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

Marco Sebastiani¹, Gemma Lepri², Claudia Iannone³, Emanuele Bozzalla Cassione⁴, Giuliana Guggino⁵, Andrea Lo Monaco⁶, Roberta Foti⁷, Marco Fornaro⁸, Maria Sole Chimenti⁹, Angelo Fassio¹⁰, Simona Truglia¹¹, Francesca Cozzini¹², Antonio Carletto¹⁰, Alessandro Giollo¹³, Addolorata Corrado¹⁴, Chiara Bazzani¹⁵, Serena Guiducci², Ennio Favalli³, Serena Bugatti⁴, Florenzo Iannone⁸, Roberto Caporali³, Andreina Manfredi¹²

Affiliations

¹ M. Sebastiani, MD, Rheumatology Unit, Azienda Unità Sanitaria Locale di Piacenza, Piacenza, and Department of Medicine and Surgery, University of Parma, Parma; Marco.sebastiani@unipr.it.
² G. Lepri, MD, S. Guiducci, MD, Division of Rheumatology, AOU Careggi, Department of Experimental and Clinical Medicine, University of Florence, Florence.
³ C. Iannone, MD, E. Favalli, MD, R. Caporali, MD, Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, and Department of Clinical Sciences and Community Health, University of Milan, Milan.
⁴ E. Bozzalla Cassione, MD, S. Bugatti, MD, Department of Internal Medicine and Therapeutics, Università di Pavia, Pavia, and Division of Rheumatology, Fondazione IRCCS Policlinico San Matteo, Pavia.
⁵ G. Guggino, MD, Rheumatology Unit, PROMISE Department, University of Palermo, Palermo.
⁶ A. lo Monaco, MD, Rheumatology Unit, Azienda Ospedaliera Universitaria S. Anna di Ferrara-Dipartimento di Scienze Mediche, University of Ferrara, Ferrara.
⁷ R. Foti, MD, Rheumatology Unit, Azienda Ospedaliero Universitaria Policlinico - San Marco di Catania, Catania.
⁸ M. Fornaro, MD, F. Iannone, MD, Rheumatology Unit, Department of Precision and Regenerative Medicine and Jonic (DiMePRe-J), University of Bari, Bari.
⁹ M. Sole Chimenti, MD, Reumatologia, allergologia e immunologia clinica, Università di Roma "Tor Vergata," Rome.
¹⁰ A. Fassio, MD, A. Carletto, MD, Rheumatology Unit, University of Verona, Verona.
¹¹ S. Truglia, MD, Dipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari - Rheumatology Unit, Sapienza Università di Roma, Rome.
¹² F. Cozzini, MD, A. Manfredi, MD, Rheumatology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, University of Modena and Reggio Emilia, Modena.
¹³ A. Giollo, MD, Rheumatology Unit, Department of Medicine-DIMED, University of Padova, Padova.
¹⁴ A. Corrado, MD, Rheumatology Unit - Department of Medical and Surgical Sciences, University of Foggia, Foggia.
¹⁵ C. Bazzani, MD, Rheumatology Unit, Spedali Civili di Brescia, Brescia, Italy.

PMID: 39681380
DOI: 10.3899/jrheum.2024-0976

Multicenter Study

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

Marco Sebastiani et al. J Rheumatol. 2025.

. 2025 May 1;52(5):420-425.

doi: 10.3899/jrheum.2024-0976.

Authors

Affiliations

¹ M. Sebastiani, MD, Rheumatology Unit, Azienda Unità Sanitaria Locale di Piacenza, Piacenza, and Department of Medicine and Surgery, University of Parma, Parma; Marco.sebastiani@unipr.it.
² G. Lepri, MD, S. Guiducci, MD, Division of Rheumatology, AOU Careggi, Department of Experimental and Clinical Medicine, University of Florence, Florence.
³ C. Iannone, MD, E. Favalli, MD, R. Caporali, MD, Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, and Department of Clinical Sciences and Community Health, University of Milan, Milan.
⁴ E. Bozzalla Cassione, MD, S. Bugatti, MD, Department of Internal Medicine and Therapeutics, Università di Pavia, Pavia, and Division of Rheumatology, Fondazione IRCCS Policlinico San Matteo, Pavia.
⁵ G. Guggino, MD, Rheumatology Unit, PROMISE Department, University of Palermo, Palermo.
⁶ A. lo Monaco, MD, Rheumatology Unit, Azienda Ospedaliera Universitaria S. Anna di Ferrara-Dipartimento di Scienze Mediche, University of Ferrara, Ferrara.
⁷ R. Foti, MD, Rheumatology Unit, Azienda Ospedaliero Universitaria Policlinico - San Marco di Catania, Catania.
⁸ M. Fornaro, MD, F. Iannone, MD, Rheumatology Unit, Department of Precision and Regenerative Medicine and Jonic (DiMePRe-J), University of Bari, Bari.
⁹ M. Sole Chimenti, MD, Reumatologia, allergologia e immunologia clinica, Università di Roma "Tor Vergata," Rome.
¹⁰ A. Fassio, MD, A. Carletto, MD, Rheumatology Unit, University of Verona, Verona.
¹¹ S. Truglia, MD, Dipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari - Rheumatology Unit, Sapienza Università di Roma, Rome.
¹² F. Cozzini, MD, A. Manfredi, MD, Rheumatology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, University of Modena and Reggio Emilia, Modena.
¹³ A. Giollo, MD, Rheumatology Unit, Department of Medicine-DIMED, University of Padova, Padova.
¹⁴ A. Corrado, MD, Rheumatology Unit - Department of Medical and Surgical Sciences, University of Foggia, Foggia.
¹⁵ C. Bazzani, MD, Rheumatology Unit, Spedali Civili di Brescia, Brescia, Italy.

PMID: 39681380
DOI: 10.3899/jrheum.2024-0976

Abstract

Objective: 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.

Methods: 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%).

Results: 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.

Conclusion: 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.

Keywords: combination therapy; comorbidity; interstitial lung disease; nintedanib; rheumatoid arthritis; safety.

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

Affiliations

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

Authors

Affiliations

Abstract

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Medical