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ACTEMRA/RoACTEMRA treatment induced rapid improvements in signs and symptoms of RA, as early as 2 weeks after initiation

• Significantly higher ACR responses at Week 24 were seen in patients treated with ACTEMRA/RoACTEMRA plus MTX versus the comparator arm.
• Significantly more patients randomised to ACTEMRA/RoACTEMRA achieved ACR remission (ACR70 response) and DAS28 remission (<2.6) at Week 24 versus the comparator arm.
• Patients treated with ACTEMRA/RoACTEMRA responded as early as 2 weeks after therapy initiation; DAS28 decreased rapidly following initiation of ACTEMRA/RoACTEMRA treatment, with the mean improvement corresponding to at least moderate EULAR response at the first assessed time point of 2 weeks.

Key efficacy results at Week 24 in the OPTION study

Parameter	Placebo plus MTX n=204	ACTEMRA/ RoACTEMRA 8 mg/kg plus MTX n=205
ACR20 (primary endpoint)	26	59***
ACR50	11	44***
ACR70	2	22***
DAS28 remission	0.8	27***
Mean change in CRP level, mg/dl	–0.35	–2.51***
Mean change in haemoglobin level, g/dl	0.03	1.24***
Change from baseline in HAQ–DI score of ≥0.3	47	59
Mean change in HAQ–DI score	–0.34	–0.55**
Mean change in FACIT−Fatigue score	4.0	8.6***
**P<0.001; ***P<0.0001 vs. control group. Data are percentage of patients except where indicated.

 

• Patients in the ACTEMRA/RoACTEMRA 8 mg/kg plus MTX arm also had greater improvements in CRP levels that appeared within 2 weeks of the first infusion and were maintained throughout the study, as well as rapid improvements in physical function (HAQ-DI score) and fatigue (FACIT-Fatigue score).

The design of the OPTION study and a summary of baseline characteristics of participants can be found in the Phase III Trials section of the website.

Reference:
Smolen JS, et al. Lancet 2008; 371:987–997.
Figures and tables reproduced from the Lancet © 2008, with permission from Elsevier.