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.
J Rheumatol
; 44(2): 142-146, 2017 02.
Article
in En
| MEDLINE
| ID: mdl-27909081
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Arthritis, Rheumatoid
/
Antirheumatic Agents
/
Antibodies, Monoclonal, Humanized
Type of study:
Clinical_trials
/
Diagnostic_studies
Limits:
Adult
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Female
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
J Rheumatol
Year:
2017
Document type:
Article