Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: The Research in Active Rheumatoid Arthritis (ReAct) trial

Annals of the Rheumatic Diseases

Volumn 66, Issue 6, 2007, Pages 732-739

  Burmester, Gerd R ^a   Mariette, Xavier ^b   Montecucco, Carlomaurizio ^c   Monteagudo Sáez, Indalecio ^d   Malaise, Michel ^e   Tzioufas, Athanasios G ^f   Bijlsma, Johannes W J ^g   Unnebrink, Kristina ^h   Kary, Sonja ^h   Kupper, Hartmut ^h  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b BICÊTRE HOSPITAL   (France)

^c UNIVERSITY OF PAVIA   (Italy)

^d HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^e UNIVERSITY OF LIÈGE   (Belgium)

^f UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^g UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^h ABBOTT GMBH AND CO KG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ANTIMALARIAL AGENT; AZATHIOPRINE; CHLOROQUINE; DISEASE MODIFYING ANTIRHEUMATIC DRUG; GOLD; HYDROXYCHLOROQUINE; ISONIAZID; LEFLUNOMIDE; METHOTREXATE; PREDNISONE; SALAZOSULFAPYRIDINE;

ABDOMINAL INFECTION; ADD ON THERAPY; ADULT; ALLERGIC DISEASE; ANEMIA; ARTHROPATHY; ARTICLE; BACTEREMIA; BLOOD DISEASE; BONE INFECTION; BONE MARROW DEPRESSION; BONE MARROW TOXICITY; BREAST DISEASE; CANCER; CLINICAL PRACTICE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEMYELINATING DISEASE; DEMYELINATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FEVER; GASTROINTESTINAL DISEASE; GASTROINTESTINAL INFECTION; GUILLAIN BARRE SYNDROME; HEADACHE; HEART FAILURE; HEPATOBILIARY DISEASE; HUMAN; INFECTION; INFECTIOUS ARTHRITIS; KIDNEY DISEASE; LOWER RESPIRATORY TRACT INFECTION; LUNG DISEASE; LUNG INFECTION; LYMPHATIC SYSTEM DISEASE; LYMPHOMA; MAJOR CLINICAL STUDY; MALE; MICROCYTIC ANEMIA; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE SCLEROSIS; NEUROLOGIC DISEASE; OSTEOARTHRITIS; PANCYTOPENIA; PATIENT ATTITUDE; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SEPSIS; SKIN DISEASE; SKIN TOXICITY; SYSTEMIC LUPUS ERYTHEMATOSUS; TREATMENT RESPONSE; TUBERCULOSIS; UNSPECIFIED SIDE EFFECT; VASCULAR DISEASE; VIREMIA;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; MIDDLE AGED; OPPORTUNISTIC INFECTIONS; PATIENT DROPOUTS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 34249796662     PISSN: 00034967     EISSN: None     Source Type: Journal    
DOI: 10.1136/ard.2006.066761     Document Type: Article

References (45)

1. Breedveld K, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, for the PREMIER investigators, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 2006;54:26-37.
2. van der Heijde D, Klareskog L, Rodriguez-Valverde V, Codreanu C, Bolosiu H, Melo-Gomes J, et al. Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trial. Arthritis Rheum 2006;54:1063-74.
3. Maini RN, Breedveld FC, Kalden JR, Smolen JS, Furst D, Weisman MH, et al. Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum 2004;50:1051-65.
4. Temekonidis TI, Georgiadis AN, Alamanos Y, Bougias DV, Voulgari PV, Drosos AA. Infliximab treatment in combination with cyclosporin A in patients with severe refractory rheumatoid arthritis. Ann Rheum Dis 2002;61:822-5.
5. Godinho F, Godfrin B, El Mahou S, Navaux F, Zabraniecki L, Cantagrel A. Safety of leflunomide plus infliximab combination therapy in rheumatoid arthritis. Clin Exp Rheumatol 2004;22:328-30.
6. Flendrie M, Creemers MC, Welsing PM, van Riel PL. The influence of previous and concomitant leflunomide on the efficacy and safely of infliximab therapy in patients with rheumatoid arthritis; a longitudinal observational study. Rheumatology (Oxford) 2005;44:472-8.
7. Kalden JR, Antoni C, Alvaro-Gracia JM, Combe B, Emery P, Kremer JM, et al. Use of combination of leflunomide with biological agents in treatment of rheumatoid arthritis. J Rheumatol 2005;32:1620-31.
8. Marchesoni A, Sarzi Puttini P, Gorla R, Capirali R, Arnoldi C, Atzeni F, et al. Cyclosporine in addition to infliximab and methotrexate in refractory rheumatoid arthritis [letter]. Clin Exp Rheumatol 2005;23:916-17.
9. Combe B, Codreanu C, Fiocco U, Gaubitz M, Geusens PP, Kvien TK, et al. Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double-blind comparison. Ann Rheum Dis 2006;65:1357-62.
10. Perdriger A, Mariette X, Kuntz JL, Brocq O, Kara-Terki R, Loet XL, et al. Safely of infliximab in combination with leflunomide or azathioprine in daily clinical practice. J Rheumatol 2006;33:865- 9.
11. Nordstrom DC, Konttinen L, Korpela M, Tiippana-Kinnunen T, Eklund K, Forsberg S, et al. Classic disease modifying anti-rheumatic drugs (DMARDs) in combination with infliximab. The Finnish experience. Rheumatol Int 2006;26:741-8.
12. van Riel PLCM, Taggart AJ, Sony J, Gaubitz M, Nab HW, Pedersen R, et al. Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: the ADORE study. Ann Rheum Dis 2006;65:1478-83.
13. Hochberg MC, Lebwohl MG, Plevy SE, Hobbs KF, Yocum DE. The benefit/risk profile of TNF-blocking agents: findings of a consensus panel. Semin Arthritis Rheum 2005;34:819-36.
14. Amett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24.
15. Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44-8.
16. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727- 35.
17. van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/ International League Against Rheumatism Criteria. Arthritis Rheum 1996;39:34-40.
18. Fries JF, Spitz PW, Young DY. The dimensions of health outcomes: the Health Assessment Questionnaire, disability and pain scales. J Rheumatol 1982;9:789-93.
19. Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Predictors of infection in rheumatoid arthritis. Arthritis Rheum 2002;46:2294-300.
20. Listing J, Strangfeld A, Kary S, Rau R, von Hinueber U, Stoyanova-Scholz M, et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum 2005;52:3403-12.
21. 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;54:628-34.
22. World Health Organization Statistical Information System (WHOSIS). http://www3.who.int/whosis/mort/table1.cfm?path=whosis,inds,mort,mort_ table1&language=english (accessed 12 March 2007).
23. National Cancer Institute. Surveillance, Epidemiology, and End Results (SEER) Program Public-Use Data (1973-1999), DCCPS, Surveillance Research Program, Cancer Statistics Branch, released April 2002, based on the November 2001 submission. Bethesda, MD: National Cancer Institute, 2002.
24. Fransen J, Creemers MC, van Riel PL. Remission in rheumatoid arthritis: agreement of the disease activity score (DAS28) with the ARA preliminary remission criteria. Rheumatology (Oxford) 2004;43:1252-55.
25. Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum 2004;50:1400-11.
26. Genovese MC, Bathon JM, Fleischmann RM, Mordand LW, Martin RW, Whitmore JB, et al. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol 2005;32:1232-42.
27. Schiff MH, Burmester GR, Kent JD, Pangan AL, Kupper H, Fitzpatrick SB, et al. Safely analyses of adalimumab (HUMIRA®) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis 2006;65:889-94.
28. Hyrich KL, Symmons DP, Watson KD, Silman AJ. Comparison of the response to infliximab or etanercept monotherapy with the response to cotherapy with methotrexate or another disease-modifying antirheumatic drug in patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum 2006;54:1786-94.
29. Kvien TK, Heiberg MS, Lie E, Kaufmann C, Mikkelsen K, Nordvȧg B-Y, et al. A Norwegian DMARD register: prescriptions of DMARDs and biological agents to patients with inflammatory rheumatic diseases. Clin Exp Rheumatol 2005;23(5 suppl 39):S188-94.
30. Aletaha D, Smolen JS. The rheumatoid arthritis patient in the clinic: comparing more than 1,300 consecutive DMARD courses. Rheumatology (Oxford) 2002;41:1367-74.
31. O'Dell JR, Leff R, Paulsen G, Haire C, Mallek J, Eckoff PJ, et al. Treatment of rheumatoid arthritis with methotrexate and hydroxychloroquine, methotrexate and sulfasalazine, or a combination of the three medications: results of a two-year, randomized, double-blind, plgcebo-controlled trial. Arthritis Rheum 2002;46:1164-70.
32. O'Dell JR, Petersen K, Leff R, Palmer W, Schned E, Blakely K, et al. Etanercept in combination with sulfasalazine, hydroxychloroquine, or gold in the treatment of rheumatoid arthritis. J Rheumatol 2006;33:213-18.
33. 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;46:2287-93.
34. Dixon W, Watson K, Hyrich K, Lunt M, Silman A, Symmons D. The incidence of serious infections is not increased in patients with rheumatoid arthritis treated with anti-TNF drugs compared to those treated with traditional DMARDS: results from a national prospective study [abstract]. Arthritis Rheum 2005;52(suppl):S738.
35. Carmona L, Gomez-Reino JJ, Rodriguez-Valverde V, Montero D, Pascual-Gomez E, Mola EM, et al. Effectiveness of recommendations to prevent reactivation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonists. Arthritis Rheum 2005;52:1766- 72.
36. Adding J, Fored CM, Brandt L, Baecklund E, Bertilsson L, Coster 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.
37. Askling J, Fored CM, Brandt L, Baecklund E, Bertilsson L, Feltelius N, et al. Risks of solid cancers in patients with rheumatoid arthritis and after treatment with tumour necrosis factor antagonists. Ann Rheum Dis 2005;64:1421-6.
38. Askling J, Fored CM, Baecklund E, Brandt L, Backlin C, Ekbom A, et al. Haematopoietic malignancies in rheumatoid arthritis: lymphoma risk and characteristics after exposure to tumour necrosis factor antagonists. Ann Rheum Dis 2005;64:1414-20.
39. Geborek P, Bladstrom A, Turesson C, Gulfe A, Petersson IF, Saxne T, et al. Tumour necrosis factor blockers do not increase overall tumour risk in patients with rheumatoid arthritis, but may be associated with an increased risk of lymphomas. Ann Rheum Dis 2005;64:699-703.
40. 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;295:2275-85 [erratum in: JAMA 2006;295:2482].
41. Baecklund E, Iliadou A, Askling J, Ekbom A, Backlin C, Grananth F, et al. Association of chronic inflammation, not its treatment, with increased lymphoma risk in rheumatoid arthritis. Arthritis Rheum 2006;54:692-701.
42. Sihvonen S, Korpela M, Laippala P, Mustonen J, Pastemock A. Death rates and causes of death in patients with rheumatoid arthritis: a population-based study. Scand J Rheumatol 2004;33:221-7 [erratum in Scand J Rheumatol 2006;35:332].
43. Weinbtatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor a monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003;48:35-45 [erratum in Arthritis Rheum 2003;48:855,
44. Arthritis Rheum 2004;22:144].
45. van de Putte LB, Atkins C, Malaise M, Sony J, Russell AI, van Riel PL, et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis 2004;63:508-16.