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P261. Improved quality of life in response to combined oral and topical mesalazine (PENTASA®) for ulcerative colitis: Results from the PINCE trial

P261. Improved quality of life in response to combined oral and topical mesalazine (PENTASA®) for ulcerative colitis: Results from the PINCE trial

C.S.J. Probert1, P. Broberg2, A. Dignass3, P. Marteau4

1University of Bristol, Bristol, United Kingdom; 2Ferring Pharmaceuticals, Saint-Prex, Switzerland; 3Markus Hospital, Frankfurt, Germany; 4Lariboisière Hospital, Paris, France

Objectives: Ulcerative colitis (UC) is a chronic inflammatory disorder of the colon, the symptoms of which can be devastating in terms of their debilitating effects. These symptoms can have a major impact on patients' quality of life (QoL) as well as influencing which treatments are selected for the management of the disease. The PINCE study demonstrated that in patients treated with combined oral and enema formulations of mesalazine (PENTASA®) there was improvement of clinical symptoms compared with the oral formulation alone at 4 weeks (89% versus 62%, respectively) and at 8 weeks (86% versus 68%, respectively) [1]. A secondary objective of this study was to investigate QoL in response to combined enema and oral mesalazine in patients with active UC.

Aims and Methods: The analysis included patients with extensive active mild/moderate UC in the PINCE study. Patients received mesalazine (1 g/day) or placebo enema for 4 weeks. Both groups also received oral mesalazine (2 g twice daily) for 8 weeks. Euro-Quality of Life (Euro-QoL) was assessed at 0, 2, 4 and 8 weeks, this includes five items covering mobility, self-care, usual activity, pain/discomfort and anxiety/depression. Each question had three response categories: no problem; some problems; inability or extreme problems.

Results: Of the 116 intent-to-treat patients, 63 were in the active enema group and 53 in the placebo enema group. After 4 weeks of treatment, use of mesalazine enema compared to placebo enema significantly improved patients' mobility (p = 0.048), usual activity (p = 0.034) and anxiety/depression (p = 0.049). The mesalazine enema was also associated with a trend towards improved pain/discomfort (p = 0.053). With respect to self-care, there were no relevant changes during the study in either treatment group. To assess acceptability of combination therapy, patients were asked after 8 weeks of treatment, if they would be prepared to take a combination therapy in the future; 83.6% of the mesalazine enema and 84.9% of the placebo enema group would be willing to take a combination therapy in the future.

Conclusions: These data show that the combination of oral and enema mesalazine provides a real and measurable benefit on the QoL of patients with active UC. Euro-QoL dimensions for mobility, usual activity, and anxiety/depression were all significantly improved following combined oral and enema mesalazine. The combination therapy was also extremely well accepted with more than 80% of the patients willing to use the treatment in the future.

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