Efficacy and safety of baricitinib were assessed in this study. The primary endpoint of this study was the overall response rate of baricitinib treatment at 6 months. The treatment response was defined as previously described.17 (link) A complete response (CR) was defined as no evidence of active disease: (1) ESR<20 mm/hour and CRP<10 mg/L, (2) no progression of vessel damage and (3) the dose of GC<15 mg/day prednisone (or equivalence). A partial response (PR) was defined as (1) ESR<40 mm/hour or decrease over 50% compared with baseline, (2) CRP<20 mg/L or decrease over 50% compared with baseline and (3) not fulfilling the other two criteria of CR. Patients who did not meet the partial treatment response criteria were considered as having no response (NR) to baricitinib. Relapses was defined according to 2018 EULAR recommendations3 (link): the presence of typical signs or symptoms of TAK with at least one of the following: (1) current activity on imaging or biopsy; (2) ischaemic complications attributed to TAK or (3) Persistently elevated inflammatory markers excluding other causes. Among the patients with disease relapses, those who had clinical features of ischaemia or evidence of active aortic inflammation resulting in progressive aortic or large vessel dilatation, stenosis or dissection were classified as major relapse, while those without the above features were defined as minor relapse.
Adverse events were recorded at each visit. Liver dysfunction was defined as the elevation of ALT or AST over the upper normal limit. Adverse events of special interest included infections, venous thrombosis, malignancy, cardiovascular events, renal dysfunction and liver dysfunction related to baricitinib.
Adverse events were recorded at each visit. Liver dysfunction was defined as the elevation of ALT or AST over the upper normal limit. Adverse events of special interest included infections, venous thrombosis, malignancy, cardiovascular events, renal dysfunction and liver dysfunction related to baricitinib.
