Session 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.
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 January 30, 2023.
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ACR Meeting Abstracts - 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/