Abstract

Background and aim: Oral mesalazine and sulfasalazine (SASP) are key drugs for treating ulcerative colitis (UC). The efficacy of switching from one of the several mesalazine formulations to another is largely unknown. This study assessed the efficacy of switching among three types of mesalazine formulation and SASP for UC therapy. Methods: UC patients receiving high-dose mesalazine/SASP who switched to other formulations due to disease activity were considered eligible. Efficacy was evaluated 2, 6, and 12 months after switching. Results: A total of 106 switches in 88 UC patients were analyzed. The efficacy at 2 months after switching was observed in 23/39 (59%) cases from any mesalazine formulation to SASP, in 18/55 (33%) cases from one mesalazine to another, and in 2/12 (17%) cases from SASP to any mesalazine formulation. Nine of 43 effective cases showed inefficacy or became intolerant post-switching. Delayed efficacy more than two months after switching was observed in four cases. Steroid-free remission was achieved in 42/106 (39%) cases—within 100 days in 35 of these cases (83%). Conclusions: Switching from mesalazine to SASP was effective in more than half of cases. The efficacy of switching between mesalazine formulations was lower but may be worth attempting in clinical practice from a safety perspective.

Highlights

  • Ulcerative colitis (UC) is a chronic idiopathic disorder characterized by manifestations such as rectal bleeding, diarrhea, abdominal pain, a fever, anemia, and loss of body weight

  • The efficacy of switching between high-dose mesalazine/SASP is a clinical question with great interest in real clinical practice, as patients in whom high-dose mesalazine/SASP is insufficiently effective may be switched to immunosuppressive agents or biologics that are likely to be accompanied by adverse events and a high expense

  • Patients who had received the highest dose of mesalazine formation or SASP approved in Japan (4 g/day for time-dependent mesalazine (Pentasa), 3.6 g/day for pH-dependent mesalazine (Asacol), and 4.8 g/day for once-daily multi-matrix system (MMX) mesalazine(Lialda)) were included

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Summary

Introduction

Ulcerative colitis (UC) is a chronic idiopathic disorder characterized by manifestations such as rectal bleeding, diarrhea, abdominal pain, a fever, anemia, and loss of body weight. [1]. There are various medications for UC, such as 5-aminosalicylic acids, thiopurines, corticosteroids, calcineurin inhibitors, anti-tumor necrosis factor (TNFα) antibodies, anti-α4β7integrin antibodies, and Janus kinase inhibitors [2,3] These medications, are not always effective in UC patients, and some show a loss of response despite initial efficacy. The efficacy of switching between high-dose mesalazine/SASP is a clinical question with great interest in real clinical practice, as patients in whom high-dose mesalazine/SASP is insufficiently effective may be switched to immunosuppressive agents or biologics that are likely to be accompanied by adverse events and a high expense. We investigated the short- and long-term efficacy of switching among mesalazine/SASP formulations in UC patients who had already received high-dose mesalazine/SASP

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Evaluated Outcomes
Statistical Analyses
Patient Characteristics

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