Remibrutinib reduces itch, sleep problems, and activity impairment in patients with CSU

In patients with chronic spontaneous urticaria (CSU), impairment of activity and sleep as well as itch were reduced by various dosages of remibrutinib. Regarding the fast onset of effect, most improvements were already achieved after 2 weeks.

In a previously published phase 2b dose-finding study, the Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib was found efficacious in reducing the weekly Urticaria Activity Score (UAS7) in patients with moderate-to-severe CSU across all tested doses [1]. Dr Ana Giménez-Arnau (Autonomous University and Pompeu Fabra University, Spain) presented a current analysis that evaluated remibrutinib’s performance on itch severity, and interference of activity and sleep within this trial [2].

The 311 adult participants of the phase 2b study were randomised to receive treatment with placebo or 6 different dosing regimens of remibrutinib ranging from 10 mg once daily to 100 mg twice daily over 12 weeks on a background medication with H₁-antihistamines. Assessment tools of the novel analysis were weekly results in Itch Severity Score (ISS7), Sleep Interference Score (SIS7), and Activity Interference Score (AIS7).

The participants had a mean age of 45 years, 71.4% were women, and they had a CSU presence of 4.9 years. Mean values for ISS7, SIS7, and AIS7 at the start of the trial varied between 12.6–14.6, 10.2–12.2, and 10.5–13.1 for the different remibrutinib doses, while the corresponding measures in the placebo group were 11.8, 10.3, and 10.8.

At week 2, itch reductions in ISS7 on any regimen of the study drug ranged from 6.3–9.5 compared with 1.1 on placebo. After 12 weeks, the values for reduction were in a similar range: 6.9–9.4 compared with 3.1 for the remibrutinib arms and placebo. After 3 months, 26.7–46.5% of participants attained an ISS7 of 0, meaning they had no itch, compared with 19% with ISS7 of 0 in the placebo arm.

Likewise, the SIS7 findings decreased between 5.2 and 8.6 in the remibrutinib arms compared with 1.3 in the placebo arm at week 2 and 6.3–8.7 compared with 2.9 at week 12, respectively. Already at week 2, the rate of participants without sleep interference was 34.9–44.2% for the different remibrutinib regimens compared with 12.5% on placebo.

The participants treated with remibrutinib also reached less impairment of activity than the ones receiving placebo, indicated by changes in AIS7 of -5.2 to -9.1 (week 2), -6.3 to -9.1 (week 12) on remibrutinib compared with -1.8 (week 2) and -3.0 (week 12) on placebo. As in the other measures, the proportions reaching an AIS7 of 0 were also superior across all remibrutinib doses in contrast to placebo. The phase 3 assessment for remibrutinib in CSU is already underway.

1. 
   
   1. Maurer M, et al. J Allergy Clin Immunol. 2022;150:1498-1506
   2. Giménez-Arnau A, et al. Remibrutinib treatment improves itch, sleep and activity in chronic spontaneous urticaria patients: phase 2b study results. P2778, EADV Congress 2023, 11–14 October, Berlin, Germany.

 

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Posted on 28 November, 202327 March, 2024