Nintedanib in Rheumatoid Arthritis-Related Interstitial Lung Disease: Real-World Safety Profile and Risk of Side Effects and Discontinuation

Some concerns remain about the safety of nintedanib in patients with rheumatoid arthritis-related interstitial lung disease (RA-ILD), such as in the presence of comorbidities or in combination with biologic, targeted synthetic, and/or conventional synthetic disease-modifying antirheumatic drugs (DMA...

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Published in:Journal of rheumatology Vol. 52; no. 5; p. 420
Main Authors: Sebastiani, Marco, Lepri, Gemma, Iannone, Claudia, Cassione, Emanuele Bozzalla, Guggino, Giuliana, Lo Monaco, Andrea, Foti, Roberta, Fornaro, Marco, Chimenti, Maria Sole, Fassio, Angelo, Truglia, Simona, Cozzini, Francesca, Carletto, Antonio, Giollo, Alessandro, Corrado, Addolorata, Bazzani, Chiara, Guiducci, Serena, Favalli, Ennio, Bugatti, Serena, Iannone, Florenzo, Caporali, Roberto, Manfredi, Andreina
Format: Journal Article
Language:English
Published: Canada 01.05.2025
Subjects:
Aged
Antirheumatic Agents - adverse effects
Antirheumatic Agents - therapeutic use
Arthritis, Rheumatoid - complications
Arthritis, Rheumatoid - drug therapy
Comorbidity
Drug Therapy, Combination
Female
Humans
Indoles - adverse effects
Indoles - therapeutic use
Italy
Lung Diseases, Interstitial - drug therapy
Lung Diseases, Interstitial - etiology
Male
Middle Aged
Registries
Retrospective Studies
Treatment Outcome
Italy
combination therapy
nintedanib
comorbidity
interstitial lung disease
rheumatoid arthritis
safety
ISSN:1499-2752, 1499-2752
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Summary:Some concerns remain about the safety of nintedanib in patients with rheumatoid arthritis-related interstitial lung disease (RA-ILD), such as in the presence of comorbidities or in combination with biologic, targeted synthetic, and/or conventional synthetic disease-modifying antirheumatic drugs (DMARDs). In this multicenter study, we retrospectively evaluated 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. Our secondary aim was to investigate the causes of nintedanib discontinuation. Sixty-five patients treated with nintedanib in accordance with the current therapeutic indications were enrolled in the study. Nintedanib was prescribed in combination with DMARDs and/or steroids in 62 patients (95.4%). The 12-month retention rate of nintedanib was 76.7% and the drug was effective in about 80% of patients with ≥ 6 months of follow-up. Adverse events (AEs) were recorded in 36 subjects (55.3%), and these were mainly gastroenteric. Thirty-one subjects required a reduction of the nintedanib dose; among them, a transient or permanent reduction of the daily dose of nintedanib allowed the continuation of the treatment in 22, whereas 15 (23.1%) withdrew from the drug. All reductions and discontinuations were owing to treatment-related AEs. Comorbidities were significantly associated with side effects in multivariate analysis, whereas AEs due to nintedanib were the main cause of discontinuation. Combination therapy with DMARDs did not reduce the safety and effectiveness of nintedanib, and AEs were the main cause of drug withdrawal or dose reduction, mainly owing to comorbidities.
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ISSN:1499-2752
1499-2752
DOI:10.3899/jrheum.2024-0976