Efficacy and Safety of Adalimumab 80 mg Weekly in Luminal Crohn's Disease

Bouguen G1, Laharie D, Nancey S, Hebuterne X, Flourie B, Filippi J, Roblin X, Trang C, Bourreille A, Babouri A, Bretagne JF, Siproudhis L, Peyrin-Biroulet L. Inflamm Bowel Dis. 2015 Mar 23. [Epub ahead of print]
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1*Department of Hepato-Gastroenterology, University Hospital of Rennes, Pontchaillou and Inserm U991 University of Rennes 1, Rennes, France; †Department of Hepato-Gastroenterology, University Hospital of Bordeaux, Hôpital Haut-Lévêque, Bordeaux, France; ‡Department of Hepato-Gastroenterology, University Hospital Lyon-Sud, University Claude Bernard Lyon 1, Lyon, France; §Department of Gastroenterology and Clinical Nutrition, University Hospital of Nice, University of Nice Sophia Antipolis, Nice, France; ‖Department of Hepato-Gastroenterology, University Hospital of Saint-Etienne, Saint-Etienne, France; ¶Institut des Maladies de l'appareil Digestif (IMAD), University Hospital of Nantes, Nantes, France; and **Inserm, U954 and Department of Hepato-Gastroenterology, University Hospital of Nancy, Université de Lorraine, Vandoeuvre-les-Nancy, France.


BACKGROUND: In case of a loss of response to adalimumab, some patients with Crohn's disease may derive benefit from increasing the dosing frequency to 40 mg weekly. Efficacy and safety of adalimumab 80 mg weekly remain unknown.

METHODS: From February 2011 to September 2012, all adults who had active Crohn's disease, defined at least by Crohn's disease activity index >150 and 1 objective sign of inflammation, and required an adalimumab dose escalation to 80 mg weekly were enrolled in a prospective multicenter cohort study. Crohn's disease activity index and C-reactive protein levels were recorded during the first 14 weeks following adalimumab optimization and at 6 months. All adverse events were recorded.

RESULTS: Forty-two patients were included. The median age was 33 years, and the median disease duration was 8.6 years. Adalimumab was associated with steroids in 28% of cases and with immunomodulators in 10% of patients. Within the 14 weeks after adalimumab optimization, 14 patients (33.3%) achieved clinical remission (Crohn's disease activity index <150), and 23 patients (54.8%) had a clinical response. Clinical improvement was associated with a drop in the C-reactive protein level from 18 to 5 mg/L (P = 0.0008). After a median follow-up of 14.5 months, 5 patients underwent major abdominal surgery. Adverse events were reported in 13 patients (31%).

CONCLUSIONS: Adalimumab 80 mg weekly seems to be well-tolerated and may be effective in inducing clinical remission in patients with luminal Crohn's disease who failed to respond to 40 mg weekly or 80 mg every other week.

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