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Antifibrotic therapy slows disease progression independent of corticosteroid use

Presented By
Dr Madelon Vonk, Radboud University, the Netherlands
ACR 2019

A subgroup analysis of the SENSCIS trial showed that nintedanib slows decline of lung function in patients with systemic sclerosis–associated interstitial lung disease (SSc-ILD) independent of intake of corticosteroids [1].

ILD is a frequent manifestation of SSc and the leading cause of death in these patients. Nintedanib is an antifibrotic agent that is approved for therapy of idiopathic lung fibrosis. In the SENSCIS trial, the largest trial ever performed in patients with SSc-ILD, nintedanib slowed the decline in forced vital capacity (FVC) by 44% [2]. During the ACR meeting, a subgroup analysis assessed the benefit of antifibrotic therapy according to corticosteroid use [1]. Patients with SSc-ILD with ≥10% fibrosis of the lungs on high-resolution computer tomography were randomised to receive nintedanib 150 mg twice daily or placebo. Patients taking prednisone ≤10 mg/day or equivalent were allowed to participate. Lung function outcomes and adverse events (irrespective of causality) were analysed in subgroups of patients who did and did not use corticosteroids.

A total of 71.5% of patients in the nintedanib group and 66.3% in the placebo group also used corticosteroids. Mean FVC at baseline was 2,499 mL in patients who used corticosteroids and 2,501 mL in patients who did not. Nintedanib reduced the annual rate of decline in FVC (mL/year) versus placebo both in patients who did and did not use corticosteroids, with no difference in the treatment effect between subgroups detected (treatment-by-time-by-subgroup interaction P=0.82; see Figure).

The adverse event profile of nintedanib was similar between the subgroups by corticosteroid use, but the proportions of patients with nausea or vomiting adverse events were lower, and the proportion with upper respiratory tract infection was higher, in those who used corticosteroids. The authors concluded that antifibrotic therapy shows similar efficacy and tolerability independent of therapy with corticosteroids.

Figure: Annual rate of decline in FVC (mL/year) over 52 weeks in the SENSCIS trial in subgroups by use of corticosteroids [1]
FVC, forced vital capacity; CI, confidence interval; SE, standard error

    1. Vonk M, et al. Abstract 1643. ACR 2019. 8-13 November, Atlanta (GA/USA).
    2. Distler O, et al. N Engl J Med 2019;380:2518-28.


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