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Randomized Controlled Trial
. 2024 Mar 1;63(3):639-647.
doi: 10.1093/rheumatology/kead280.

Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease

Yannick Allanore  1 , Dinesh Khanna  2 , Vanessa Smith  3 , Martin Aringer  4 , Anna-Maria Hoffmann-Vold  5 , Masataka Kuwana  6 , Peter A Merkel  7 , Christian Stock  8 , Steven Sambevski  9 , Christopher P Denton  10 ; SENSCIS Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease

Yannick Allanore et al. Rheumatology (Oxford). .

Abstract

Objectives: To investigate the course of interstitial lung disease (ILD) and the effects of nintedanib in patients with limited cutaneous systemic sclerosis (lcSSc).

Methods: In the SENSCIS trial, patients with SSc-ILD were randomized to receive nintedanib or placebo. Patients who completed the SENSCIS trial were eligible to enter SENSCIS-ON, in which all patients received open-label nintedanib.

Results: Among 277 patients with lcSSc treated in the SENSCIS trial, the rate (s.e.) of decline in forced vital capacity (FVC; ml/year) over 52 weeks was -74.5 (19.2) in the placebo group and -49.1 (19.8) in the nintedanib group (difference: 25.3 [95% CI -28.9, 79.6]). Among 249 patients with data at week 52, mean (s.e.) change in FVC at week 52 was -86.4 (21.1) ml in the placebo group and -39.1 (22.2) ml in the nintedanib group. Among 183 patients with lcSSc who participated in SENSCIS-ON and had data at week 52, mean (s.e.) change in FVC from baseline to week 52 of SENSCIS-ON was -41.5 (24.0) ml in patients who took placebo in the SENSCIS trial and initiated nintedanib in SENSCIS-ON and -45.1 (19.1) ml in patients who took nintedanib in the SENSCIS trial and continued it in SENSCIS-ON.

Conclusion: Patients with lcSSc may develop progressive fibrosing ILD. By targeting pulmonary fibrosis, nintedanib slows decline in lung function in patients with lcSSc and ILD.

Trial registration: ClinicalTrials.gov (https://clinicaltrials.gov), NCT02597933 and NCT03313180.

Keywords: antifibrotic agents; pulmonary fibrosis; pulmonary function tests; scleroderma; systemic.

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Figures

Figure 1.
Figure 1.
Rate of decline in forced vital capacity (FVC) (ml/year) over 52 weeks in patients with limited cutaneous systemic sclerosis (lcSSc) and interstitial lung disease in the SENSCIS trial in subgroups by (A) time since first non-Raynaud symptom, (B) anti-topoisomerase I antibody (ATA) status, (C) raised inflammatory markers, and (D) use of mycophenolate at baseline
Figure 1.
Figure 1.
(Continued)
Figure 2.
Figure 2.
Rate of decline in forced vital capacity (FVC) (ml/year) over 52 weeks in patients with limited cutaneous systemic sclerosis (lcSSc) and interstitial lung disease in subgroups by baseline characteristics in the SENSCIS trial. aC-reactive protein ≥6 mg/l and/or platelets ≥330 × 109/l. ATA: anti-topoisomerase I antibody
Figure 3.
Figure 3.
Change from baseline in forced vital capacity (FVC) (ml) at week 52 in patients with limited cutaneous systemic sclerosis and interstitial lung disease in the SENSCIS and SENSCIS-ON trials. Based on patients with data at week 52
See this image and copyright information in PMC

References

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