Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON
Objective We assessed adverse events and changes in forced vital capacity (FVC) in patients treated with open-label nintedanib over 148 weeks of SENSCIS-ON, the extension of the SENSCIS trial.Methods Adverse events and changes in FVC over 148 weeks of SENSCIS-ON were assessed in patients who receive...
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BMJ Publishing Group
2025-02-01
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| Series: | RMD Open |
| Online Access: | https://rmdopen.bmj.com/content/11/1/e005086.full |
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| author | Yannick Allanore Dinesh Khanna Oliver Distler Maureen D Mayes Madelon C Vonk Kristin B Highland Arata Azuma Veronika Kohlbrenner Margarida Alves Alexandra James |
| author_facet | Yannick Allanore Dinesh Khanna Oliver Distler Maureen D Mayes Madelon C Vonk Kristin B Highland Arata Azuma Veronika Kohlbrenner Margarida Alves Alexandra James |
| author_sort | Yannick Allanore |
| collection | DOAJ |
| description | Objective We assessed adverse events and changes in forced vital capacity (FVC) in patients treated with open-label nintedanib over 148 weeks of SENSCIS-ON, the extension of the SENSCIS trial.Methods Adverse events and changes in FVC over 148 weeks of SENSCIS-ON were assessed in patients who received nintedanib in SENSCIS and continued nintedanib in SENSCIS-ON (‘continued nintedanib’ group) and in patients who received placebo in SENSCIS or received nintedanib for ≤28 days in a drug–drug interaction study and then received nintedanib in SENSCIS-ON (‘initiated nintedanib’ group).Results The continued nintedanib group comprised 197 patients, and the initiated nintedanib group comprised 247 patients (231 from SENSCIS). Diarrhoea was the most frequent adverse event, reported in 152 (77.2%) and 183 (74.1%) patients in the continued nintedanib and initiated nintedanib groups, respectively. Among patients in the continued and initiated nintedanib groups, respectively, 53 (26.9%) and 148 (59.9%) had ≥1 dose reduction, 72 (36.5%) and 131 (53.0%) had ≥1 treatment interruption and 29 (14.7%) and 72 (29.1%) had adverse events that led to treatment discontinuation. Mean (SE) changes in FVC (mL) at week 148 were −189.1 (29.5) in the continued nintedanib group and −126.4 (26.4) in the initiated nintedanib group.Conclusion The safety profile of nintedanib over 148 weeks of SENSCIS-ON was consistent with that reported in SENSCIS. Changes in FVC during SENSCIS and SENSCIS-ON supported a continued effect of nintedanib on slowing the decline in lung function, but showed continued progression of SSc-ILD. |
| format | Article |
| id | doaj-art-c7f8c6a718e04ed2aba26be1ed3d40d6 |
| institution | DOAJ |
| issn | 2056-5933 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
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| series | RMD Open |
| spelling | doaj-art-c7f8c6a718e04ed2aba26be1ed3d40d62025-08-20T02:45:09ZengBMJ Publishing GroupRMD Open2056-59332025-02-0111110.1136/rmdopen-2024-005086Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ONYannick Allanore0Dinesh Khanna1Oliver Distler2Maureen D Mayes3Madelon C Vonk4Kristin B Highland5Arata Azuma6Veronika Kohlbrenner7Margarida Alves8Alexandra James9Department of Rheumatology A, Université Paris Descartes, Faculté de Médecine, Paris, FranceDivision of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USADepartment of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, SwitzerlandDivision of Rheumatology and Clinical Immunogenetics, The University of Texas Health Science Center John P and Katherine G McGovern Medical School, Houston, Texas, USA2 Department of Rheumatology, Radboud University Medical Center, Nijmegen, The NetherlandsCleveland Clinic, Cleveland, Ohio, USA4Dept of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, JapanInflammation Medicine, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut, USABoehringer Ingelheim International GmbH, Ingelheim, Germany7 Elderbrook Solutions GmbH, Bietigheim-Bissingen, GermanyObjective We assessed adverse events and changes in forced vital capacity (FVC) in patients treated with open-label nintedanib over 148 weeks of SENSCIS-ON, the extension of the SENSCIS trial.Methods Adverse events and changes in FVC over 148 weeks of SENSCIS-ON were assessed in patients who received nintedanib in SENSCIS and continued nintedanib in SENSCIS-ON (‘continued nintedanib’ group) and in patients who received placebo in SENSCIS or received nintedanib for ≤28 days in a drug–drug interaction study and then received nintedanib in SENSCIS-ON (‘initiated nintedanib’ group).Results The continued nintedanib group comprised 197 patients, and the initiated nintedanib group comprised 247 patients (231 from SENSCIS). Diarrhoea was the most frequent adverse event, reported in 152 (77.2%) and 183 (74.1%) patients in the continued nintedanib and initiated nintedanib groups, respectively. Among patients in the continued and initiated nintedanib groups, respectively, 53 (26.9%) and 148 (59.9%) had ≥1 dose reduction, 72 (36.5%) and 131 (53.0%) had ≥1 treatment interruption and 29 (14.7%) and 72 (29.1%) had adverse events that led to treatment discontinuation. Mean (SE) changes in FVC (mL) at week 148 were −189.1 (29.5) in the continued nintedanib group and −126.4 (26.4) in the initiated nintedanib group.Conclusion The safety profile of nintedanib over 148 weeks of SENSCIS-ON was consistent with that reported in SENSCIS. Changes in FVC during SENSCIS and SENSCIS-ON supported a continued effect of nintedanib on slowing the decline in lung function, but showed continued progression of SSc-ILD.https://rmdopen.bmj.com/content/11/1/e005086.full |
| spellingShingle | Yannick Allanore Dinesh Khanna Oliver Distler Maureen D Mayes Madelon C Vonk Kristin B Highland Arata Azuma Veronika Kohlbrenner Margarida Alves Alexandra James Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON RMD Open |
| title | Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON |
| title_full | Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON |
| title_fullStr | Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON |
| title_full_unstemmed | Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON |
| title_short | Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON |
| title_sort | continued nintedanib in patients with systemic sclerosis associated interstitial lung disease 3 year data from senscis on |
| url | https://rmdopen.bmj.com/content/11/1/e005086.full |
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