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Abstract Number: 0917

Drug-Drug Interaction Study of Nintedanib (Ofev®) and the Combination of Ethinylestradiol and Levonorgestrel (Microgynon®) in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

Madelon Vonk1, Mandy Avis2, Kristell Marzin3, Salome Mack3, Sven Wind3 and Martina Gahlemann4, 1Department of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands, Nijmegen, Netherlands, 2Boehringer Ingelheim B.V., Alkmaar, The Netherlands, Alkmaar, Netherlands, 3Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany, Biberach an der Riss, Germany, 4Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland, Basel, Switzerland

Meeting: ACR Convergence 2020

Keywords: interstitial lung disease, Systemic sclerosis, Women's health

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Session Information

Date: Saturday, November 7, 2020

Session Title: Systemic Sclerosis & Related Disorders – Clinical Poster II

Session Type: Poster Session B

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

Background/Purpose: Nintedanib is a tyrosine kinase inhibitor that has been approved for the treatment of SSc-ILD. As nintedanib may cause fetal harm, patients taking nintedanib should avoid pregnancy. The combination of ethinylestradiol and levonorgestrel is a commonly used oral contraceptive. We investigated the pharmacokinetics (PK) of the combination of ethinylestradiol and levonorgestrel alone and with nintedanib at steady-state in female patients with SSc-ILD.

Methods: We conducted an open-label, two-period, fixed-sequence, drug–drug interaction study (NCT03675581). Female patients aged ≥18 years, with SSc (based on 2013 ACR/EULAR criteria) and ≥10% extent of fibrotic ILD on a high-resolution computed tomography (HRCT) scan were eligible to participate. In Period 1, patients received a single tablet containing 30 μg ethinylestradiol and 150 μg levonorgestrel (reference treatment) ≥3 days before the first administration of nintedanib in Period 2. In Period 2, patients received a second tablet containing 30 μg ethinylestradiol and 150 μg levonorgestrel after continuous intake of nintedanib 150 mg bid for ≥10 consecutive days (test treatment). The primary PK endpoints were the areas under the concentration–time curve of ethinylestradiol and levonorgestrel in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) and the maximum measured concentrations of ethinylestradiol and levonorgestrel in plasma (Cmax). The areas under the concentration–time curve of ethinylestradiol and levonorgestrel in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) were secondary PK endpoints. The relative exposure to ethinylestradiol and levonorgestrel when administered alone versus in combination with nintedanib was assessed using an ANOVA model.

Results: PK data were analyzed from 15 treated patients. Plasma concentration–time profiles of ethinylestradiol and levonorgestrel were similar after administration alone or after administration of nintedanib 150 mg bid for ≥10 consecutive days (Figure). Total exposure to ethinylestradiol (AUC0-tz and AUC0-∞) was similar when ethinylestradiol and levonorgestrel were administered alone or after multiple administrations of nintedanib and peak exposure to ethinylestradiol (Cmax) slightly increased (by approximately 16%) after multiple administrations of nintedanib (Table). No differences in total or peak exposure to levonorgestrel (AUC0-tz or Cmax) were observed when ethinylestradiol and levonorgestrel were administered alone or after multiple administrations of nintedanib (Table).

Conclusion: PK results indicate that there is no relevant effect of nintedanib 150 mg bid on the plasma exposure to ethinylestradiol and levonorgestrel in female patients with SSc-ILD.


Disclosure: M. Vonk, Actelion Pharmaceuticals, 1, 2, 3, Boehringer Ingelheim, 1, 2, Roche, 1, 2, GlaxoSmithKline, 1, 2, Ferrer, 1; M. Avis, Boehringer Ingelheim, 1; K. Marzin, Boehringer Ingelheim, 1; S. Mack, Boehringer Ingelheim, 1; S. Wind, Boehringer Ingelheim, 1; M. Gahlemann, Boehringer Ingelheim, 1.

To cite this abstract in AMA style:

Vonk M, Avis M, Marzin K, Mack S, Wind S, Gahlemann M. Drug-Drug Interaction Study of Nintedanib (Ofev®) and the Combination of Ethinylestradiol and Levonorgestrel (Microgynon®) in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/drug-drug-interaction-study-of-nintedanib-ofev-and-the-combination-of-ethinylestradiol-and-levonorgestrel-microgynon-in-patients-with-systemic-sclerosis-associated-interstitial-lung-di/. Accessed July 2, 2022.
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