Abstract
Nintedanib attenuates non-IPF progressive pulmonary fibrosis (PPF) in clinical trials but real-world safety and efficacy are lacking.
To assess the impact of nintedanib on the clinical course of patients with PPF.
8 UK centres collected standardised data retrospectively and prospectively from patients in whom nintedanib was initiated for PPF between 2019-2020 through an early access programme. Primary analysis: lung function change in the 12 months pre- and post-nintedanib initiation. Secondary analyses: symptoms, drug safety and tolerability.
126 patients included; 67(53%) females, mean age 60(±13) years. At initiation of nintedanib, mean FVC 58% and DLCO 33%. 63% prescribed oxygen, 68% prescribed prednisolone (median dose 10mg) and 69% prescribed steroid sparing agent. In the 12 months after nintedanib initiation, lung function decline was significantly lower than in the preceding 12 months; FVC -113mL vs -235ml, (p=0.013) and absolute DLCO -2.87% vs -5.79%; (p=0.02). Response to nintedanib was not influenced by ILD diagnosis, age, CT pattern, or MRC dyspnoea grade. 71% of patients reported side effects. 80% of patients were still taking nintedanib at 12 months. No serious adverse events.
In PPF, real-world efficacy of nintedanib mirrors that of clinical trials reducing lung function decline by approximately 50%. Nintedanib was safe and tolerable.
To assess the impact of nintedanib on the clinical course of patients with PPF.
8 UK centres collected standardised data retrospectively and prospectively from patients in whom nintedanib was initiated for PPF between 2019-2020 through an early access programme. Primary analysis: lung function change in the 12 months pre- and post-nintedanib initiation. Secondary analyses: symptoms, drug safety and tolerability.
126 patients included; 67(53%) females, mean age 60(±13) years. At initiation of nintedanib, mean FVC 58% and DLCO 33%. 63% prescribed oxygen, 68% prescribed prednisolone (median dose 10mg) and 69% prescribed steroid sparing agent. In the 12 months after nintedanib initiation, lung function decline was significantly lower than in the preceding 12 months; FVC -113mL vs -235ml, (p=0.013) and absolute DLCO -2.87% vs -5.79%; (p=0.02). Response to nintedanib was not influenced by ILD diagnosis, age, CT pattern, or MRC dyspnoea grade. 71% of patients reported side effects. 80% of patients were still taking nintedanib at 12 months. No serious adverse events.
In PPF, real-world efficacy of nintedanib mirrors that of clinical trials reducing lung function decline by approximately 50%. Nintedanib was safe and tolerable.
| Original language | English |
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| Publication status | Unpublished - 1 Oct 2022 |
| Event | Irish Thoracic Society Winter Meeting - Dublin Duration: 1 Dec 2022 → 3 Dec 2022 https://irishthoracicsociety.com/its-scientific-meeting/its-scientific-meeting-2022/ |
Conference
| Conference | Irish Thoracic Society Winter Meeting |
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| City | Dublin |
| Period | 1/12/22 → 3/12/22 |
| Internet address |
