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P392 Body mass index has no effect on treatment response in Crohn's disease patients with moderate disease activity who receive adalimumab

K. Soufleris*1, K. Fasoulas1, N. Kafalis1, G. Lazaraki1, D. Tzilves1

1Theagenion CHT, Gastroenterology Department, Thessaloniki, Greece

Background

There is ample evidence that obesity negatively affects treatment response to biologics in patients with autoimmune diseases. Data regarding the impact of obesity on treatment success of non-weight-based biologic therapies like adalimumab in patients with inflammatory bowel disease (IBD) are conflicting.

Methods

Ambulatory patients with Crohn's disease of at least moderate severity (Harvey–Bradshaw Index-HBI > 7) and active endoscopic disease at baseline were eligible for inclusion to the study. We only included patients with minimal systemic toxicity and normal serum albumin levels. The primary outcome of the study was clinical, biological, and endoscopic remission 24 weeks post treatment initiation. All patients received induction with adalimumab 160/80 mg at Weeks 0/2 followed by adalimumab 40 mg every 2 weeks. C-reactive protein (C-RP) and faecal calprotectin were measured (BÜHLMANN IBDoc® home based test) in all patients at baseline and 3 and 6 months later. All patients were evaluated by endoscopy 6 months after treatment was started. Clinical remission was defined as HBI <5, biological remission as faecal calprotectin < 250 μg/g and C-RP normalisation, and endoscopic remission as absence of ulcers. Patients with a body mass index (BMI) >30 were characterised as obese.

Results

We included 49 patients over a period of 2 years: 18 males, mean age 41.3 years, mean BMI 27.13 (range 19–41), 33 bio-naive, 44 on monotherapy. Clinical and biological remission was achieved by 33 patients (67.3%) and mucosal healing by 29 patients (59.1%). Obese patients had similar remission rates with non-obese patients. We did not observe any correlation of any BMI cut-off value with clinical, biological, and endoscopic remission. Post hoc analysis revealed that only elevated baseline calprotectin (p = 0.047) and disease duration longer than 2 years (p = 0.042) were predictive of treatment failure.

Conclusion

Treatment success of adalimumab was not affected by BMI in this single-centre real life study of patients with Crohn's disease of strictly moderate disease activity. Lower inflammatory burden (as indicated by calprotectin levels) and short disease duration were associated with higher remission rates. The role of obesity in response to current fixed-dose biologic dosing regimens in IBD merits further investigation.