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Reduction of FVC decline in systemic sclerosis-associated ILD

Presented By
Dr Kristin Highland, Cleveland Clinic, Ohio, USA
ERS 2019

An analysis of the SENSCIS trial showed that the rate of decline in forced vital capacity (FVC) was reduced in patients with systemic sclerosis (SSc)-associated interstitial lung disease (ILD) treated with nintedanib compared with placebo [1].

The large, randomised, controlled SENSCIS trial included 576 patients with SSc who also suffered from ILD with an HRCT scan that showed fibrosis affecting at least 10% of the lungs. Participants had a relatively short course of SSc with a maximum disease duration of 7 years. Participants were assigned to 52 weeks of placebo or 150 mg nintedanib twice weekly in addition to their usual immunosuppressive therapy, which in most cases was mycophenolate mofetil (MMF).

“SENSCIS met its primary endpoint: a reduction in the annual rate of decline in FVC,” said Dr Kristin Highland (Cleveland Clinic, Ohio, USA). After a year, in patients who took nintedanib, FVC declined by a mean of 52 mL, which was significantly less than the mean 93 mL decline seen among those who were given placebo. This translated into a 44% lower annual rate of lung function decline in patients taking nintedanib compared with placebo [2]. A subgroup analysis of the SENSCIS data presented at this year´s EULAR meeting showed that patients treated with MMF had a similar benefit from the therapy with nintedanib [3]. Treatment results were also independent of SSc subtype, sex, age, and race [3].

At the ERS meeting, Dr Highland presented a post-hoc analysis according to percentage of FVC loss. “Improvement with regard to change of FVC began early in treatment, with the efficacy curves separating by week 12 and continuing to diverge,” said Dr Highland. Over 52 weeks, the proportion of patients with any decline in FVC was lower in the nintedanib group compared with placebo, highlighting the high efficacy of the treatment.

The most frequent adverse event during therapy with nintedanib was diarrhoea. Prof. Highland pointed out that this can easily be managed; for example, by concomitant therapy with loperamide or by a dose reduction.

Dr Highland concluded that the open-label SENSCIS on continuation will allow for further data collection on safety and will establish whether treatment effects are sustainable longterm.

    1. Highland K. Abstract RCT1883, ERS 2019, 29 Sept-2 Oct, Madrid, Spain.
    2. Distler O, et al. N Engl J Med 2019;380(26):2518-28.
    3. Distler O, et al. Abstract OP0017, EULAR 2019, 12-15 June, Madrid, Spain.


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