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Five-year efficacy and safety of Tocilizumab Monotherapy in patients with Rheumatoid Arthritis who were Methotrexate- and Biologic-naive or free of Methotrexate for 6 months: the AMBITION Study

Citation

Jones, G and Wallace, T and McIntosh, MJ and Brockwell, L and Gomez-Reino, JJ and Sebba, A, Five-year efficacy and safety of Tocilizumab Monotherapy in patients with Rheumatoid Arthritis who were Methotrexate- and Biologic-naive or free of Methotrexate for 6 months: the AMBITION Study, Journal of Rheumatology, 44, (2) pp. 142-146. ISSN 0315-162X (2017) [Refereed Article]

Copyright Statement

Copyright 2017 The Journal of Rheumatology

DOI: doi:10.3899/jrheum.160287

Abstract

OBJECTIVE: To report on the 5-year efficacy and safety results of the AMBITION (Actemra versus Methotrexate double-Blind Investigative Trial In mONotherapy) monotherapy study (ClinicalTrials.gov: NCT00109408, NCT00720798).

METHODS: Patients with rheumatoid arthritis for whom biologics had not failed or who did not discontinue methotrexate because of lack of efficacy or tolerability were followed up for 5 years to assess the efficacy and serious adverse events (SAE) of tocilizumab (TCZ) monotherapy.

RESULTS: Longterm efficacy results showed that efficacy was maintained or improved for up to 264 weeks in patients receiving TCZ monotherapy. Serious infection was the most frequent SAE; no new safety signals were reported.

CONCLUSION: Longterm monotherapy with TCZ demonstrated continuing efficacy and safety.

Item Details

Item Type:Refereed Article
Keywords:biological therapy, methotrexate, clinical trials, disease activity, rheumatoid arthritis
Research Division:Medical and Health Sciences
Research Group:Clinical Sciences
Research Field:Rheumatology and Arthritis
Objective Division:Health
Objective Group:Clinical Health (Organs, Diseases and Abnormal Conditions)
Objective Field:Skeletal System and Disorders (incl. Arthritis)
Author:Jones, G (Professor Graeme Jones)
ID Code:112976
Year Published:2017 (online first 2016)
Web of Science® Times Cited:2
Deposited By:Menzies Institute for Medical Research
Deposited On:2016-12-06
Last Modified:2017-11-01
Downloads:0

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