Are immunomodulatory therapies safe in patients with inflammatory bowel disease? 23 years of single center experience

Year 2023, Volume: 22 Issue: 3, 142 - 149, 22.12.2023

Ali Atay , Yasemin Özderin Özin Dilara Turan Gökçe Müge Büyükaksoy , Gamze Demirel Meral Akdoğan Kayhan Zeki Mesut Yalın Kılıç Emin Altıparmak

https://doi.org/10.17941/agd.1405423

Cited By: 1

Abstract

Background and Aims: Immunomodulatory therapies are important cornerstones in the treatment of inflammatory bowel disease, and azathioprine and methotrexate are the agents that are mainly use, which inhibit purine synthesis. It may not always be possible to use these agents in effective doses due to their unresponsiveness or side-effect profiles. In our study, it was aimed to present a 23-year experience compiling side effects requiring treatment discontinuation in order to evaluate the safety profile of immunomodulatory agents. Materials and Method: Adverse effects that necessitate discontinuation of treatment in patients who were followed up with the diagnosis of inflammatory bowel disease between 1999-2022, were currently receiving anti-tumor necrosis factor therapy, and had a history of using azathioprine or methotrexate at the treatment dose were retrospectively evaluated. Patients who did not receive immunomodulatory agents at the therapeutic dose and patients who had conditions that did not require discontinuation of treatment were excluded. Results: The study group consisted of 410 patients, 310 patients with Crohn's disease and 100 patients with ulcerative colitis. Azathioprine was used in 325 patients and methotrexate was used in 85 patients. The mean age of the patients was 42.6 ± 13.4 years, and 257 of them were male (62.6%). Azathioprine treatment duration was 4.2 ± 3.5 years in patients with Crohn's disease and 3.0 ± 2.6 years in patients with ulcerative colitis. Side effects that required discontinuation were determined that 18 (5.5%) patients who used azathioprine and 6 (7%) patients who used methotrexate, and all of side effects consisted of grade 2 side effects. There was no significant difference between the two groups in the frequency of side effects (p: 0.59). Treatment-related hematologic or solid organ malignancy were not detected in either treatment group during the follow-up period. Conclusion: Considering the side-effect profile of azathioprine and methotrexate in patients followed up with the diagnosis of inflammatory bowel disease, there is no significant difference between the two groups, and these agents can be used safely with closely follow-up during the treatment.

Keywords

Immunomodulatory therapy, Crohn, ulcerative colitis

Ethical Statement

Bu çalışma 16.08.2023 tarihinde Ankara Şehir Hastanesi Yerel Etik Kurulu’nun E1-21-3893 sayılı kararı ile onaylanmıştır. Araştırma protokolünde Helsinki Deklarasyon protokolüne uyulmuştur. Çalışmamızda Helsinki Deklerasyonu Prensiplerine uyulmuştur.

İnflamatuvar bağırsak hastalığı olan hastalarda immünmodülatör tedaviler güvenli mi? 23 yıllık tek merkez deneyimi

Abstract

Giriş ve Amaç: İmmünmodülatör ajanlar inflamatuvar bağırsak hastalığı tedavisinde önemli köşe taşlarından olup pürin sentezini inhibe eden azatioprin ve metotreksat başlıca kullanılmakta olan ajanlardandır. Bu ajanların yanıtsızlık veya yan etki profilleri nedeni ile her zaman efektif dozda kullanılmaları mümkün olmayabilir. Çalışmamızda immünmodülatör ajanların güvenlik profilinin değerlendirilmesi amacı ile tedavi kesilmesini gerektirecek yan etkilerin derlendiği 23 yıllık deneyimin sunulması amaçlandı. Gereç ve Yöntem: 1999-2022 yılları arasında inflamatuvar bağırsak hastalığı tanısı ile takipli olan, halihazırda anti-tümör nekrozis faktör tedavisi almakta olup tedavi dozunda azatioprin veya metotreksat kullanım geçmişi olan hastalarda tedavi kesilmesini gerektirecek yan etkiler geriye dönük olarak incelendi. İmmünmodülatör ajanları tedavi dozunda almamış olan hastalar ile tedavi kesilmesini gerektirmeyecek durumların gözlendiği hastalar dışlandı. Bulgular: Çalışma grubu 310 Crohn hastalığı ve 100 ülseratif koliti olan hasta olmak üzere 410 hastadan oluşuyordu. 325 hastada azatioprin, 85 hastada metotreksat kullanım öyküsü mevcuttu. Hastaların ortalama yaşı 42.6 ± 13.4 yıl olup 257’si erkek (%62.6) idi. Azatioprin kullanım süresi Crohn hastalarında 4.2 ± 3.5 yıl, ülseratif kolit olan hastalarda 3.0 ± 2.6 yıl idi. Azatioprin kullanmış olan hastaların 18’inde (%5.5), metotreksat kullanmış olan hastaların 6’sında (%7) kesilmesini gerektirecek yan etkiler geliştiği tespit edildi ve yan etkilerin tamamı 2. derece yan etkilerden oluşmaktaydı. İmmünmodülatör ajanların tedavi bırakmayı gerektiren yan etki sıklığında iki grup arasında anlamlı fark saptanmadı (p: 0.59). Her iki tedavi grubunda da takip süresince tedavi ilişkili hematolojik veya solid organ malignitesi saptanmadı. Sonuç: İnflamatuvar bağırsak hastalığı tanısı ile takipli hastalarda azatioprin ve metotreksat yan etki profili göz önüne alındığında iki grup arasında anlamlı fark olmayıp tedavi süresince yakın takip ile güvenli kullanılabilecek ajanlardır.

Keywords

İmmünmodülatör tedavi, Crohn hastalığı, ülseratif kolit

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