Top

Techniques in Coloproctology

Published in:

01-11-2014 | Original Article

Comparison of the effectiveness of infliximab and adalimumab in preventing postoperative recurrence in patients with Crohn’s disease: an open-label, pilot study

Authors: A. Tursi, W. Elisei, M. Picchio, C. Zampaletta, G. Pelecca, R. Faggiani, G. Brandimarte

Published in: Techniques in Coloproctology | Issue 11/2014

Abstract

Background

Endoscopic and clinical recurrence of Crohn’s disease (CD) appears in up to 80 and 30 % of patients, respectively, 1 year after surgery. Both infliximab (IFX) and adalimumab (ADA) have been demonstrated to be effective in reducing the possibility of recurrence after surgery, but head-to-head studies have not been performed so far. The aim of this open-label prospective study was to compare endoscopic, histological and clinical recurrence after 1 year of treatment with IFX or ADA as postoperative prophylaxis in CD patients with a high risk of recurrence.

Methods

Consecutive CD patients who underwent curative ileocolonic resection were randomized to receive IFX or ADA for 1 year. Co-primary endpoints were endoscopic, histological and clinical recurrence after 12 months of therapy.

Results

Twenty consecutive CD patients (9 males and 11 females; median age 32.5 years, range 20–39 years) were enrolled after undergoing curative ileocolonic resection. Among the 10 patients treated with IFX, 2 (20 %) had endoscopic recurrence compared to 1 (10 %) in the group of 10 ADA patients (p = 1.0). Three out of 10 (30 %) IFX patients and 2 out of 10 (20 %) ADA patients had histological recurrence (p = 1.0). No significant clinical differences were found between the two groups.

Conclusions

IFX and ADA were similar in preventing histological, endoscopic and clinical recurrence after curative ileocolonic resection in high risk CD patients.

Loftus EV, Schoenfeld P, Sandborn WJ (2002) The epidemiology and natural history of Crohn’s disease in population-based patient cohorts from North America: a systematic review. Aliment Pharmacol Ther 16:51–60PubMedCrossRef

Jess T, Riis L, Vind I et al (2007) Changes in clinical characteristics, course, and prognosis of inflammatory bowel disease during the last 5 decades: a population-based study from Copenhagen, Denmark. Inflamm Bowel Dis 13:481–489PubMedCrossRef

Nos P, Domenech E (2008) Postoperative Crohn’s disease recurrence: a practical approach. World J Gastroenterol 14:5540–5548PubMedCrossRefPubMedCentral

Olaison G, Smedh K, Sjodahl R (1992) Natural course of Crohn’s disease after ileocolic resection: endoscopically visualized ileal ulcers preceding symptoms. Gut 33:331–335PubMedCrossRefPubMedCentral

Rutgeerts P, Geboes K, Vantrappen G et al (1990) Predictability of the postoperative course of Crohn’s disease. Gastroenterology 99:956–963PubMed

Van Assche G, Dignass A, Reinisch W et al (2010) The second European evidence-based consensus on the diagnosis and management of Crohn’s disease: special situations. J Crohns Colitis 4:63–101PubMedCrossRef

Reese GE, Nanidis T, Borysiewicz C, Yamamoto T, Orchard T, Tekkis PP (2008) The effect of smoking after surgery for Crohn’s disease: a meta-analysis of observational studies. Int J Colorectal Dis 23:1213–2121PubMedCrossRef

Simillis C, Yamamoto T, Reese GE et al (2008) A meta-analysis comparing incidence of recurrence and indication for reoperation after surgery for perforating versus nonperforating Crohn’s disease. Am J Gastroenterol 103:196–205PubMedCrossRef

Hofer B, Böttger T, Hernandez-Richter T, Seifert JK, Junginger T (2001) The impact of clinical types of disease manifestation on the risk of early postoperative recurrence in Crohn’s disease. Hepatogastroenterology 48:152–155PubMed

10.

Sachar DB, Lemmer E, Ibrahim C et al (2009) Recurrence patterns after first resection for structuring or penetrating Crohn’s disease. Inflamm Bowel Dis 15:1071–1075PubMedCrossRef

11.

Parente F, Sampietro GM, Molteni M et al (2004) Behaviour of the bowel wall during the first year after surgery is a strong predictor of symptomatic recurrence of Crohn’s disease: a prospective study. Aliment Pharmacol Ther 20:959–968PubMedCrossRef

12.

Hellers G (1979) Crohn’s disease in Stockholm county 1955–1974. A study of epidemiology, results of surgical treatment and long-term prognosis. Acta Chir Scand Suppl 490:1–84PubMed

13.

Doherty G, Bennett G, Patil S, Cheifetz A, Moss AC (2009) Interventions for prevention of post-operative recurrence of Crohn’s disease. Cochrane Database Syst Rev 7:CD006873

14.

Ford AC, Kane SV, Khan KJ et al (2011) Efficacy of 5-aminosalicylates in Crohn’s disease: systematic review and meta-analysis. Am J Gastroenterol 106:617–629PubMedCrossRef

15.

Caprilli R, Andreoli A, Capurso L et al (1994) Oral mesalazine (5-aminosalicylic acid; Asacol) for the prevention of post-operative recurrence of Crohn’s disease. Gruppo Italiano per lo Studio del Colon e del Retto (GISC). Aliment Pharmacol Ther 8:35–43PubMedCrossRef

16.

Florent C, Cortot A, Quandale P et al (1996) Placebo-controlled clinical trial of mesalazine in the prevention of early endoscopic recurrences after resection for Crohn’s disease. Groupe d’Etudes Thérapeutiques des Affections Inflammatoires Digestives (GETAID). Eur J Gastroenterol Hepatol 8:229–233PubMedCrossRef

17.

Rutgeerts P, Hiele M, Geboes K et al (1995) Controlled trial of metronidazole treatment for prevention of Crohn’s recurrence after ileal resection. Gastroenterology 108:1617–1621PubMedCrossRef

18.

Rutgeerts P, Van Assche G, Vermeire S et al (2005) Ornidazole for prophylaxis of postoperative Crohn’s disease recurrence: a randomized, double-blind, placebo-controlled trial. Gastroenterology 128:856–861PubMedCrossRef

19.

Hanauer SB, Korelitz BI, Rutgeerts P et al (2004) Post-operative maintenance of Crohn’s disease remission with 6-mercaptopurine, mesalamine or placebo: a 2 year trial. Gastroenterology 127:723–729PubMedCrossRef

20.

D’Haens GR, Vermeire S, Van Assche G et al (2008) Therapy of metronidazole with azathioprine to prevent postoperative recurrence of Crohn’s disease: a controlled randomized trial. Gastroenterology 135:1123–1129PubMedCrossRef

21.

Reinisch W, Angelberger S, Petritsch W et al (2010) Azathioprine versus mesalazine for prevention of postoperative clinical recurrence in patients with Crohn’s disease with endoscopic recurrence: efficacy and safety results of a randomised, double-blind, double-dummy, multicentre trial. Gut 59:752–759PubMedCrossRef

22.

Regueiro M, Schraut W, Baidoo L et al (2009) Infliximab prevents Crohn’s disease recurrence after ileal resection. Gastroenterology 136:441–450PubMedCrossRef

23.

Armuzzi A, Felice C, Papa A et al (2013) Prevention of postoperative recurrence with azathioprine or infliximab in patients with Crohn’s disease: an open-label pilot study. J Crohns Colitis 7:e623–e629PubMedCrossRef

24.

Aguas M, Bastida G, Cerrillo E et al (2012) Adalimumab in prevention of postoperative recurrence of Crohn’s disease in high-risk patients. World J Gastroenterol 18:4391–4398PubMedCrossRefPubMedCentral

25.

Papamichael K, Archavlis E, Lariou C, Mantzaris GJ (2012) Adalimumab for the prevention and/or treatment of post-operative recurrence of Crohn’s disease: a prospective, two-year, single center, pilot study. J Crohns Colitis 6:924–931PubMedCrossRef

26.

De Cruz P, Kamm MA, Hamilton AL et al (2012) Adalimumab prevents post-operative Crohn’s disease recurrence, and is superior to thiopurines: early results from the POCER study. Gastroenterology 142:S212CrossRef

27.

Harvey RF, Bradshaw JM (1980) A simple index of Crohn’s disease activity. Gut 1:514

28.

Geboes K, Riddell R, Ost A, Jensfelt B, Persson T, Löfberg R (2000) A reproducible grading scale for histological assessment of inflammation in ulcerative colitis. Gut 47:404–409PubMedCrossRefPubMedCentral

29.

Buisson A, Chevaux JB, Allen PB, Bommelaer G, Peyrin-Biroulet L (2012) Review article: the natural history of postoperative Crohn’s disease recurrence. Aliment Pharmacol Ther 35:625–633PubMedCrossRef

30.

Buisson A, Chevaux JB, Bommelaer G, Peyrin-Biroulet L (2012) Diagnosis, prevention and treatment of postoperative Crohn’s disease recurrence. Dig Liver Dis 44:453–460PubMedCrossRef

31.

Peyrin-Biroulet L, Deltenre P, Ardizzone S et al (2009) Azathioprine and 6-mercaptopurine for the prevention of postoperative recurrence in Crohn’s disease: a meta-analysis. Am J Gastroenterol 104:2089–2096PubMedCrossRef

32.

Ardizzone S, Maconi G, Sampietro GM et al (2004) Azathioprine and mesalamine for prevention of relapse after conservative surgery for Crohn’s disease. Gastroenterology 127:730–737PubMedCrossRef

33.

Sorrentino D, Terrosu G, Avellini C, Maiero S (2007) Infliximab with low-dose methotrexate for prevention of postsurgical recurrence of ileocolonic Crohn’s disease. Arch Intern Med 167:1804–1807PubMedCrossRef

34.

Savarino E, Bodini G, Dulbecco P et al (2013) Adalimumab is more effective than azathioprine and mesalamine at prevention of postoperative recurrence of Crohn’s disease: a randomized controlled trial. Am J Gastroenterol 108:1731–1742PubMedCrossRef

35.

Best WR, Becktel JM, Singleton JW, Kern F Jr (1979) Development of a Crohn’s disease activity index. Gastroenterology 70:439–444

36.

Tursi A (2001) Delayed orocecal transit time and bacterial overgrowth in Crohn’s disease. J Clin Gastroenterol 32:274–275PubMedCrossRef

37.

Moran G, Kaplan G, Yang H et al (2012) Inflammatory uncomplicated phenotype at the start of biological therapy predicts best surgery-free outcomes. J Crohns Colitis 6(Suppl 1):S137CrossRef

38.

Ahmed T, Rieder F, Fiocchi C, Achkar JP (2011) Pathogenesis of postoperative recurrence in Crohn’s disease. Gut 60:553–652PubMedCrossRef

39.

Yoshida K, Fukunaga K, Ikeuchi H et al (2012) Scheduled infliximab monotherapy to prevent recurrence of Crohn’s disease following ileocolonic or ileal resection: a 3-year prospective randomized open trial. Inflamm Bowel Dis 18:1617–1623PubMedCrossRef

Title: Comparison of the effectiveness of infliximab and adalimumab in preventing postoperative recurrence in patients with Crohn’s disease: an open-label, pilot study
Authors: A. Tursi
W. Elisei
M. Picchio
C. Zampaletta
G. Pelecca
R. Faggiani
G. Brandimarte
Publication date: 01-11-2014
Publisher: Springer Milan
Published in: Techniques in Coloproctology / Issue 11/2014
Print ISSN: 1123-6337
Electronic ISSN: 1128-045X
DOI: https://doi.org/10.1007/s10151-014-1177-1

At a glance: The STEP trials

Springer Medicine

Comparison of the effectiveness of infliximab and adalimumab in preventing postoperative recurrence in patients with Crohn’s disease: an open-label, pilot study

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 11/2014

Comments to “Perianal injectable bulking agents as treatment for faecal incontinence in adults”

A pilot study of extralevator abdominoperineal excision for primary melanoma of the anorectum

Transverse loop colostomy and colonic motility

Temporary sacral neuromodulation under local anaesthesia using new anatomical reference points

Perineal stapled prolapse resection (PSPR) in elderly patients for external rectal prolapse: early experience

Experience with a new device for pathological assessment of colonic endoscopic submucosal dissection