ACTEMRA/RoACTEMRA is indicated for the treatment of RA as monotherapy in cases where patients are intolerant to methotrexate (MTX) or where continued treatment with MTX is inappropriate.1 The efficacy and safety of ACTEMRA/RoACTEMRA monotherapy in RA patients have been examined in clinical studies (ACT-RAY, ACT-SURE and AMBITION) across different patient populations. The key efficacy findings from these studies are summarised here.
ACTEMRA/RoACTEMRA (tocilizumab) monotherapy in patients with methotrexate inadequate response (MTX-IR)
ACTEMRA/RoACTEMRA monotherapy offers comparable disease control to ACTEMRA/RoACTEMRA combination therapy at week 242,3
The ACT-RAY study evaluated the clinical efficacy and safety of adding ACTEMRA/RoACTEMRA to MTX versus switching from MTX to ACTEMRA/RoACTEMRA monotherapy in biologic-naïve adult patients with moderate to severe active RA (DAS28 >4.4) despite MTX treatment.2,3
ACT-RAY was a 2-year, double-blind, Phase IIIb, randomised, placebo-controlled study and the primary efficacy outcome was DAS28 remission rate (DAS28 <2.6) at Week 24.2,3
DAS28 remission rates (DAS28 <2.6) at Week 24 were comparable for both groups.2
ACR responses at Week 24 were comparable for both groups.2
Progression of structural damage was assessed using the Genant-modified Sharp score (GSS) and there were no significant differences in the reduction of progression of joint damage with or without MTX at 24 weeks.3
Change from baseline in radiographic scores at Week 243
The majority of the patients demonstrated near complete arrest of progression of structural damage, with no significant differences between groups.3
ACTEMRA/RoACTEMRA (tocilizumab) monotherapy in patients with disease-modifying anti-rheumatic drug or anti-tumour necrosis factor-inadequate response (DMARD-IR or TNF-IR)4
- The ACT-SURE study compared safety and efficacy measures in patients who received ACTEMRA/RoACTEMRA monotherapy versus patients who received ACTEMRA/RoACTEMRA in combination with one or more DMARDs.4
- Of 1,681 patients in the safety and intention-to-treat (ITT) populations, 14% (n=239) received ACTEMRA/RoACTEMRA monotherapy. Of monotherapy patients, 72% were TNF-IR; 37% of add-on DMARD patients were TNF-IR, and 22% of patients with add-on DMARDs received >1 DMARD.4
- At Week 24, efficacy end points were comparable between groups4
ACTEMRA/RoACTEMRA (tocilizumab) monotherapy in MTX-naïve* patients5
* MTX-naïve or MTX-free for 6 months prior to randomisation
- The AMBITION trial enrolled patients who had not been treated with MTX within 6 months prior to randomisation and who had not discontinued previous MTX treatment as a result of clinically important toxic effects or lack of response. The majority (67%) of patients were naïve to MTX and biologic therapy.5
- Patients were randomised to either 8 mg/kg of ACTEMRA/RoACTEMRA given every 4 weeks as monotherapy or weekly MTX (dose titrated from 7.5 mg to a maximum of 20 mg weekly over an 8-week period).5
- The primary endpoint of the AMBITION study was the proportion of patients achieving ACR20 response at Week 24.5
Treatment with ACTEMRA/RoACTEMRA monotherapy was superior to treatment with MTX (ITT) at Week 245
- RoACTEMRA® (tocilizumab) Summary of Product Characteristics. Roche Registration Limited. August 2011.
- Dougados M, et al. Ann Rheum Dis 2011; 70(Suppl. 3):73.
- Dougados M, et al. Arthritis Rheum 2011; 63(Suppl. 10):S1032.
- Sibilia J, et al. Ann Rheum Dis 2011; 70(Suppl. 3):466.
- Jones G, et al. Ann Rheum Dis 2010; 69:88–96.