Body surface area associated with nintedanib dose interruption in fibrotic ILD

Increased body surface area reduces the likelihood that patients with fibrosing interstitial lung disease will reduce/discontinue their nintedanib dose, according to clinical study results. This study highlights the importance of understanding baseline factors to ensure the safety and tolerability of nintedanib to prevent the progression of pulmonary fibrosis.

In a retrospective analysis, researchers primarily evaluated58 patients (mean age71.98 years; 70.7% male) receiving nintedanib to understand which baseline characteristics influence nintedanib dose adjustment or discontinuation. 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). Taken together, the percentage of patients who required a lower dose of nintedanib (31%; n = 18) or discontinued treatment due to adverse events (27.6%; n = 16) > maintained the full dose (41.4%; n = 24). Common adverse events leading to discontinuation included diarrhea, nausea, vomiting and hepatotoxicity, according to the researchers.

After adjusting for potential confounders, the researchers found that with each decimal point increase in baseline body surface area, the odds of nintedanib dose reduction/discontinuation were significantly lower ( pan>After adjustmentOR=0.224; 95%CI [confidence interval]is0.092-0.546). This was the only independent and significant baseline risk factor found in multivariable logistic regression analysis.

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

Compared with patients with a body surface area >1.73 m2, patients with a body surface area ≤1.73 m2 who received the full dose of nintedanib had a decreased one-year survival rate (P<0.001). The researchers also noted that a body surface area of u200bu200b1.73 square meters or less was associated with early onset of drug intolerance or side effects, as these patients were at high risk of withdrawal (aHR=5.16; P<0.001).

Our findings suggest that patients with lower[body surface area] are more likely to experience adverse events, particularly in the gastrointestinal tract, during treatment with nintedanib. Furthermore, these effects occur early in the course of drug administration.

References:https://www.healio.com/news/pulmonology/20240730/body-surface-area-linked-to-nintedanib-dose-disruption-in-fibrotic-ild