Efficacy and safety of tofacitinib in rheumatoid arthritis-associated interstitial lung disease: TReasure real-life data

Abstract Background/Aim: Rheumatoid arthritis associated interstitial lung disease (RA-ILD) is a major concern in RA patients and events of ILD have been reported in patients treated with tofacitinib in RA clinical trials and in the post-marketing setting. The aim of this study was to assess the real-life efficacy and safety of tofacitinib in patients with RA-ILD. Methods RA patients with ILD diagnosis based on the HRCT images of the lungs from eight different centers recruited to study. As a control group, RA patients without ILD under tofacitinib was included. Demographic data, patients’ characteristics, available pulmonary function tests regarding RA and RA-ILD at the visit in which tofacitinib was initiated and for the last follow-up visit under tofacitinib were recorded. Reasons of tofacitinib discontinuation were also recorded. Drug retention rates were compared by log-rank test. p value < 0.05 was considered statistically significant. Results A total of 47 (42.6% male) RA patients with RA-ILD and a control group of 387 (17.8 % male) patients without RA-ILD were included in the analysis. After the median of 12 (9–19) months follow-up period, mean FEV1%; 82.1 vs. 82.8 (pre and post-treatment, respectively, p = 0.079), mean FVC%; 79.8 vs. 82.8 (pre and post-treatment, respectively, p = 0.014) were stable and worsening was observed 2/18 (11.1%) patients. Retention rates were similar (p = 0.21, log-rank). In RA-ILD group, most common cause of drug discontinuation was infections (6.3 vs 2.4 per 100 patient-years). Conclusion The treatment strategy of RA-ILD patients are still based on small observational studies. High rate of discontinuation due infections was observed in RA-ILD patients under tofacitinib; however, RA-ILD patients were older than RA patients without ILD.