Patients with Crohn’s Disease Are More Likely to Remain on Biologics than Immunomodulators: A Meta-Analysis of Treatment Durability

Digestive Diseases and Sciences

Volumn 60, Issue 8, 2015, Pages 2408-2418

  Shah, Eric D ^a   Siegel, Corey A ^b   Chong, Kelly ^c   Melmed, Gil Y ^a  

^a CEDARS SINAI MEDICAL CENTER   (United States)

^b DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^c VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

Adverse outcomes adverse events; Compliance issues in IBD; Outcomes research measurements; Side effects of medications

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; BIOLOGICAL PRODUCT; CERTOLIZUMAB PEGOL; IMMUNOMODULATING AGENT; INFLIXIMAB; MERCAPTOPURINE; METHOTREXATE; NATALIZUMAB; PLACEBO; VEDOLIZUMAB; IMMUNOLOGIC FACTOR; IMMUNOSUPPRESSIVE AGENT;

ARTICLE; CROHN DISEASE; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; MAINTENANCE THERAPY; META ANALYSIS; NUMBERS NEEDED TO TREAT; OPEN STUDY; PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REMISSION; STATISTICAL SIGNIFICANCE; SYSTEMATIC REVIEW; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; COMPARATIVE EFFECTIVENESS; MEDICATION COMPLIANCE; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME;

BIOLOGICAL PRODUCTS; COMPARATIVE EFFECTIVENESS RESEARCH; CROHN DISEASE; HUMANS; IMMUNOLOGIC FACTORS; IMMUNOSUPPRESSIVE AGENTS; MEDICATION ADHERENCE; METHOTREXATE; NUMBERS NEEDED TO TREAT; TREATMENT OUTCOME;

EID: 84937524797     PISSN: 01632116     EISSN: 15732568     Source Type: Journal    
DOI: 10.1007/s10620-015-3618-8     Document Type: Article

References (53)

1. Long MD, Farraye FA, Okafor PN, Martin C, Sandler RS, Kappelman MD. Increased risk of pneumocystis jiroveci pneumonia among patients with inflammatory bowel disease. Inflamm Bowel Dis. 2013;19:1018–1024.
2. Dignass A, Van Assche G, Lindsay JO, et al. The second european evidence-based consensus on the diagnosis and management of Crohn’s disease: current management. J Crohns Colitis. 2010;4:28–62.
3. Lichtenstein GR, Hanauer SB, Sandborn WJ, Gastroenterology PPCoACo. Management of Crohn’s disease in adults. Am J Gastroenterol. 2009;104:465–483; quiz 464, 484.
4. Meuwis MA, Vernier-Massouille G, Grimaud JC, et al. Serum calprotectin as a biomarker for Crohn’s disease. J Crohns Colitis. 2013;7:e678–e683.
5. Park KT, Bass D. Inflammatory bowel disease–attributable costs and cost–effective strategies in the united states: a review. Inflamm Bowel Dis. 2011;17:1603–1609.
6. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Engl J Med. 2010;362:1383–1395.
7. Cheifetz AS, Melmed GY, Spiegel B, et al. Setting priorities for comparative effectiveness research in inflammatory bowel disease: results of an international provider survey, expert rand panel, and patient focus groups. Inflamm Bowel Dis. 2012;18:2294–2300.
8. Louis E, Mary JY, Vernier-Massouille G, et al. Maintenance of remission among patients with Crohn’s disease on antimetabolite therapy after infliximab therapy is stopped. Gastroenterology. 2012;142:63–70; quiz e31.
9. French H, Mark Dalzell A, Srinivasan R, El-Matary W. Relapse rate following azathioprine withdrawal in maintaining remission for Crohn’s disease: a meta-analysis. Dig Dis Sci. 2011;56:1929–1936.
10. Jackson CA, Clatworthy J, Robinson A, Horne R. Factors associated with non-adherence to oral medication for inflammatory bowel disease: a systematic review. Am J Gastroenterol. 2010;105:525–539.
11. Shah E, Kim S, Chong K, Lembo A, Pimentel M. Evaluation of harm in the pharmacotherapy of irritable bowel syndrome. Am J Med. 2012;125:381–393.
12. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369:711–721.
13. Higgins JP, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
14. Holden WL, Juhaeri J, Dai W. Benefit–risk analysis: a proposal using quantitative methods. Pharmacoepidemiol Drug Saf. 2003;12:611–616.
15. Alonso-Ruiz A, Pijoan JI, Ansuategui E, Urkaregi A, Calabozo M, Quintana A. Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and metaanalysis of efficacy and safety. BMC Musculoskelet Disord. 2008;9:52.
16. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7:177–188.
17. Sweeting MJ, Sutton AJ, Lambert PC. What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data. Stat Med. 2004;23:1351–1375.
18. Harbord RM, Egger M, Sterne JA. A modified test for small-study effects in meta-analyses of controlled trials with binary endpoints. Stat Med. 2006;25:3443–3457.
19. Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn’s disease. Crohn’s Disease cA2 Study Group. N Engl J Med. 1997;337:1029–1035.
20. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet. 2002;359:1541–1549.
21. Rutgeerts P, D’Haens G, Targan S, et al. Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn’s disease. Gastroenterology. 1999;117:761–769.
22. Feagan BG, Greenberg GR, Wild G, et al. Treatment of active Crohn’s disease with mln0002, a humanized antibody to the alpha4beta7 integrin. Clin Gastroenterol Hepatol. 2008;6:1370–1377.
23. Ghosh S, Goldin E, Gordon FH, et al. Natalizumab for active Crohn’s disease. N Engl J Med. 2003;348:24–32.
24. Feagan BG, Rochon J, Fedorak RN, et al. Methotrexate for the treatment of Crohn’s disease. The North American Crohn’s Study Group Investigators. N Engl J Med. 1995;332:292–297.
25. Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn’s disease: the CLASSIC-I trial. Gastroenterology. 2006;130:323–333; quiz 591.
26. Winter TA, Wright J, Ghosh S, Jahnsen J, Innes A, Round P. Intravenous cdp870, a pegylated fab’ fragment of a humanized antitumour necrosis factor antibody, in patients with moderate-to-severe Crohn’s disease: an exploratory study. Aliment Pharmacol Ther. 2004;20:1337–1346.
27. Watanabe M, Hibi T, Lomax KG, et al. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn’s disease. J Crohns Colitis. 2012;6:160–173.
28. Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the charm trial. Gastroenterology. 2007;132:52–65.
29. Sandborn WJ, Hanauer SB, Rutgeerts P, et al. Adalimumab for maintenance treatment of Crohn’s disease: results of the classic II trial. Gut. 2007;56:1232–1239.
30. Willoughby JM, Beckett J, Kumar PJ, Dawson AM. Controlled trial of azathioprine in Crohn’s disease. Lancet. 1971;2:944–947.
31. Feagan BG, Fedorak RN, Irvine EJ, et al. A comparison of methotrexate with placebo for the maintenance of remission in Crohn’s disease. North American Crohn’s Study Group Investigators. N Engl J Med. 2000;342:1627–1632.
32. Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2005;353:1912–1925.
33. Singleton JW, Law DH, Kelley ML, Mekhjian HS, Sturdevant RA. National cooperative Crohn’s disease study: adverse reactions to study drugs. Gastroenterology. 1979;77:870–882.
34. Summers RW, Switz DM, Sessions JT, et al. National cooperative Crohn’s disease study: results of drug treatment. Gastroenterology. 1979;77:847–869.
35. Winship DH, Summers RW, Singleton JW, et al. National cooperative Crohn’s disease study: study design and conduct of the study. Gastroenterology. 1979;77:829–842.
36. Candy S, Wright J, Gerber M, Adams G, Gerig M, Goodman R. A controlled double blind study of azathioprine in the management of Crohn’s disease. Gut. 1995;37:674–678.
37. Rosenberg JL, Levin B, Wall AJ, Kirsner JB. A controlled trial of azathioprine in Crohn’s disease. Am J Dig Dis. 1975;20:721–726.
38. Oren R, Moshkowitz M, Odes S, et al. Methotrexate in chronic active Crohn’s disease: a double-blind, randomized, israeli multicenter trial. Am J Gastroenterol. 1997;92:2203–2209.
39. National Institutes of Health. Highest Priority Challenge Topics, p 12. http://grants.nih.gov/grants/funding/challenge_award/High_Priority_Topics.pdf.
40. Nahon S, Lahmek P, Saas C, et al. Socioeconomic and psychological factors associated with nonadherence to treatment in inflammatory bowel disease patients: results of the ISSEO survey. Inflamm Bowel Dis. 2011;17:1270–1276.
41. Horne R, Parham R, Driscoll R, Robinson A. Patients’ attitudes to medicines and adherence to maintenance treatment in inflammatory bowel disease. Inflamm Bowel Dis. 2009;15:837–844.
42. Johnson FR, Hauber B, Özdemir S, Siegel CA, Hass S, Sands BE. Are gastroenterologists less tolerant of treatment risks than patients? Benefit–risk preferences in Crohn’s disease management. J Manag Care Pharm. 2010;16:616–628.
43. Suissa D, Brassard P, Smiechowski B, Suissa S. Number needed to treat is incorrect without proper time-related considerations. J Clin Epidemiol. 2012;65:42–46.
44. Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn’s disease activity index. National Cooperative Crohn’s Disease Study. Gastroenterology. 1976;70:439–444.
45. D’haens G, Van Deventer S, Van Hogezand R, et al. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn’s disease: a European multicenter trial. Gastroenterology. 1999;116:1029–1034.
46. Song F, Loke YK, Walsh T, Glenny AM, Eastwood AJ, Altman DG. Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews. BMJ. 2009;338:b1147.
47. Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007;146:829–838.
48. Sandborn WJ, Schreiber S, Feagan BG, et al. Certolizumab pegol for active Crohn’s disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011;9:670–678.
49. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn’s disease. N Engl J Med. 2007;357:228–238.
50. Targan SR, Feagan BG, Fedorak RN, et al. Natalizumab for the treatment of active Crohn’s disease: results of the encore trial. Gastroenterology. 2007;132:1672–1683.
51. Rutgeerts P, Van Assche G, Sandborn WJ, et al. Adalimumab induces and maintains mucosal healing in patients with Crohn’s disease: data from the extend trial. Gastroenterology. 2012;142:1102–1111.
52. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med. 2007;357:239–250.
53. Arora S, Katkov W, Cooley J, et al. Methotrexate in Crohn’s disease: results of a randomized, double-blind, placebo-controlled trial. Hepatogastroenterology. 1999;46:1724–1729.