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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 24^2,3

 

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

 

References:

1. RoACTEMRA^® (tocilizumab) Summary of Product Characteristics. Roche Registration Limited. August 2011.
2. Dougados M, et al. Ann Rheum Dis 2011; 70(Suppl. 3):73.
3. Dougados M, et al. Arthritis Rheum 2011; 63(Suppl. 10):S1032.
4. Sibilia J, et al. Ann Rheum Dis 2011; 70(Suppl. 3):466.
5. Jones G, et al. Ann Rheum Dis 2010; 69:88–96.