Comparing JAK Inhibitors and Calcineurin Inhibitors Combined with Steroids for Treating Interstitial Lung Disease in Antisynthetase Syndrome Adults

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Janus kinase JAK inhibitors compared to calcineurin inhibitors as initial treatments for interstitial lung disease linked to antisynthetase syndrome. This prospective, randomized, open-label study aims to identify which treatment better improves lung function and prevents disease progression, helping doctors and patients make clearer treatment decisions. Eligible adults with this condition who have not received prior treatment will be randomly assigned to one of two groups. One group will take a JAK inhibitor tofacitinib, baricitinib, or upadacitinib along with a standard glucocorticoid regimen, while the other will receive a calcineurin inhibitor tacrolimus or cyclosporine combined with the same glucocorticoid treatment. Both treatments last for 12 months, with doses given orally and glucocorticoids tapered over time. Participants will be monitored through lung function tests, high-resolution CT scans, and laboratory assessments during treatment and follow-up. The main outcome is the survival rate at 12 months. Researchers will also measure changes in lung function, CT imaging scores, glucocorticoid dose reduction, and disease activity levels. Safety and laboratory parameters will be closely observed throughout the study period, which lasts one year.

A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome