All the trials using tofacitinib for maintenance of remission in UC have allowed the use of concomitant therapies except glucocorticoids. Mesalamine, a drug used in mild-to-moderate UC is often continued in patients receiving other drugs for maintenance. In this study, we plan to compare the effect of withdrawing mesalamine and continuing monotherapy with tofacitinib versus continuing dual therapy with tofacitinib and mesalamine. We hypothesize that the continuation of tofacitinib monotherapy after withdrawing mesalamine will be as efficacious and safe as continuation of the combination in remission maintenance in UC.
Diagnosed cases of UC by endoscopy and biopsy
Patients in clinical remission for at least 3 months on Tofacitinib and mesalamine
Incomplete evaluation
Uncertain diagnosis
Active disease
Subjects with Crohn's disease, microscopic colitis and collegenous colitis or IBD-U
Parallel
Tofacitinib
DrugTofacitinib alone will be continued at a dose of 11 mg once a day
Tofacitinib plus mesalamine
DrugBoth tofacitinib 11 mg once a day and mesalamine will be continued
Time to relapse of colitis
Relapse of ulcerative colitis will be diagnosed based on the study subject's clinical findings
Serum biomarker C-reactive protein
Changes in the level of serum biomarker C-reactive protein
Serum biomarker calprotectin
Changes in the level of serum biomarker calprotectin
Physician global assessment
The physician will assess the overall clinical condition of the subject on a visual analog scale from 0 to 100
Adverse effects
The adverse effects of the study drugs (venous thromboembolism, nasopharyngitis, diarrhea) and any other patient-reported adverse effects
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