Response to: 'Correspondence on 'Safety and tolerability of nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from the SENSCIS trial'' by Bredemeier.

Following the publication of data on the safety and tolerability of nintedanib in the SENSCIS trial,1 2 and INBUILD trial,3 Dr Bredemeier has raised the question of the risk of serious respiratory infections with nintedanib treatment in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) and other interstitial lung diseases (ILDs).4 We have made a thorough investigation into this question and concluded that the evidence from clinical trials does not suggest an increased risk of infections in patients treated with nintedanib. Further, the mechanistic effects of nintedanib, an inhibitor of tyrosine kinases, do not suggest a plausible mechanism by which nintedanib would affect the risk of infection.5 We acknowledge that in the SENSCIS trial, there were numerical imbalances between the nintedanib and placebo groups in the percentages of patients with overall serious infections (6.6% vs 3.5%) or serious lower respiratory tract infections (3.5% vs 1.7%). This difference was driven largely by serious adverse events of pneumonia (2.8% (n=8) vs 0.3% (n=1)), when pneumonia was defined using …