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The OPTION trial enrolled patients who had an inadequate clinical response to methotrexate (MTX). ACTEMRA/RoACTEMRA 8 mg/kg or placebo were given every 4 weeks for 24 weeks in combination with stable MTX (10 mg to 25 mg weekly). At the end of the 24-week study period, patients who met the inclusion criteria could continue in an ongoing, long-term, open-label follow-up study.

Baseline characteristics were well-balanced between treatment groups with respect to demographics, treatment history, disease activity and laboratory parameters.

Baseline demographics and disease characteristics in the OPTION study (ITT population)

	OPTION
	ACTEMRA/ RoACTEMRA 8 mg/kg plus MTX n=205	Placebo plus MTX n=204
Demographics and treatment history
Female, %	85	78
Age, years	50.8 (11.8)	50.6 (12.1)
RA duration, years	7.5 (7.3)	7.8 (7.2)
Number of DMARDs used before study	1.5 (1.4)*	1.7 (1.5)*
Disease activity and laboratory tests
Swollen joint count	19.5 (11.3)	20.7 (11.7)
Tender joint count	31.9 (15.5)	32.8 (16.1)
HAQ–DI	1.6 (0.6)	1.5 (0.6)
CRP, mg/dl	2.6 (2.6)	2.4 (2.8)
DAS28	6.8 (0.9)	6.8 (0.9)
Data are mean (SD) except where indicated. * Not counting previous use of MTX.

 

ACTEMRA/RoACTEMRA in combination with MTX was an effective and well-tolerated therapeutic approach in patients with moderate to severe active RA with an inadequate response to MTX.

Detailed results of the OPTION study can be found in the Efficacy and Safety and Tolerability sections 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.