Adalimumab for the prevention and/or treatment of post-operative recurrence of Crohn's disease: A prospective, two-year, single center, pilot study

摘要

Background: Infliximab has shown efficacy at preventing post operative recurrence (POR) of Crohn's disease (CD). This study aimed at evaluating whether adalimumab can prevent and treat POR of CD. Methods: This prospective, single-center, open-label, two-year study included 23 patients who had undergone ileocecal resection for refractory or complicated CD and were at high-risk for POR. Patients received adalimumab from post operative day 14 (Group I, n = 8) or at 6. months post operatively after confirmation of endoscopic recurrence (PO-ER) despite treatment with azathioprine, infliximab, or 5-ASA (patients intolerant to infliximab and azathioprine, Group II, n = 15). Symptom assessment and laboratory tests were performed at monthly visits. Endoscopic findings were graded using the Rutgeerts score (RS) at 6 and 24. months after initiation of adalimumab. Primary end-points were maintenance (group I) or achievement of mucosal healing (Group II). Secondary end-points were prevention of post operative clinical recurrence (PO-CR) (Group I) and endoscopic and clinical improvement (group II). Results: In Group I, PO-ER (RS. ≥. i2) was seen in one patient at 6. months PO, whereas a second patient developed PO-ER and PO-CR after 24. months of treatment. In Group II, all patients had PO-ER whereas 9 (60%) patients had PO-CR at study enrolment; after 24. months of treatment 9/15 (60%) patients achieved complete (RS-i0, n = 3) or near complete (RS-i1, n = 6) mucosal healing and 5/9 (56%) clinical remission. No serious adverse events were reported. Conclusions: This pilot study suggests that adalimumab may prevent PO-ER and treat PO-ER/CR in high risk patients for POR of CD.