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P151. Shorter time to cessation of rectal bleeding with combined oral and topical mesalazine (PENTASA®) for ulcerative colitis: Results from the PINCE trial

P151. Shorter time to cessation of rectal bleeding with combined oral and topical mesalazine (PENTASA®) for ulcerative colitis: Results from the PINCE trial

P. Marteau1, S. Lindgren2, P. Broberg3, C.S.J. Probert4

1Lariboisière Hospital, Paris, France; 2University Hospital MAS, Malmoe, Sweden; 3Ferring Pharmaceuticals, Saint Prex, Switzerland; 4University of Bristol, Bristol, United Kingdom

Objectives: The quality of life of patients with active ulcerative colitis (UC) can be dramatically improved by the rapid cessation of symptoms. The PINCE study looked at combined oral and enema mesalazine (PENTASA®) versus oral mesalazine alone, and demonstrated improvement of UC symptoms in patients at 4 weeks (89% vs 62%, respectively) and at 8 weeks (86% vs 68%, respectively) [1]. A secondary objective of the PINCE study was to investigate the time to cessation of rectal bleeding.

Aims and Methods: PINCE included patients with extensive active mild/moderate UC. Patients received mesalazine or placebo enema (1 g/day) for 4 weeks. Both arms also received oral mesalazine (2 g twice daily) for 8 weeks. Time to cessation of rectal bleeding was calculated from patient diaries.

Results: Rectal bleeding ceased in 40/52 patients (76.9%) in the mesalazine enema group, and in 16/30 patients (53.3%) in the placebo enema group (eight patients in the active group and 13 in the placebo group did not have rectal bleeding at baseline). The mesalazine enema group had a significantly shorter time to cessation of rectal bleeding than the placebo enema group (p = 0.0025). Mean duration of rectal bleeding was 21.0 days with mesalazine enema and 24.4 days with placebo enema (Table). In 35.0% and 25.0% of patients, rectal bleeding ceased within 7 days of study start in the mesalazine and placebo enema groups, respectively; rectal bleeding ceased later than day 28 in 32.5% and 37.5%, respectively. In 50% of mesalazine enema patients, there was cessation of rectal bleeding at ∼28 days (from Kaplan–Meier analysis), whereas this was achieved after >56 days in the placebo enema group. The time to the cessation of rectal bleeding in patients with frank blood at baseline was also shorter with mesalazine enema and in these patients there was cessation of rectal bleeding in 50% of the mesalazine enema group at ∼21 days, whereas it took >56 days in the placebo enema group.

Table. Time to cessation of rectal bleeding (days), ITT population
EnemaBaseline ScoreNMeanRange
MesalazineTraces of blood1118.40–51
 Frank blood2520.50–53
 Mainly blood431.51–46
 Total4021.00–53
PlaceboTraces of blood721.31–51
 Frank blood718.93–49
 Mainly blood254.546–63
 Total1624.41–63

Conclusions: Cessation of rectal bleeding was achieved by significantly more patients with mesalazine enema than with placebo enema. In addition, the time taken to cease rectal bleeding was significantly shorter in patients receiving combination oral and enema mesalazine than oral mesalazine alone, demonstrating improved efficacy of combination treatment in reducing the symptoms of UC.

1. Marteau P, et al. Gut 2005;54:960–5.