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
Citations
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Biologic agents for rheumatoid arthritis—negotiating the NICE technology appraisals
TL;DR: The treatment algorithm published by NICE is discussed, and alternatives where perceived deficiencies exist are suggested, including rituximab, which may be a more efficacious choice at this stage in some patient groups.
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Early start and stop of biologics: has the time come?
TL;DR: The current treatment paradigm as well as the possibility of an induction-maintenance regimen with biological disease-modifying antirheumatic drugs in early rheumatoid arthritis are discussed.
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Comparative Effectiveness of Tocilizumab and TNF Inhibitors in Rheumatoid Arthritis Patients: Data from the Rheumatic Diseases Portuguese Register, Reuma.pt.
Vasco C. Romão,Maria José Santos,Joaquim Polido-Pereira,Cátia Duarte,P. Nero,C. Miguel,José António Costa,Miguel Bernardes,Fernando Pimentel-Santos,Filipe Barcelos,Lúcia Costa,José António Melo Gomes,José Alberto Pereira da Silva,Jaime Branco,José Canas da Silva,José António Pereira da Silva,João Eurico Fonseca,Helena Canhão +17 more
TL;DR: Compared with TNFi, tocilizumab was associated with greater likelihood of achieving DAS28, CDAI, and SDAI remission/LDA and EULAR good response and Boolean remission and EUlAR good/moderate response did not differ significantly between groups.
Journal ArticleDOI
Biological agents in monotherapy for the treatment of rheumatoid arthritis.
Cem Gabay,Paul Hasler,Diego Kyburz,Alexander So,Peter M. Villiger,J. von Kempis,Ulrich A. Walker +6 more
TL;DR: The data is reviewed for four biological agents approved for use as monotherapy in Switzerland (adalimumab, certolizumab pegol, etanercept and tocilIZumab) in order to formulate a consensus statement on their roles in biologic monotherapy of RA.
Journal ArticleDOI
Tocilizumab: a novel humanized anti-interleukin 6 receptor antibody for the treatment of patients with rheumatoid arthritis.
TL;DR: TCZ at this dose is more effective than placebo, MTX or other DMARDs in reducing disease activity and improving health-related quality of life (HR-QoL) in patients with moderate to severe RA.
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