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.
RCT Entities:
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.
Authors: M Camus; S Esses; B Pariente; L Le Bourhis; C Douay; V Chardiny; I Mocan; K Benlagha; E Clave; A Toubert; L Mayer; M Allez Journal: Mucosal Immunol Date: 2013-08-14 Impact factor: 7.313
Authors: A Tursi; W Elisei; M Picchio; C Zampaletta; G Pelecca; R Faggiani; G Brandimarte Journal: Tech Coloproctol Date: 2014-06-12 Impact factor: 3.781
Authors: Gary R Lichtenstein; Edward V Loftus; Kim L Isaacs; Miguel D Regueiro; Lauren B Gerson; Bruce E Sands Journal: Am J Gastroenterol Date: 2018-03-27 Impact factor: 10.864