Crohn's Disease Activity and Concomitant Immunosuppressants Affect the Risk of Serious and Opportunistic Infections in Patients Treated with Adalimumab

American Journal of Gastroenterology

Volumn 111, Issue 12, 2016, Pages 1806-1815

  Osterman, Mark T ^a   Sandborn, William J ^b   Colombel, Jean Frederic ^c   Peyrin Biroulet, Laurent ^d   Robinson, Anne M ^e   Zhou, Qian ^e   Lewis, James D ^a  

^a PENN PRESBYTERIAN MEDICAL CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c MOUNT SINAI MEDICAL CENTER   (United States)

^d UNIVERSITY HOSPITAL OF NANCY   (France)

^e ABBVIE INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; BUDESONIDE; CORTICOSTEROID; IMMUNOSUPPRESSIVE AGENT; MERCAPTOPURINE; METHOTREXATE; PLACEBO; PREDNISONE; TUMOR NECROSIS FACTOR INHIBITOR; ANTIINFLAMMATORY AGENT; IMMUNOLOGIC FACTOR;

ADULT; ARTICLE; CONTROLLED STUDY; CROHN DISEASE; CROHN DISEASE ACTIVITY INDEX; DISEASE ACTIVITY; DISEASE ASSOCIATION; FEMALE; FOLLOW UP; HEALTH CARE QUALITY; HERPES ZOSTER; HUMAN; INFECTION RISK; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NONHUMAN; OPEN STUDY; OPPORTUNISTIC INFECTION; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VACCINATION; COMBINATION DRUG THERAPY; MIDDLE AGED; MULTIVARIATE ANALYSIS; OPPORTUNISTIC INFECTIONS; PATHOPHYSIOLOGY; PROPORTIONAL HAZARDS MODEL; RISK FACTOR; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

ADALIMUMAB; ADRENAL CORTEX HORMONES; ADULT; ANTI-INFLAMMATORY AGENTS; CROHN DISEASE; DRUG THERAPY, COMBINATION; FEMALE; HERPES ZOSTER; HUMANS; IMMUNOLOGIC FACTORS; IMMUNOSUPPRESSIVE AGENTS; MALE; METHOTREXATE; MIDDLE AGED; MULTIVARIATE ANALYSIS; OPPORTUNISTIC INFECTIONS; PROPORTIONAL HAZARDS MODELS; RISK FACTORS; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

EID: 84988710033     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1038/ajg.2016.433     Document Type: Article

References (33)

1. Terdiman JP, Gruss CB, Heidelbaugh JJ et al. American Gastroenterological Association Institute guidelines on the use of thiopurines, methotrexate, and anti-TNF- biologic drugs for the induction and maintenance of remission in infl ammatory Crohn's disease. Gastroenterology 2013; 145: 1459-63.
2. Lichtenstein GR, Feagan BG, Cohen RD et al. Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow-up in the TREAT TM registry. Am J Gastroenterol 2012; 107: 1409-22.
3. Toruner M, Loft us EV Jr, Harmsen WS et al. Risk factors for opportunistic infections in patients with infl ammatory bowel disease. Gastroenterology 2008; 134: 929-36.
4. Gupta G, Lautenbach E, Lewis JD. Incidence and risk factors for herpes zoster among patients with infl ammatory bowel disease. Clin Gastroenterol Hepatol 2006; 4: 1483-90.
5. Osterman MT, Lichtenstein GR. Current and future anti-TNF therapy for infl ammatory bowel disease. Curr Treat Options Gastroenterol 2007; 10: 195-207.
6. Ford AC, Peyrin-Biroulet LP. Opportunistic infections with anti-tumor necrosis factor- therapy in infl ammatory bowel disease: meta-analysis of randomized controlled trials. Am J Gastroenterol 2013; 108: 1268-76.
7. Bewtra M, Fairchild AO, Gilroy E et al. Infl ammatory bowel disease patients' willingness to accept medication risk to avoid future disease relapse. Am J Gastroenterol 2015; 110: 1675-81.
8. Colombel JF, Sandborn WJ, Reinisch W et al. Infl iximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010; 362: 1383-95.
9. Osterman MT, Haynes K, Delzell E et al. Eff ectiveness and safety of immuno modulators with anti-TNF therapy for Crohn's disease. Clin Gastroenterol Hepatol 2015; 13: 1293-301.
10. Jones J, Kaplan GG, Peyrin-Biroulet LP et al. Eff ects of concomitant immunomodulator therapy on effi cacy and safety of anti-tumor necrosis factor therapy for Crohn's disease: a meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol 2015; 13: 2233-40.
11. 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: 323-33.
12. 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: 1232-9.
13. Sandborn WJ, Rutgeerts P, Enns R et al. Adalimumab induction therapy for Crohn's disease previously treated with infl iximab. Ann Intern Med 2007; 146: 829-38.
14. Colombel J-F, 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.
15. 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: 1102-11.
16. Lofb erg R, Louis EV, Reinisch W et al. Adalimumab produces clinical remission and reduces extraintestinal manifestations in Crohn's disease: results from CARE. Infl amm Bowel Dis 2012; 18: 1-9.
17. Panaccione R, Loft us EV Jr, Binion D et al. Effi cacy and safety of adalimumab in Canadian patients with moderate to severe Crohn's disease: results of the adalimumab in Canadian subjects with moderate to severe Crohn's disease (ACCESS) trial. Can J Gastroenterol 2011; 8: 419-25.
18. Watanabe M, Hibi T, Lomax KG et al. Long-term safety and effi cacy of adalimumab in in Japanese patients with moderate to severe Crohn's disease. J Crohns Colitis 2014; 8: 1407-16.
19. Watanabe M, Hibi T, Mostafa NM et al. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease. J Crohns Colitis 2012; 6: 160-73.
20. Panaccione R, Colombel JF, Sandborn WJ et al. Adalimumab maintains remission of Crohn's disease aft er up to 4 years of treatment: data from CHARM and ADHERE. Aliment Pharmacol Th er 2013; 38: 1236-47.
21. Kamm MA, Hanauer SB, Panaccione R et al. Adalimumab sustains steroid-free remission aft er 3 years of therapy for Crohn's disease. Aliment Pharmacol Th er 2011; 34: 306-17.
22. Baddley JW, Winthrop KL, Chen L et al. Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy: results of the SAfety assessment of Biologic thERapy (SABER) study. Ann Rheum Dis 2014; 73: 942-8.
23. Brownlee M, Aiello LP, Cooper ME et al. Complications of diabetes mellitus. In Williams Textbook of Endocrinology, 12th edn Melmed S, Polonsky KS, Larsen PR, Kronenberg HM (eds.). Saunders Elsevier: Philadelphia, PA, USA, 2011.
24. Grijalva CG, Chen L, Delzell E et al. Initiation of tumor necrosis factor- Antagonists and the risk of hospitalization for infection in patients with autoimmune disease. JAMA 2011; 306: 2331-9.
25. Mickey RM, Greenland S. Th e impact of confounder selection criteria on eff ect estimation. Am J Epidemiol 1989; 129: 125-37.
26. Advisory Committee on Immunization Practices. Recommended adult immunization schedule: United States, 2011. Ann Intern Med 2011; 154: 168-73.
27. Au K, Reed G, Curtis JR et al. High disease activity is associated with an increased risk of infection in patients with rheumatoid arthritis. Ann Rheum Dis 2011; 70: 785-91.
28. Emery P, Gallo G, Boyd H et al. Association between disease activity and risk of serious infections in subjects with rheumatoid arthritis treated with etanercept or disease-modifying anti-rheumatic drugs. Clin Exp Rheumatol 2014; 32: 653-60.
29. Weaver A, Troum O, Hooper M et al. Rheumatoid arthritis disease activity and disability aff ect the risk of serious infection events in RADIUS 1. J Rheumatol 2013; 40: 1275-81.
30. Schreiber S, Reinisch W, Colombel JF et al. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn's disease. J Crohns Colitis 2013; 7: 213-21.
31. D'Haens GR, Baert F, van Assche G et al. Early combined immunosuppression or conventional management of patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet 2008; 371: 660-7.
32. Beukelman T, Xie F, Chen L et al. Rates of hospitalized bacterial infection associated with juvenile idiopathic arthritis and its treatment. Arthritis Rheum 2012; 64: 2773-80.
33. Zhang J, Xie F, Delzell E et al. Association between vaccination against herpes zoster and risk of herpes zoster infection among older patients with selected immune-mediated diseases. JAMA 2012; 308: 43-9.