Findings of nintedanib's safety and tolerability published

Date: Fri 21st August 2020

Earlier this year in April, the European Commission approved nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults. Results from Phase III of the SENSCIS trial showed that nintedanib is able to effectively slow the rate of lung fibrosis, and therefore can slow the loss of lung function.

The effects of SSc can lead to fibrosis in the body's organs, including the lungs. This can lead to inflammation and scarring of the walls of the small air sacs (alveoli), resulting in difficulty breathing; this is called interstitial lung disease (ILD). SSc-ILD is the cause of approximately 35% of deaths in people living with SSc, making it the leading cause of mortality. The availability of this drug, therefore, will help to save several lives, especially as this is the first and only treatment approved for people living with SSc-ILD. Whilst a positive step, there were some concerns about the adverse side-effects of nintedanib, mainly to do with the gastrointestinal system. A team of researchers based in the USA, UK, Germany, Switzerland and Japan sought to examine the results of the SENSCIS trial to assess the safety and tolerability of nintedanib in people with SSc-ILD (1).

The most common adverse gastrointestinal system event associated with nintedanib was described to be diarrhoea, which ranges from mild to moderate intensity, and has previously not led to discontinuation of treatment. In this study, 288 people received nintedanib and 288 people received a placebo, and adverse events and dose adjustments were examined over the course of 52 weeks. Results indicated that diarrhoea and other gastrointestinal side-effects were more likely to occur in those receiving nintedanib than those receiving the placebo, however these adverse events were not more frequent in individuals who have underlying gastrointestinal issues. This demonstrates that there should not be an exclusion of people from receiving this treatment for this reason. Importantly, dose adjustment emerged as a helpful way of minimising the impact of adverse events and helping individuals remain on this therapy.

Overall, these results illustrate that there is safety and tolerability of nintedanib, provided that clinicians make appropriate decisions in terms of the dosage. Similar findings were observed in the INPULSIS trial, investigating the effect of nintedanib on idiopathic pulmonary fibrosis, and the INBUILD trial, looking at the effect of nintedanib on various ILDs that were progressive and caused fibrosis; in these two trials and the SENSCIS trial, nintedanib reduced the rate of lung damage caused by fibrosis . Use of this treatment therefore represents a viable way of improving the survival rates and quality of life of people living with SSc-ILD. SRUK will continue to share the findings of other trials concerning nintedanib to ensure our community is well-informed.


1) Seibold JR, Maher TM, Highland KB, et al. Safety and tolerability of nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from the SENSCIS trial [published online ahead of print, 2020 Aug 5]. Ann Rheum Dis. 2020;annrheumdis-2020-217331. doi:10.1136/annrheumdis-2020-217331