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. 2022 Dec;81(12):1722-1729.
doi: 10.1136/ard-2022-222564. Epub 2022 Aug 16.

Continued treatment with nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from SENSCIS-ON

Yannick Allanore  1 , Madelon C Vonk  2 , Oliver Distler  3 , Arata Azuma  4 , Maureen D Mayes  5 , Martina Gahlemann  6 , Alexandra James  7 , Veronika Kohlbrenner  8 , Margarida Alves  9 , Dinesh Khanna  10 , Kristin B Highland  11 ; SENSCIS-ON trial investigators
Affiliations

Continued treatment with nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from SENSCIS-ON

Yannick Allanore et al. Ann Rheum Dis. 2022 Dec.

Abstract

Objectives: In the SENSCIS trial in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) versus placebo, with adverse events that were manageable for most patients. An open-label extension trial, SENSCIS-ON, is assessing safety and FVC decline during longer term nintedanib treatment.

Methods: Patients who completed the SENSCIS trial or a drug-drug interaction (DDI) study of nintedanib and oral contraceptive on treatment were eligible to enter SENSCIS-ON. Adverse events and changes in FVC over 52 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 and initiated nintedanib in SENSCIS-ON or who received nintedanib for ≤28 days in the DDI study ('initiated nintedanib' group).

Results: There were 197 patients in the continued nintedanib group and 247 in the initiated nintedanib group. Diarrhoea was reported in 68.0% and 68.8% of patients in these groups, respectively. Adverse events led to discontinuation of nintedanib in 4.6% and 21.5% of the continued nintedanib and initiated nintedanib groups, respectively. Mean (SE) changes in FVC from baseline to week 52 of SENSCIS-ON were -58.3 (15.5) mL in the continued nintedanib group and -44.0 (16.2) mL in the initiated nintedanib group.

Conclusions: The safety profile of nintedanib over 52 weeks of SENSCIS-ON was consistent with that reported in SENSCIS. The change in FVC over 52 weeks of SENSCIS-ON was similar to that observed in the nintedanib group of SENSCIS.

Keywords: Autoimmune Diseases; Pulmonary Fibrosis; Scleroderma, Systemic.

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Conflict of interest statement

Competing interests: Yannick Allanore has received consulting fees from Boehringer Ingelheim (BI) and Sanofi; speaking fees from AbbVie, BI, Janssen; and has participated on Data Safety Monitoring Boards or Advisory Boards for BI, Chemomab, Curzion, Medsenic, Menarini, Prometheus, Sanofi. Madelon C Vonk reports grants from BI, Ferrer, Galapagos, Janssen; speaking fees from BI, Janssen, Merck Sharp & Dohme; has participated on a Data Safety Monitoring Board or Advisory Board for Corbus; and has an unpaid role with EUSTAR. Oliver Distler has received grants from BI, Kymera, Mitsubishi Tanabe; consultancy fees from AbbVie, Acceleron Pharma, Alcimed, Amgen, AnaMar, Arxx Therapeutics, AstraZeneca, Bayer, Beacon, Blade Therapeutics, BI, Corbus Pharmaceuticals, CSL Behring, 4P Science, Galapagos, Glenmark Pharmaceuticals, Horizon Therapeutics (Curzion), Inventiva, Kymera, Lupin, Merck Sharp & Dohme, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Pfizer, Prometheus Biosciences, Roivant Sciences, Sanofi, Topadur; speaking fees from Bayer, BI, Janssen, Medscape; and holds patent US8247389 for the treatment of SSc; he is Chair of the Executive Committee for the FOREUM Foundation, Co-Chair of the ERS/EULAR Guidelines, President of EUSTAR, a Member of the Board of Trustees for the Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) and the Hartmann Müller Foundation, and a Senate member of the Swiss Academy of Medical Sciences (SAMW). Arata Azuma reports grants from BI; consulting fees from BI, Kyorin, Taiho, Toray; speaking fees from BI. Maureen D Mayes reports grants paid to her institution from BI, Corbus, Eicos, Horizon Therapeutics, Mitsubishi Tanabe; payment for acting as a grant reviewer from Actelion; speaking fees from Medtelligence; and has participated on Data Safety Monitoring Boards or Advisory Boards for BI, Eicos, Mitsubishi Tanabe. Martina Gahlemann, Veronika Kohlbrenner and Margarida Alves are employees of BI. Alexandra James is an employee of Elderbrook Solutions GmbH, which was contracted by BI to conduct the analyses presented in this manuscript. Dinesh Khanna reports grants from Bristol Myers Squibb, Horizon Therapeutics, Pfizer; consulting fees from AbbVie, Actelion, BI, Bristol Myers Squibb, CSL Behring, Genentech, Horizon Therapeutics, Talaris, Theraly; speaking fees from AbbVie, Actelion, BI, CSL Behring, Genentech, Horizon Therapeutics; has a leadership or fiduciary role with Eicos; has received royalties or licenses for the University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0; and owns stock in Eicos. Kristin B Highland reports grants paid to her institution from BI; consulting and speaking fees from BI; and is a Scientific Advisory Committee Member for the National Scleroderma Foundation in the USA.

Figures

Figure 1
Figure 1
Disposition of patients in SENSCIS-ON.
Figure 2
Figure 2
Change from baseline in FVC (mL) at week 52 in SENSCIS and SENSCIS-ON. Changes were based on data from patients with available data at baseline and at week 52. FVC, forced vital capacity.
Figure 3
Figure 3
Absolute change from baseline in FVC (mL) over time in SENSCIS-ON. Baseline was the last measurement on or before the date of first trial drug intake in SENSCIS-ON. FVC, forced vital capacity.
Figure 4
Figure 4
Absolute change from baseline in FVC (mL) in SENSCIS and SENSCIS-ON (pooled). A digital version of this figure with a voiceover explaining the data is available at: https://www.globalmedcomms.com/respiratory/SENSCISandSENSCIS-ON. FVC, forced vital capacity.
Figure 5
Figure 5
Proportions of patients with relative increases and declines in FVC (mL) from baseline to week 52 of SENSCIS-ON. Percentages were calculated using the number of patients with available data at baseline and at week 52 as the denominator. FVC, forced vital capacity.
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References

    1. van den Hoogen F, Khanna D, Fransen J, et al. . 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League against rheumatism collaborative initiative. Arthritis Rheum 2013;65:2737–47. 10.1002/art.38098 - DOI - PMC - PubMed
    1. Jaeger VK, Wirz EG, Allanore Y, et al. . Incidences and risk factors of organ manifestations in the early course of systemic sclerosis: a longitudinal EUSTAR study. PLoS One 2016;11:e0163894. 10.1371/journal.pone.0163894 - DOI - PMC - PubMed
    1. Hoffmann-Vold A-M, Fretheim H, Halse A-K, et al. . Tracking impact of interstitial lung disease in systemic sclerosis in a complete nationwide cohort. Am J Respir Crit Care Med 2019;200:1258–66. 10.1164/rccm.201903-0486OC - DOI - PubMed
    1. Hoffmann-Vold A-M, Allanore Y, Alves M, et al. . Progressive interstitial lung disease in patients with systemic sclerosis-associated interstitial lung disease in the EUSTAR database. Ann Rheum Dis 2021;80:219–27. 10.1136/annrheumdis-2020-217455 - DOI - PMC - PubMed
    1. Goh NS, Hoyles RK, Denton CP, et al. . Short-Term pulmonary function trends are predictive of mortality in interstitial lung disease associated with systemic sclerosis. Arthritis Rheumatol 2017;69:1670–8. 10.1002/art.40130 - DOI - PubMed

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