DOP086 Intestinal resection in Crohn's disease is associated with significant and durable improvement in health related quality of life although to a lesser extent in women and smokers. Results from the POCER study

Background: Health-related QoL (HRQoL) measures perceptions, illness experience, and functional status. Crohn’s disease patients have lower HRQoL, poorer function and more emotional distress than healthy individuals, even when in remission. HRQoL improves with medically or surgically induced remission. We evaluated the effects of surgery on HRQoL. Methods: Mucosal healing was the target in the Post-Operative Crohn’s Endoscopic Recurrence (POCER) treat-to-target study. Drug treatments included metronidazole, and thiopurine or adalimumab for high risk patients (smoker, perforating disease, 2nd operation). Patients were randomised to colonoscopy at 6 months with intensified treatment for endoscopic recurrence (“active care”) or no colonoscopy (“standard care”). All patients were colonoscoped at 18 months. HRQoL was assessed with a general (SF36) and disease-specific (IBDQ) questionnaire pre-operatively and at 6, 12 and 18 months. CRP, CDAI and faecal calprotectin (FC) were measured longitudinally. Results: 174 patients (median age 38, 55% female) were included. HRQoL was poor pre-operatively: median SF36 = 40 (where maximum = 100, Australian normal = 70 90) and IBDQ = 120 (maximum = 224, average score in Australian Crohn’s disease patients=156). For all patients both SF36 and IBDQ improved significantly at 6 months to 78 and 178 respectively, and this was sustained at 12 months (81 and 183) and 18 months (80 and 182 respectively). Females had lower HRQoL than males post-op at 6 (SF36 p = 0.012; IBDQ p = 0.007) and 12 months (SF36 p = 0.001, IBDQ p = 0.006). Smokers had poorer HRQoL compared to non-smokers at both 12 and 18 months: SF36 at 12 month p = 0.002, and IBDQ at 12 and 18 months (p = 0.046, p = 0.047 respectively). Persistent endoscopic remission, thiopurine or adalimumab therapy and treatment step up were not associated with changes in HRQoL. There was a significant inverse correlation between CDAI and both SF-36 and IBDQ at 6, 12 and 18 months. HRQoL did not correlate with endoscopic remission, CRP or FC. Conclusions: Intestinal resection of all macroscopic Crohn’s disease, with a focus on maintaining remission, is associated with significant and sustained improvement in general and disease-specific HRQoL. The lower HRQoL in female patients and smokers may reflect partly their lower QoL in the healthy and IBD populations, but this requires further investigation. A higher clinical disease activity index, but not direct measures of active disease or type of drug therapy, is associated with a lower HRQoL, suggesting that symptoms reflect subjective personal factors and not active mucosal disease or drug effects.E.K. Wright ... J.M. Andrews ... P.A. Bampton ... et al

Efficacy of thiopurines and adalimumab in preventing Crohn's disease recurrence in high-risk patients - a POCER study analysis

Background: Crohn's disease recurs in the majority of patients after intestinal resection. Aim: To compare the relative efficacy of thiopurines and anti-TNF therapy in patients at high risk of disease recurrence. Methods: As part of a larger study comparing post-operative management strategies, patients at high risk of recurrence (smoker, perforating disease, ≥2nd operation) were treated after resection of all macroscopic disease with 3 months metronidazole together with either azathioprine 2 mg/kg/day or mercaptopurine 1.5 mg/kg/day. Thiopurine-intolerant patients received adalimumab induction then 40 mg fortnightly. Patients underwent colonoscopy at 6 months with endoscopic recurrence assessed blind to treatment. Results: A total of 101 patients [50% male; median (IQR) age 36 (25–46) years] were included. There were no differences in disease history between thiopurine- and adalimumab-treated patients. Fifteen patients withdrew prior to 6 months, five due to symptom recurrence (of whom four were colonoscoped). Endoscopic recurrence (Rutgeerts score i2–i4) occurred in 33 of 73 (45%) thiopurine vs. 6 of 28 (21%) adalimumab-treated patients [intention-to-treat (ITT); P = 0.028] or 24 of 62 (39%) vs. 3 of 24 (13%) respectively [per-protocol analysis (PPA); P = 0.020]. Complete mucosal endoscopic normality (Rutgeerts i0) occurred in 17/73 (23%) vs. 15/28 (54%) (ITT; P = 0.003) and in 27% vs. 63% (PPA; P = 0.002). The most advanced disease (Rutgeerts i3 and i4) occurred in 8% vs. 4% (thiopurine vs. adalimumab). Conclusions: In Crohn's disease patients at high risk of post-operative recurrence adalimumab is superior to thiopurines in preventing early disease recurrence.P. De Cruz ... J. M. Andrews ... et al