Nintedanib for non-IPF progressive pulmonary fibrosis : 12-month outcome data from a real-world multicentre observational study
Copyright ©The authors 2023..
Background: Nintedanib slows lung function decline for patients with non-idiopathic pulmonary fibrosis progressive pulmonary fibrosis (PPF) in clinical trials, but the real-world safety and efficacy are not known.
Methods: In this retrospective cohort study, standardised data were collected from patients in whom nintedanib was initiated for PPF between 2019 and 2020 through an early-access programme across eight centres in the United Kingdom. Rate of lung function change in the 12 months pre- and post-nintedanib initiation was the primary analysis. Symptoms, drug safety, tolerability and stratification by interstitial lung disease subtype and computed tomography pattern were secondary analyses.
Results: 126 patients were included; 67 (53%) females; mean±sd age 60±13 years. At initiation of nintedanib, mean forced vital capacity (FVC) was 1.87 L (58% predicted) and diffusing capacity of the lung for carbon monoxide (D LCO) was 32.7% predicted. 68% of patients were prescribed prednisolone (median dose 10 mg) and 69% were prescribed a steroid-sparing agent. In the 12 months after nintedanib initiation, lung function decline was significantly lower than in the preceding 12 months: FVC -88.8 mL versus -239.9 mL (p=0.004), and absolute decline in D LCO -2.1% versus -6.1% (p=0.004). Response to nintedanib was consistent in sensitivity and secondary analyses. 89 (71%) out of 126 patients reported side-effects, but 86 (80%) of the surviving 108 patients were still taking nintedanib at 12 months with patients reporting a reduced perception of symptom decline. There were no serious adverse events.
Conclusion: In PPF, the real-world efficacy of nintedanib replicated that of clinical trials, significantly attenuating lung function decline. Despite the severity of disease, nintedanib was safe and well tolerated in this real-world multicentre study.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
|---|---|
| Enthalten in: |
ERJ open research - 9(2023), 2 vom: 16. März |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Raman, Lavanya [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
|---|
| Anmerkungen: |
Date Revised 24.03.2023 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.1183/23120541.00423-2022 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM354551558 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM354551558 | ||
| 003 | DE-627 | ||
| 005 | 20231226062452.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1183/23120541.00423-2022 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1181.xml |
| 035 | |a (DE-627)NLM354551558 | ||
| 035 | |a (NLM)36949962 | ||
| 035 | |a (PII)00423-2022 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Raman, Lavanya |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Nintedanib for non-IPF progressive pulmonary fibrosis |b 12-month outcome data from a real-world multicentre observational study |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 24.03.2023 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a Copyright ©The authors 2023. | ||
| 520 | |a Background: Nintedanib slows lung function decline for patients with non-idiopathic pulmonary fibrosis progressive pulmonary fibrosis (PPF) in clinical trials, but the real-world safety and efficacy are not known | ||
| 520 | |a Methods: In this retrospective cohort study, standardised data were collected from patients in whom nintedanib was initiated for PPF between 2019 and 2020 through an early-access programme across eight centres in the United Kingdom. Rate of lung function change in the 12 months pre- and post-nintedanib initiation was the primary analysis. Symptoms, drug safety, tolerability and stratification by interstitial lung disease subtype and computed tomography pattern were secondary analyses | ||
| 520 | |a Results: 126 patients were included; 67 (53%) females; mean±sd age 60±13 years. At initiation of nintedanib, mean forced vital capacity (FVC) was 1.87 L (58% predicted) and diffusing capacity of the lung for carbon monoxide (D LCO) was 32.7% predicted. 68% of patients were prescribed prednisolone (median dose 10 mg) and 69% were prescribed a steroid-sparing agent. In the 12 months after nintedanib initiation, lung function decline was significantly lower than in the preceding 12 months: FVC -88.8 mL versus -239.9 mL (p=0.004), and absolute decline in D LCO -2.1% versus -6.1% (p=0.004). Response to nintedanib was consistent in sensitivity and secondary analyses. 89 (71%) out of 126 patients reported side-effects, but 86 (80%) of the surviving 108 patients were still taking nintedanib at 12 months with patients reporting a reduced perception of symptom decline. There were no serious adverse events | ||
| 520 | |a Conclusion: In PPF, the real-world efficacy of nintedanib replicated that of clinical trials, significantly attenuating lung function decline. Despite the severity of disease, nintedanib was safe and well tolerated in this real-world multicentre study | ||
| 650 | 4 | |a Journal Article | |
| 700 | 1 | |a Stewart, Iain |e verfasserin |4 aut | |
| 700 | 1 | |a Barratt, Shaney L |e verfasserin |4 aut | |
| 700 | 1 | |a Chua, Felix |e verfasserin |4 aut | |
| 700 | 1 | |a Chaudhuri, Nazia |e verfasserin |4 aut | |
| 700 | 1 | |a Crawshaw, Anjali |e verfasserin |4 aut | |
| 700 | 1 | |a Gibbons, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Hogben, Charlotte |e verfasserin |4 aut | |
| 700 | 1 | |a Hoyles, Rachel |e verfasserin |4 aut | |
| 700 | 1 | |a Kouranos, Vasilis |e verfasserin |4 aut | |
| 700 | 1 | |a Martinovic, Jennifer |e verfasserin |4 aut | |
| 700 | 1 | |a Mulholland, Sarah |e verfasserin |4 aut | |
| 700 | 1 | |a Myall, Katherine J |e verfasserin |4 aut | |
| 700 | 1 | |a Naqvi, Marium |e verfasserin |4 aut | |
| 700 | 1 | |a Renzoni, Elisabetta A |e verfasserin |4 aut | |
| 700 | 1 | |a Saunders, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Steward, Matthew |e verfasserin |4 aut | |
| 700 | 1 | |a Suresh, Dharmic |e verfasserin |4 aut | |
| 700 | 1 | |a Thillai, Muhunthan |e verfasserin |4 aut | |
| 700 | 1 | |a Wells, Athol U |e verfasserin |4 aut | |
| 700 | 1 | |a West, Alex |e verfasserin |4 aut | |
| 700 | 1 | |a Mitchell, Jane A |e verfasserin |4 aut | |
| 700 | 1 | |a George, Peter M |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t ERJ open research |d 2015 |g 9(2023), 2 vom: 16. März |w (DE-627)NLM255762003 |x 2312-0541 |7 nnns |
| 773 | 1 | 8 | |g volume:9 |g year:2023 |g number:2 |g day:16 |g month:03 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1183/23120541.00423-2022 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 9 |j 2023 |e 2 |b 16 |c 03 | ||