Bimzelx efficacy and safety in Chinese patients

[Fred]

This trial to evaluate Bimzelx (bimekizumab) in Chinese patients with psoriasis, represents the largest clinical trial of bimekizumab conducted in an Asian population to date.

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The BE SHINING study by Cai et al., the phase 3 trial to evaluate bimekizumab in Chinese patients with psoriasis, represents the largest clinical trial of bimekizumab conducted in an Asian population to date. Asian patients with psoriasis have been reported to exhibit distinct pathophysiologic and phenotypic features from those observed in Western populations. This study provides essential validation that the clinical outcomes established in global trials are reproducible within the context of Asian patients.

Indeed, the dual inhibition of IL-17A and IL-17F by bimekizumab yields a profound clinical response in this Chinese cohort. In the present trial, 74.0% of patients achieved PASI 75 as early as week 4, and notably, 94.0% and 65.0% reached PASI 90 and PASI 100, respectively, at week 16. Overall, these findings confirm that the high-level efficacy of bimekizumab established in global clinical trials is consistently maintained in this regional setting.

Regarding safety, bimekizumab demonstrated a tolerable safety profile in the BE SHINING study, with no new safety signals identified. Consistent with global clinical trials, upper respiratory tract infections were the most common treatment-emergent adverse events (TEAEs). Interestingly, no cases of oral candidiasis were reported, similar to findings from a Korean study, but contrasting with data from global and Japanese populations where oral candidiasis was a relatively common TEAE. As the authors suggested, a small sample size or a short observation period may partially explain this discrepancy. However, the comparable size (n = 133) to the Japanese cohort (n = 108) and the typical early onset of candidiasis during the first 16 weeks of treatment in global trials suggest that population-specific factors, such as characteristic oral microbiomes or distinct immunologic profiles, may play an important role. These findings highlight the need for real-world data on bimekizumab in Asian populations and further mechanistic studies to clarify the factors driving this phenomenon.

Another notable safety finding was the higher frequency of hepatic events compared with global clinical trials. Given that the rate of hepatic events was similar between the bimekizumab and placebo groups and considering the pharmacologic profile of IL-17 inhibitors, these events are unlikely to be directly related to the drug. Instead, they may reflect the high baseline prevalence of hepatic disorders (21.1%) in this population, which the authors suggest is likely associated with metabolic dysfunction–associated steatotic liver disease (MASLD). Clinicians may nevertheless consider monitoring liver function in patients with psoriasis at high risk of hepatic events (i.e. underlying MASLD, obesity or excessive alcohol consumption) while receiving bimekizumab when clinically indicated, not to detect drug-related hepatotoxicity but to assess underlying liver disease. Patients should also be encouraged to adopt lifestyle modifications, even when psoriasis is well controlled with bimekizumab.

In summary, this study reaffirms that bimekizumab delivers a rapid and profound clinical response, including high rates of PASI 90 and PASI 100 in Chinese patients with psoriasis, consistent with previous global trials. Although distinct patterns in the rates of oral candidiasis and hepatic events were observed in this regional cohort, these findings do not alter the overall favourable benefit–risk profile of bimekizumab. Further real-world studies are warranted to confirm these observations and to clarify the population-specific factors that may influence clinical outcomes in Asian patients.

Source: onlinelibrary.wiley.com

*Funding: None declared

Bimzelx (bimekizumab)