Earlier discontinuation of TNF-α inhibitor therapy in female patients with inflammatory bowel disease is related to a greater risk of side effects
Schultheiss, Johannes P D; Brand, Eelco C; Lamers, Evert; van den Berg, Willemijn C M; van Schaik, Fiona D M; Oldenburg, Bas; Fidder, Herma H
(2019) Alimentary Pharmacology & Therapeutics, volume 50, issue 4, pp. 386 - 396
(Article)
Abstract
BACKGROUND: In rheumatoid arthritis and psoriasis female sex has been shown to be associated with discontinuation of anti-tumour necrosis factor-α (TNF-α) therapy. AIM: To retrospectively assess the association between sex and TNF-α drug persistence in patients with inflammatory bowel disease (IBD). METHODS: All IBD patients on anti-TNF-α therapy with a
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minimum follow-up of 12 months in a single tertiary centre were identified. Patient and treatment characteristics and reasons for anti-TNF-α discontinuation were recorded. Overall and cause-specific drug persistence was analysed with Kaplan-Meier followed by Cox proportional hazards regression models. RESULTS: We included 529 patients (49.9% male) with 631 treatment episodes (2280 anti-TNF-α treatment years) and 289 discontinuations of therapy. Female sex (adjusted hazard ratio [aHR] 1.42, 95% confidence interval [CI] 1.16-1.74), greater age at start of therapy per decade (aHR 1.15, 95% CI 1.04-1.27] and dose escalation (aHR 3.74, 95% CI 2.78-5.02) were associated with TNF-α inhibitor discontinuation. Total cohort cause-specific analysis identified female sex to be associated with side effects (aHR 4.05, 95% CI 2.36-6.98) but not to other discontinuation reasons. Adalimumab (aHR 1.70, 95% CI 1.11-2.60) and golimumab (aHR 4.97, 95% CI 2.30-10.74) use and dose-escalation (aHR 7.71, 95% CI 5.28-11.26) were associated with secondary loss of response. CONCLUSION: Drug persistence of anti-TNF-α therapy is lower in females as compared to males, mainly because of higher rates of side effects in females. Understanding the sex specific differences in effectiveness and safety of anti-TNF-α compounds can aid physicians in clinical decision-making.
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Keywords: Gastroenterology, Pharmacology (medical), Hepatology, Journal Article
ISSN: 0269-2813
Publisher: Wiley-Blackwell
Note: Funding Information: Declaration of funding interests: E.C. Brand is supported by the Alexandre Suerman programme for MD and PhD students of the University Medical Center Utrecht, Netherlands. This research received no specific grant from any funding agency in the public, commercial or not‐for‐profit sectors. Funding Information: Declaration of personal interests: E.C. Brand has received un‐ restricted research funding from Pfizer BV as co investigator; B. Oldenburg has received unrestricted research Grants from Abbvie, Dr. Falk, MSD, Takeda, Pfizer, Ferring, Cablon and has participated in the advisory board of Pfizer, Jansen, Abbvie, Takeda; and MSD. Herma H. Fidder has done consultation for Abbvie BV, Janssen BV, Ferring BV and Takeda BV. The remaining authors disclose no conflicts. Publisher Copyright: © 2019 John Wiley & Sons Ltd
(Peer reviewed)