Study Identifies Nintedanib Therapy and More Advanced Disease as Predictors of Weight Loss in IPF

The treatment of idiopathic pulmonary fibrosis (IPF) has been revolutionized by the discovery and implementation of antifibrotic therapies (medications that reduce tissue scarring), such as Genentech’s Esbriet (pirfenidone), and Boehringer Ingelheim’s Ofev.

However, previous clinical trials have shown that patients often become intolerant of antifibrotic therapies, frequently require dose adjustments, or even treatment discontinuation.

“Both the ASCEND [NCT01366209] and the INPULSIS [NCT01335464; NCT01335477] trials demonstrated that nausea and diarrhea are common  during treatment with pirfenidone and nintedanib, respectively, affecting 30–63% of the participants. These side effects may interfere with nutrient intake and absorption, and thus can result in weight loss, an effect that can be particularly concerning in such a frail population,” the investigators wrote.

Furthermore, “in our practice, we have observed a number of patients with striking weight loss despite minimal or no gastrointestinal side-effects,” the researchers said.

Based on this observation, investigators from the Cleveland Clinic Foundation carried out a study to evaluate body weight changes in IPF patients who were tolerant to antifibrotic therapies to look for factors that might influence weight loss.

Their study, “Choice of antifibrotic medication and disease severity predict weight loss in idiopathic pulmonary fibrosis,” was published in the journal Pulmonary Pharmacology & Therapeutics.

Data on patients’ demographics, comorbidities, lung function tests, and body mass index (BMI) were pulled from the participants’ medical records at baseline, and at six and 12 months after beginning treatment.

Study participants were mostly older Caucasian males, who were former smokers. At baseline, most patients were either overweight or obese, with a median BMI of 31.1 kg/m2. (Of note, a person is considered obese with a BMI higher than 30.0 kg/m2, and overweight with a BMI between 25.0 kg/m2 and 30.0 kg/m2.)

This effect was stronger in patients who had been treated with Ofev, in which 61% had lost more than 5% of their initial body weight, compared to those who had been treated with Esbriet, in which 30% had lost more than 5% of their initial body weight during the study.

Further statistical analyses confirmed that Ofev treatment and a high score in the composite physiologic index (CPI, a measure of disease severity and progression based on computed tomography (CT) scans) were both predictors of weight loss in IPF patients.