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

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.