Safety and Tolerability of Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease in the SENSCIS Trial: Subgroup Analysis Based on Demographic Characteristics

Oliver Distler¹, Kristin Highland ², Maureen Mayes ³, Masataka Kuwana ⁴, Lesley Saketkoo ⁵, Madelon Vonk ⁶, Michael Kreuter ⁷, Laura Hummers ⁸, Ute von Wangenheim ⁹, Martina Gahlemann ¹⁰, Veronika Kohlbrenner ¹¹, Margarida Alves ¹², Emmanuelle Clerisme-Beaty ¹² and Arata Azuma ¹³, ¹Dept. of Rheumatology, University Hospital Zürich, Zürich, Switzerland, Zürich, Switzerland, ²Cleveland Clinic, Cleveland, Ohio, USA, Cleveland, OH, ³Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, Texas, USA, Houston, TX, ⁴Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan, Bunkyo-ku, Tokyo, Japan, ⁵New Orleans Scleroderma and Sarcoidosis Patient Care and Research Center, New Orleans; Tulane University School of Medicine, University Medical Center – Comprehensive Pulmonary Hypertension Center, USA, New Orleans, ⁶Department of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands, Nijmegen, Gelderland, Netherlands, ⁷Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik, University of Heidelberg, Member of the German Center for Lung Research, Germany, Germany, Germany, ⁸Johns Hopkins University School of Medicine, Division of Rheumatology, Baltimore, MD, USA, Baltimore, MD, ⁹Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany, Biberach an der Riss, ¹⁰Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland, Basel, Switzerland, ¹¹Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA, Ridgefield, ¹²Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, Ingelheim am Rhein, Germany, ¹³Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan, Tokyo, Japan

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: autoimmune diseases, interstitial lung disease, Scleroderma, therapy and fibrosis

Session Information

Date: Sunday, November 10, 2019

Title: Systemic Sclerosis & Related Disorders – Clinical Poster I

Session Type: Poster Session (Sunday)

Session Time: 9:00AM-11:00AM

Background/Purpose: In the SENSCIS trial in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), the adverse events associated with nintedanib were manageable for most patients and characterized mainly by gastrointestinal events. We assessed the safety and tolerability of nintedanib in subgroups defined based on demographic characteristics at baseline.

Methods: Adverse events that occurred over 52 weeks of treatment, irrespective of causality, were assessed in subgroups of patients by age (< 65, ≥65 years), gender, race (White, Asian, Black/African-American) and weight (≤65, >65 kg) at baseline. Descriptive analyses, based on comparing the proportions of patients who had adverse events across subgroups, were performed in subjects who received ≥1 dose of trial drug.

Results: A total of 576 patients received trial drug (288 nintedanib; 288 placebo). At baseline, mean (SD) age was 54.0 (12.2) years and weight was 69.7 (15.9) kg. The majority of patients were female (75.2%) and white (67.2%). The adverse event profile of nintedanib, and the proportions of patients with adverse events leading to treatment discontinuation, were generally similar across subgroups defined by age, gender, race, and weight (Tables 1 and 2). Diarrhea was the most frequently reported adverse event with nintedanib in all the subgroups. Decreased appetite and decreased weight were reported more frequently in nintedanib-treated patients aged ≥65 years than < 65 years. Nausea and vomiting were reported more frequently in female than male patients treated with nintedanib. Liver test abnormalities were reported more frequently in nintedanib-treated patients who were female, aged ≥65 years, or Asian. Premature treatment discontinuations were more common in patients who were female, aged ≥65 years, or had a weight < 65kg.The number of Black/African-American patients was too small to allow conclusions to be drawn about adverse events in this subgroup.

Conclusion: The safety and tolerability profile of nintedanib in patients with SSc-ILD was generally consistent across subgroups of patients defined by age, gender, race and weight. A management plan based on the recommendations given in clinical trials may help patients to manage the most common adverse events associated with nintedanib therapy.

Disclosure: O. Distler, A. Menarini, 5, Abbvie, Acceleron, 5, Acceleron Pharma, 5, Actelion, 2, 5, 8, Actelion Pharmaceuticals, 2, 5, 8, 9, Amgen, 5, AnaMar, 2, 5, Bayer, 2, 5, 8, 9, Biogen Idec, 2, 5, Blade Therapeutics, 5, Boehringer Ingelheim, 2, 5, 8, 9, Catenion, 5, 9, ChemomAb, 2, 5, ChemomAB, 5, CSL Behring, 5, Ergonex, 5, espeRare Foundation, 2, 5, Genentech/Roche, 2, 5, GlaxoSmithKline, 5, GSK, 2, 5, Holds Patent mir-29 for the treatment of systemic sclerosis, 9, Inventiva, 2, 5, iQvia, 5, Italfarmaco, 2, 5, Italfarmco, 5, Lilly, 2, 5, med, 5, 8, medac, 5, Medac, 2, 5, MedImmune, 2, 5, Medscape, 5, 8, 9, Menarini, 8, Mepha, 8, Mitsubishi Tanabe, 2, 5, Mitsubishi Tanabe Pharma, 2, 5, MSD, 5, 8, Novartis, 2, 5, 8, 9, Patent, 9, Patent issued, 9, Pfizer, 2, 5, 8, Pharmacyclics, 2, 5, Roche, 5, 8, 9, Sanofi, 2, 5, Sinoxa, 2, 5, Target Bio Science, 5, Target BioScience, 5, UCB, 2, 5, 9, UCB in the area of potential treatments of scleroderma and its complications, 2, 5; K. Highland, Actelion Pharmaceuticals, 2, 8, 9, Bayer, 8, Bayer Healthcare, 8, Boehringer Ingelheim, 2, 5, 8, 9, Eiger Pharmaceuticals, 2, Genentech, 2, 8, Gilead Sciences, 8, Reata Pharmaceuticals, 2, United Therapeutics, 2, 8; M. Mayes, Boehringer Ingelheim, 5, 8, 9, Corbus, 9, Corbus Pharma, 9, Eicos, 9, Eicos Sciences, 9, Galapagos, 5, 9, GlaxoSmithKline, 9, Mitsubishi Tanabe Pharma, 5, Mitsubishi-Tanabe, 5, Reata Pharma, 9, Reata Pharmaceuticals, 9, Sanofi, 9; M. Kuwana, Abbvie, 2, 8, Actelion, 2, 8, Actelion Pharmaceuticals, 2, 8, Astellas, 2, 8, Bayer, 5, Boehringer Ingelheim, 5, Boehringer-Ingelheim, 5, Chugai, 2, 5, 8, Corbus, 5, CSL Behring, 5, CSL Berling, 5, Eisai, 2, 8, Eli Lilly, 2, Janssen, 8, Japan Blood Products Organization, 8, MBL, 7, 8, Ono, 2, 8, Pfizer, 2, Reata, 5, Tanabe-Mitsubishi, 2, 8; L. Saketkoo, None; M. Vonk, Actelion, 2, 5, 8, actelion, 2, 5, 8, Actelion Pharmaceuticals, 2, 5, 8, Boehringer Ingelheim, 5, 8, Boehringer ingelheim, 5, 8, Ferrer, 2, Ferrer International, 2, Ferrier, 2, GSK, 5, 6, Roche, 8; M. Kreuter, Boehringer Ingelheim, 2, 5, 8, Roche, 2, 5, 8, Galapagos, 5; L. Hummers, Boehringer Ingelheim, 2, 5, Boehringer-Ingelheim, 2, 5, Corbus, 2, Corbus Pharmacueticals, 2, CSL Behring, 5, Cumberland, 2, Cumberland Pharmaceuticals, 2, Cytori, 2, Cytori Therapeutics, 2, GlaxoSmithKline, 2; U. von Wangenheim, Boehringer Ingelheim, 3; M. Gahlemann, Boehringer Ingelheim, 3; V. Kohlbrenner, Boehringer Ingelheim, 3; M. Alves, Boehringer Ingelheim, 3; E. Clerisme-Beaty, Boehringer Ingelheim, 3; A. Azuma, Asahikasei Pharma Co., 5, 9, Boehringer Ingelheim, 5, 9, Shionogi & Co., Ltd, 5, 9, Taiho Pharmaceutical Co., Ltd, 5, 9.

To cite this abstract in AMA style:

Distler O, Highland K, Mayes M, Kuwana M, Saketkoo L, Vonk M, Kreuter M, Hummers L, von Wangenheim U, Gahlemann M, Kohlbrenner V, Alves M, Clerisme-Beaty E, Azuma A. Safety and Tolerability of Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease in the SENSCIS Trial: Subgroup Analysis Based on Demographic Characteristics [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/safety-and-tolerability-of-nintedanib-in-patients-with-systemic-sclerosis-associated-interstitial-lung-disease-in-the-senscis-trial-subgroup-analysis-based-on-demographic-characteristics/. Accessed .

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