Long-term psoriasis treatment with bimekizumab results in maintained efficacy

More than 80% of patients with psoriasis preserved their Psoriasis Area and Severity Index (PASI)100 response over 2 years of treatment with bimekizumab in a pooled analysis of several phase 3 trials. The safety results over 48 weeks were consistent with previous shorter-term results.

Dual IL-17A/F inhibition with bimekizumab has demonstrated a meaningful benefit for patients with moderate-to-severe plaque psoriasis in various phase 3 clinical trials [1–3]. Its high efficacy is explained by its mechanisms of action (see Figure) [4]. “What happens long-term becomes the critical question,” stressed Prof. Kenneth Gordon (Medical College of Wisconsin, WI, USA). Therefore, a pooled analysis was performed of 5 phase 3 and 3b trials to assess the long-term efficacy and safety of the drug over 2 years [5]. During the initial phase 3 periods, 62.4% (n=850) of the study population on bimekizumab reached PASI100. The 86.9% of responders with a PASI of at least 90 at week 16 were enrolled in the open-label extension trials.

Figure: Mechanism of action of bimekizumab [4]

By selectively binding to IL-17-A, IL-17F, and the IL-17A/F heterodimer, bimekizumab inhibits the activation of the IL-17RA/RCreceptor complex by these cytokines and the subsequent inflammatory cascade.Reprinted from Adams R, et. Al (2020). Front. Immunol. 11:1894 under the terms of the Creative Commons CC BY.

The open-label extension results were very similar between participants who stayed on the 4-weekly dosing (Q4W) and those who switched to 320 mg of bimekizumab every 8 weeks (Q8W). After 48 weeks of continuous treatment, PASI100 was preserved in 85.1% (Q4W) and 83.8% of patients (Q8W). Corresponding results of maintained Investigator Global Assessment of 0/1 after 2 years were 94.3% (Q4W) and 96.7% (Q8W). Furthermore, the rate of patients who continued to have ≤1% of body surface area affected was over 90%.

The pooled long-term safety analysis of 2,186 patients and 3,796 patient-years (PY) revealed no unexpected results. The most common treatment-emergent adverse events were nasopharyngitis (18.4/100 PY), oral candidiasis (13.0/100 PY), and upper respiratory tract infections (7.8/100 PY). Of note, 98.1% of patients with oral candidiasis reported a mild or moderate infection, and no serious cases of oral candidiasis occurred. The incidence of serious infections was low (1.2/100 PY). Overall, the Q8W regimen led to a lower proportion of adverse events than the Q4W dosing. “As the results of Q8W were so similar to Q4W we can go for this dosing interval,” Prof. Gordon said.

Prof. Gordon concluded that the clinical response rates at week 16 were maintained through 2 years of bimekizumab and the agent continued to be well tolerated with long-term use.

1. 
   
   1. Gordon KB, et al. Lancet. 2021;397(10273):475–486
   2. Freitas E, et al. Drugs. 2021;81(15):1751–1762.
   3. Reich K, et al. Lancet. 2021;397(10273):487–498.
   4. Adams R, et al. Front Immunol 2020;11:1894.
   5. Gordon KB, et al. Bimekizumab efficacy and safety through two years in patients with moderate to severe plaque psoriasis: Analysis of pooled data from five phase 3/3b clinical trials. S026, AAD 2022 Annual Meeting, 25–29 March, Boston, MA, USA.

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Posted on 17 May, 202219 May, 2022