Infections requiring hospitalization in the abatacept clinical development program: An epidemiological assessment

Arthritis Research and Therapy

Volumn 12, Issue 2, 2010, Pages

  Simon, Teresa A ^a   Askling, Johan ^b   Lacaille, Diane ^c   Franklin, Jarrod ^d,e   Wolfe, Frederick ^f   Covucci, Allison ^a   Suissa, Samy ^g   Hochberg, Marc C ^h  

^a BRISTOL MYERS SQUIBB   (United States)

^b KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^c UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^d UNIVERSITY OF MANCHESTER   (United Kingdom)

^e UNIVERSITY OF SHEFFIELD   (United Kingdom)

^f UNIVERSITY OF KANSAS SCHOOL OF MEDICINE WICHITA   (United States)

^g MCGILL UNIVERSITY   (Canada)

^h UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; CORTICOSTEROID; DISEASE MODIFYING ANTIRHEUMATIC DRUG; INFLIXIMAB; METHOTREXATE; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; TUMOR NECROSIS FACTOR INHIBITOR; ANTIBODY CONJUGATE; ANTIRHEUMATIC AGENT; TUMOR NECROSIS FACTOR ALPHA;

ARTICLE; HEALTH PROGRAM; HOSPITAL INFECTION; HOSPITALIZATION; HUMAN; INFECTION; INFECTION RISK; OPPORTUNISTIC INFECTION; PNEUMONIA; RHEUMATOID ARTHRITIS; ADOLESCENT; ADULT; AGED; COMORBIDITY; DOUBLE BLIND PROCEDURE; DRUG ANTAGONISM; EUROPE; FEMALE; INCIDENCE; MALE; MIDDLE AGED; NORTH AMERICA; RANDOMIZED CONTROLLED TRIAL; STATISTICS;

ADOLESCENT; ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; COMORBIDITY; DOUBLE-BLIND METHOD; EUROPE; FEMALE; HOSPITALIZATION; HUMANS; IMMUNOCONJUGATES; INCIDENCE; MALE; MIDDLE AGED; NORTH AMERICA; OPPORTUNISTIC INFECTIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TUMOR NECROSIS FACTOR-ALPHA; YOUNG ADULT;

EID: 77950663683     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/ar2984     Document Type: Article

References (34)

1. Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum 2002, 46:2287-2293. 10.1002/art.10524, 12355475.
2. Smitten AL, Choi HK, Hochberg MC, Suissa S, Simon TA, Testa MA, Chan KA. The risk of hospitalized infection in patients with rheumatoid arthritis. J Rheumatol 2008, 35:387-393.
3. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 2006, 295:2275-2285. 10.1001/jama.295.19.2275, 16705109.
4. Dixon WG, Symmons DP, Lunt M, Watson KD, Hyrich KL, Silman AJ. Serious infection following anti-tumor necrosis factor alpha therapy in patients with rheumatoid arthritis: lessons from interpreting data from observational studies. Arthritis Rheum 2007, 56:2896-2904. 10.1002/art.22808, 2435418, 17763441.
5. Tan P, Anasetti C, Hansen JA, Melrose J, Brunvand M, Bradshaw J, Ledbetter JA, Linsley PS. Induction of alloantigen-specific hyporesponsiveness in human T lymphocytes by blocking interaction of CD28 with its natural ligand B7/BB1. J Exp Med 1993, 177:165-173. 10.1084/jem.177.1.165, 2190874, 7678111.
6. Moreland LW, Alten R, Bosch F, Appelboom T, Leon M, Emery P, Cohen S, Luggen M, Shergy W, Nuamah I, Becker JC. Costimulatory blockade in patients with rheumatoid arthritis: a pilot, dose-finding, double-blind, placebo-controlled clinical trial evaluating CTLA-4Ig and LEA29Y eighty-five days after the first infusion. Arthritis Rheum 2002, 46:1470-1479. 10.1002/art.10294, 12115176.
7. Kremer JM, Westhovens R, Leon M, Di Giorgio E, Alten R, Steinfeld S, Russell A, Dougados M, Emery P, Nuamah IF, Williams GR, Becker JC, Hagerty DT, Moreland LW. Treatment of rheumatoid arthritis by selective inhibition of T-cell activation with fusion protein CTLA4Ig. N Engl J Med 2003, 349:1907-1915. 10.1056/NEJMoa035075, 14614165.
8. Kremer JM, Dougados M, Emery P, Durez P, Sibilia J, Shergy W, Steinfeld S, Tindall E, Becker JC, Li T, Nuamah IF, Aranda R, Moreland LW. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase iib, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005, 52:2263-2271. 10.1002/art.21201, 16052582.
9. Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, Birbara C, Box J, Natarajan K, Nuamah I, Li T, Aranda R, Hagerty DT, Dougados M. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med 2005, 353:1114-1123. 10.1056/NEJMoa050524, 16162882.
10. Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Li T, Ge Z, Becker JC, Westhovens R. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med 2006, 144:865-876.
11. Weinblatt M, Combe B, Covucci A, Aranda R, Becker JC, Keystone E. Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and nonbiologic disease-modifying antirheumatic drugs: A one-year randomized, placebo-controlled study. Arthritis Rheum 2006, 54:2807-2816. 10.1002/art.22070, 16947384.
12. Genovese MC, Schiff M, Luggen M, Becker JC, Aranda R, Teng J, Li T, Schmidely N, Le Bars M, Dougados M. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy. Ann Rheum Dis 2008, 67:547-554. 10.1136/ard.2007.074773, 17921185.
13. Simon TA, Smitten AL, Meng M, Franklin J, Askling J, Lacaille D, Wolfe F, Suissa S, Hochberg M. Observed and expected hospitalized infections in the abatacept clinical development program: An updated epidemiological assessment. American College of Rheumatology, November; Boston, Massachusetts 2007, FRI 821/849.
14. Simon TA, Covucci A, Meng M, Skovron ML. Descriptive overtime analysis of infections and malignancies in the abatacept clinical development program. American College of Rheumatology; November; Boston, Massachusetts 2007, FRI 1039/1271.
15. Schiff M, Keiserman M, Codding C, Songcharoen S, Berman A, Nayiager S, Saldate C, Li T, Aranda R, Becker JC, Lin C, Cornet PL, Dougados M. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis 2008, 67:1096-1103. 10.1136/ard.2007.080002, 2564802, 18055472.
16. Schiff M, Pritchard C, Zhou X, Bahrt K, Genovese MC. The efficacy of abatacept in patients with active rheumatoid arthritis and an inadequate response to anti-TNF therapy: The ARRIVE trial. Arthritis Rheum 2007, 56:-S391. Abstract 942.
17. Symmons DP, Silman AJ. The Norfolk Arthritis Register (NOAR). Clin Exp Rheumatol 2003, 21:S94-99.
18. Lacaille D, Anis AH, Guh DP, Esdaile JM. Gaps in care for rheumatoid arthritis: a population study. Arthritis Rheum 2005, 53:241-248. 10.1002/art.21077, 15818655.
19. Askling J, Fored CM, Geborek P, Jacobsson LT, van Vollenhoven R, Feltelius N, Lindblad S, Klareskog L. Swedish registers to examine drug safety and clinical issues in RA. Ann Rheum Dis 2006, 65:707-712. 10.1136/ard.2005.045872, 1798175, 16414975.
20. Wolfe F, Caplan L, Michaud K. Treatment for rheumatoid arthritis and the risk of hospitalization for pneumonia: associations with prednisone, disease-modifying antirheumatic drugs, and anti-tumor necrosis factor therapy. Arthritis Rheum 2006, 54:628-634. 10.1002/art.21568, 16447241.
21. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986, 7:177-188. 10.1016/0197-2456(86)90046-2, 3802833.
22. Wilson EB, Hilferty MM. The distribution of chi-square. Proc Nat Acad Sci 1931, 17:684-688. 10.1073/pnas.17.12.684, 1076144, 16577411.
23. Salliot C, Dougados M, Gossec L. Risk of serious infections during rituximab, abatacept and anakinra treatments for rheumatoid arthritis: meta-analyses of randomised placebo-controlled trials. Ann Rheum Dis 2009, 68:25-32. 10.1136/ard.2007.083188, 2596305, 18203761.
24. Dobloug JH, Forre O, Kvien TK, Egeland T, Degre M. Natural killer (NK) cell activity of peripheral blood, synovial fluid, and synovial tissue lymphocytes from patients with rheumatoid arthritis and juvenile rheumatoid arthritis. Ann Rheum Dis 1982, 41:490-494. 10.1136/ard.41.5.490, 1001029, 6181746.
25. Fox RI, Fong S, Tsoukas C, Vaughan JH. Characterization of recirculating lymphocytes in rheumatoid arthritis patients: selective deficiency of natural killer cells in thoracic duct lymph. J Immunol 1984, 132:2883-2887.
26. Koetz K, Bryl E, Spickschen K, O'Fallon WM, Goronzy JJ, Weyand CM. T cell homeostasis in patients with rheumatoid arthritis. Proc Natl Acad Sci USA 2000, 97:9203-9208. 10.1073/pnas.97.16.9203, 16846, 10922071.
27. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticosteroids. Rev Infect Dis 1989, 11:954-963.
28. Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Predictors of infection in rheumatoid arthritis. Arthritis Rheum 2002, 46:2294-2300. 10.1002/art.10529, 12355476.
29. Lacaille D, Guh DP, Abrahamowicz M, Anis AH, Esdaile JM. Use of nonbiologic disease-modifying antirheumatic drugs and risk of infection in patients with rheumatoid arthritis. Arthritis Rheum 2008, 59:1074-1081. 10.1002/art.23913, 18668604.
30. Listing J, Strangfeld A, Kary S, Rau R, von Hinueber U, Stoyanova-Scholz M, Gromnica-Ihle E, Antoni C, Herzer P, Kekow J, et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum 2005, 52:3403-3412. 10.1002/art.21386, 16255017.
31. Curtis JR, Xi J, Patkar N, Xie A, Saag KG, Martin C. Drug-specific and time-dependent risks of bacterial infection among patients with rheumatoid arthritis who were exposed to tumor necrosis factor alpha antagonists. Arthritis Rheum 2007, 56:4226-4227. 10.1002/art.23050, 2561262, 18050253.
32. Askling J, Dixon W. The safety of anti-tumour necrosis factor therapy in rheumatoid arthritis. Curr Opin Rheumatol 2008, 20:138-144. 10.1097/BOR.0b013e3282f4b392, 18349742.
33. Food and Drug Administration. Guidance for Industry. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. , http://www.fda.gov/cber/gdlns/pharmacovig.htm
34. Solomon DH. The comparative safety and effectiveness of TNF-alpha antagonists. J Manag Care Pharm 2007, 13:S7-18.