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Observational Study
. 2021 May;53(9):1021-1029.
doi: 10.1111/apt.16315. Epub 2021 Mar 14.

Effectiveness and safety of methotrexate monotherapy in patients with Crohn's disease refractory to anti-TNF-α: results from the ENEIDA registry

Francisco Mesonero  1 , Jesús Castro-Poceiro  2 , Jose M Benítez  3 , Blau Camps  2 , Marisa Iborra  4 , Alicia López-García  2 , Paola Torres  2 , María Esteve  2 , Joan Tosca  4 , Federico Bertoletti  2 , Pedro Almela  5 , Xavier Calvet  2 , Isabel Vera  1 , Luis Bujanda  6 , Fernando Gomollón  7 , Cristina Rodríguez  8 , Beatriz Antolín  9 , David Busquets  10 , Alejandro Hernández  11 , Montserrat Rivero  12 , David Monfort I Miquel  2 , Andrés Castaño-García  13 , Javier P Gisbert  1 , Eugeni Domènech  2 , Antonio López-Sanromán  1 ; ENEIDA Project of GETECCU
Affiliations
Observational Study

Effectiveness and safety of methotrexate monotherapy in patients with Crohn's disease refractory to anti-TNF-α: results from the ENEIDA registry

Francisco Mesonero et al. Aliment Pharmacol Ther. 2021 May.

Abstract

Background: Methotrexate can be used to maintain remission in Crohn's disease patients who are intolerant to thiopurines. Data on its use as monotherapy in other scenarios are limited.

Aim: To assess the effectiveness of methotrexate monotherapy in Crohn's disease patients after previous failure to anti-tumour necrosis factor (anti-TNFα) drugs.

Methods: A retrospective, observational multicentre study of data from the Spanish ENEIDA registry. Participants were patients with active Crohn's disease and previous failure to anti-TNFα started on methotrexate monotherapy. Short-term effectiveness was assessed at 12-16 weeks based on Harvey-Bradshaw index (HBI): clinical remission as HBI ≤ 3 points and clinical response as HBI drop of ≥ 3 points over baseline. Long-term effectiveness was defined as steroid-free methotrexate persistence from 12 to 16 weeks until maximum follow up. Adverse events were recorded.

Results: Data were compiled for 110 patients treated with methotrexate after a failed response to one (39%) or two (55.6%) anti-TNFα agents. Short-term clinical response and remission rates were 60% and 30.9% respectively. Of 74 patients who continued after week 16, long-term effectiveness was achieved in 82% and 74% at 12 and 24 months respectively. In the multivariate analysis, non-remission at short term (vs remission) was associated with long-term failure (HR 2.58, 95%CI 1.95-3.68, P = 0.028). Adverse events (evaluated in 100 patients) were recorded in 44%, and in 30.4% of these patients, they led to methotrexate discontinuation.

Conclusions: The benefits observed suggest methotrexate monotherapy could be a valid option in Crohn's disease patients with previous failure to anti-TNFα.

Keywords: Crohn's disease; anti-tumour necrosis factor α; methotrexate.

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References

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