achieved PASI 100 at week 20, increasing to 58.9% by week 28.1 Overall, 45.2% were identified as having super response (complete skin clearance at both week 20 and week 28).1
SRes were slightly younger, with 64.3% aged <45 years compared to 59.7% in non-SRes.1 SRes generally had lower body weight, with 93.8% weighing <90kg compared to 85.7% in non-SRes.1 While SRes were more likely to be overweight (body mass index [BMI] 24 to <28kg/m2) (43.3% vs. 29.4%), they were less likely to be obese (BMI ≥28kg/m2) (17.5% vs. 27.7%) compared to non-SRes.1 SRes were also less likely to have comorbid hyperlipidemia (19.4% vs. 25.2%) or hyperuricemia (7.1% vs. 15.1%).1
Moreover, baseline disease severity was lower in SRes: 54.1% of SRes had PASI scores ≥20 (vs. 58.0% in non-SRes), 69.4% had BSA ≥20% (vs. 79.8% in non-SRes), and 19.4% had an IGA score of 4 (vs. 26.9% in non-SRes.1 Notably, SRes were more likely to have never used prior non-biologic systemic therapy for psoriasis compared to non-SRes (67.4% vs. 51.3%).1 Logistic regression analysis identified the absence of prior non-biologic systemic therapy as a significant predictor of achieving super response (odds ratio [OR]=0.520; 95% CI: 0.292-0.914).1
In summary, SRes to guselkumab tended to be younger, have lower body weight, have moderate psoriasis at baseline, and have never used non-biologic systemic treatment, with the latter identified as a significant predictor of exceptional response.1
