Guselkumab Effective, Well-Tolerated for Psoriasis in Real-World Clinical Settings

Guselkumab treatment is both efficacious and well-tolerated among patients with moderate-to-severe plaque psoriasis in a real-world clinical setting, according to recent findings in South Korea, regardless of previous biologic therapy experiences.1

These results represented the conclusion of research authored by such investigators as Bong Seok Shin, MD, PhD, from the Chosun University College of Medicine Department of Dermatology in South Korea. Shin et al. noted that research leading to regulatory approvals of guselkumab had been carried out within controlled settings and was likely not representative of real-world clinical settings.2

The team highlighted that routine clinical practice-specific information on the drug’s use for psoriasis would be informative for therapeutic treatment decision making.

“This observational study aimed to evaluate the effectiveness and safety of guselkumab in Korean patients with moderate-to-severe plaque psoriasis in a real-world clinical setting,” Shin and colleagues wrote.1 “This study was conducted to fulfill the requirement of a local pharmacovigilance plan after regulatory drug approval according to the risk management plan in South Korea.”

At 44 clinical centers in South Korea, the investigators carried out their prospective, non-interventional, observational study. Guselkumab is indicated for adult individuals living with moderate-to-severe plaque psoriasis who are also designated as candidates for systemic therapy or phototherapy in this country.

Those who were being given guselkumab based on the product label over the course of routine clinical practice were deemed by the investigative team as eligible for inclusion in this analysis.

To diminish any risk of selection bias for study participants, the team enrolled participants consecutively over the course of routine clinic appointments. The drug itself was administered through the use of subcutaneous injection following its approved dosing schedule: an initial dose of 100 mg at the 0 and 4-week mark. This was then followed by maintenance doses every 8 weeks. Those participating as subjects were monitored over a period of up to 56 weeks.

Medical records served as Shin and colleagues' primary data source. All information had been documented using case report forms. They highlighted that the timing and frequency of follow-up interactions aligned with standard clinical care practices.

At the point of baseline there were clinical assessments, as well as at the 4-week mark (visit 2). Assessments then would take place approximately every 8 weeks from the 12-week through 44-week mark (visits 3–7). In the timeframe between February 2019 - March 2022, there were 707 individuals enrolled in the analysis, and 79.5% of these individuals completed the full 56-week follow-up.

At the seventh visit, the investigative team observed the highest proportions of trial participants attaining absolute Psoriasis Area and Severity Index (PASI) scores of ≤3, ≤2, and ≤1, with 96.0%, 86.7%, and 59.0%, respectively.

Greater likelihood among biologic-naïve subjects was identified in achieving an absolute PASI ≤3 between visits 5 and 7, versus biologic-experienced individuals, with statistical significance achieved at the seventh visit (P = .001). In a similar vein, the team found that a substantially greater proportion of biologic-naïve subjects in the analysis attained an absolute PASI ≤2 at visits 6 and 7, with P = .0014 at the visit 7.

Steady improvements in scores on the Dermatology Life Quality Index (DLQI) throughout the study period were also observed by Shin and colleagues. Specifically, they noted 64.1% of trial participants reported a DLQI score of 0 or 1 by visit 7.

Such an improvement was highlighted by the investigators as consistent across different groups regardless of prior biologic use. For guselkumab, they found that the estimated 1-year drug survival rate had been 92.7%.

In looking at adverse events, the investigative team identified such events in 22.5% of subjects, which equated to an incidence rate of 42.1 events per 100 patient-years. When they evaluated serious adverse events, it was noted that such events took place in 1.8% of participants, with a total of 14 events, corresponding to an incidence rate of 2.4 per 100 patient-years (95% confidence interval: 1.2–3.7).

“The absence of a control group impacts interpretation of effectiveness outcomes, and missing data may affect the overall accuracy and completeness of the findings,” they noted.1 “In addition, the study did not analyze psoriasis responses based on anatomical regions affected or the types of prior biologics received...Lastly, as may be the case in any real-world study, under-reporting of less common AEs may occur.”

References

1. Shin BS, Kim M, Suh MK, et al (2025). Effectiveness and Safety of Guselkumab in Patients With Moderate-to-Severe Plaque Psoriasis in Real-World Practice in Korea: A Prospective, Multicenter, Observational, Postmarketing Surveillance Study. J Dermatol. https://doi.org/10.1111/1346-8138.17757.

2. G. Trifirò and S. Crisafulli, “A New Era of Pharmacovigilance: Future Challenges and Opportunities,” Frontiers in Drug Safety and Regulation 2 (2022): 866898, https://doi.org/10.3389/fdsfr.2022.866898.