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P678 Treatment of moderate to severe UC patients with new 5ASA tablets

R. Laoun*1, R. Hofmann2

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

Background

In previous mesalazine trials, patients with mild-to-moderate UC disease were investigated. Mesalazine is not thought to be efficacious for severe patients. For the first time, we present the efficacy results of mesalazine in moderate to severe patients.

Methods

In the largest mesalazine induction trial, 737 patients (mean MAYO 7.7 at screening) completed an 8-week 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 in 3 groups: remitters, responders and non-responders to 8 weeks of 3.2 g/day. They received, respectively, 1.6 g/day, 3.2 g/day, or 4.8 g/day, respectively, of mesalazine (a new 1600 mg tablet). For each patient, the site endoscopic scoring was reviewed by a central reader.

Results

During screening, of 675 patients who entered the OLE, 73.2% and 26.8% had an MES of 2 and 3, respectively. None of the patients had an MES of 0 or 1. 53.8% of the moderate to severe patients were in endoscopic remission after 38 weeks of treatment with 1600 mg mesalazine. Of 494 patients with moderate endoscopic activity, 57.7% were in endoscopic remission (MES ≤ 1) and 28.34% in total endoscopic remission (MES = 0) after 38 weeks. Of 181 patients with severe endoscopic activity, 43.1% achieved endoscopic remission (MES ≤ 1) and 14.9% total endoscopic remission (MES = 0) after 38 weeks. Picture 1 shows the endoscopic result of such a case. 64.2% and 14.5% of all patients in OLE had a moderate or severe partial mayo score, respectively.

Picture 1: Patient 34804001.

51% and 50% of moderate and severe patients, respectively, achieved clinical remission with a PMS score ≤ 1 at Week 38 of the study. 88.9% and 83.7% of moderate and severe patients, respectively, were in clinical remission or had only mild clinical activity at Week 38 of the study. TEAE were 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

The new 1600 mg mesalazine tablet was effective in achieving endoscopic remission (MES≤1) in both moderate and severe UC. Our results show that corticosteroids, immunomodulator and biologics can be avoided in moderate and some severe UC patients by dose escalation or prolongation of high-dose mesalazine therapy.