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P689 An observational study on Crohn’s disease activity pattern and long-term outcomes of management strategies in the routine clinical setting in Greece

G. Paspatis*1, S. Potamianos2, K. Triantafyllou3, C. Tzathas4, G. Theocharis5, S. Michopoulos6, E. Akriviadis7, J. Karagiannis8, G. Alexopoulou9, A. Boubougianni9, A. Kouloumenta9, S. Ladas10

1Department of Gastroenterology, Benizelion General Hospital, Heraklion, Greece, 2Department of Gastroenterology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece, 3Hepatogastroenterology Unit, Second Department of Internal Medicine and Research Institute, Attikon University General Hospital, Medical School, Athens, Greece, 4Gastroenterology Department, Tzaneion General Hospital, Piraeus, Greece, 5Department of Gastroenterology, University Hospital of Patras, Rio/Patra, Greece, 6Department of Gastroenterology, Alexandra University Hospital, Athens, Greece, 7Department of Internal Medicine, General Hospital of Thessaloniki, Hippokratio, Thessaloniki, Greece, 8Gastroenterology Unit, Konstantopoulio Hospital, Athens, Greece, 9MSD, Athens, Greece, 10Department of Medicine & Gastroenterology, Medical School, ‘Laiko’ University General Hospital of Athens, University of Athens, Athens, Greece

Background

The present study aimed to provide real-world data regarding the severity, management and long-term outcomes in inadequately controlled Crohn’s disease (CD) patients across Greece.

Methods

A prospective, observational study in 18–65 year-old CD patients inadequately controlled with their current therapy for whom their physician decided to switch treatment. Visits occurred at enrolment (time of switch), 30 ± 4; 54 ± 4; and 104 ± 8 weeks post-enrolment.

Results

Enrolled were 66 eligible patients (median age 35.8 years; 56.1% males) by 9 hospital sites in Greece. The patients were followed for a median of 2.0 years; 87.9% completed the 2-year follow-up. At enrolment, 66.7% (44/66) had ‘mild’ (CDAI < 220); 30.3% (20/66) ‘moderate-to-severe’ (CDAI 220–450); and 3.0% (2/66) ‘severe’ (CDAI > 450) disease activity. A median of 2.3 years had elapsed from diagnosis to enrolment. Involvement of both small and large intestine was reported in 65.2% (63.6% of ‘mild’, and 70.0% of ‘moderate to severe’); extraintestinal manifestations in 51.5% (47.7% and 60.0%, respectively); prior CD-related surgeries in 24.2% (20.5% and 35.0%, respectively). The treatments received by the overall population at enrolment (initial switch) and at the end of 2 years were azathioprine (AZA 42.4% and 25.8%); 6-mercaptopurine (6-MP 3.0% and 1.5%); 5-ASA (40.9% and 25.8%); corticosteroids (CS; 36.4% and 1.5%); infliximab (74.2% and 65.2%); adalimumab (10.6% and 12.1%), and methotrexate (3.0% and 6.1%). At the end of the 2 years, 6.1% were not receiving any treatment. In the overall population, the baseline CDAI score (median 174.5) decreased by a median of 142.0, 145.5, and 146.0 points at 30, 54, and 104 weeks, respectively (p < 0.001 for all). CDAI decreased by 125.0, 122.0, and 135.0 amongst ‘mild’, and by 230.0, 230.0, and 227.0 points amongst ‘moderate-to-severe’ patients, respectively (p < 0.001 for all). The 1- and 2-year CD-related surgery incidence rate was 0.08 and 0.05 per person-year for the overall population (0.02 and 0.03 for ‘mild’; 0.20 and 0.11 for ‘moderate to severe’). The respective hospitalisation incidence rates were 0.27 and 0.16 for the overall population (0.22 and 0.13 for ‘mild’; 0.40 and 0.24 for ‘moderate to severe’).

Conclusion

In the routine care setting of inadequately controlled CD patients, mild disease activity is more prevalent; yet ‘mild’ similarly to ‘moderate-to-severe’ patients are frequently burdened by extraintestinal complications, small and large intestine involvement, and prior CD-related surgeries. The switching strategy primarily included anti-TNF biologics. Over the 2-year study observation period, the disease activity as evaluated with the CDAI score was decreased; the use of 5-ASA, AZA, 6-MP, and CS was reduced; and surgery and hospitalisation incidence rates declined.