Background/Purpose: In the SENSCIS trial in patients with SSc-ILD, nintedanib reduced the rate of decline in forced vital capacity (FVC) (mL/year) over 52 weeks by 44% compared with placebo, with adverse events that were manageable for most patients. The safety and efficacy of nintedanib over the longer term are being assessed in the open-label extension trial, SENSCIS-ON.

Methods: In the SENSCIS trial, patients were randomized to receive nintedanib or placebo until the last patient reached week 52 but for ≤100 weeks. Patients with SSc-ILD who completed the SENSCIS trial or a drug–drug interaction (DDI) study of nintedanib and oral contraceptive (NCT03675581) were eligible to enter SENSCIS-ON. In descriptive analyses, we analyzed changes from baseline in FVC (mL) and adverse events over 100 weeks in patients who received nintedanib in SENSCIS and continued nintedanib in SENSCIS-ON (the “continued nintedanib” group) and in patients who received placebo in SENSCIS and initiated nintedanib in SENSCIS-ON or who received nintedanib for ≤28 days in the DDI study (the “initiated nintedanib” group). Analyses were based on observed FVC data available at the respective time-point.

Results: The continued nintedanib group comprised 197 patients and the initiated nintedanib group comprised 247 patients (231 from SENSCIS; 16 from the DDI study). In these groups, respectively, mean (SD) FVC at inclusion in SENSCIS-ON was 2379 (754) mL and 70.4 (18.1) % predicted and 2443 (814) mL and 70.8 (17.9) % predicted. In total, 148 (75.1%) and 145 (58.7%) patients in the continued nintedanib and initiated nintedanib groups, respectively, were receiving nintedanib at week 100 of SENSCIS-ON. Mean (SE) changes in FVC from baseline to week 100 of SENSCIS-ON were −135.7 (24.7) mL in patients who continued nintedanib in SENSCIS-ON, −69.2 (26.5) mL in patients who initiated nintedanib in SENSCIS-ON, and −104.3 (18.2) mL in all patients in SENSCIS-ON (Figure), similar to the change from baseline to week 100 in nintedanib-treated patients in the SENSCIS trial (−100.0 [36.7] mL) and lower than the change from baseline to week 100 in the placebo group of the SENSCIS trial (−164.4 [38.4] mL). Diarrhea was the most frequent adverse event (Table). Over 100 weeks, liver test abnormalities were reported in 26 patients (13.2%) in the continued nintedanib group and 56 patients (22.7%) in the initiated nintedanib group. Adverse events led to discontinuation of nintedanib in 19 (9.6%) patients in the continued nintedanib group and 65 (26.3%) patients in the initiated nintedanib group.

Conclusion: The safety profile of nintedanib over 100 weeks in SENSCIS-ON was consistent with that reported in the SENSCIS trial. The decline in FVC over 100 weeks in patients treated with nintedanib in SENSCIS-ON was consistent with the decline in FVC in patients treated with nintedanib over 100 weeks in the SENSCIS trial. These findings support a clinically meaningful benefit of nintedanib in slowing the progression of SSc-ILD.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/continued-treatment-with-nintedanib-in-patients-with-systemic-sclerosis-associated-interstitial-lung-disease-ssc-ild-two-year-data-from-senscis-on/