The comparative safety and effectiveness of TNF-α antagonists in adult rheumatoid arthritis study by the AHRQ effective health care program

Journal of Managed Care Pharmacy

Volumn 13, Issue 1 SUPPL., 2007, Pages

  Solomon, Daniel H ^a,b,c  

^a Division of Pharmacoepidemiology and Pharmacoeconomics   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Adalimumab; Anti TNF therapies; Cost effectiveness; Effective health care; Effectiveness; Etanercept; Infliximab; Medicare; Safety; TNF antagonists

Indexed keywords

ADALIMUMAB; ANTIBIOTIC AGENT; CELECOXIB; CORTICOSTEROID; CYCLOOXYGENASE 2 INHIBITOR; CYCLOSPORIN; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; INFLIXIMAB; LEFLUNOMIDE; METHOTREXATE; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; PREDNISONE; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; ROFECOXIB; SALAZOSULFAPYRIDINE; STEROID; TUMOR NECROSIS FACTOR ALPHA; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; VALDECOXIB; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY;

ABNORMAL LABORATORY RESULT; ANTIINFLAMMATORY ACTIVITY; ARTICLE; ASTHENIA; BACTERIAL INFECTION; BASAL CELL CARCINOMA; CANCER; CANCER RISK; CLINICAL TRIAL; COLON ADENOCARCINOMA; COMBINATION CHEMOTHERAPY; CONFUSION; COST EFFECTIVENESS ANALYSIS; COUGHING; CROHN DISEASE; DEMYELINATING DISEASE; DISEASE ACTIVITY; DISEASE SEVERITY; DRUG APPROVAL; DRUG COST; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG POTENTIATION; DRUG SAFETY; DRUG STRUCTURE; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FLU LIKE SYNDROME; GUILLAIN BARRE SYNDROME; HEALTH PROGRAM; HEART INFARCTION; HERPES ZOSTER; HOSPITALIZATION; HUMAN; HYPERSENSITIVITY; HYPONATREMIA; INFECTION; INFECTION RISK; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE REACTION; INJECTION SITE SWELLING; LOW DRUG DOSE; LUPUS LIKE SYNDROME; LYMPHOCYTOPENIA; LYMPHOMA; MEDICARE; MONOTHERAPY; MULTIPLE SCLEROSIS; MYCOBACTERIUM TUBERCULOSIS; NAUSEA; NEUROLOGIC DISEASE; NONHUMAN; OPTIC NEURITIS; PARESTHESIA; PATIENT COMPLIANCE; PHARYNGITIS; PNEUMONIA; PRURITUS; RECTUM CANCER; RHEUMATOID ARTHRITIS; RHINITIS; SHORT FORM 36; SINUSITIS; SKIN HYPERTROPHY; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VISUAL DISORDER; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; DRUG ANTAGONISM; FEMALE; GOVERNMENT; LEGAL ASPECT; MIDDLE AGED; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; REVIEW; UNITED STATES;

ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; FEMALE; HUMANS; MEDICARE; METHOTREXATE; MIDDLE AGED; MULTICENTER STUDIES; RANDOMIZED CONTROLLED TRIALS; TUMOR NECROSIS FACTOR-ALPHA; UNITED STATES; UNITED STATES AGENCY FOR HEALTHCARE RESEARCH AND QUALITY;

EID: 34247213521     PISSN: 10834087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (32)

1. Medicare Prescription Drug, Improvement, and Modernization Act § 1013. Pub L No. 108-173 (2003). Available at: http://www.medicare.gov/ medicarereform/108s1013.htm. Accessed October 24, 2006.
2. U.S. Dept. of Health and Human Services, Agency for Healthcare Research and Quality (AHRQ) Web site. DEcIDE network centers. Available at: http:/ /effectivehealthcare.ahrq.gov/decide/decideList.cfm. Accessed October 24, 2006.
3. U.S. Food and Drug Administration, Center for Drug Evaluation and Research Web site. Arava (leflunomide tablet). Available at: http://www.fda.gov/cder/foi/nda/98/20905_arava.htm. Accessed October 25, 2006.
4. U.S. Food and Drug Administration, Center for Drug Evaluation and Research Web site. Celebrex (celecoxib) tablets. Available at: http://www.fda.gov/cder/foi/nda/98/20998.htm. Accessed October 25, 2006.
5. U.S. Food and Drug Administration, Center for Drug Evaluation and Research Web site. Vioxx (rofecoxib) tablets. Available at: http://www.fda.gov/cder/foi/nda/99/021042_52_Vioxx.htm. Accessed October 25, 2006.
6. U.S. Food and Drug Administration, Center for Drug Evaluation and Research Web site. Etanercept product approval information. Available at: http://www.fda.gov/cder/biologics/products/etanimm110298.htm. Accessed October 25, 2006.
7. U.S. Food and Drug Administration, Center for Drug Evaluation and Research Web site. Infliximab product approval information. Available at: http://www.fda.gov/cder/biologics/products/inflcen111099.htm. Accessed October 25, 2006.
8. U.S. Food and Drug Administration, Center for Drug Evaluation and Research Web site. Adalimumab product approval information. Available at: http://www.fda.gov/cder/biologics/products/adalabb123102.htm. Accessed October 25, 2006.
9. U.S. Food and Drug Administration, Center for Drug Evaluation and Research Web site. Label and approval history. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ index.cfm?fuseaction=Search.Label ApprovalHistory#apphist. Accessed October 25, 2006.
10. Pharmaceutical Research and Manufacturers of America Web site. Biotechnology: Medicines in Development, July 2006 Report. Available at: http://www.phrma.org/files/Biotech%202006.pdf. Accessed October 25, 2006.
11. Pucino F, Harbus PT, Goldbach-Mansky R. Use of biologics in rheumatoid arthritis: where are we going? Am J Health Syst Pharm. 2006;63(suppl 4):S19-S41.
12. Lipsky PE, van der Heijde DMFM, St. Clair EW, et al., for The Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med. 2000;343:1594-1602.
13. Weinblatt ME, Kremer JM, Bankhurst AD, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999;340: 253-59.
14. Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human anti-tumor necrosis-α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA Trial. Arthritis Rheum. 2003;48:35-45.
15. Marra C. Rheumatoid arthritis: a primer for pharmacists. Am J Health Syst Pharm. 2006;63(suppl 4):S4-S10.
16. St. Clair EW, van der Heijde DMFM, Smolen JS, et al. Combination of infliximab and methotrexate for early rheumatoid arthritis - a randomized, controlled trial. Arthritis Rheum. 2004;50:3432-43.
17. Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med. 2000;343:1586-93.
18. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER Study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis that had not had previous methotrexate treatment. Arthritis Rheum. 2006;54:26-37.
19. Finckh A, Simard JF, Duryea J, et al. The effectiveness of anti-tumor necrosis factor therapy in preventing progressive radiographic joint damage in rheumatoid arthritis: population-based study. Arthritis Rheum. 2006;54:54-59.
20. Nikas SN, Voulgari PV, Alamanos Y, et al. Efficacy and safety of switching from infliximab to adalimumab: a comparative controlled study. Ann Rheum Dis. 2006:65:257-60.
21. Dixon WG, Watson K, Lunt M, et al. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy - results from the British Society for Rheumatology Biologics Register. Arthritis Rheum. 2006;54:2368-76.
22. Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor-α neutralizing agent. N Engl J Med. 2001;345: 1098-104.
23. Askling J, Fored CM, Brandt L, et al. Risk and case characteristics of tuberculosis in rheumatoid arthritis associated with tumor necrosis factor antagonists in Sweden. Arthritis Rheum. 2005;52:1986-92.
24. Mohan AK, Coté TR, Block JA, Manadan AM, Siegel JN, Braun MM. Tuberculosis following use of etanercept, a tumor necrosis factor inhibitor. Clin Infect Dis. 2004;39:295-99.
25. Schiff MH, Burmester GR, Kent JD, et al. Safety analyses of adalimumab (HUMIRA) in global clinical trials and U.S. postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis. 2006;65:889-94.
26. U.S. Food and Drug Administration Web site. Remicade drug information, 1998. Available at: http://www.fda.gov/cder/foi/label/1998/ inflcenO82498lb.pdf. Accessed November 1, 2006.
27. U.S. Food and Drug Administration Web site. Remicade drug information, 2000. Available at: http://www.fda.gov/cder/foi/label/2000/ infleen111099lb.pdf. Accessed November 1, 2006.
28. Wallis RS, Ehlers S. Tumor necrosis factor and granuloma biology: explaining the differential infection risk of etanercept and infliximab. Semin Arthritis Rheum. 2005;34(suppl 1):34-38.
29. Wolfe F, Michaud K. Lymphoma in rheumatoid arthritis: the effect of methotrexate and anti-tumor necrosis factor therapy in 18,572 patients. Arthritis Rheum. 2004;50:1740-51.
30. 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 malignancy: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295:2275-85.
31. O'Dell JR, Haire CE, Erikson N, et al. Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications. N Engl J Med. 1996;334:1287-94.
32. Mohan N, Edwards ET, Cupps TR, et al. Demyelination occurring during anti-tumor necrosis factor-α therapy for inflammatory arthritides. Arthritis Rheum. 2001;44:2862-69.