A multicenter, prospective, observational study of the long-term outcomes of Crohn's disease patients under routine care management in Greece.

ABSTRACT

BACKGROUND: Real-world data on management patterns and long-term outcomes of patients with inadequately controlled Crohn's disease (CD) in Greece are scarce. METHODS: This was a multicenter, prospective observational study of 18-65-year-old CD patients whose physicians judged that their current therapy was inadequate to control their condition and therefore decided to switch treatment. Data were collected at enrollment (time of switch), and 30, 54 and 104 weeks post-enrollment. RESULTS: Sixty-six eligible patients (median age 35.8 years; 56.1% males; median CD diagnosis duration 2.3 years) were enrolled by nine hospital sites. At the time of treatment switch, 66.7% had "mild" (CD activity index [CDAI] <220) and 30.3% "moderate-to-severe" (220≤CDAI≤450) disease activity. Ileocolonic involvement, extraintestinal manifestations, prior CD-related surgeries and prior corticosteroid use were reported in 65.2%, 51.5%, 24.2% and 78.8% of patients, respectively. Throughout the study, most patients were managed with anti-tumor necrosis factor (TNF) medications (74.2%/74.1% infliximab; 10.6%/13.8% adalimumab at enrollment/end of study, respectively). At 54 and 104 weeks post-enrollment, the baseline CDAI score (median 174.5) decreased to 145.5 and 146.0 points (P<0.001) and the baseline C-reactive protein level (median 13.6 mg/L) decreased to 3.5 and 3.0 mg/L (P<0.001), respectively, not differing statistically between patients with "mild" and "moderate-to-severe" disease activity. In this patient population, 56.1% were corticosteroid-free throughout observation, while for the remaining 43.9%, the mean percentage corticosteroid-free period was 80.2%. CD-related surgeries and hospitalizations were reported in 8.1% and 19.4%, respectively. CONCLUSION: Under routine care in Greece, inadequately controlled CD patients were mainly switched to anti-TNFs, which lowered disease activity and reduced corticosteroid use.