P48 Maintenance response of guselkumab in the Chinese population: an interim analysis of an observational study

Abstract Maintenance treatment with biologics is recommended for the treatment of moderate-to-severe psoriasis; however, treatment withdrawal occurs frequently in the real world. In a post-approval commitment (PAC) study (NCT04914429), guselkumab demonstrated efficacy in Chinese patients with moderate-to-severe plaque psoriasis. Here, we report interim analysis results from the observational post-PAC study evaluating health-related quality of life (HRQoL) and psoriasis relapse within 24 weeks following guselkumab withdrawal. This prospective, observational study enrolled patients who achieved a psoriasis area and severity index (PASI) 75 response at Week 44 in the PAC study. In the framework of a decentralized clinical trial design, patients utilized an electronic patient-reported outcome system to report on HRQoL, psoriasis status, and administration of systemic treatment for psoriasis. HRQoL was assessed by the dermatology life quality index (DLQI) at baseline, then every 12 weeks through Week 48. Psoriasis relapse was defined as the initiation of a new systemic treatment for psoriasis. Off-treatment duration (OTD) was defined as the time between the last guselkumab administration at Week 44 in the PAC study and the date of the first dose of any systemic treatment for psoriasis, loss to follow-up, death, or end of the study. A planned interim analysis was conducted when all patients had completed questionnaires 24 weeks after guselkumab withdrawal. The data cut-off (DCO) date was 3 June 2024. A total of 243 patients were enrolled. As of DCO, two patients withdrew from the study due to loss of follow-up. Most patients were male [n = 194 (79.8%)] and mean [standard deviation (SD)] age was 41.2 (12.3) years. At baseline, nearly all patients had PASI <3 [94.2% (229/243)] and Investigator’s Global Assessment 0/1 [91.4% (222/243)]. DLQI scores gradually increased after guselkumab withdrawal, from a mean (SD) of 4.8 (4.4) on the index date to 5.2 (4.6) at Week 12 and 7.2 (6.0) at Week 24 [mean (SD) change: 0.4 (4.5) at Week 12; 2.5 (6.2) at Week 24]. Overall, 5.8% (14/241) of patients had a psoriasis relapse. The mean (SD) OTD was 157.6 (1.1) days; the median OTD was not reached. Patients in this post-PAC study in China experienced gradual deterioration of HRQoL after guselkumab withdrawal. Only a small proportion of patients experienced a psoriasis relapse during 24 weeks of follow-up, suggesting treatment response was generally maintained after guselkumab withdrawal. Results from the planned interim analysis were not conclusive due to the limited duration of follow-up; long-term data analysis will be conducted upon study completion at Week 48.