Remibrutinib for Sjögren’s syndrome impresses in phase II trial

The selective potent oral BTK inhibitor remibrutinib has shown favourable efficacy and safety in the treatment of patients with Sjögren’s syndrome, according to the results of a phase II trial.

The trial included 73 patients with moderate-to-severe Sjögren’s syndrome (median age 53.0 years, 97.3 percent women, 68.5 percent White). The inclusion criteria were positivity for anti-Ro/Sjögren’s syndrome-related antigen A antibodies, EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) ≥5, and EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) ≥5.

The patients were randomly assigned to receive remibrutinib 100 mg either once (n=25) or twice (n=24) a day or placebo (n=24) for the 24-week study treatment period. The change from baseline in ESSDAI at week 24 was assessed as the primary endpoint. Secondary endpoints were change from baseline in ESSDAI over time, change from baseline in ESSPRI over time, and safety. Researchers also explored other endpoints such as changes to the salivary flow rate, soluble biomarkers, blood transcriptomic, and serum proteomic profiles.

Compared with placebo, treatment with remibrutinib led to significant improvements in ESSDAI score over 24 weeks (−2.86, p=0.003) but not in ESSPRI score (ΔESSPRI 0.17, p=0.663).

A trend towards improvement in unstimulated salivary flow was observed in the remibrutinib group.

Remibrutinib also showed a favourable safety profile during the entire treatment period. Treatment with the drug resulted in significant changes in gene expression in blood, as well as in serum protein abundance compared with placebo.