Functional Progression after Dose Suspension or Discontinuation of Nintedanib in Idiopathic Pulmonary Fibrosis: A Real-Life Multicentre Study
Background. Idiopathic pulmonary fibrosis (IPF) is a chronic interstitial lung disease with rapidly progressive evolution and an unfavorable outcome. Nintedanib (NTD) is an antifibrotic drug that has been shown to be effective in slowing down the progression of the disease. The aim of our study was...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2024-01-01
|
| Series: | Pharmaceuticals |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1424-8247/17/1/119 |
| _version_ | 1797342768962469888 |
|---|---|
| author | Barbara Ruaro Andrea Salotti Nicolò Reccardini Stefano Kette Beatrice Da Re Salvatore Nicolosi Umberto Zuccon Marco Confalonieri Lucrezia Mondini Riccardo Pozzan Michael Hughes Paola Confalonieri Francesco Salton |
| author_facet | Barbara Ruaro Andrea Salotti Nicolò Reccardini Stefano Kette Beatrice Da Re Salvatore Nicolosi Umberto Zuccon Marco Confalonieri Lucrezia Mondini Riccardo Pozzan Michael Hughes Paola Confalonieri Francesco Salton |
| author_sort | Barbara Ruaro |
| collection | DOAJ |
| description | Background. Idiopathic pulmonary fibrosis (IPF) is a chronic interstitial lung disease with rapidly progressive evolution and an unfavorable outcome. Nintedanib (NTD) is an antifibrotic drug that has been shown to be effective in slowing down the progression of the disease. The aim of our study was to examine the efficacy, especially in terms of the functional decline, and the safety profile of NTD in patients treated with the recommended dose and subjects who reduced or suspended the therapy due to the occurrence of adverse reactions. Methods. We conducted a real-life retrospective study based on the experience of NTD use in two centers between 2015 and 2022. Clinical data were evaluated at baseline, at 6 and 12 months after the NTD introduction in the whole population and in subgroups of patients who continued the full-dose treatment, at a reduced dosage, and at the discontinuation of treatment. The following data were recorded: the demographic features, IPF clinical features, NTD therapeutic dosage, tolerability and adverse events, pulmonary function tests (PFTs), the duration of treatment upon discontinuation, and the causes of interruption. Results. There were 54 IPF patients who were included (29.6% females, with a median (IQR) age at baseline of 75 (69.0–79.0) years). Twelve months after the introduction of the NTD therapy, 20 (37%) patients were still taking the full dose, 11 (20.4%) had reduced it to 200 mg daily, and 15 (27.8%) had stopped treatment. Gastrointestinal intolerance predominantly led to the dose reduction (13.0%) and treatment cessation (20.4%). There were two deaths within the initial 6 months (3.7%) and seven (13.0%) within 12 months. Compared to the baseline, the results of the PFTs remained stable at 6 and 12 months for the entire NTD-treated population, except for a significant decline in the DLCO (% predicted value) at both 6 (38.0 ± 17.8 vs. 43.0 ± 26.0; <i>p</i> = 0.041) and 12 months (41.5 ± 15.3 vs. 44.0 ± 26.8; <i>p</i> = 0.048). The patients who continued treatment at the full dose or a reduced dosage showed no significant differences in the FVC and the DLCO at 12 months. Conversely, those discontinuing the NTD exhibited a statistically significant decline in the FVC (% predicted value) at 12 months compared to the baseline (55.0 ± 13.5 vs. 70.0 ± 23.0; <i>p</i> = 0.035). Conclusions. This study highlights the functional decline of the FVC at 12 months after the NTD initiation among patients discontinuing therapy but not among those reducing their dosage. |
| first_indexed | 2024-03-08T10:38:03Z |
| format | Article |
| id | doaj.art-118e5b52e59447bba05de3daca595530 |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-08T10:38:03Z |
| publishDate | 2024-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-118e5b52e59447bba05de3daca5955302024-01-26T18:06:07ZengMDPI AGPharmaceuticals1424-82472024-01-0117111910.3390/ph17010119Functional Progression after Dose Suspension or Discontinuation of Nintedanib in Idiopathic Pulmonary Fibrosis: A Real-Life Multicentre StudyBarbara Ruaro0Andrea Salotti1Nicolò Reccardini2Stefano Kette3Beatrice Da Re4Salvatore Nicolosi5Umberto Zuccon6Marco Confalonieri7Lucrezia Mondini8Riccardo Pozzan9Michael Hughes10Paola Confalonieri11Francesco Salton12Department of Pulmonology, University Hospital of Cattinara, 34149 Trieste, ItalyDepartment of Pulmonology, University Hospital of Cattinara, 34149 Trieste, ItalyDepartment of Pulmonology, University Hospital of Cattinara, 34149 Trieste, ItalyDepartment of Pulmonology, University Hospital of Cattinara, 34149 Trieste, ItalyDepartment of Pulmonology, University Hospital of Cattinara, 34149 Trieste, ItalyDepartment of Pulmonology, University Hospital of Cattinara, 34149 Trieste, ItalyPulmonology Unit, General Hospital “Santa Maria degli Angeli”, 33170 Pordenone, ItalyDepartment of Pulmonology, University Hospital of Cattinara, 34149 Trieste, ItalyDepartment of Pulmonology, University Hospital of Cattinara, 34149 Trieste, ItalyPulmonology Unit, General Hospital “Santa Maria degli Angeli”, 33170 Pordenone, ItalyDivision of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester Salford Royal NHS Foundation Trust, Manchester M6 8HD, UKDepartment of Pulmonology, University Hospital of Cattinara, 34149 Trieste, ItalyDepartment of Pulmonology, University Hospital of Cattinara, 34149 Trieste, ItalyBackground. Idiopathic pulmonary fibrosis (IPF) is a chronic interstitial lung disease with rapidly progressive evolution and an unfavorable outcome. Nintedanib (NTD) is an antifibrotic drug that has been shown to be effective in slowing down the progression of the disease. The aim of our study was to examine the efficacy, especially in terms of the functional decline, and the safety profile of NTD in patients treated with the recommended dose and subjects who reduced or suspended the therapy due to the occurrence of adverse reactions. Methods. We conducted a real-life retrospective study based on the experience of NTD use in two centers between 2015 and 2022. Clinical data were evaluated at baseline, at 6 and 12 months after the NTD introduction in the whole population and in subgroups of patients who continued the full-dose treatment, at a reduced dosage, and at the discontinuation of treatment. The following data were recorded: the demographic features, IPF clinical features, NTD therapeutic dosage, tolerability and adverse events, pulmonary function tests (PFTs), the duration of treatment upon discontinuation, and the causes of interruption. Results. There were 54 IPF patients who were included (29.6% females, with a median (IQR) age at baseline of 75 (69.0–79.0) years). Twelve months after the introduction of the NTD therapy, 20 (37%) patients were still taking the full dose, 11 (20.4%) had reduced it to 200 mg daily, and 15 (27.8%) had stopped treatment. Gastrointestinal intolerance predominantly led to the dose reduction (13.0%) and treatment cessation (20.4%). There were two deaths within the initial 6 months (3.7%) and seven (13.0%) within 12 months. Compared to the baseline, the results of the PFTs remained stable at 6 and 12 months for the entire NTD-treated population, except for a significant decline in the DLCO (% predicted value) at both 6 (38.0 ± 17.8 vs. 43.0 ± 26.0; <i>p</i> = 0.041) and 12 months (41.5 ± 15.3 vs. 44.0 ± 26.8; <i>p</i> = 0.048). The patients who continued treatment at the full dose or a reduced dosage showed no significant differences in the FVC and the DLCO at 12 months. Conversely, those discontinuing the NTD exhibited a statistically significant decline in the FVC (% predicted value) at 12 months compared to the baseline (55.0 ± 13.5 vs. 70.0 ± 23.0; <i>p</i> = 0.035). Conclusions. This study highlights the functional decline of the FVC at 12 months after the NTD initiation among patients discontinuing therapy but not among those reducing their dosage.https://www.mdpi.com/1424-8247/17/1/119idiopathic pulmonary fibrosis (IPF)interstitial pneumoniainterstitial lung disease (ILD)Nintedanib (NTD)pulmonary function tests (PFTs)high-resolution computed tomography (HRTC) |
| spellingShingle | Barbara Ruaro Andrea Salotti Nicolò Reccardini Stefano Kette Beatrice Da Re Salvatore Nicolosi Umberto Zuccon Marco Confalonieri Lucrezia Mondini Riccardo Pozzan Michael Hughes Paola Confalonieri Francesco Salton Functional Progression after Dose Suspension or Discontinuation of Nintedanib in Idiopathic Pulmonary Fibrosis: A Real-Life Multicentre Study Pharmaceuticals idiopathic pulmonary fibrosis (IPF) interstitial pneumonia interstitial lung disease (ILD) Nintedanib (NTD) pulmonary function tests (PFTs) high-resolution computed tomography (HRTC) |
| title | Functional Progression after Dose Suspension or Discontinuation of Nintedanib in Idiopathic Pulmonary Fibrosis: A Real-Life Multicentre Study |
| title_full | Functional Progression after Dose Suspension or Discontinuation of Nintedanib in Idiopathic Pulmonary Fibrosis: A Real-Life Multicentre Study |
| title_fullStr | Functional Progression after Dose Suspension or Discontinuation of Nintedanib in Idiopathic Pulmonary Fibrosis: A Real-Life Multicentre Study |
| title_full_unstemmed | Functional Progression after Dose Suspension or Discontinuation of Nintedanib in Idiopathic Pulmonary Fibrosis: A Real-Life Multicentre Study |
| title_short | Functional Progression after Dose Suspension or Discontinuation of Nintedanib in Idiopathic Pulmonary Fibrosis: A Real-Life Multicentre Study |
| title_sort | functional progression after dose suspension or discontinuation of nintedanib in idiopathic pulmonary fibrosis a real life multicentre study |
| topic | idiopathic pulmonary fibrosis (IPF) interstitial pneumonia interstitial lung disease (ILD) Nintedanib (NTD) pulmonary function tests (PFTs) high-resolution computed tomography (HRTC) |
| url | https://www.mdpi.com/1424-8247/17/1/119 |
| work_keys_str_mv | AT barbararuaro functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT andreasalotti functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT nicoloreccardini functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT stefanokette functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT beatricedare functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT salvatorenicolosi functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT umbertozuccon functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT marcoconfalonieri functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT lucreziamondini functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT riccardopozzan functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT michaelhughes functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT paolaconfalonieri functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy AT francescosalton functionalprogressionafterdosesuspensionordiscontinuationofnintedanibinidiopathicpulmonaryfibrosisareallifemulticentrestudy |