Antifibrotic therapy with nintedanib is beneficial for patients with negative prognostic factors

A post-hoc analysis of the SENSCIS trial showed that treatment with nintedanib slows lung function decline in patients with negative prognostic factors. This supports the early use of antifibrotic therapy, particularly in patients with a high risk for loss of lung function.

In the phase 3 SENSCIS trial (NCT02597933), nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks by 44% versus placebo in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). “The SENSCIS trial reflected a real-world population and allowed broad inclusion criteria,” Prof. Christopher Denton (University College London, United Kingdom) explained [1,2]. “Our analysis aimed to assess the effect of nintedanib on the rate of FVC decline but focusing on participants with risk factors for rapid FVC decline,” he said. The rate of decline in FVC over 52 weeks was analysed in participants with the following risk factors at baseline: early SSc (<18 months since the onset of first non-Raynaud symptom), elevated inflammatory markers (CRP ≥6 mg/L and/or platelets ≥330 x 10⁹/L), and significant skin fibrosis using 2 approaches: modified Rodnan skin score (mRSS) 15–40 or mRSS ≥ 18.

Compared with the total population of the SENSCIS trial, participants with 1 of these risk factors at baseline had a greater decline in lung function. “Conversely, once these patients are on nintedanib, there is a stabilisation,” Prof. Denton said. These results support the prompt initiation of nintedanib in patients with SSc-ILD to preserve lung function and improve patient outcomes.

“I think this is an important analysis in terms of our clinical practice and perhaps future trial designs. It does support using nintedanib in this group of patients that might be at particular risk for lung function decline,” Prof. Denton concluded.

1. Denton CP, et al. Effect of nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) and risk factors for rapid decline in forced vital capacity: further analyses of the SENSCIS trial. OP0157, EULAR 2022 Congress, 1–4 June, Copenhagen, Denmark.
2. Distler O, et al. N Engl J Med. 2019;380:2518–2528.

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Posted on 21 July, 202229 February, 2024