Nintedanib maintains safety, efficacy long-term in patients with SSc-associated ILD
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Nintedanib maintains its safety and efficacy for up to 3 years in patients with systemic sclerosis-associated interstitial lung disease, according to data published the Annals of the Rheumatic Diseases.
“Nintedanib, a tyrosine kinase inhibitor with anti-inflammatory and antifibrotic properties, has been licensed for the treatment of SSc-ILD, as well as for the treatment of idiopathic pulmonary fibrosis (IPF) and other chronic fibrosing ILDs with a progressive phenotype,” Yannick Allanore, MD, PhD, of Descartes University, in Paris, and colleagues wrote. “The efficacy and safety of nintedanib in patients with SSc-ILD were investigated in the SENSCIS trial, in which patients were randomized to receive nintedanib or placebo until the last patient had reached week 52 but for a maximum of 100 weeks.
“Data collected over the whole SENSCIS trial (up to 100 weeks of treatment) suggested that nintedanib provided a sustained benefit on slowing the progression of SSc-ILD over 100 weeks, with adverse events that were manageable for most patients,” they added. “An open-label extension of SENSCIS, SENSCIS-ON, is assessing the safety and tolerability of nintedanib over the longer term. Exploratory data on FVC are also being collected.”
For the SENSCIS-ON extension trial, Allanore and colleagues included participants who completed the SENSCIS study, as well as those from an open-label drug-to-drug interaction study that assessed nintedanib (Ofev, Boehringer Ingelheim) in women with SSc-ILD. The previous SENSCIS study included patients with SSc-ILD and an onset of first non-Raynaud symptoms within the prior 7 years, an extent of fibrotic ILD on high resolution CT greater than or equal to 10%,and a forced vital capacity greater than or equal to 40% predicted.
If patients were receiving nintedanib 150 mg or placebo twice daily in the parent studies, they then received nintedanib 100 mg or 150 mg twice daily in the current SENSCIS-ON study. The dose was allowed to be reduced and therapy paused to allow adverse events to resolve. Additionally, the researchers measured forced vital capacity at baseline and weeks 4, 12, 24, 36 and 52 of SENSCIS-ON.
Extension endpoints included any adverse events with onset from the first dose through week 52. The researchers defined serious adverse events as those that resulted in death or were life-threatening to the point of requiring a hospital visit or admittance.
Efficacy endpoints at week 52 of SENSCIS-ON included absolute change from baseline in forced vital capacity, proportions of patients with changes in forced vital capacity, the cumulative distribution of patients by absolute change from baseline in FVC percent predicted, and changes in baseline in the modified Rodnan skin score (mRSS), the St. George’s Respiratory Questionnaire score and the University of California Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract V.20 instrument total score.
The extension study included 197 patients who were continuing nintedanib from a previous trial and 247 who were newly initiating therapy with the drug. Among patients continuing nintedanib, 68% of patients reported diarrhea, according to the researchers. This event was also reported by 68.8% of the newly initiated patients. Adverse events led to 4.6% of continuing patients, and 21.5% of new patients, to cease therapy. There was an average change in forced vital capacity from baseline of –58.3 mL in the continuing group and –44 mL in the new patient group, the researchers wrote.
“These data suggest that continued treatment with nintedanib, up to 3 years in duration, had a manageable safety and tolerability profile in patients with SSc-ILD,” Allanore and colleagues wrote. “The adverse event profile of nintedanib over 52 weeks in SENSCIS-ON was consistent with that reported over the 52 weeks of initial use in SENSCIS.
“These findings are consistent with a sustained clinically meaningful benefit of nintedanib in slowing the progression of SSc-ILD and support the prompt initiation of nintedanib in patients with SSc and pulmonary fibrosis,” they added.
References:
Wollin L, et al. J Scleroderma Relat Disord. 2019;doi:10.1177/2397198319841842.
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