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CIMZIA(R) (certolizumab pegol), Significantly Reduces Structural Damage and Rheumatoid Arthritis Signs & Symptoms for Up to One Year
Date:11/7/2007

>ACR 50 7.6 38.0* 39.9*

ACR 70 3.5 21.2* 23.2*

Six and 12 month mean mTSS changes from baseline for RAPID 1

CIMZIA(R) CIMZIA(R)

(certolizumab (certolizumab

pegol) pegol)

Placebo & MTX 200mg & MTX 400mg & MTX

Six months 1.3 0.2* 0.2*

12 months 2.8 0.4* 0.2*

*p<0.001

In the six-month RAPID 2 trial, 619 patients were randomly allocated to receive one of three treatment regimens:

-- 246 patients received 400 mg formulation CIMZIA at the start of the

study and at weeks two and four, then 200 mg given every two weeks,

together with methotrexate;

-- 246 patients received 400 mg formulation CIMZIA every two weeks,

together with methotrexate;

-- 127 patients received placebo every two weeks, together with

methotrexate.

In all three arms of the study the dose of methotrexate was 10mg per week or greater. Patients were assessed for improvement in signs and symptoms of RA. The primary endpoint for the study RAPID 2 was ACR20 responder rate at week 24.

In both studies, CIMZIA given at a dosage of 200mg every two weeks was equally effective as a dosage of 400mg every two weeks.

Six month ACR Responses for RAPID 2

CIMZIA(R) CIMZIA(R)

(certolizumab (certolizumab

pegol) pegol)

Placebo & MTX 200mg & MTX 400mg & MTX

ACR 20 8.7 57.3
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SOURCE UCB
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