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 Type:	Refereed Article
Keywords:	biological therapy, methotrexate, clinical trials, disease activity, rheumatoid arthritis
Research Division:	Biomedical and Clinical Sciences
Research Group:	Clinical sciences
Research Field:	Rheumatology and arthritis
Objective Division:	Health
Objective Group:	Clinical health
Objective Field:	Clinical health not elsewhere classified
UTAS Author:	Jones, G (Professor Graeme Jones)
ID Code:	112976
Year Published:	2017 (online first 2016)
Web of Science® Times Cited:	29
Deposited By:	Menzies Institute for Medical Research
Deposited On:	2016-12-06
Last Modified:	2022-06-16
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