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P707 38 Weeks treatment of UC patients with different daily doses of mesalazine

R. Laoun*1, R. Hofmann2

1Tillotts Pharma AG, Medical Affairs, Rheinfelden, Switzerland, 2Tillotts Pharma, Medicines Management, Rheinfelden, Switzerland

Background

In everyday practice, the management of UC patients is not limited to a 6 week induction period. Patients in clinical remission will continue treatment to maintain remission and avoid recurrence. For non-remitters or for patients with clinical response, the treating physician faces several choices. He could maintain the same treatment for a longer period or increase the dosage of the initial therapy or just switch to another therapeutic class. In this analysis, we present the results of maintaining UC patients on 3.2 g/day or 4.8 g/day for a longer period than the short 8 weeks of induction.

Methods

737 patients (average MAYO 7.7 at screening) completed an 8 week randomised induction period with 3.2 g/day of mesalazine. 675 patients entered an open-label extension for a total of 38 weeks (including induction period). They were separated into 3 groups: remitters, responders and non-responders to 8 weeks of 3.2 g/day. They, respectively, received 1.6 g/day, 3.2 g/day or 4.8 g/day of a new 1600 mg mesalazine tablet.

Results

44% of all patients achieved clinical and endoscopic remission at Week 38. 53.8% of all patients achieved an endoscopic remission (MES ≤1, Mayo Endoscopic Score) at Week 38. 45.7% patient had a history of distal disease (proctitis and proctosigmoiditis). Similar endoscopic remissions were achieved in patients with any disease extent history including patients with distal disease of ulcerative colitis (Figure 1).

Figure 1: Mucosal healing at Week 38. 133 (65.8%), 108 (39.4%) and 59 patients (29.6%) achieved clinical and endoscopic remission at Week 38 with 1.6 g/day, 3.2 g/day and 4.8 g/day, respectively. 142 (70.3%), 93 (33.9%) and 61 (30.7%) patients achieved clinical remission (Stool score of 0 and rectal bleeding score of 0) at Week 38 with 1.6 g/d, 3.2 g/day and 4.8 g/day, respectively. 143 (70.8%), 138 (50.4%) and 82 (41.2%) patients achieved endoscopic remission (MES ≤1) at Week 38 with 1.6 g/day, 3.2 g/day and 4.8 g/day, respectively. 76 (37.6%), 64 (23.4%) and 27 (13.6%) achieved endoscopic remission (MES = 0) at Week 38 with 1.6 g/day, 3.2 g/day and 4.8 g/day, respectively.

TEAE incidence was similar between the 1.6 g/day, 3.2 g/day and 4.8 g/day treatment groups (29.2%, 26.6% and 19.1%, respectively).

Conclusion

Patients who did not respond to 3.2 g/day, either partially or fully, could benefit from a longer treatment period or even a 4.8 g/day of mesalazine to achieve total clinical and endoscopic remission with a similar and good safety profile. High endoscopic remission was also found in patients with distal disease extent.