Reduced nintedanib dose shows comparable efficacy to higher dose in IPF

Key takeaways:

• 100 mg of twice-daily nintedanib showed comparable mortality and hospitalization rates as a 150 mg dose.
• Clinicians often give patients with IPF the reduced dose because of side effects.

HONOLULU — Risk for mortality and hospitalization did not differ between patients with idiopathic pulmonary fibrosis taking 100 mg or 150 mg nintedanib twice daily, according to a real-world analysis presented at the CHEST Annual Meeting.

A twice-daily dose of 150 mg nintedanib (Ofev, Boehringer Ingelheim) is supported by the phase 3 randomized controlled INBUILD trial; however, researchers note that clinicians tend to lower it to 100 mg because of side effects.

Andrew Harold Limper

“In practice, a fraction of patients use 100 mg [nintedanib] twice a day due to side effects at the higher dose,” Andrew Harold Limper, MD, FCCP, professor of medicine and biochemistry and director of the Thoracic Disease Research Unit at Mayo Clinic College of Medicine, told Healio.

In a retrospective claims-based analysis of data from the OptumLabs Data Warehouse, Limper and colleagues assessed 346 patients with IPF receiving twice-daily 150 mg of nintedanib and 346 propensity score-matched patients with IPF receiving twice-daily 100 mg of nintedanib to compare all-cause mortality and hospitalization rates between the two doses.

Propensity score matching factored in age, sex, race/ethnicity, residence region, insurance type, additional medication use, oxygen use, smoking status, health care use and comorbidities, according to researchers.

Between patients treated with 150 mg and patients treated with 100 mg, the risk for all-cause mortality (HR = 0.65; 95% CI, 0.29-1.49) and hospitalization (HR = 0.98; 95% CI, 0.71-1.35) did not significantly differ, signaling comparable efficacy between the doses.

Even though this is only an observational retrospective analysis, Limper told Healio it is important that clinicians know that there was no impact on mortality or hospitalization rates when the dose was lowered.

“Future studies will be needed to confirm our initial observations,” Limper told Healio. “This could include using data derived from prospective registry studies, or perhaps even randomized controlled trials to test dosing of nintedanib in the future. Once again, our studies are retrospective and observational. However, they do provide important first insights into this important topic.

“Clinicians should continue to watch for additional new literature on the effects [of] dosing of nintedanib and associated efficacy in patients with IPF,” Limper added.

In terms of limitations, Limper highlighted two notable cons of the OptumLabs Data Warehouse during his presentation: It is made up of mostly private insurance and Medicare Advantage from UnitedHealth and access to data is relatively restrictive.

Reference:

• The impact of nintedanib dosing on clinical outcomes: An analysis of real-world data. Published Oct. 2, 2023. Accessed Oct. 2, 2023.