Nintedanib has greater impact on SSc-ILD in patients without cough, dyspnea at baseline
Click Here to Manage Email Alerts
Nintedanib reduces the rate of forced vital capacity decline more significantly in patients with systemic sclerosis-associated interstitial lung disease who reported no dyspnea or cough at baseline, data show.
“Prior treatment trials for SSc‐ILD have enrolled patients with symptoms of shortness of breath or cough at study entry,” Elizabeth Volkmann, MD, MS, an associate professor and scleroderma program director at the University of California, Los Angeles, and study co-author, told Healio. “However, in the SENSCIS trial, shortness of breath or cough was not an entry criterion.
“Therefore, a subgroup of patients enrolled in this study were asymptomatic with respect to their ILD at baseline,” she added. “This provided a unique opportunity to evaluate the course of ILD in an asymptomatic population and to determine whether treatment response to nintedanib differs based on the presence of shortness of breath or cough.”
To evaluate the safety and efficacy of nintedanib (Ofev, Boehringer Ingelheim) in patients with SSc-ILD, with and without cough and dyspnea at baseline, Volkmann and colleagues conducted a post hoc analysis of the SENSCIS trial, using patient-provided answers in the St. George’s Respiratory Questionnaire. Patients were considered to have a cough or dyspnea if they indicated they had coughed or experienced shortness of breath “most days a week,” “several days a week” or “a few days a month.”
According to the researchers, who published their findings in Rheumatology, nintedanib’s impact was numerically greater in patients without shortness of breath or coughing symptoms. However, there was no statistically significant difference between patients who were asymptomatic and those who reported symptoms.
“Patients who reported no cough or shortness of breath at baseline experienced a significant decline in lung function over 1 year in the absence of treatment,” Volkmann said. “There was no significant difference in treatment response to nintedanib based on the presence or absence of cough or shortness of breath at baseline, although nintedanib had a numerically greater effect on reducing FVC decline in patients without cough or shortness of breath.”
At baseline, 114 patients out of 575 did not have a cough, and 172 out of 574 did not have dyspnea. Patients with and without a cough who received a placebo saw a similar decline of forced vital capacity over 52 weeks, with –95.6 mL per year and –83.4 mL per year, respectively. Patients with and without dyspnea who received placebo experienced a decline of –95.8 mL per year and –87.7 mL per year.
The effect of nintedanib compared with placebo on the rate of FVC was “more pronounced” in patients without a cough (difference = 1.26; 95% CI, –11.1 to 159.8) than in those with a cough (difference = 31.5; 95% CI, –11.1 to 74.1). The difference was also pronounced in patients without dyspnea (difference = 79.8; 95% CI, 9.8-149.7) and patients with dyspnea (difference = 25.7; 95% CI, –19.9 to 71.3).
“These findings demonstrate that asymptomatic patients can experience significant ILD progression over the course of 1 year,” Volkmann said. “Relying on symptom assessment alone to make treatment decisions may lead to worse SSc‐ILD‐related outcomes.”
Collapse
Click Here to Manage Email Alerts