Ninfetanib Improves and Stabilizes Lung Function in Systemic Sclerosis

November 18, 2019

Patients who have systemic sclerosis-associated interstitial lung disease and received nintedanib were more likely to have improved lung function than patients who received a placebo, according to a new study. Not only did nintedanib improve forced vital capacity, but patients who received the drug were less likely to experience declining clinical status and more likely to see their conditions stabilize.

Patients who have systemic sclerosis-associated interstitial lung disease and received nintedanib were more likely to have improved lung function than patients who received a placebo, according to a new study. Not only did nintedanib improve forced vital capacity, but patients who received the drug were less likely to experience declining clinical status and more likely to see their conditions stabilize.

Systemic sclerosis (SSc) is a rare autoimmune disorder that affects connective tissue, noted by various clinical features such as vasculopathy, abnormal activity of the immune system, cellular inflammation, vasculopathy, and fibrosis of internal organs as well as the skin. Systemic sclerosis can also affect the lungs. Not only is interstitial lung disease (ILD) frequently observed in these patients, but it is also a leading cause of death.

Clinicians routinely measure mean change in forced vital capacity to help them evaluate outcomes in treatment-related outcomes in patients who have interstitial lung disease as well as those who have SSc-ILD, but they must also determine the clinical relevance of the forced vital capacity value based on the degree by which forced vital capacity changes. Previous research conducted on using either cyclophosphamide or mycophenolate mofetil versus placebo produced results of minimal clinical importance, noted by either forced vital capacity improvement of at least three percent or deterioration of -3.3 percent.

In a new phase III randomized, double-blind, placebo-controlled parallel-group trial known as SENSCIS, researchers investigated the effects of administering nintedanib 150 mg twice daily versus placebo in patients who have SSc-ILD.  In this study, SSc-ILD was defined as having at least 10 percent lung fibrosis with a baseline forced vital capacity of greater than 40 percent and a DLCO that ranged from 30-89 percent of the predicted value. Researchers included data from 575 patients with comparable baseline characteristics who were randomized one to one to receive either oral nintedanib or placebo.

After 52 weeks, 66 of the 287 patients who received nintedanib (23 percent), experienced a 3 percent or greater improvement in their forced vital capacity. Of the placebo group, 43/288, or 15 percent of patients experienced similar improvements (OR 1.69; 95% ci 1.11-2.59; P=0.014). The number of patients in the interventional group who either had improved forced vital capacity or stabilized symptoms ( (66% vs. 56%; OR 1.52; 95% CI 1.08–2.13; P=0.015) was significantly greater than that of the placebo arm. Moreover, the number of patients in the nintedanib arm whose clinical status worsened was significantly lower than the placebo arm (34% vs. 44%; OR 0.66; 95% CI 0.47–0.92; P=0.015).

REFERENCE

ABSTRACT NUMBER 708 "Improvement and Stabilization of Lung Function in Patients with SSc-ILD Treated with Nintedanib vs Placebo in a Randomized, Placebo-Controlled Phase III Trial: Proportions of Patients with FVC Changes Using Cutoffs Previously Proposed to Define Minimally Clinically Important Differences."