TY - JOUR
T1 - Safety and tolerability of nintedanib in patients with systemic sclerosis-associated interstitial lung disease
T2 - data from the SENSCIS trial
AU - Seibold, James R.
AU - Maher, Toby M.
AU - Highland, Kristin B.
AU - Assassi, Shervin
AU - Azuma, Arata
AU - Hummers, Laura Kathleen
AU - Costabel, Ulrich
AU - Von Wangenheim, Ute
AU - Kohlbrenner, Veronika
AU - Gahlemann, Martina
AU - Alves, Margarida
AU - Distler, Oliver
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2020.
PY - 2020/11/1
Y1 - 2020/11/1
N2 - Objectives To characterise the safety and tolerability of nintedanib and the dose adjustments used to manage adverse events in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Methods In the SENSCIS trial, patients with SSc-ILD were randomised to receive nintedanib 150 mg two times per day or placebo. To manage adverse events, treatment could be interrupted or the dose reduced to 100 mg two times per day. We assessed adverse events and dose adjustments over 52 weeks. Results A total of 576 patients received nintedanib (n=288) or placebo (n=288). The most common adverse event was diarrhoea, reported in 75.7% of patients in the nintedanib group and 31.6% in the placebo group; diarrhoea led to permanent treatment discontinuation in 6.9% and 0.3% of patients in the nintedanib and placebo groups, respectively. In the nintedanib and placebo groups, respectively, 48.3% and 12.2% of patients had ≥1 dose reduction and/or treatment interruption, and adverse events led to permanent discontinuation of the trial drug in 16.0% and 8.7% of patients. The adverse events associated with nintedanib were similar across subgroups defined by age, sex, race and weight. The rate of decline in forced vital capacity in patients treated with nintedanib was similar irrespective of dose adjustments. Conclusions The adverse event profile of nintedanib in patients with SSc-ILD is consistent with its established safety and tolerability profile in patients with idiopathic pulmonary fibrosis. Dose adjustment is important to minimise the impact of adverse events and help patients remain on therapy.
AB - Objectives To characterise the safety and tolerability of nintedanib and the dose adjustments used to manage adverse events in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Methods In the SENSCIS trial, patients with SSc-ILD were randomised to receive nintedanib 150 mg two times per day or placebo. To manage adverse events, treatment could be interrupted or the dose reduced to 100 mg two times per day. We assessed adverse events and dose adjustments over 52 weeks. Results A total of 576 patients received nintedanib (n=288) or placebo (n=288). The most common adverse event was diarrhoea, reported in 75.7% of patients in the nintedanib group and 31.6% in the placebo group; diarrhoea led to permanent treatment discontinuation in 6.9% and 0.3% of patients in the nintedanib and placebo groups, respectively. In the nintedanib and placebo groups, respectively, 48.3% and 12.2% of patients had ≥1 dose reduction and/or treatment interruption, and adverse events led to permanent discontinuation of the trial drug in 16.0% and 8.7% of patients. The adverse events associated with nintedanib were similar across subgroups defined by age, sex, race and weight. The rate of decline in forced vital capacity in patients treated with nintedanib was similar irrespective of dose adjustments. Conclusions The adverse event profile of nintedanib in patients with SSc-ILD is consistent with its established safety and tolerability profile in patients with idiopathic pulmonary fibrosis. Dose adjustment is important to minimise the impact of adverse events and help patients remain on therapy.
KW - autoimmune diseases
KW - pulmonary fibrosis
KW - systemic sclerosis
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U2 - 10.1136/annrheumdis-2020-217331
DO - 10.1136/annrheumdis-2020-217331
M3 - Article
C2 - 32759258
AN - SCOPUS:85092514163
SN - 0003-4967
VL - 79
SP - 1478
EP - 1484
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 11
ER -