Impact of remibrutinib on dermatology-related quality of life in patients with chronic spontaneous urticaria in the Phase 3 REMIX-1 and REMIX-2 studies

Abstract

Prérequis/contexte

Remibrutinib is an oral, highly selective Bruton's tyrosine kinase inhibitor that has demonstrated superiority vs placebo (pbo) in change from baseline in Urticaria Activity Scores at week (Wk) 12, with a favourable safety profile, in the primary analysis of the REMIX-1 and 2 studies.

Objectifs

Here, we report the effect of remibrutinib on Dermatology-Related Quality of Life (DLQI) in REMIX-1 and 2 up to Wk 52. Our objective was to evaluate whether long-term treatment with remibrutinib sustains improvements in QOL.

Méthodes

REMIX-1/-2 are identical phase 3 studies, in adults CSU patients inadequately controlled by H1-AH. Patients were randomised 2: 1 to receive oral remibrutinib 25 mg or pbo twice daily (bid) over a 24-Wk double-blind treatment period. This was followed by a 28-Wk open-label treatment period, in which all patients, including those previously receiving pbo, were assigned to remibrutinib 25 mg bid. The number of patients that achieved DLQI = 0–1 (no impact on patient's life) and the DLQI change from baseline were recorded up to Wk 52.

Résultats/discussions

At baseline, patients in both trials reported on average a high disease impact of CSU on QOL, based on DLQI scores (mean ± SD: 14.2 ± 7.0 vs 13.5 ± 6.8 in REMIX-1 and 14.0 ± 7.5 vs 13.6 ± 6.7 in REMIX-2). Significantly more patients treated with remibrutinib vs pbo achieved no impact of disease on QOL, i.e. DLQI = 0–1 (imputed data) at Wk 12 (REMIX-1: 39.0 vs 22.2%, P < 0.001; REMIX-2: 35.7 vs 18.3%, P < 0.001) and at Wk 24 (REMIX-1: 46.1 vs 28.1%, P < 0.001; REMIX-2: 40.7 vs 20.3%, P < 0.001). DLQI was greater at Wks 4, 12 and 24 with remibrutinib vs pbo. At Wk 52, there was an improvement in DLQI change from baseline (mean ± SD; observed data) for all patients (REMIX-1: −9.9 ± 7.3 with remibrutinib and −9.3 ± 7.7 with remibrutinib post pbo; REMIX-2: −9.6 ± 8.4 with remibrutinib and −8.5 ± 8.0 with remibrutinib post pbo).

Conclusion

Remibrutinib demonstrated significant improvements in DLQI vs pbo. For patients in the remibrutinib arm, the improvement in DLQI was sustained up to Wk 52. For patients who received pbo and transitioned to receive remibrutinib at Wk 24, a comparable improvement in DLQI was achieved at Wk 52.