Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: The AMBITION study
Graeme Jones,Anthony Sebba,Jieruo Gu,Mitchell B. Lowenstein,Armando Calvo,Juan J. Gomez-Reino,Daniel Siri,Matija Tomšič,Emma Alecock,Thasia G. Woodworth,Mark C. Genovese +10 more
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TLDR
Tocilizumab monotherapy is better than methotrexate monotherapy, with rapid improvement in RA signs and symptoms, and a favourable benefit–risk, in patients for whom treatment with methotRexate or biological agents has not previously failed.Abstract:
Background: The anti-interleukin (IL) 6 receptor antibody tocilizumab inhibits signalling of IL6, a key cytokine in rheumatoid arthritis (RA) pathogenesis. Objective: To evaluate through the AMBITION study the efficacy and safety of tocilizumab monotherapy versus methotrexate in patients with active RA for whom previous treatment with methotrexate/biological agents had not failed. Methods: This 24-week, double-blind, double-dummy, parallel-group study, randomised 673 patients to either tocilizumab 8 mg/kg every 4 weeks, or methotrexate, starting at 7.5 mg/week and titrated to 20 mg/week within 8 weeks, or placebo for 8 weeks followed by tocilizumab 8 mg/kg. The primary end point was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 24. Results: The intention-to-treat analysis demonstrated that tocilizumab was better than methotrexate treatment with a higher ACR20 response (69.9 vs 52.5%; p 3×– Conclusion: Tocilizumab monotherapy is better than methotrexate monotherapy, with rapid improvement in RA signs and symptoms, and a favourable benefit–risk, in patients for whom treatment with methotrexate or biological agents has not previously failed. Trial registration number: NCT00109408read more
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Pathophysiology and Pharmacologic Control of Osseous Mandibular Condylar Resorption
TL;DR: By understanding the known pathways that lead to condylar resorption and the individual patient's susceptibilities, targeted pharmacotherapy might be able to disturb these pathways and prevent further condylars Resorption.
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Efficacy of abatacept and tocilizumab in patients with rheumatoid arthritis treated in clinical practice: results from the nationwide Danish DANBIO registry
Henrik Leffers,Mikkel Østergaard,Bente Glintborg,Niels Steen Krogh,Heidi Foged,Ulrik Tarp,Tove Lorenzen,Annette Hansen,Michael Sejer Hansen,Martin Skov Jacobsen,Lene Dreyer,Merete Lund Hetland +11 more
TL;DR: In patients with RA, a good-or-moderate EULAR response was achieved in ≥70% of patients treated with abatacept or tocilizumab for 24 weeks in routine care, except for the more rapid CRP decline among tocilIZumab-treated patients, directly caused by interleukin 6 inhibition.
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Tocilizumab inhibits progression of joint damage in rheumatoid arthritis irrespective of its anti-inflammatory effects: disassociation of the link between inflammation and destruction
TL;DR: IL-6 inhibition with TCZ plus MTX retards joint damage progression independently of its impact on disease activity, indicating that the effects of IL- 6 inhibition on progression of joint damage in RA are among the most profound currently attainable.
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Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for the treatment of rheumatoid arthritis not previously treated with disease-modifying antirheumatic drugs and after the failure of conventional disease-modifying antirheumatic drugs only: systematic review and economic evaluation.
Mark Stevenson,Rachel Archer,J. Tosh,Emma Simpson,Emma Everson-Hock,John Stevens,Mónica Hernández-Alava,Suzy Paisley,Kath Dickinson,David Scott,Adam Young,Allan Wailoo +11 more
TL;DR: A mathematical model was constructed to simulate the experiences of hypothetical patients and bDMARDs appear to have cost per QALY values greater than the thresholds stated by the National Institute for Health and Care Excellence for interventions to be cost-effective.
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Lipid profile changes in patients with chronic inflammatory arthritis treated with biologic agents and tofacitinib in randomized clinical trials: a systematic review and meta-analysis.
Alejandro Souto,Eva Salgado,José Ramón Maneiro,Antonio Mera,Loreto Carmona,Juan J. Gomez-Reino +5 more
TL;DR: In this paper, a systematic literature search was performed to analyze lipid changes in patients with rheumatoid arthritis and patients with spondyloarthritis treated with biologic agents or tofacitinib in randomized clinical trials (RCTs).
References
More filters
Journal ArticleDOI
Modified disease activity scores that include twenty-eight-joint counts : development and validation in a prospective longitudinal study of patients with rheumatoid arthritis
M.L.L. Prevoo,M.A. van 't Hof,H.H. Kuper,M.A. van Leeuwen,L. B. A. Van De Putte,P.L.C.M. van Riel +5 more
TL;DR: The Modified DAS that included 28-joint counts were able to discriminate between high and low disease activity (as indicated by clinical decisions of rheumatologists) and are as valid as disease activity scores that include more comprehensive joint counts.
Journal ArticleDOI
American college of rheumatology preliminary definition of improvement in rheumatoid arthritis
David T. Felson,David T. Felson,Jennifer J. Anderson,Jennifer J. Anderson,Maarten Boers,Claire Bombardier,Claire Bombardier,Daniel E. Furst,Daniel E. Furst,Charles H. Goldsmith,Charles H. Goldsmith,Linda M. Katz,Linda M. Katz,Robert W. Lightfoot,Robert W. Lightfoot,Harold E. Paulus,Harold E. Paulus,Vibeke Strand,Vibeke Strand,Peter Tugwell,Peter Tugwell,Michael E. Weinblatt,Michael E. Weinblatt,H. James Williams,H. James Williams,Frederick Wolfe,Stephanie Kieszak +26 more
TL;DR: The results suggest that the definition of improvement presented is statistically powerful and does not identify a large percentage of placebo-treated patients as being improved, which the authors hope will be used widely in RA trials.
Journal ArticleDOI
Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group.
Ravinder N. Maini,E W St Clair,F. C. Breedveld,Daniel E. Furst,Joachim R. Kalden,Michael H. Weisman,Josef S. Smolen,Paul Emery,G Harriman,Marc Feldmann,Peter E. Lipsky +10 more
TL;DR: Infliximab was well-tolerated; withdrawals for adverse events as well as the occurrence of serious adverse events or serious infections did not exceed those in the placebo group.
Journal ArticleDOI
Cytokine Pathways and Joint Inflammation in Rheumatoid Arthritis
Ernest Choy,Gabriel S. Panayi +1 more
TL;DR: Current slow-acting antirheumatic drugs have limited efficacy and many side effects and do not improve the long-term prognosis of rheumatoid arthritis.
Journal ArticleDOI
A Comparison of Etanercept and Methotrexate in Patients with Early Rheumatoid Arthritis
Joan M. Bathon,Richard J. Martin,Roy Fleischmann,John Tesser,Michael Schiff,Edward C. Keystone,Mark C. Genovese,Mary Chester M. Wasko,Larry W. Moreland,Arthur L. Weaver,Joseph A. Markenson,Barbara K. Finck +11 more
TL;DR: Subcutaneous [corrected] etanercept acted more rapidly to decrease symptoms and slow joint damage in patients with early active rheumatoid arthritis.
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