SENSCIS trial shows nintedanib reduces the decline of lung function in patients with limited cutaneous systemic sclerosis and ILD

According to research published in Rheumatology, nintedanib reduces the decline of lung functionality in patients with limited cutaneous systemic sclerosis (SSc) and interstitial lung disease (ILD). 

Dr. Allanore and colleagues conducted the SENCIS and SENCIS-ON trials to investigate the progression of ILD and the effects of nintedanib in patients with limited cutaneous SSc. In the previous study, patients with SSc who had experienced their first non-Raynaud symptom within the past 7 years were randomly assigned to receive either nintedanib 150mg twice daily or a placebo. Additionally, they were required to be taking prednisone at a dosage of 10mg or less per day and/or to be on a stable regimen of mycophenolate or methotrexate for a minimum of 6 months. These patients received blinded treatment for a duration ranging from 52 weeks to a maximum of 100 weeks. The researchers noted that nintedanib led to a 44% reduction in the rate of decline in forced vital capacity (FVC) (measured in milliliters per year) over the course of 52 weeks compared to the placebo in the SENSCIS trial involving patients with SSc-ILD. 

The results of a 2019 study revealed that individuals with ILD associated with SSc who were taking nintedanib experienced a slower annual rate of FVC decrease compared to those who were on a placebo. In this trial, the adverse event profile of nintedanib was similar to that observed in patients with idiopathic pulmonary fibrosis. Gastrointestinal side effects, notably diarrhea, occurred more frequently with nintedanib than with the placebo. 

In another randomized controlled trial conducted in 2022 spanning 100 weeks, nintedanib was shown to decelerate the progression of SSc-ILD, and the associated side effects were generally manageable for patients. According to the on-treatment analysis, the adjusted mean (standard error) annual reduction rate in FVC over the 100-week period was 55.1 (12.3) ml/year for the nintedanib group (n = 286) and 94.0 (11.7) ml/year for the placebo group (n = 288), resulting in a difference of 38.9 ml/year. The adverse event profile of nintedanib over the 100-week period remained consistent with what was observed over 52 weeks. 

In conclusion, the study led by Dr. Allanore and colleagues shed light on the course of ILD and the beneficial effects of nintedanib treatment. Moreover, the extended investigation through the SENSCIS-ON trial further elucidated the potential of nintedanib to slow the progression of SSc-ILD over a longer duration, with manageable side effects for patients. These findings underscore the importance of tailored interventions for individuals with limited cutaneous SSc and ILD, offering a promising avenue for improving their quality of life and disease management. 

References 

  1. Allanore Y, Khanna D, Smith V, Aringer M, Hoffmann-Vold AM, Kuwana M, et al. Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease. Rheumatology. 2023 Jun 9. 
  2. Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, et al. Nintedanib for systemic sclerosis–associated interstitial lung disease. New England Journal of Medicine. 2019 Jun 27;380(26):2518-28. 
  3. Maher TM, Distler O, Allanore Y, Ogura T, Varga J, Vettori S, et al. Effect of nintedanib on progression of systemic sclerosis-associated interstitial lung disease (SSc-ILD) beyond 52 weeks: data from the SENSCIS trial. InC22. ILD THERAPY III 2020 May (pp. A4558-A4558). American Thoracic Society. 

 

  

  

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