Baricitinib and the Risk of Incident Interstitial Lung Disease: A Descriptive Clinical Case Report from Clinical Trials

Abstract

Objectives: Interstitial lung disease (ILD) occurs in up to 30% of patients with rheumatoid arthritis (RA), resulting in increased morbidity and death in the absence of proven therapies. The aim of this study is to estimate the number of incident ILD cases reported through development studies with baricitinib in patients with RA. Methods: Estimates were based on 3770 patients with RA from eight randomized clinical trials (four phase 3, three phase 2, one phase 1b) and one long-term extension study on baricitinib for which ILD was not an exclusion criterion with 12,358 patient-years of exposure (PYE).Results: Twenty-one non-infectious cases of ILD were reported with an exposure-adjusted incidence rate (EAIR) of 0.17 per 100 PYE. Of the 21 cases, six were reported as serious and 15 as non-serious resulting in an incidence rate of 0.05 per 100 PYE and 0.12 per 100 PYE, respectively. There were also 11 cases caused by an infectious agent: seven serious (IR: 0.06 per 100 PYE) and four non-serious cases (IR: 0.03 per 100 PYE). Conclusions: The findings of this analysis in patients with RA treated with baricitinib are consistent with a low risk to develop non-infectious ILD during baricitinib treatment, similar to that observed with other Janus kinase inhibitors.

Rheumatoid arthritis‐associated interstitial lung disease hotspots and future directions: A Web‐of‐Science based scientometric and visualization study

“… 45 Furthermore, baricitinib treatment for RA patients is associated with a low risk of developing noninfectious ILD, similar to what has been observed with other jak inhibitors. 46 It is anticipated that JAK inhibitors can boost hope for RA‐ILD patients as more research into them is conducted.…”

Potential Rheumatoid Arthritis-Associated Interstitial Lung Disease Treatment and Computational Approach for Future Drug Development

“…Baricitinib is a JAK1/JAK2 inhibitor suggested as a treatment for patients with RA-ILD who do not respond to the initial treatment with MTX [ 120 ]. An analysis of 3770 patients with RA from eight randomized clinical trials and one long-term extension study on baricitinib showed promising effects in lowering the risk of ILD development [ 121 ]. When 11 patients with RA and 4 patients with RA-ILD were treated with baricitinib for 6 months, a considerable decrease in inflammation was observed in patients with RA-ILD via a reduction in KL-6, which is a biomarker of RA-ILD.…”

Better Safe than Sorry: Rheumatoid Arthritis, Interstitial Lung Disease, and Medication—A Narrative Review

“…In a descriptive, multicentric, retrospective cohort study that included data pooled from eight randomized trials, with 3770 RA patients treated with baricitinib, with 12,358 patient-years of exposure, Salvarani et al identified 21 ILD cases with an exposure-adjusted incidence rate (EAIR) of 0.17 per 100 patient-years of exposure (PYE), proving a low risk of developing ILD during treatment [ 65 ].…”