Systemic sclerosis & Raynaud's
Real-life efficacy and safety of nintedanib in systemic sclerosis-interstitial lung disease: data from an Italian multicentre study
Authors' conclusion
In a real-life clinical scenario, NTD, in combination with immunosuppressants, may stabilise lung function. GI side effects are frequent and NTD dose adjustment may be necessary to retain the drug in patients with SSc-ILD.
Study context
- Population
- Patients with SSc-ILD treated with nintedanib (NTD), Italy (65% female, mean age 57.6±13.4 years, mean disease duration 8.8±7.6 years)
- Participants
- 90 vs 40
- Exposure
- 12 months before vs 12 months after NTD introduction
- Prior 12 monthsn = 90reference
- 12 months after NTDn = 40
- Outcome
- Patients with significant lung progression (%pFVC decline)
- Follow-up
- 12 months after NTD vs the 12 months prior to NTD
Methodological detailsmulticentre, real-life
- Multicentre
- Real-life
Main finding
As reported in the abstract
- Significant lung progression significantly lower at 12 months after NTD than in the previous 12 months (60% vs 17.5%, p=0.007)
- Stabilisation in %pFVC at 12 months after NTD (64±14 to 62±19, p=0.416)
- Follow-up data at 12 months available for 40 (44%) patients
Observational data: associations, not effects.
Further findings
%pFVC, baseline to 12 months after NTD
- Stabilisation in %pFVC: 64±14 to 62±19
- P = 0.416
Modified Rodnan skin score (mRSS) change · 12 months
- No significant mRSS change
Deaths during follow-up
- Deaths
- 4
- Patients died during follow-up
- 4
Safety
Gastrointestinal (GI) side effects
- NTD maintained after dose adjustment (after a mean time of 3.6±3.1 months)
- 23 (25%)
- GI side effects recorded in 35 (39%) patients
NTD discontinuation
- NTD stopped after a median time of 4.5 (1-6) months
- 9 (10%)
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Real-life efficacy and safety of nintedanib in systemic sclerosis-interstitial lung disease: data from an Italian multicentre study. RMD Open. Published 22 February 2023. doi:10.
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