Lack of effect of methotrexate in budesonide-refractory collagenous colitis

Andreas Münch,^1,* Johan Bohr,^2,3,* Lina Vigren,⁴ Curt Tysk,^2,3,* Magnus Ström<sup>1,*

1</sup>Division of Gastroenterology and Hepatology, Department of Clinical and Experimental Medicine, Faculty of Health Science, Linköping University, Linköping, ²Division of Gastroenterology, Department of Medicine, Örebro University Hospital, Örebro University, Örebro, ³School of Health and Medical Science, Örebro University, Örebro, ⁴Division of Gastroenterology, Department of Clinical Science, Lund University, Malmö, Sweden

^*These authors are members of the Swedish Organization for the study of Inflammatory Bowel Disease (SOIBD), a national organization for gastroenterologists, colorectal surgeons, and basic scientists

Background: In most cases, collagenous colitis can be treated effectively with budesonide. However, some patients develop side effects or have chronic symptoms refractory to budesonide. This paper reports an open case series of patients intolerant or refractory to budesonide who were treated with methotrexate (MTX).
Methods and patients: Nine patients (seven women) with a median (range) age of 62 (44–77) years were studied. Bowel movements were registered during 1 week prior to baseline and after 6 and 12 weeks’ treatment, enabling calculation of the mean bowel movements/day. All patients underwent colonoscopy with biopsies before inclusion to confirm diagnosis. Open treatment with MTX was given 15 mg subcutaneously weekly for 6 weeks and was increased to 25 mg for a further 6 weeks if symptoms were unresponsive to the first 6 weeks’ treatment. The endpoint was clinical remission, which was defined as a mean <3 stools/day and mean <1 watery stool/day/week at Week 12. The Short Health Scale was used at baseline and Week 12 to assess health-related quality of life.
Results: Five patients fulfilled the treatment according to the protocol and four patients discontinued the study after 3–6 weeks because of adverse events. No patient achieved clinical remission at Week 12. The mean stool frequency/day at baseline was 6.0 stools/day, thereof 5.4 watery stools/day and after 12 weeks treatment 6.4 stools/day, thereof 5.7 watery/day. No patient appreciated an improvement of health-related quality of life.
Conclusion: Short-term treatment with MTX had no clinical effect in collagenous colitis patients intolerant or refractory to budesonide. Alternative therapies should be investigated in these patients.

Keywords: microscopic colitis, health-related quality of life, Short Health Scale, MTX, stools, diarrhea