Efficacy and safety of remibrutinib, a selective potent oral BTK inhibitor, in Sjögren's syndrome: results from a randomised, double-blind, placebo-controlled phase 2 trial.

Quantitative titres of all three disease-related autoantibody (SS-B, SSA-Ro-60, SSA-Ro-52/Trim21) decreased in the remibrutinib groups from baseline up to week 24 compared with placebo, following a decreasing trend similar to total IgG levels ( figure 4 ).

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The medical relevance was further supported by the fact that in contrast to placebo, remibrutinib showed a strong trend to increase the salivary flow rate, thereby modifying reduced salivary flow which is a cardinal symptom of SjS with important consequences for oral health. 25 26 This increase of the unstimulated flow was small in absolute terms, which may be due to the long average disease duration of patients in the study who may already have significantly destroyed salivary tissue which can no longer be regenerated.

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Unstimulated salivary flow showed a trend towards improvement in remibrutinib groups at week 12 which became stronger at week 24, with no obvious change from baseline in the placebo group ( figure 2C ).

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