Guselkumab Demonstrates Long-Term Efficacy, Safety in Patients With Psoriasis

Results of a real-world, retrospective study indicated that guselkumab showed high drug survival, safety, and long-term efficacy over 36 months in patients with psoriasis, according to research published in Dermatology and Therapy.¹

Jan Hugo, MD

“Patients who participate in clinical trials are quite different from those seen in daily clinical practice for many reasons (eg, strict exclusion criteria, age distribution),” Jan Hugo, MD, associated with the Department of Dermatovenereology at Charles University in the Czech Republic, and colleagues, wrote.

“Therefore, real-world evidence (RWE) provides important information about specific attributes of different biologics in different patients. Due to the novelty of the drug, there is a strong need for long-term, real-world data.”

Investigators utilized Czech Republic registry (BIOREP) data of adult patients with moderate-to-severe psoriasis being treated with guselkumab. The database included information on demographics, comorbidities, safety and efficacy of treatment, Psoriasis Area and Severity Index (PASI) scores, and Dermatology Life Quality Index (DLQI) scores. In addition to demographics, disease course, family health history, personal medical history, smoking status, and previous systemic and biologic treatment information were collected. All patients that have received 1 or more doses of guselkumab 100 mg administered subcutaneously were eligible for the study.

Ultimately, 333 patients were included in the analysis. Most patients were male (66.7%; n = 222), the mean age at guselkumab initiation was 48.6 years, and the mean disease duration was 22.1 years. At the 36-month mark, 58 patients completed treatment.

Patients receiving guselkumab reported significant improvements in the PASI score, with the mean PASI score decreasing from 16 at baseline to 0.7, 0.9, and 0.8 after 12, 24, and 36 months of treatment, respectively. The absolute PASI scores ≤ 3 and ≤ 1 were attained in 93.9% and 77.9%, respectively, at 12 months, 77.9% and 94.2%, respectively, at 24 months, and 94.8% and 70.7%, respectively, at the end of the study period.

PASI 90 was achieved in 81.8%, 75.4%, and 75.9% at 12, 24, and 36 months, respectively. PASI 100 was attained in 57.1%, 50.7%, and 55.2% at 12, 24, and 36 months of treatment, respectively. Bio-naïve and normal-weight patients were more likely to achieve PASI 90 and PASI 100 when compared with bio-experienced and overweight patients; however, psoriatic arthritis (PsA) did not influence results.

The DLQI score also showed significant improvement, with mean DLQI scores decreasing from 14.2 at baseline to 0.9, 1.0, and 0.7 at 12, 24, and 36 months, respectively. Patients achieving PASI 100 reported lower DLQI when compared with patients with PASI 90.

A total of 26 adverse events were noted in 23 patients (6.9%), with the most common being COVID-19. Only 0.6% of patients discontinued treatment due to adverse events. The main reason for discontinuation was loss of effectiveness (7.1%).

The drug survival rate was high and minimally declined throughout the study period, reaching 91.6% at 12 months and 85.5% at 36 months. Drug survival was not impacted by presence of PsA, weight, or previous biological treatment.

The long follow-up period with a large sample of patients strengthened the study, along with the analyses of skin improvement and drug survival. However, the retrospective nature and absence of a control group hindered results.

“This study confirmed data from clinical trials and previous real-world analyses regarding the high efficacy and good safety profile of guselkumab,” Hugo concluded. “We were able to show that both efficacy and safety remain stable over a long time period and do not tend to deteriorate in any significant way.”

References

1. ^{Hugo J, Kojanova M, Turkova B, Gkalpakiotis S; BIOREP Study Group. Long-Term Efficacy, Safety, and Drug Survival of Guselkumab in Patients with Psoriasis: Real-World Data from the Czech Republic BIOREP Registry [published online ahead of print, 2023 Feb 1]. Dermatol Ther (Heidelb). 2023;1-15. doi:10.1007/s13555-023-00893-4}