Comparative Response Of Combination Therapy Vs. Mono Therapy In Steroid Dependent Ulcerative Colitis Patients

Ulcerative colitis (UC) is an idiopathic inflammatory bowel disease (IBD) characterized by a chronic relapsing/intermittent clinical course. Steroids offer efficient and prompt relief of symptoms in a high proportion of ulcerative colitis (UC). Although most patients initially respond to corticosteroids, after 1 year, approximately 25% become steroid-dependent. The aim of this prospective study was to assess whether the administration the efficacy of azathioprine (AZA) and mesalamine combination to AZA monotherapy in maintaining remission of steroid-dependent ulcerative colitis (UC). The present study was carried out in the Department of Gastroenterology, IMS, BHU, Varanasi, India. A total of 136 patients age sex matched were included in the study after written informed consent fulfilling inclusion and exclusion criteria's. Patients with steroid-dependent UC in remission were randomized to receive AZA alone (1.5 mg/kg) (group 1) or in combination with mesalamine (800 mg tid) (group 2). Each group had 59 patients. Patients were considered in remission when steroid was withdrawn, an Ulcerative Colitis Clinical Activity Index (UCCAI) score of <2, an Ulcerative Colitis Disease Activity Index (UCDAI) score of 0, and a negative colonoscopy and histology. Followup was carried out every monthly for 2 year. Clinical examination, hematological and biochemical test were carried out routinely. Sigmoidoscopy and completion of inflammatory bowel disease quality-of-life questionnaire (IBD-Q) and UCDAI every 3 months; and 3) total colonoscopy with biopsies at the end of the study. Out of 136 patients 110 patients were analysed and rest 18 (13.23%) were lost in followup and 4 patients in each group developed side effects or poor compliance with treatment and were withdrawn from the study. Five patients receiving monotherapy (group 1) relapsed after the first year of the study and 3 after the second year of the study (14.54%). In the combination group (group 2) 2 patients relapsed after the first year of study and 2 after the second year of the study (7.27%) having statistically significant when compared with group 1 (p<0.05). Relapse rates were significant whether analyzed by intention-to-treat or per protocol. There were no significant differences between groups in time to relapse or discontinuation of treatment, UCCAI, UCDAI, or IBD-Q scores. Adverse events were similar both the groups and statistically non significant. Patients with steroid-dependent UC successfully maintained in remission on AZA and mesalamine and however relapse rate were more common in patients on azathioprine alone.