Body surface area linked to nintedanib dose disruption in fibrotic ILD

Key takeaways:

• As body surface area went up, the odds for nintedanib dose reduction/discontinuation went down.
• Researchers found lower 1-year survival rates with a body surface area of 1.73 m² or less vs. more than 1.73 m².

Increased body surface area lowered the likelihood for nintedanib dose reduction/discontinuation among patients with fibrotic interstitial lung disease, according to results published in Respiratory Medicine.

“The study emphasizes the importance of recognizing baseline factors to ensure the safety and tolerability of nintedanib, thereby preventing the progression of pulmonary fibrosis,” Emanuel Costa, MD, of Hospital de Braga in Portugal, and colleagues wrote.

In a retrospective analysis, Costa and colleagues assessed 58 patients (mean age, 71.98 years; 70.7% men) with fibrotic ILD receiving nintedanib to find out what baseline characteristics impact dose adjustment or discontinuation of nintedanib.

The most common diagnosis in this cohort was idiopathic pulmonary fibrosis (69%; n = 40), followed by hypersensitivity pneumonitis (17.2%; n = 10) and connective tissue disease-ILD (13.8%; n = 8).

When combined, the percentage of patients who needed a lower dose of nintedanib (31%; n = 18) or stopped treatment because of adverse events (27.6%; n = 16) was greater than the percentage of patients who maintained the full dose (41.4%; n = 24).

Frequent adverse events that led to discontinuation included diarrhea, nausea, vomiting and hepatoxicity, according to researchers.

After adjusting for potential confounding factors, researchers found significantly reduced odds for nintedanib dose reduction/discontinuation with each decimal point increase in baseline body surface area (adjusted OR = 0.224; 95% CI, 0.092-0.546). This was the only independent and significant baseline risk factor identified in multivariate logistic regression analysis.

With this finding in mind, researchers performed a receiver operating characteristic analysis to determine the optimal cutoff value for body surface area and found high sensitivity (73%), specificity (91.7%), positive predictive value (92.6%) and negative predictive value (71%) with a cutoff of 1.73 m² or less.

One-year survival rates went down among patients receiving the full nintedanib dose with a body surface area of 1.73 m² or less vs. more than 1.73 m² (P < .001).

Researchers additionally noted that body surface area of 1.73 m² or less is linked to early onset drug intolerance or adverse effects, as these patients had a high risk for drop out (aHR = 5.16; P < .001).

“Our findings suggest that patients with lower [body surface area] are more susceptible to adverse events, particularly gastrointestinal, during nintedanib treatment,” Costa and colleagues wrote. “Furthermore, the occurrence of these effects is early in the drug administration.”