Incidence Rates of Interstitial Lung Disease Events in Tofacitinib-Treated Rheumatoid Arthritis Patients

Journal of Clinical Rheumatology, Aug 2020 doi: 10.1097/RHU.0000000000001552.

This study highlights the importance of accounting for known risk factors of RA-ILD in clinical practice. Interstitial lung disease (ILD) is an extra-articular manifestation of RA. The post-hoc investigated incidence rates of ILD in patients with RA, receiving tofacitinib 5 or 10 mg twice daily, and identified potential risk factors for ILD. This post-hoc analysis comprised a pooled analysis of patients receiving tofacitinib 5 or 10 mg twice daily or placebo from 21 Phase 1-4, and 2 long-term extension studies. Interstitial lung disease events were adjudicated as “probable” (supportive clinical evidence) or “possible” (no supportive clinical evidence) compatible adverse events. Incidence rates (patients with events per 100 patient-years) were calculated for ILD events.In this post-hoc analysis across P1, P2, P3, P3 and LTE studies, the IR for ILD events was 0.18 per 100 patient-years, for both doses of tofacitinib, and ILD events appeared to be associated with known risk factors. In a descriptive case-matched control analysis (by age and gender), ILD events were numerically higher in patients with known risk factors for ILD, including Asian ancestry, current smokers, DAS28–4(ESR) score and age (≥65 years).However, results from this study are limited to patients with RA who had been included in clinical trials, which may differ from patients with RA in routine clinical practice