Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis : data from the INBUILD trial
© 2023. The Author(s)..
OBJECTIVES: Some patients with rheumatoid arthritis develop interstitial lung disease (RA-ILD) that develops into progressive pulmonary fibrosis. We assessed the efficacy and safety of nintedanib versus placebo in patients with progressive RA-ILD in the INBUILD trial.
METHODS: The INBUILD trial enrolled patients with fibrosing ILD (reticular abnormality with traction bronchiectasis, with or without honeycombing) on high-resolution computed tomography of >10% extent. Patients had shown progression of pulmonary fibrosis within the prior 24 months, despite management in clinical practice. Subjects were randomised to receive nintedanib or placebo.
RESULTS: In the subgroup of 89 patients with RA-ILD, the rate of decline in FVC over 52 weeks was -82.6 mL/year in the nintedanib group versus -199.3 mL/year in the placebo group (difference 116.7 mL/year [95% CI 7.4, 226.1]; nominal p = 0.037). The most frequent adverse event was diarrhoea, which was reported in 61.9% and 27.7% of patients in the nintedanib and placebo groups, respectively, over the whole trial (median exposure: 17.4 months). Adverse events led to permanent discontinuation of trial drug in 23.8% and 17.0% of subjects in the nintedanib and placebo groups, respectively.
CONCLUSIONS: In the INBUILD trial, nintedanib slowed the decline in FVC in patients with progressive fibrosing RA-ILD, with adverse events that were largely manageable. The efficacy and safety of nintedanib in these patients were consistent with the overall trial population. A graphical abstract is available at: https://www.globalmedcomms.com/respiratory/INBUILD_RA-ILD . Key Points • In patients with rheumatoid arthritis and progressive pulmonary fibrosis, nintedanib reduced the rate of decline in forced vital capacity (mL/year) over 52 weeks by 59% compared with placebo. • The adverse event profile of nintedanib was consistent with that previously observed in patients with pulmonary fibrosis, characterised mainly by diarrhoea. • The effect of nintedanib on slowing decline in forced vital capacity, and its safety profile, appeared to be consistent between patients who were taking DMARDs and/or glucocorticoids at baseline and the overall population of patients with rheumatoid arthritis and progressive pulmonary fibrosis.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:42 |
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| Enthalten in: |
Clinical rheumatology - 42(2023), 9 vom: 20. Sept., Seite 2311-2319 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Matteson, Eric L [VerfasserIn] |
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| Links: |
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| Themen: |
Adverse drug event |
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| Anmerkungen: |
Date Completed 10.08.2023 Date Revised 11.10.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1007/s10067-023-06623-7 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM35711695X |
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| 100 | 1 | |a Matteson, Eric L |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis |b data from the INBUILD trial |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Revised 11.10.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a OBJECTIVES: Some patients with rheumatoid arthritis develop interstitial lung disease (RA-ILD) that develops into progressive pulmonary fibrosis. We assessed the efficacy and safety of nintedanib versus placebo in patients with progressive RA-ILD in the INBUILD trial | ||
| 520 | |a METHODS: The INBUILD trial enrolled patients with fibrosing ILD (reticular abnormality with traction bronchiectasis, with or without honeycombing) on high-resolution computed tomography of >10% extent. Patients had shown progression of pulmonary fibrosis within the prior 24 months, despite management in clinical practice. Subjects were randomised to receive nintedanib or placebo | ||
| 520 | |a RESULTS: In the subgroup of 89 patients with RA-ILD, the rate of decline in FVC over 52 weeks was -82.6 mL/year in the nintedanib group versus -199.3 mL/year in the placebo group (difference 116.7 mL/year [95% CI 7.4, 226.1]; nominal p = 0.037). The most frequent adverse event was diarrhoea, which was reported in 61.9% and 27.7% of patients in the nintedanib and placebo groups, respectively, over the whole trial (median exposure: 17.4 months). Adverse events led to permanent discontinuation of trial drug in 23.8% and 17.0% of subjects in the nintedanib and placebo groups, respectively | ||
| 520 | |a CONCLUSIONS: In the INBUILD trial, nintedanib slowed the decline in FVC in patients with progressive fibrosing RA-ILD, with adverse events that were largely manageable. The efficacy and safety of nintedanib in these patients were consistent with the overall trial population. A graphical abstract is available at: https://www.globalmedcomms.com/respiratory/INBUILD_RA-ILD . Key Points • In patients with rheumatoid arthritis and progressive pulmonary fibrosis, nintedanib reduced the rate of decline in forced vital capacity (mL/year) over 52 weeks by 59% compared with placebo. • The adverse event profile of nintedanib was consistent with that previously observed in patients with pulmonary fibrosis, characterised mainly by diarrhoea. • The effect of nintedanib on slowing decline in forced vital capacity, and its safety profile, appeared to be consistent between patients who were taking DMARDs and/or glucocorticoids at baseline and the overall population of patients with rheumatoid arthritis and progressive pulmonary fibrosis | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Adverse drug event | |
| 650 | 4 | |a Arthritis rheumatoid | |
| 650 | 4 | |a Clinical trial | |
| 650 | 4 | |a Interstitial lung disease | |
| 650 | 4 | |a Pulmonary fibrosis | |
| 650 | 7 | |a nintedanib |2 NLM | |
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| 650 | 7 | |a Protein Kinase Inhibitors |2 NLM | |
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| 700 | 1 | |a Burmester, Gerd R |e verfasserin |4 aut | |
| 700 | 1 | |a Mueller, Heiko |e verfasserin |4 aut | |
| 700 | 1 | |a Moros, Lizette |e verfasserin |4 aut | |
| 700 | 1 | |a Kolb, Martin |e verfasserin |4 aut | |
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