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Positive Phase III Results With Tocilizumab (RoACTEMRA) in Early RA
Positive data have been announced from two phase III trials that evaluated tocilizumab (RoACTEMRA; Roche) in patients with rheumatoid arthritis (RA). The long-term extension (LTE) follow-up of the AMBITION study demonstrated long-term efficacy of tocilizumab monotherapy, and the FUNCTION study showed the clinical benefits of tocilizumab, alone or in combination with methotrexate (MTX), when used to treat patients with early RA. The two studies will be presented at the European League Against Rheumatism (EULAR) annual congress in Madrid, Spain.
A post hoc exploratory analysis evaluated the efficacy and safety of tocilizumab (8 mg/kg) monotherapy in patients in the AMBITION trial who entered the long-term extension (LTE) phase. A total of 139 patients received tocilizumab monotherapy.
Results from the efficacy analysis over the extended trial period showed that 65% of these patients (n = 90) remained on monotherapy until week 240. Of these:
- The number of patients achieving remission continued to increase or was maintained over time, with 66.7% of patients achieving remission (as measured by DAS28
- Disease activity (as measured by the swollen joint count [SJC] and the tender join count [TJC]) continued to decrease or was maintained up to week 240. The SJC was reduced from 19.0 at the start of the trial to 1.8 at week 240, and the TJC was reduced from 32.5 to 3.8.
The FUNCTION study evaluated the efficacy and safety of tocilizumab in combination with MTX and as monotherapy in early RA patients who had not previously received MTX. Secondary endpoints demonstrated statistically significant improvements in the signs and symptoms of RA and physical function, and a reduction in structural joint damage, at 52 weeks when tocilizumab (8 mg/kg) was used with MTX. Tocilizumab monotherapy demonstrated superiority over MTX alone in achieving disease remission at week 24. In addition, although statistical significance was not met, clinically meaningful improvements were seen in RA signs and symptoms at week 24 and in the inhibition of structural joint damage to week 52.
RoACTEMRA (tocilizumab) is the first humanized interleukin-6 (IL-6) receptor agonist approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).
Source: Roche; June 13, 2013.