Methods
- The SENSCIS trial enrolled subjects with SSc-ILD with first non-Raynaud symptom <7 years before screening, extent of fibrotic ILD ≥10% on an HRCT scan, FVC ≥40% predicted and diffusion capacity of the lung for carbon monoxide (DLco) 30–89% predicted. Subjects on prednisone ≤10 mg/day or equivalent and/or stable therapy with mycophenolate or methotrexate for ≥6 months prior to randomization were allowed to participate.
- The SENSCIS trial was designed to demonstrate a reduction in the rate of decline in FVC (mL/year) in subjects treated with nintedanib versus placebo over 52 weeks. However, subjects could remain on randomized blinded treatment until the last subject reached week 52 (but for ≤100 weeks), resulting in a variable length of follow-up.
- FVC was measured at baseline and at week 2, 4, 6, 12, 24, 36, 52, 68, 84 and 100. A post-treatment follow-up visit, at which FVC data were collected, was conducted 28 days after the end of treatment. Subjects who prematurely discontinued treatment were asked to continue to attend visits, including the post-treatment follow-up visit, until the end of the trial.
- The rate of decline in FVC (mL/year) over the whole trial was assessed in a descriptive and exploratory manner. Given the variable length of follow-up beyond week 52, three methods were used:
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*Measurements taken between randomization and last trial drug intake.
- Analysis 2, which most closely reflected an intent-to-treat analysis, was considered the most relevant method.
- Time to absolute decline in FVC >5% and >10% predicted or relative decline in FVC (mL) >5% and >10% over 100 weeks were assessed post-hoc using a Cox’s regression model. Post-treatment data from subjects who discontinued when the last subject reached week 52 were not included.
- Safety was assessed based on adverse events reported, irrespective of causality, up to the last drug intake plus 28 days.