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Genentech, Inc.
Biogen Idec
Amgen
Wyeth
UCB
Biologic Therapies for Rheumatoid Arthritis
B-Cell Therapies
Rituximab
Efficacy of B-cell depletion in rheumatoid arthritis patients refractory to anti-tumour necrosis factor (TNF)-a agents: an open label observational study.
Brulhart L, Ciurea A, Finckh A, et al.
Ann Rheum Dis. 2006 Mar 15; [Eub ahead of print].
Date Published: March 2006
Keywords: anti-TNF-alpha, B cells, clinical trials, combination drug therapy, inhibitors, lymphocyte depletion, monoclonal antibodies, open-label study, tumor necrosis factor (TNF)
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The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial.
Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al.
Arthritis Rheum. 2006;54:1390-1400.
Date Published: May 2005
Keywords: ACR improvement criteria, biological agents, clinical trials, combination drug therapy, disease activity score (DAS), disease-modifying antirheumatic drugs (DMARDs), dosage, double-blind method, efficacy, glucocorticoids, intravenous infusions, methotrexate, oral administration, phase 2b, placebo, randomized controlled trials, rheumatoid arthritis, rituximab, safety
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Abatacept
Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition [published correction appears in N Engl J Med. 2005;353:2311].
Genovese MC, Becker JC, Schiff M, et al.
N Engl J Med. 2005;353:1114-1123.
Date Published: September 2005
Keywords: abatacept, ACR improvement criteria, adverse effects, anti-TNF-alpha, clinical trials, costimulation modulators, disease-modifying antirheumatic drugs (DMARDs), double-blind method, efficacy, inhibitors, multicenter study, phase 3, randomized controlled trials, rheumatoid arthritis, safety, tumor necrosis factor (TNF)
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Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase iib, double-blind, randomized, placebo-controlled trial [published correction appears in Arthritis Rheum. 2005;52:3321].
Kremer JM, Dougados M, Emery P, et al.
Arthritis Rheum. 2005;52:2263-2271.
Date Published: August 2005
Keywords: abatacept, ACR improvement criteria, adverse effects, clinical trials, costimulation modulators, disease activity score (DAS), dosage, double-blind method, efficacy, immunogenicity, joints, methotrexate, multicenter study, phase 2, placebo, randomized controlled trials, rheumatoid arthritis, safety
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Treatment of rheumatoid arthritis by selective inhibition of T-cell activation with fusion protein CTLA4Ig.
Kremer JM, Westhovens R, Leon M, et al.
N Engl J Med. 2003;349:1907-1915.
Date Published: November 2003
Keywords: ACR improvement criteria, antigen-presenting cells, antigens, anti-TNF-alpha, clinical trials, CTLA-4Ig, dosage, lymphocyte activation, placebo, quality of life, randomized controlled trials, recombinant fusion proteins, rheumatoid arthritis, SF-36, T cells
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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.
Moreland LW, Alten R, Van den Bosch F, et al.
Arthritis Rheum. 2002;46:1470-1479.
Date Published: June 2002
Keywords: ACR improvement criteria, adverse effects, antigen-presenting cells, autoimmune disease, clinical trials, costimulation modulators, CTLA-4Ig, dosage, dose-response relationship, double-blind method, efficacy, intravenous infusions, LEA29Y, multicenter study, pathogenesis, placebo, randomized controlled trials, rheumatoid arthritis, safety, T cells
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Anakinra
A multicentre, double blind, randomised, placebo controlled trial of anakinra (Kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate.
Cohen SB, Moreland LW, Cush JJ, et al, and the 990145 Study Group.
Ann Rheum Dis. 2004;63:1062-1068.
Date Published: September 2004
Keywords: ACR improvement criteria, adverse effects, anakinra, clinical trials, C-reactive protein (CRP), dosage, double-blind method, efficacy, erythrocyte sedimentation rate, injection-site reactions, interleukin-1, methotrexate, multicenter study, placebo, randomized controlled trials, rheumatoid arthritis, safety, subcutaneous injections
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Anakinra, a recombinant human interleukin-1 receptor antagonist (r-metHuIL-1ra), in patients with rheumatoid arthritis: a large, international, multicenter, placebo-controlled trial.
Fleischmann RM, Schechtman J, Bennett R, et al.
Arthritis Rheum. 2003;48:927-934.
Date Published: April 2003
Keywords: adverse effects, anakinra, antagonists, clinical trials, combination drug therapy, comorbidity, corticosteroids, disease-modifying antirheumatic drugs (DMARDs), double-blind method, infections, multicenter study, NSAIDs, patient dropouts, placebo, randomized controlled trials, receptors, rheumatoid arthritis, safety, subcutaneous injections
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Adalimumab
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.
Breedveld FC, Weisman MH, Kavanaugh AF, et al.
Arthritis Rheu. 2006;54:26-37.
Date Published: January 2006
Keywords: ACR improvement criteria, adalimumab, adverse effects, clinical trials, combination drug therapy, disease activity score (DAS), disease progression, double-blind method, efficacy, joints, methotrexate, monotherapy, multicenter study, oral administration, radiography, randomized controlled trials, remission, rheumatoid arthritis, safety, subcutaneous injections
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Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed.
van de Putte LB, Atkins C, Malaise M, et al.
Ann Rheum Dis. 2004;63:508-516.
Date Published: May 2004
Keywords: ACR improvement criteria, adalimumab, adverse effects, clinical trials, disease-modifying antirheumatic drugs (DMARDs), dosage, dose-response relationship, double-blind method, efficacy, EULAR responses, HAQ DI, Health Assessment Questionnaire Disability Index, infections, injection-site reactions, malignancy, monotherapy, multicenter study, phase 3, randomized controlled trials, rheumatoid arthritis, safety
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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.
Keystone EC, Kavanaugh AF, Sharp JT, et al.
Arthritis Rheum. 2004;50:1400-1411.
Date Published: May 2004
Keywords: ACR improvement criteria, adalimumab, adverse effects, anti-TNF-alpha, clinical trials, combination drug therapy, cytokines, dosage, dose-response relationship, double-blind method, Health Assessment Questionnaire Disability Index, infections, joints, methotrexate, monoclonal antibodies, multicenter study, patient dropouts, proinflammatory, radiography, randomized controlled trials, rheumatoid arthritis, subcutaneous injections, tumor necrosis factor (TNF)
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Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis).
Furst DE, Schiff MH, Fleischmann RM, et al.
J Rheumatol. 2003;30:2563-2571.
Date Published: December 2003
Keywords: ACR improvement criteria, adalimumab, adverse effects, analgesics, anti-TNF-alpha, clinical trials, combination drug therapy, corticosteroids, disease-modifying antirheumatic drugs (DMARDs), efficacy, infections, monoclonal antibodies, NSAIDs, placebo, randomized controlled trials, rheumatoid arthritis, safety, subcutaneous injections, TNF-alpha, tumor necrosis factor (TNF)
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Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial [published correction appears in Arthritis Rheum.2003;48:855].
Weinblatt ME, Keystone EC, Furst DE, et al.
Arthritis Rheum . 2003;48:35-45.
Date Published: January 2003
Keywords: ACR response, adalimumab, anti-TNF-alpha, clinical trials, combination drug therapy, dosage, dose-response relationship, double-blind method, efficacy, methotrexate, monoclonal antibodies, randomized controlled trials, rheumatoid arthritis, safety, subcutaneous injections, TNF-alpha, tumor necrosis factor (TNF)
View Abstract
Etanercept added to background methotrexate therapy in patients with rheumatoid arthritis: continued observations.
Kremer JM, Weinblatt ME, Bankhurst AD, et al.
Arthritis Rheum. 2003;48:1493-1499.
Date Published: June 2003
Keywords: ACR improvement criteria, adverse effects, clinical trials, combination drug therapy, corticosteroids, dosage, efficacy, etanercept, methotrexate, open-label study, randomized controlled trials, rheumatoid arthritis, safety
View Abstract
Etanercept therapy in rheumatoid arthritis: a randomized, controlled trial.
Moreland LW, Schiff MH, Baumgartner SW, et al.
Ann Intern Med. 1999;130:478-486.
Date Published: March 1999
Keywords: ACR improvement criteria, adverse effects, clinical trials, disease-modifying antirheumatic drugs (DMARDs), dose-response relationship, double-blind method, efficacy, etanercept, joints, multicenter study, phase 2, placebo, randomized controlled trials, receptors, recombinant fusion proteins, rheumatoid arthritis, subcutaneous injections, tumor necrosis factor (TNF)
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A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate.
Weinblatt ME, Kremer JM, Bankhurst AD, et al.
N Engl J Med. 1999;340:253-259.
Date Published: January 1999
Keywords: clinical trials, combination drug therapy, etanercept, methotrexate, multicenter study, randomized controlled trials, rheumatoid arthritis, tumor necrosis factor (TNF)
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Predictors of joint damage in patients with early rheumatoid arthritis treated with high-dose methotrexate with or without concomitant infliximab: results from the ASPIRE trial.
Smolen JS, Van Der Heijde DM, St Clair EW, et al, and the Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset (ASPIRE) Study Group.
Arthritis Rheum. 2006;54:702-710.
Date Published: March 2006
Keywords: chronic, clinical trials, combination drug therapy, C-reactive protein (CRP), disease progression, erythrocyte sedimentation rate, infliximab, joints, methotrexate, placebo, radiography, randomized controlled trials, rheumatoid arthritis
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Evidence of radiographic benefit of treatment with infliximab plus methotrexate in rheumatoid arthritis patients who had no clinical improvement: a detailed subanalysis of data from the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study.
Smolen JS, Han C, Bala M, et al, and the ATTRACT Study Group.
Arthritis Rheum. 2005;52:1020-1030.
Date Published: April 2005
Keywords: ACR improvement criteria, anti-TNF-alpha, clinical trials, combination drug therapy, C-reactive protein (CRP), disease activity score (DAS), disease progression, inflammation, infliximab, joints, methotrexate, placebo, radiography, randomized controlled trials, rheumatoid arthritis
View Abstract
Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate.
Maini RN, Breedveld FC, Kalden JR, et al, for the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group.
Arthritis Rheum. 2004;50:1051-1065
Date Published: April 2004
Keywords: ACR improvement criteria, clinical trials, combination drug therapy, dosage, efficacy, HAQ DI, Health Assessment Questionnaire Disability Index, infliximab, intravenous infusions, methotrexate, placebo, quality of life, randomized controlled trials, rheumatoid arthritis, safety, SF-36
View Abstract
Infliximab and methotrexate in the treatment of rheumatoid arthritis.
Lipsky PE, van der Heijde DM, St Clair EW, et al, for the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group.
N Engl J Med. 2000;343:1594-1602
Date Published: November 2000
Keywords: ACR improvement criteria, anti-TNF-alpha, chimeric, clinical trials, disease progression, dosage, efficacy, infliximab, intravenous infusions, joints, methotrexate, monoclonal antibodies, multicenter study, oral administration, placebo, quality of life, radiography, randomized controlled trials, rheumatoid arthritis, TNF-alpha, tumor necrosis factor (TNF)
View Abstract
RA Clinical Issues
Safety issues related to emerging therapies for rheumatoid arthritis [review].
Keystone EC.
Clin Exp Rheumatol. 2004;22(5 suppl 35):S148-S150.
Date Published: September 2004
Keywords: abatacept, CD20 antigens, CTLA-4Ig, monoclonal antibodies, rheumatoid arthritis, rituximab, safety, tumor necrosis factor (TNF)
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Safety of rituximab in the treatment of B cell malignancies: implications for rheumatoid arthritis [review].
Hainsworth JD.
Arthritis Res Ther. 2003;5(suppl 4):S12-S16.
Date Published: December 2003
Keywords: adverse effects, anti-CD20, B cells, chimeric, intravenous infusions, lymphocyte depletion, malignancy, monoclonal antibodies, oncology, rheumatoid arthritis, rituximab, safety
View Abstract
RA Overview
B-cell targeting in rheumatoid arthritis and other autoimmune diseases.
Edwards JC, Cambridge G.
Nat Rev Immunol. 2006;6:394-403.
Date Published: May 2006
Keywords: autoantibodies, autoimmune disease, B cells, B-cell-targeted therapy, efficacy, lymphocyte depletion, monoclonal antibodies, rheumatoid arthritis, rituximab
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B cell targeted therapies in autoimmune diseases.
Isenberg D.
J Rheumatol Suppl. 2006;77:24-28.
Date Published: May 2006
Keywords: antibodies, autoimmune disease, B cells, B-cell-targeted therapy, cryoglobulinemia, lymphocyte activation, lymphocyte depletion, myositis, rheumatoid arthritis, rituximab, systemic lupus erythematosus (SLE)
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Pro-inflammatory cytokines in rheumatoid arthritis: pathogenetic and therapeutic aspects [review].
Smolen JS, Redlich K, Zwerina J, et al.
Clin Rev Allergy Immunol. 2005;28:230-248.
Date Published: June 2005
Keywords: abatacept, B cells, costimulation modulators, cytokines, disease-modifying antirheumatic drugs (DMARDs), inflammation, interleukin-6, joints, phase 2, phase 3, proinflammatory, receptors, rheumatoid arthritis, rituximab, tumor necrosis factor (TNF)
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Do we need new treatment that goes beyond tumor necrosis factor blockers for rheumatoid arthritis?
Voll RE, Kalden JR.
Ann N Y Acad Sci. 2005;1051:799-810.
Date Published: June 2005
Keywords: abatacept, ACR improvement criteria, antibodies, anti-CD20, anti-TNF-alpha, B cells, biological agents, blocking agents, chemokines, combination drug therapy, costimulation modulators, CTLA-4Ig, disease-modifying antirheumatic drugs (DMARDs), inflammation, interleukin-6, joints, mechanism of action, methotrexate, monoclonal antibodies, receptors, recombinant fusion proteins, rheumatoid arthritis, rituximab, T cells, tumor necrosis factor (TNF)
View Abstract