Nintedanib in Rheumatoid Arthritis–Related Interstitial Lung Disease: Real-World Safety Profile and Risk of Side Effects and Discontinuation
Authors' 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.
Study context
- Population
- Patients with RA-ILD from the Italian GISEA registry
- Participants
- 65 patients
- Outcome
- Safety of nintedanib and role of comorbidities and disease-modifying antirheumatic drugs (DMARDs) on drug safety and withdrawal
Methodological detailsmulticentre, registry-based (GISEA), real-world
- Multicentre
- Registry-based (GISEA)
- Real-world
Main finding
As reported in the abstract
- 12-month retention rate
- 76.7%
- Adverse events (AEs) (mainly gastroenteric)
- 36 (55.3%)
- Dose reduction required
- 31
- Continued treatment after dose reduction
- 22
- Withdrew from drug
- 15 (23.1%)
Observational data: associations, not effects.
Further findings
Causes of nintedanib discontinuation
- AEs due to nintedanib were the main cause of discontinuation
Effectiveness in patients with ≥ 6 months of follow-up
- Effective
- about 80%
Safety
| Outcome | Values |
|---|---|
| AEs (mainly gastroenteric) | Nintedanib 55.3% |
| Withdrawal due to treatment-related AEs | Nintedanib 23.1% |
Original publication
Nintedanib in Rheumatoid Arthritis–Related Interstitial Lung Disease: Real-World Safety Profile and Risk of Side Effects and Discontinuation. J Rheumatol. Published 15 December 2024. doi:10.
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