Idiopathic pulmonary fibrosis (IPF) antifibrotics pirfenidone and nintedanib have similar efficacy, although pirfenidone is associated with less real-world treatment discontinuations due to adverse side effects, according to study findings published in BMJ Open Respiratory Research.
Investigators in Spain assessed the real-world efficacy and safety of pirfenidone and nintedanib, both of which are approved in Spain for IPF treatment. The primary endpoints were differences in treatment persistence, time to first adverse event, and time to death.
The investigators conducted an observational, multicenter, prospective longitudinal study at 6 tertiary pulmonary clinics in Andalusia, Spain. Included patients were at least 19 years of age, had been diagnosed with IPF between 2015 and 2021, and had received at least 1 dose of antifibrotic treatment. The researchers defined the baseline visit as the first day of treatment; follow-up was done every 6 months. Patients with interstitial lung diseases other than IPF were excluded.
Overall, 232 patients treated with nintedanib (n=85) or pirfenidone (n=147) were included in analysis. Participants were predominantly men (80.2%); few currently smoked (7.8%); and about two-thirds (64.7%) had at least 1 comorbidity, most commonly respiratory or cardiovascular. There were no significant baseline characteristic differences between the nintedanib and pirfenidone cohorts.
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[T]he efficacy of the antifibrotics is similar in the real world (in terms of mortality), but their safety profiles are different, with pirfenidone being associated with a lower number of withdrawals, mainly due to fewer side effects.
The investigators saw a decreased risk for treatment withdrawal among patients on pirfenidone vs those on nintedanib (hazard ratio, 0.65; 95% CI, 0.46-0.94; P =.002). In those using nintedanib vs pirfenidone, treatment discontinuations due to any cause were 64.0% vs 54.4%, respectively; discontinuation due to adverse events were 42.4% vs 23.1%, respectively; and discontinuations due to death occurred in 17.6% vs 27.8% of participants, respectively.
Overall, 64.1% of patients reported significant adverse effects, most commonly gastrointestinal (46.4% nintedanib vs 29.9% pirfenidone; P =.012). Other significant between group differences were diarrhea (63.1% vs 10.9%; P <.001) and photosensitivity (0.0% vs 23.1%; P <.001), respectively.
Compared with the nintedanib group, time to first side effect was similar in the pirfenidone group, and time to withdrawal was longer in the pirfenidone group. The investigators noted that women were more likely to withdraw due to side effects, especially gastrointestinal events.
Between-group survival was similar, with 2-year mortality rates of 88.6% for nintendanib, and 85.5% for pirfenidone.
Study limitations include the observational design, self-reporting of all adverse events, and the inability to adequately assess treatment adherence.
“The main results of this study show that the efficacy of the antifibrotics is similar in the real world (in terms of mortality), but their safety profiles are different, with pirfenidone being associated with a lower number of withdrawals, mainly due to fewer side effects,” the investigators concluded. The study authors added, “Both treatments had a similar time to patient-reported adverse events, suggesting that side effects associated with pirfenidone were less intense or severe.”
Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
This article originally appeared on Pulmonology Advisor
