Adverse events push RA-ILD patients to discontinue nintedanib

In patients with rheumatoid arthritis (RA)-related interstitial lung disease (ILD), combination therapy with disease-modifying antirheumatic drugs (DMARDs) does not negatively influence the safety and efficacy of nintedanib, reports a study. The main drivers of drug withdrawal or dose reduction in these individuals are adverse events (AEs), primarily due to comorbidities.

The authors conducted a multicentre study to assess the safety of nintedanib in a real-world population of patients with RA-ILD from the Italian Group for the Study of Early Arthritis (GISEA) registry and the possible role of comorbidities and DMARDs on drug safety and withdrawal. In addition, they explored the different causes of nintedanib discontinuation.

Sixty-five RA-ILD patients treated with nintedanib in accordance with the current therapeutic indications participated in this study. Of these, 62 (95.4 percent) received nintedanib in combination with DMARDs and/or steroids.

The retention rate of nintedanib at 12 months was 76.7 percent, with nearly 80 percent of patients demonstrating drug effectiveness over ≥6 months of follow-up. More than half of these individuals (n=36, 55.3 percent) reported experiencing AEs, most of which were gastroenteric in nature.

Dose reduction of nintedanib was performed in 31 patients. A transient or permanent daily dose reduction allowed in 22 participants to continue their treatment, but 15 (23.1 percent) ultimately withdrew from nintedanib use.

“All reductions and discontinuations were owing to treatment-related AEs,” the authors said. “Comorbidities were significantly associated with side effects in multivariate analysis, whereas AEs due to nintedanib were the main cause of discontinuation.”