Ustekinumab Demonstrates Superior Drug Survival Among Biologic-Naïve Psoriasis Patients in Large Danish Registry Study
Key Insights
Ustekinumab showed significantly superior drug survival compared to adalimumab and secukinumab among biologic-naïve psoriasis (search) patients, with a 5-year discontinuation risk of 37% versus 51% and 54% respectively.
Among bio-experienced patients, newer biologics including guselkumab, bimekizumab, and risankizumab demonstrated the highest 2-year drug survival rates compared to ustekinumab.
The nationwide Danish cohort study analyzed 4,438 psoriasis (search) patients from DERMBIO registry, providing real-world evidence on treatment persistence across eight different biologic therapies.
A comprehensive analysis of Denmark's national psoriasis (search) registry has revealed significant differences in drug survival rates among biologic therapies, with ustekinumab demonstrating superior persistence in treatment-naïve patients compared to other established biologics. The findings, published in JAMA, provide crucial real-world evidence for treatment selection in clinical practice.
Registry Study Reveals Treatment Persistence Patterns
The nationwide cohort study, led by Christopher Willy Schwarz, MD, PhD, from Copenhagen University Hospital–Herlev and Gentofte's Department of Dermatology and Allergy, analyzed data from DERMBIO, Denmark's national clinical registry covering more than 90% of biologic-treated psoriasis (search) cases across the country. The analysis included 4,438 individuals with diagnosed psoriasis, of whom 61.2% were male, with a mean age of 45.0 years at first treatment initiation.
Among biologic-naïve patients, the study examined 3,790 treatment series across three major biologics: 2,646 with adalimumab, 767 with ustekinumab, and 377 with secukinumab. The standardized risk of drug discontinuation at five years was significantly lower for ustekinumab at 0.37 (95% CI, 0.33–0.41) compared to adalimumab at 0.51 (95% CI, 0.49–0.54) and secukinumab at 0.54 (95% CI, 0.48–0.60).
Bio-Experienced Patients Show Different Patterns
For bio-experienced patients, the analysis included 3,403 treatment series across eight different biologics. At the two-year mark, ustekinumab showed a standardized absolute risk of cessation of 0.39 (95% CI, 0.36–0.43). However, three newer biologics demonstrated significantly lower discontinuation rates: bimekizumab at 0.27 (95% CI, 0.20–0.34), risankizumab at 0.25 (95% CI, 0.15–0.36), and guselkumab at 0.29 (95% CI, 0.22–0.36).
The study population included 23.4% of patients with concomitant psoriatic arthritis (search), reflecting the real-world complexity of psoriasis (search) management. Patients were enrolled in the registry at treatment initiation and followed with assessments at approximately 3 to 4 months, then at various intervals thereafter.
Biosimilar Demonstrates Comparable Efficacy
In parallel developments, a phase 3 randomized, double-blind study published in JAAD International demonstrated that the ustekinumab biosimilar DMB-3115 (Imuldosa; Accord BioPharma (search)) showed comparable efficacy and safety to reference ustekinumab through 52 weeks in patients with moderate to severe plaque psoriasis (search).
The study enrolled 598 patients who were randomized 1:1 to receive either DMB-3115 or reference ustekinumab from weeks 0 to 28, followed by rerandomization at week 28. The least squares mean percent reduction in Psoriasis (search) Area and Severity Index (PASI) scores was 77.5% with DMB-3115 and 77.9% with ustekinumab at week 8, increasing to 87.6% and 87.9%, respectively, by week 12.
Safety profiles were also comparable between the biosimilar and reference product. Treatment-emergent adverse events were reported in 47.5% of patients receiving DMB-3115 and 49.8% of those receiving ustekinumab during the initial treatment period.
Clinical Implications for Treatment Selection
The registry findings highlight important considerations for treatment selection in routine clinical practice. "Among bioexperienced patients with psoriasis (search), bimekizumab, guselkumab, and risankizumab had the highest 2-year drug survival," the investigators concluded. "These findings highlight differences in treatment persistence across biologics and may inform treatment selection in routine clinical practice."
The study methodology included careful consideration of treatment interruptions, with courses merged when the same biologic was restarted following brief interruptions defined as less than one month for adalimumab and brodalumab, under two months for secukinumab, bimekizumab, ixekizumab, and guselkumab, and under four months for ustekinumab and risankizumab.
The biosimilar study researchers noted that "this study demonstrated equivalent efficacy between DMB-3115 and ustekinumab, as shown by the similar LS mean percent changes in PASI score from baseline. Both treatments provided improved efficacy in patients with moderate to severe plaque psoriasis (search) with no clinically meaningful differences in efficacy and safety."