Meta-Analysis Confirms Similar Safety, Efficacy Between Adalimumab Biosimilars, Humira

A systematic review and meta-analysis of 7 randomized controlled trials (RCT) found no significant differences in efficacy and safety indicators between adalimumab biosimilars and the reference product (Humira) for treatment of moderate to severe psoriasis.

Psoriasis affects 2% to 4% of the United States population, and treatments targeting tumor necrosis factor (TNF)-α “have demonstrated significant clinical benefits” for patients with immune-mediated inflammatory diseases, including psoriasis, the authors wrote. Adalimumab, a monoclonal antibody to TNF, has demonstrated efficacy and safety in moderate to severe psoriasis in multiple clinical trials, they added. The goal of their meta-analysis of seven RCTs involving 2589 patients was to provide “evidence-based information for psoriasis medical treatment.”

Adalimumab was approved by the FDA to treat psoriasis in 2008. Adalimumab biosimilars were first marketed in Europe in 2018 and in the US in 2023, and there are several biosimilars on the market in the US, Europe, China, and other regions.

No significant differences in efficacy indicators between adalimumab biosimilars and reference product

Overall, after 16 weeks, there were no significant difference between groups in response rates based on decreases in the Psoriasis Area and Severity Index (PASI), including PASI 75 (75% or greater decrease), PASI 50, PASI 90, and PASI 100. PASI 50 values were compared in 2 studies, PASI 75 in 6 studies, PASI 90 in 2 studies, and PASI 100 in 2 studies. Meta-analysis of pooled data for PASI 50, PASI 75, PASI 90 and PASI 100 at 16 weeks found no significant differences in efficacy between groups (relative risk 0.99; 95% CI, 0.95-1.03).

At later time points, 1 trial reported PASI 75 rates of 93% and 92% at 20 weeks, 97% and 95% at 32 weeks, and 96% and 93% at 48 weeks in the adalimumab biosimilar and reference product groups, with no significant differences at any of the 3 time points. One study compared PASI 75 at 24 weeks, also reporting no significant difference, finding 75% and 72% response rates in the biosimilar and reference product groups.

No significant differences in safety indicators

At 16 weeks, treatment emergent adverse events (TEAEs) were compared in 4 of the 7 trials, with no significant differences between biosimilar and originator groups. Similarly, there were no significant differences between groups in serious adverse events (SAEs) in 3 studies, nasopharyngitis incidence in 2 studies, withdrawal due to AEs in 5 studies, incidence of infection in 2 studies, and AEs of special interest in 3 studies. Comparisons at 24 weeks also did not show any significant differences between groups.

Five studies evaluated AEs, TEAEs, and SAEs from week 1 to week 16, and some of these studies also evaluated the same indicators at weeks 17 to 51. Meta-analyses of these safety indicators from week 1 to 51 found no significant differences between the adalimumab biosimilar and reference product groups.

The authors concluded, “adalimumab biosimilar agents exhibit efficacy and safety profiles that are equivalent to those of their reference agents.” However, they added that since the number of studies and number of patients included were small, “more multicenter, large-sample trials are therefore needed in the future.”

Reference

Li C, Sunhe Y, Zhou H, Dong W. Efficacy and safety evaluations of adalimumab biosimilars in the treatment of psoriasis. J Dermatolog Treat. 2023;34(1):2249145. doi:10.1080/09546634.2023.2249145