- Design
- Systematic review and meta-analysis of phase III randomised trials
- Population
- 9 trials, 4,532 adults with moderate-to-severe plaque psoriasis
- Primary outcome
- Mean percent change in PASI at 12 weeks
- Effect
- Mean difference 0.44 (95% CI -0.99 to 1.88, p=0.54); anti-drug antibodies RR 0.68 (0.55 to 0.85)
A meta-analysis of nine phase III randomised trials compared ustekinumab biosimilars with the reference product in moderate-to-severe plaque psoriasis. In total 4,532 patients contributed to the primary outcome.
The pooled mean difference in percent PASI change at 12 weeks was 0.44 (95% CI -0.99 to 1.88, p=0.54). Other efficacy and safety outcomes did not differ significantly, apart from small differences at 28 weeks that the authors judged not clinically meaningful. Anti-drug antibodies were less frequent with biosimilars (RR 0.68, 95% CI 0.55 to 0.85), but with substantial heterogeneity (I² 71%) and very low certainty.
All trials were industry funded and follow-up was 52 weeks or less. Within those limits, biosimilars look comparable, which matters most where cost decides whether a patient gets a biologic at all. Availability and pricing of specific products in India vary and should be checked locally.
- Consider an ustekinumab biosimilar where cost or access limits the reference product.
- Pooled PASI at 12 weeks did not differ significantly between biosimilars and the reference product.
- Trials ran 52 weeks or less; keep reviewing response over the long term.
- Do not read the antibody finding as an advantage; certainty was very low.
Why it matters
It supports using lower-cost versions of an established biologic without assuming a trade-off in efficacy.
Don't overread it
All included trials were industry funded with follow-up of 52 weeks or less; the antibody finding was very low certainty.
The statistics, in plain English
A confidence interval spanning zero for PASI difference means no difference was detected, and its width (-0.99 to 1.88) suggests any gap is small. An I² of 71% means the antibody result varied a lot between trials, so it should be treated as unreliable.
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