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Haripriya Gupta

 

Haripriya Gupta

Royal Shrewsbury Hospital, United Kingdom

Abstract Title:

Ustekinumab biosimilars versus reference ustekinumab in moderate-to-severe plaque psoriasis: A systematic review and meta-analysis

Research Interests:

Background: Ustekinumab biosimilars offer a cost-effective alternative to reference ustekinumab for moderate-to-severe plaque psoriasis, but robust randomized evidence confirming their long-term efficacy and safety remains limited. This systematic review and meta-analysis compares the clinical effectiveness, safety, and tolerability of ustekinumab biosimilars versus reference ustekinumab in adults with moderate-to-severe plaque psoriasis.

Methods: A systematic electronic database search was conducted per PRISMA guidelines, including randomized controlled trials (RCTs) and observational studies comparing ustekinumab biosimilars with reference ustekinumab. Twelve trial reports from nine distinct RCTs, involving over 3,600 patients, were included. Co-primary efficacy outcomes were change in Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety outcomes included treatment-related adverse events (TRAEs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), infections, nasopharyngitis, and COVID-19. Random-effects mean differences (MDs) and odds ratios (ORs) with 95% confidence intervals (CIs) were calculated at Week 12 and final follow-up, with heterogeneity assessed via I².

Results: Baseline characteristics were similar across groups. PASI at final follow-up showed no meaningful difference between biosimilar and reference ustekinumab (MD 0.28, 95% CI −0.56 to 1.12; p = 0.52; I² = 4%). DLQI was comparable, with moderate heterogeneity (MD −0.35, 95% CI −1.02 to 0.33; p = 0.32; I² = 57%). No clinically relevant differences emerged for TRAEs (OR 0.83, 95% CI 0.55–1.26), TEAEs (OR 0.89, 95% CI 0.68–1.16), SAEs (OR 0.67, 95% CI 0.35–1.27), infections (OR 1.12, 95% CI 0.77–1.64), nasopharyngitis (OR 1.48, 95% CI 0.66–3.32), or COVID-19 (OR 0.92, 95% CI 0.57–1.48).

Conclusions: Ustekinumab biosimilars demonstrate equivalent therapeutic outcomes, safety, and patient acceptability compared with reference ustekinumab in moderate-to-severe plaque psoriasis, supporting their integration into routine dermatological practice.