DOP083. Prospective, longitudinal observational study in therapeutic management of mild to moderate ulcerative colitis (OPTIMUM): follow-up at one year
S. Nahon1, G. Tucat2, P. Niez3, G. Bonnaud4, 1Centre Hospitalier Le Raincy, Gastroenterology, Montfermeil, France, 2CREGG, Gastroenterology, Paris, France, 3Ferring Pharmaceuticals France, Medical, Gentilly, France, 4Clinique des Cèdres, Cornebarrieu, France
OPTIMUM study was set up in France in 2011. Its objective was to describe the progression and methods of therapeutic management of mild to moderate ulcerative colitis (UC), to assess remission rate, duration of remissions and prognostic factors for relapse in patients with a flare-up.
From June 2011 to June 2012, 812 patients over 18 years of age with a mild to moderate flare-up of UC (51% women, average age of 45±15 years) were included in the observational study by 130 gastroenterologists (64% office based). A three-years monitoring is planned. The time period selected for a visit to one year is 365±100 days after the inclusion visit.
In July 2013, the one-year visit data (time period of 369±42 days) was available for 504 patients (62%); 419 (83%) were in remission during the first year. According to the UCCS score (Ulcerative Colitis Clinical Score), at one-year visit, 397 (79%) patients were in remission, 67 (13%) had mild activity and 33 (7%) had moderate activity. Remission was achieved after a median period of 59 days (95% CI [53–77 days]) after the inclusion consultation. At the end of the visit, treatment with 5-ASA alone was prescribed in 479 patients (59%), treatment combining 5-ASA and another UC treatment in 175 patients (22%) and another UC-treatment not including 5-ASA in 99 patients (12%). The UC treatment at the period of remission was the one prescribed at the end of the inclusion visit in 366 patients (87%). After adjusting for the UCCS score and the level of injury at visit, the patients treated solely with 5-ASA at the end of the inclusion visit were in remission faster than the patients treated without 5-ASA (p = 0.013); but the difference with patients treated with 5-ASA in combination with another treatment was not statistically significant (p = 0.062). At one year, the remission rate was 82.5% (95% IC [78.0%-86.6%]) in the group treated with 5-ASA alone prescribed at the end of the inclusion visit vs 71.4% (95% IC [64.0%-78.4%]) in the group treated with 5-ASA in combination with another treatment. At the one-year visit, a UC treatment was in on going in 426 patients (84%). Compliance was good in 92 of 394 patients (23%). In total, at least one adverse event was reported in 15 patients (3%). Colorectal cancer or dysplasia was diagnosed in three patients (0.6%).
During treatment, the period of remission of mild to moderate UC flare-up is about two months. After one year of monitoring, about 80% of patients are in remission. The continuation of the OPTIMUM observational study will help refine these results and, in particular, analyse possible relapses over three years of monitoring.