Baricitinib for Takayasu arteritis refractory to TNF-α inhibitors: a multicentre, single-arm trial.

Abstract

This study aimed to assess the efficacy and safety of baricitinib in Takayasu arteritis (TAK) refractory to TNF-α inhibitors. We conducted a multicentre, single-arm trial between February 2021 and August 2023. Patients with TAK unresponsive to at least 6 months of TNF-α inhibitors were treated with baricitinib 4 mg daily for up to 48 weeks, while continuing of immunosuppressants and glucocorticoids. Clinical features, inflammatory parameters, imaging changes and treatment data were collected during follow-up. The primary end point was the overall response (ORR) (complete response [CR] plus partial response [PR]) at 24 weeks. A total of 10 patients (nine female and one male) patients were enrolled, with median age of 29 years (26.0, 35.3) and a median disease duration of 56.5 months (31.8, 88.5). The ORR at 24 weeks was 80%, with six patients achieving CR and two achieving PR. Disease progression was noted in the remaining two patients. Disease activity, ESR and CRP at 24 weeks were significantly decreased compared with those at baseline. The median glucocorticoid dosage decreased from 20.0 mg/day (15.0, 26.3) at baseline (P < 0.001) to 6.3 mg/day (4.4, 10.6) at 24 weeks. No relapse was observed in the eight patients who achieved a response. The adverse effects (AEs) included upper respiratory tract infection (n = 2) and diarrhoea (n = 1), with no serious AEs reported. Baricitinib is effective in patients with TAK resistant to conventional treatments and anti-TNF-α therapy and demonstrates a notable steroid-sparing effect. ClinicalTrials.gov; NCT06662721.