- 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.
Dr Ana Giménez-Arnau (Autonomous University and Pompeu Fabra University, Spain) presented the current analysis, which evaluated remibrutinib’s performance on itch severity as well as interference of activity and sleep within the framework of a phase 2b dose-finding study (NCT03926611) for patients with moderate-to-severe CSU1.
The 311 adult participants 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 baseline characteristics of the participants included a mean age of 45 years, 71.4% were women, and 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.
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 and -3.0 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.
Dr Giménez-Arnau indicated that phase 3 assessment for remibrutinib in CSU is already underway.