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Effectiveness and tolerability of methotrexate monotherapy in Crohn’s disease patients: a multicenter observational study

BACKGROUND: Methotrexate monotherapy is recommended as a maintenance therapy for Crohn’s disease (CD). However, long-term follow-up data are scarce. OBJECTIVES: We aimed to examine the effectiveness and tolerability of methotrexate monotherapy in 94 CD patients from three inflammatory bowel disease...

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Autores principales: Park, Jihye, Chun, Jaeyoung, Park, Soo Jung, Park, Jae Jun, Kim, Tae Il, Yoon, Hyuk, Cheon, Jae Hee
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10467270/
https://www.ncbi.nlm.nih.gov/pubmed/37655055
http://dx.doi.org/10.1177/17562848231191664
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author Park, Jihye
Chun, Jaeyoung
Park, Soo Jung
Park, Jae Jun
Kim, Tae Il
Yoon, Hyuk
Cheon, Jae Hee
author_facet Park, Jihye
Chun, Jaeyoung
Park, Soo Jung
Park, Jae Jun
Kim, Tae Il
Yoon, Hyuk
Cheon, Jae Hee
author_sort Park, Jihye
collection PubMed
description BACKGROUND: Methotrexate monotherapy is recommended as a maintenance therapy for Crohn’s disease (CD). However, long-term follow-up data are scarce. OBJECTIVES: We aimed to examine the effectiveness and tolerability of methotrexate monotherapy in 94 CD patients from three inflammatory bowel disease Clinics in Korea. DESIGN: This was a multicenter retrospective observational study. METHODS: Patients with active CD treated with methotrexate monotherapy were included. Clinical characteristics, laboratory indicators, endoscopy indices were evaluated at baseline, 6, 12, and 24 months. Independent factors associated with long-term clinical and endoscopic outcomes were determined. RESULTS: Methotrexate was administered orally (70.2%) or parenterally (29.8%). The mean methotrexate induction dose was 15.3 ± 0.4 mg/week, and the mean duration of therapy was 26.2 months. Of 76 patients who were treated for >6 months, the clinical remission rates were 76.3%, 74.6%, and 80.0% at 6, 12, and 24 months, respectively, by per-protocol analysis. The mean CRP levels were 7.5 ± 1.3, 5.3 ± 1.2, 3.8 ± 0.7, and 2.6 ± 0.5 mg/L at 0, 6, 12, and 24 months, respectively. Of 31 patients who underwent follow-up endoscopy after 27.5 months, the endoscopic remission rate was 38.7%. Baseline hemoglobin level <10 g/dL was a significant independent factor negatively associated with clinical remission at 6 [odds ratio (OR): 0.023, 95% confidence interval (CI): 0.003–0.206, p = 0.001] and 12 (OR: 0.079, 95% CI: 0.009–0.699, p = 0.023) months. Parenteral administration was a significant independent factor positively associated with clinical remission (OR: 11.231, 95% CI: 1.027–122.811, p = 0.047) and endoscopic remission (hazard ratio: 4.711, 95% CI: 1.398–15.874, p = 0.012) at 12 months. CONCLUSIONS: Methotrexate monotherapy was effective and tolerable as a maintenance therapy in CD patients.
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spelling pubmed-104672702023-08-31 Effectiveness and tolerability of methotrexate monotherapy in Crohn’s disease patients: a multicenter observational study Park, Jihye Chun, Jaeyoung Park, Soo Jung Park, Jae Jun Kim, Tae Il Yoon, Hyuk Cheon, Jae Hee Therap Adv Gastroenterol Original Research BACKGROUND: Methotrexate monotherapy is recommended as a maintenance therapy for Crohn’s disease (CD). However, long-term follow-up data are scarce. OBJECTIVES: We aimed to examine the effectiveness and tolerability of methotrexate monotherapy in 94 CD patients from three inflammatory bowel disease Clinics in Korea. DESIGN: This was a multicenter retrospective observational study. METHODS: Patients with active CD treated with methotrexate monotherapy were included. Clinical characteristics, laboratory indicators, endoscopy indices were evaluated at baseline, 6, 12, and 24 months. Independent factors associated with long-term clinical and endoscopic outcomes were determined. RESULTS: Methotrexate was administered orally (70.2%) or parenterally (29.8%). The mean methotrexate induction dose was 15.3 ± 0.4 mg/week, and the mean duration of therapy was 26.2 months. Of 76 patients who were treated for >6 months, the clinical remission rates were 76.3%, 74.6%, and 80.0% at 6, 12, and 24 months, respectively, by per-protocol analysis. The mean CRP levels were 7.5 ± 1.3, 5.3 ± 1.2, 3.8 ± 0.7, and 2.6 ± 0.5 mg/L at 0, 6, 12, and 24 months, respectively. Of 31 patients who underwent follow-up endoscopy after 27.5 months, the endoscopic remission rate was 38.7%. Baseline hemoglobin level <10 g/dL was a significant independent factor negatively associated with clinical remission at 6 [odds ratio (OR): 0.023, 95% confidence interval (CI): 0.003–0.206, p = 0.001] and 12 (OR: 0.079, 95% CI: 0.009–0.699, p = 0.023) months. Parenteral administration was a significant independent factor positively associated with clinical remission (OR: 11.231, 95% CI: 1.027–122.811, p = 0.047) and endoscopic remission (hazard ratio: 4.711, 95% CI: 1.398–15.874, p = 0.012) at 12 months. CONCLUSIONS: Methotrexate monotherapy was effective and tolerable as a maintenance therapy in CD patients. SAGE Publications 2023-08-23 /pmc/articles/PMC10467270/ /pubmed/37655055 http://dx.doi.org/10.1177/17562848231191664 Text en © The Author(s), 2023 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Research
Park, Jihye
Chun, Jaeyoung
Park, Soo Jung
Park, Jae Jun
Kim, Tae Il
Yoon, Hyuk
Cheon, Jae Hee
Effectiveness and tolerability of methotrexate monotherapy in Crohn’s disease patients: a multicenter observational study
title Effectiveness and tolerability of methotrexate monotherapy in Crohn’s disease patients: a multicenter observational study
title_full Effectiveness and tolerability of methotrexate monotherapy in Crohn’s disease patients: a multicenter observational study
title_fullStr Effectiveness and tolerability of methotrexate monotherapy in Crohn’s disease patients: a multicenter observational study
title_full_unstemmed Effectiveness and tolerability of methotrexate monotherapy in Crohn’s disease patients: a multicenter observational study
title_short Effectiveness and tolerability of methotrexate monotherapy in Crohn’s disease patients: a multicenter observational study
title_sort effectiveness and tolerability of methotrexate monotherapy in crohn’s disease patients: a multicenter observational study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10467270/
https://www.ncbi.nlm.nih.gov/pubmed/37655055
http://dx.doi.org/10.1177/17562848231191664
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