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Jones G, Sebba A, Gu J, Lowenstein M, Calvo A, Gomez-Reino J, Siri D, Tomši M, Alecock E, Woodworth T, Genovese M.

Ann Rheum Dis 2010; 69:88–96.

The AMBITION study was a 24-week double-blind, randomised, Phase III study designed to compare the efficacy and safety of tocilizumab (TCZ) monotherapy with that of methotrexate (MTX) monotherapy in patients with active RA who had not previously failed MTX or biologic treatment (N=673). At baseline, patients had a mean disease duration of 6.3 years and a mean DAS28 of 6.8. The majority (66%) were MTX naïve, and 43% were DMARD naïve.

Key study results are summarised below.

TCZ monotherapy demonstrated superiority over MTX monotherapy in the primary endpoint (ACR20 response rate at Week 24 – 70% and 53%, respectively; p<0.0001) as well as in ACR50 and ACR70 response rates and DAS28 remission rates.

Superior efficacy of TCZ monotherapy was shown regardless of previous MTX exposure.

Almost one-third of TCZ-treated patients achieved either DAS28 remission or an ACR70 at Week 24 vs. 12% and 15% of MTX-treated patients (despite approximately two-thirds of patients reaching and maintaining the 20 mg MTX dose by Week 8).

The overall incidence of serious adverse events did not differ significantly between groups (3.8% TCZ vs. 2.8% MTX; p=0.4842), and infection rates were similar.

Elevations in ALT/AST occurred in both treatment groups and were more common with MTX, while increases in total, LDL and HDL cholesterol were seen in more patients in the TCZ group vs. the MTX group; these changes appeared to be associated with a reduction in systemic inflammation.

In summing up the study findings, the authors highlight that TCZ is the first biologic to show statistically superior clinical efficacy using standard endpoints compared with a standard MTX dose regimen in a 6-month study.

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