Introduction 5-Aminosalicylic Acid (5ASA) plays a key role in both induction and maintenance of remission in ulcerative colitis (UC). A number of questions remain poorly assessed by clinical trials including the role of dose, dose interval, preparation and delivery method in maintaining remission. We aimed to assess the value of preparation, dose, delivery method and dosing interval on the duration of first remission in patients with newly diagnosed UC.
Methods We retrospectively assessed an inception cohort of 100 newly diagnosed UC patients diagnosed between 2004 and 2008 and followed-up for 3 years. 69 patients took oral Pentasa and 11 took oral Asacol. The diagnosis adhered to the criteria of Lennard-Jones and clinical details were categorised according to the Montréal classification. Data were also collected on 5ASA maintenance drug (Asacol or Pentasa), dose (high dose or low dose), and delivery (oral or oral and rectal). Relapse was defined as an increase in symptoms needing an increase in anti-inflammatory therapy. Risk of relapse was evaluated using HR, and by using Cox regression to control for potential confounders.
Results From induction of remission to the end of our 3 yr follow-up, 76% of patients relapsed, with a mean time to relapse of 16 months. Mean daily dose taken of Asacol was 2.3 g/day (IQR 0 g/day) and Pentasa 2.4 g/day (IQR 2–3 g/day). We found no significant difference in the relapse rates between Asacol and Pentasa. (Relapse rate 7/11 Asacol vs 53/69 Pentesa, c2=0.574, HR 1.78 (p=0.19)). We also found no significant difference between: relapse rates for patients taking high dose 5ASA vs low dose. (Relapse rate 9/10 high dose vs 42/58 low dose, c2=0.114 HR 0.505 (p=0.223)); Oral and rectal vs oral alone (Relapse rate 10/12oral + rectal vs 59/77 oral, c2=0.374, HR 0.49 (p=0.09)); Twice daily and once daily (Relapse rate 44/60 TD vs 5/6 OD, c2=0.306, HR 2.12 (p=0.43)), and three times daily compared with twice daily (Relapse rate 20/23 TD vs 44/60 BD, c2=0.107, HR 0.82 (p=0.6)).
Conclusion The duration of first remission in UC is variable and although 5ASA are effective the majority of patients will relapse within 3 years. These data demonstrate that relapse is influenced relatively little by high dose or bi-directional therapies and there were no differences in the preparations studied. This would indicate that concordance with therapy is a vital aspect of 5ASA efficacy and clinicians should reinforce this point when discussing therapy.
Competing interests None declared.
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