Key takeaways:
- Sufferers with IPF who don’t tolerate nintedanib or pirfenidone properly typically cut back dosages.
- Lowering or stopping doses didn’t considerably enhance the chance for illness development.
SAN FRANCISCO — Lowered doses in antifibrotic remedy for sufferers with idiopathic pulmonary fibrosis didn’t considerably impression outcomes, in response to an summary introduced on the American Thoracic Society Worldwide Convention.
Nintedanib (Ofev, Boehringer Ingelheim) and pirfenidone (Esbriet, Genentech) cut back the decline of lung operate amongst sufferers who’ve IPF, Aparna C. Swaminathan, MD, college director, scientific information analysis networks, Duke Medical & Translational Science Institute, mentioned throughout her presentation.
Knowledge had been derived from Swaminathan AC, et al. Antifibrotic dose reductions and scientific outcomes in sufferers with idiopathic pulmonary fibrosis in real-world information sources. Introduced at: American Thoracic Society Worldwide Convention; Might 16-21, 2025; San Francisco.
“We additionally know that each of those medicines are poorly tolerated at full dose as a consequence of facet impact, which results in dose reductions in scientific observe,” she continued.
Aparna C. Swaminathan
“Data on the utilization of antifibrotics in response to dose depth in scientific observe is at present restricted, and the impression of decreased antifibrotic doses on IPF development just isn’t properly understood,” she mentioned.
The researchers then got down to uncover the proportions of sufferers who maintained full doses, decreased doses or stopped remedy.
“We additionally wished to judge the affiliation between these antifibrotic dose teams and scientific outcomes and to check the yearly charge of change in FVC amongst sufferers in these dose teams,” Swaminathan mentioned.
The research included 455 sufferers with IPF within the multicenter Pulmonary Fibrosis Basis Affected person Registry (PFFPR) between 2016 and 2021 and 577 sufferers with IPF within the digital well being information of the Duke College Well being System (DUHS) between 2015 and 2021.
“Throughout each cohorts, over 30% of sufferers with IPF had been maintained on both a decreased dose of an antifibrotic or had stopped antifibrotic remedy,” Swaminathan mentioned.
The PFFPR included 309 sufferers (67.9%) who remained on a full antifibrotic dose at 12 months, outlined as a day by day dose of 300 mg of nintedanib or 2,403 mg of pirfenidone.
The PFFPR additionally included 104 sufferers (22.9%) who had been on a decreased dose, outlined as lower than 300 mg of nintedanib or lower than 2,403 mg of pirfenidone every day for 90 days or longer, and 42 (9.2%) who stopped remedy.
The DUHS included 394 sufferers (68.6%) who remained on a full dose at 12 months, 160 (27.9%) who had been on a decreased dose and 20 (3.5%) who stopped remedy.
The researchers attributed dose reductions and discontinuations to poor tolerability.
At 12 months, cumulative incidences of IPF development within the PFFPR included 61.6% for individuals who stopped remedy, 58.1% for these with decreased doses and 51.3% for individuals who maintained full doses.
Adjusted hazard ratios for IPF development within the PFFPR included 1.15 (95% CI, 0.86-1.54) for sufferers with decreased remedy and 1.42 (95% CI, 0.97-2.09) for these sufferers who stopped remedy in contrast with these sufferers with full doses.
“Sufferers who had been maintained on decreased doses or who had stopped remedy did have a numerically elevated threat of IPF development, however the distinction was not statistically vital,” Swaminathan mentioned.
The outcomes from the DUHS group had been comparable at 12 months, she continued, with incidences of IPF development together with 43% for individuals who stopped remedy, 42.7% for these on decreased doses and 39.8% for these with full upkeep.
Additionally within the DUHS, adjusted hazard ratios for IPF development included 0.94 (95% CI, 0.69-1.27) for these sufferers with decreased remedy and 0.99 (95% CI, 0.48-2.03) for individuals who stopped remedy, in contrast with these sufferers with full doses.
The researchers didn’t think about any of those variations to be vital.
Yearly charges of decline in compelled important capability p.c (FVC%) predicted included –4.22% for the total dose group, –4.59% for the decreased dose group and –2.08 for individuals who stopped remedy within the PFFPR.
Swaminathan known as these charges of yearly lung operate decline comparable.
Equally, the DUHS included a –1.46% yearly charge of decline in FVC% predicted for the total dose group, a –3.72% yearly charge of decline for the decreased dose group and a –5.93% yearly charge of decline for individuals who stopped remedy.
These variations additionally weren’t statistically vital, the researchers mentioned.
Based mostly on these findings, the researchers concluded that antifibrotic doses didn’t have any vital impression on scientific outcomes.
“Greater than half of the sufferers within the PFF registry and almost half of the sufferers within the EHR expertise illness development regardless of antifibrotic remedy and no matter dose adjustment,” Swaminathan mentioned.
These outcomes could inform choices within the remedy of sufferers who expertise unwanted side effects with this remedy, the researchers continued.
“The info spotlight a big unmet medical want for more practical and tolerable remedy choices in sufferers with IPF,” Swaminathan mentioned.
For extra info:
Aparna C. Swaminathan, MD, may be reached at pulmonology@healio.com.
