Results
Subjects
- The disposition of subjects over the trial is shown in Figure 1.
Figure 1. Disposition of subjects over the SENSCIS trial
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*Completed treatment period (and follow-up visit) according to the protocol, or prematurely discontinued trial drug but attended further visits as planned.
- At baseline, subjects had moderately impaired FVC; almost half were taking mycophenolate (Figure 2).
Figure 2. Baseline characteristics of subjects in the SENSCIS trial
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ATA, anti-topoisomerase I antibody; dcSSc, diffuse cutaneous systemic sclerosis.
Exposure
- Median exposure to trial drug was 15.4 months in the nintedanib group and 15.6 months in the placebo group. Maximum exposure was 23.2 and 23.8 months, respectively.
Decline in FVC
- The adjusted mean (SE) annual rate of decline in FVC over 100 weeks was consistently lower with nintedanib versus placebo across all three analyses (Figure 3).
Figure 3. Annual rate of decline in FVC (mL/year) over 100 weeks and estimated between-group difference in FVC (mL) at week 100
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- Smaller proportions of subjects treated with nintedanib than placebo had categorical declines in FVC (Table 1).
Table 1. Time to absolute decline in FVC >5% and >10% predicted or relative decline in FVC (mL) >5% and >10% over 100 weeks
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Adverse events
- Consistent with previous studies, diarrhea was the most frequent reported adverse event (Table 2).
Table 2. Most frequently reported adverse events
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Data are n (%) of subjects with ≥1 such adverse event. Adverse events reported in >12% of subjects in either treatment group are shown. Adverse events were reported irrespective of causality and coded by preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA).
- Serious adverse events were reported in 30.6% and 27.4% of subjects treated with nintedanib and placebo, respectively.
- Adverse events led to permanent discontinuation of trial drug in 17.4% and 10.1% of subjects treated with nintedanib and placebo, respectively. Diarrhea was the adverse event that most frequently led to discontinuation of trial drug (Table 3).
Table 3. Adverse events that most frequently led to permanent discontinuation of trial drug
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Data are n (%) of subjects with ≥1 such adverse event. Events reported in >1% of subjects in either treatment group are shown.