Study finds slower FVC decline with nintedanib in patients with IPF compared to Pirfenidone
USA: Findings from a post-hoc analysis of a clinical trial revealed a slower 12-month decline in forced vital capacity (FVC) with nintedanib use compared to pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). The findings were published online in the CHEST journal.
Importantly, the researchers observed no significant differences in non-elective respiratory hospitalization or overall survival between the two groups.
Previous studies have shown antifibrotics to be effective in slowing forced vital capacity decline in IPF. However, there seemed no clarity on whether the antifibrotic type is differentially associated with FVC decline. John S Kim, University of Virginia School of Medicine, Charlottesville, VA, USA, and colleagues, therefore, performed a post-hoc analysis using CleanUP-IPF trial to determine whether there are significant differences in 12-month FVC decline between pirfenidone and nintedanib.
The primary analysis included participants who reported using nintedanib or pirfenidone upon enrollment into the trial. Spirometry was scheduled at baseline, 12-, and 24-month study visits. Changes in FVC were examined over time using linear mixed-effects models with random intercept and slope.
Models were adjusted for sex, age, coronary artery disease history, smoking history, baseline FVC, and 12-month spline term were used. Cox regression models were used to determine survival and non-elective respiratory hospitalization by antifibrotic type, with adjustment for sex, age, coronary artery disease history, smoking history, and baseline FVC and diffusing capacity for carbon monoxide.
The researchers reported the following findings:
- Out of the 513 participants with IPF randomized in CleanUP-IPF, 407 reported using pirfenidone (n=264) or nintedanib (n=143).
- The pirfenidone group had more participants with a history of coronary artery disease than nintedanib (34.1% versus 20.3%).
- Nintedanib-treated patients had a higher 12-month visit FVC compared with pirfenidone-treated patients (mean difference 106 mL). This difference was attenuated at the 24-month study visit.
- There were no significant differences in non-elective respiratory hospitalization and overall survival between pirfenidone and nintedantib-treated groups.
"Patients with idiopathic pulmonary fibrosis who used nintedanib had a slower 12-month FVC decline than pirfenidone," the researchers wrote. "Also, no significant differences were seen in non-elective respiratory hospitalization or overall survival between the two groups."
Reference:
Kim JS, Murray S, Yow E, Anstrom K, Kim HJ, Flaherty KR, Martinez FJ, Noth I. Comparison of Pirfenidone and Nintedanib: Post-Hoc Analysis of the CleanUP-IPF Study. Chest. 2023 Nov 27:S0012-3692(23)05827-0. doi: 10.1016/j.chest.2023.11.035. Epub ahead of print. PMID: 38030064.
