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Efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease treated with mycophenolate: A subgroup analysis of the SENSCIS trial

The Lancet Respiratory Medicine Jan 10, 2021

Highland KB, Distler O, Kuwana M, et al. - Given that a decrease in the rate of reduction of forced vital capacity was achieved with nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) in the Safety and Efficacy of Nintedanib in Systemic Sclerosis (SENSCIS) trial, and patients on stable therapy with mycophenolate for at least 6 months prior to randomisation could take part, researchers undertook this subgroup analysis to assess the efficacy as well as the safety of nintedanib based on mycophenolate use at baseline. In the SENSCIS trial, patients suffering from SSc-ILD were randomized (1:1) to consume 150 mg of oral nintedanib twice daily or placebo for at least 52 weeks. Findings revealed that both patients with SSc-ILD who were and were not using mycophenolate at baseline experienced a reduction in the progression of interstitial lung disease after receiving treatment with nintedanib, with no heterogeneity evident in its treatment impact between the subgroups. Similar adverse event profile was displayed by nintedanib in the subgroups by mycophenolate use. These data indicate the safety of the combination of mycophenolate and nintedanib for treating patients with SSc-ILD. There is a requirement for more data on the advantages of initial combination therapy vs a sequential approach to management of SSc-ILD.

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