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The NEJM reports a randomized placebo controlled trial of nintedanib, a tyrosine kinase inhibitor, in systemic sclerosis patients with interstitial lung disease (ILD) resulted in less pulmonary decline, but had no effect on other features of systemic sclerosis.
Systemic sclerosis patients were enrolled if within 7 years of disase onset (non-Raynaud’s) and had high-resolution computed tomographic scan showing lung fibrosis affecting at least 10% of the lungs. Patients were randomized to receive 150 mg of nintedanib, administered orally twice daily, or placebo. The primary end point was the annual rate of decline in forced vital capacity (FVC), assessed over 52 weeks.
Among 576 patients, 52% had diffuse cutaneous systemic sclerosis, and 48.4% were on background mycophenolate.
The prime outcome was the adjusted annual rate of change in FVC change:
- nintedanib group : −52.4 ml per year
- placebo group: −93.3 ml per year (difference, 41.0 ml per year; 95% confidence interval [CI], 2.9 to 79.0; P=0.04)
Other outcomes were not significant including the modified Rodnan skin score and the SGRQ at week 52.
Diarrhea, was much more common in those receiving nintedanib (75.7% vs 31.6%).
Nintedanib (Ofev) is currently FDA approved for use in idiopathic pulmonary fibrosis. It may have protective benefits in systemic sclerosis patients who develop ILD, but does not appear to otherwise benefit extrapulmonary disease progression in systemic sclerosis.