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Abstract Number: 0389

Use of Nintedanib for the Treatment of Systemic Sclerosis-associated Interstitial Lung Disease at Expert Scleroderma Centers in the United States

Elana Bernstein1, John VanBuren2, Shervin Assassi3, Flavia Castelino4, Lorinda Chung5, Chase Correia6, Luke Evnin7, Tracy Frech2, Emily Startup2, Jessica Gordon8, Faye Hant9, Laura Hummers10, Nora Sandorfi11, Ami Shah12, Victoria Shanmugam13, Virginia Steen14 and Dinesh Khanna15, 1Columbia University, New York, NY, 2University of Utah, Salt Lake City, UT, 3University of Texas McGovern Medical School at Houston, Houston, TX, 4Massachusetts General Hospital, Boston, MA, 5Stanford University, Palo Alto, CA, 6Northwestern University, Chicago, IL, 7Scleroderma Research Foundation, Brisbane, CA, 8Hospital for Special Surgery, New York, NY, 9Medical University of South Carolina, Charleston, SC, 10Johns Hopkins Univerisity, Baltimore, MD, 11University of Pennsylvania, Philadelphia, PA, 12Johns Hopkins Rheumatology, Baltimore, MD, 13The George Washington University, Great Falls, VA, 14Division of Rheumatology, Georgetown University, Washington, DC, 15University of Michigan, Ann Arbor, MI

Meeting: ACR Convergence 2021

Keywords: interstitial lung disease, Systemic sclerosis

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Session Information

Date: Saturday, November 6, 2021

Title: Systemic Sclerosis & Related Disorders – Clinical Poster I (0387–0413)

Session Type: Poster Session A

Session Time: 8:30AM-10:30AM

Background/Purpose: Interstitial lung disease (ILD) affects 40-60% of adults with systemic sclerosis (SSc) and is the leading cause of death in this population. Nintedanib, a tyrosine kinase inhibitor, was the first medication to receive Food & Drug Administration approval for the treatment of SSc-ILD, in September 2019, based on the results of the SENSCIS trial. The most common adverse event (AE) associated with nintedanib is gastrointestinal distress. Of the 288 participants who received nintedanib in the SENSCIS trial, 75.7% experienced diarrhea, 31.6% nausea, and 24.7% vomiting. Moreover, 16% of participants discontinued nintedanib due to an AE.1 It is unknown how nintedanib is being used in clinical practice. The aims of this study were to describe the nintedanib prescribing practices at expert SSc centers in the US.

Methods: We performed a prospective cohort study of patients enrolled in the Collaborative National Quality and Efficacy Registry (CONQUER) at 13 sites in the US between June 6, 2018, and March 1, 2021. CONQUER is a US-based, prospective, multicenter cohort of adults with SSc who met 2013 ACR/EULAR Classification Criteria and had a disease duration ≤ 5 years from the 1st non-Raynaud’s symptom at enrollment. We compared baseline characteristics between participants with SSc-ILD who did and did not receive nintedanib. Descriptive data are presented due to the small sample size of subjects who received nintedanib.

Results: 459 SSc patients were enrolled in CONQUER, of whom 202 (44%) had ILD. Of the 202 participants with SSc-ILD, 14 (6.9%) had taken nintedanib at some point during their SSc-ILD disease course. Among those who received nintedanib compared to those who did not, a greater proportion were male (42.9% vs. 19.1%), Hispanic (21.4% vs. 10.8%), never smokers (78.6% vs. 67.0%), Scl-70 positive (50.0% vs. 35.6%), and had crackles on exam (71.4% vs. 32.6%), while a smaller percentage were centromere positive (0% vs. 10.1%) or RNA polymerase 3 positive (7.1% vs. 22.9%) (Table 1). The median baseline diarrhea scale score of the UCLA SCTC GIT 2.0 was in the “moderate” range for those who received nintedanib and in the “none-to-mild” range for those who did not. SSc patients who received nintedanib had lower baseline forced vital capacity, total lung capacity, and diffusion capacity for carbon monoxide than those who did not (Table 2). Of the 14 patients who received nintedanib, 10 (71.4%) have remained on it, 2 (14.3%) stopped and then restarted it, and 2 (14.3%) discontinued it. Twelve of the 14 (85.7%) patients who received nintedanib were concurrently receiving mycophenolate mofetil (MMF).

Conclusion: A relatively small percentage of patients with SSc-ILD enrolled in CONQUER have received nintedanib. The majority of patients who received nintedanib did so in combination with MMF. Most patients who received nintedanib were able to remain on this therapy. Future research should explore the tolerability of nintedanib in clinical practice, including reasons for discontinuation. Longitudinal registries such as CONQUER are critical for understanding SSc care in the US.

Reference:
1. Distler O, Highland KB, Gahlemann M, et al. Nintedanib for systemic sclerosis-associated interstitial lung disease. N Engl J Med 2019;380:2518-28.

Table 1. Baseline Characteristics by Nintedanib Status

Table 2. Baseline Pulmonary Function Test Results by Nintedanib Status


Disclosures: E. Bernstein, Boehringer Ingelheim, 1, 2, 5, Pfizer, 5, Kadmon, 5, Eicos Sciences, Inc., 5, Corbus, 5; J. VanBuren, None; S. Assassi, Novartis, 2, Boehringer Ingelheim, 2, 5, 6, 12, Travel, Corbus, 2, Integrity Continuing Education, 6, Medscape, 6, Momenta, 5, CSL Behring, 2, Janssen, 5, Abbvie, 2; F. Castelino, Boehringer Ingelheim, 2, Kadmon, 5; L. Chung, Boerhinger Ingelheim, 1, 5, 6, Genentech, 2, Eicos, 1, Reata, 1; C. Correia, Boehringer Ingelheim, 2, 6; L. Evnin, Boehringer Ingelheim, 5, Actelion (a Janssen company), 5; T. Frech, None; E. Startup, None; J. Gordon, Cumberland Pharmaceuticals, 5, EICOS Sciences, 5; F. Hant, None; L. Hummers, Boerhinger Ingelheim, 1, 5, Corbus Pharmaceuticals, 1, 5, Cumberland Pharmaceuticals, 5, Kadmon Corporation, 5, Medpace, 5; N. Sandorfi, None; A. Shah, None; V. Shanmugam, None; V. Steen, Boehringer Ingelheim, 1, 2, 5, 6, Corbus, 5, Corbus, 1, Eicos Sciences, Inc, 2, 5, CSL Behring, 5, CSL Behring, 2; D. Khanna, AbbVie, 2, Acceleron, 2, Actelion, 2, Amgen, 2, Bayer, 2, 5, Boehringer Ingelheim, 2, Bristol-Myers Squibb, 5, CiviBioPharma/Eicos Sciences, Inc, 12, Leadership/Equity position (Chief Medical Officer), Corbus, 2, CSL Behring, 2, Eicos Sciences, Inc, 11, Galapagos NV, 2, Genentech/Roche, 2, Gilead, 2, GlaxoSmithKline, 2, Horizon Therapeutics, 2, 5, Immune Tolerance Network, 5, Merck Sharp & Dohme, 2, Mitsubishi Tanabe Pharma, 2, National Institutes of Health, 5, Pfizer, 5, Sanofi-Aventis, 2, United Therapeutics, 2, Prometheus, 2, Theraly, 2, AstraZeneca, 2.

To cite this abstract in AMA style:

Bernstein E, VanBuren J, Assassi S, Castelino F, Chung L, Correia C, Evnin L, Frech T, Startup E, Gordon J, Hant F, Hummers L, Sandorfi N, Shah A, Shanmugam V, Steen V, Khanna D. Use of Nintedanib for the Treatment of Systemic Sclerosis-associated Interstitial Lung Disease at Expert Scleroderma Centers in the United States [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/use-of-nintedanib-for-the-treatment-of-systemic-sclerosis-associated-interstitial-lung-disease-at-expert-scleroderma-centers-in-the-united-states/. Accessed .
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