RESEARCH - Golimumab, a human antibody to TNF, in active RA despite MTX: GO-FORWARD

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Ann Rheum Dis. Published Online First: 9 December 2008.

doi:10.1136/ard.2008.099010

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Extended Report

Golimumab, a human antibody to TNF- given by monthly subcutaneous

injections, in active rheumatoid arthritis despite methotrexate: The

GO-FORWARD Study

C. Keystone 1*, Mark C. Genovese 2, Lars Klareskog 3,

C. Hsia 4, T. Hall 5, Pedro C. Miranda 6, Jacek Pazdur 7,

Sang-Cheol Bae 8, Palmer 9, Zrubek 10, Wiekowski

11, Sudha Visvanathan 10, Zhong Wu 10 and Mahboob U. Rahman 4

1 University of Toronto and Mount Sinai Hospital, Canada

2 Stanford University, United States

3 Karolinska Institute and Karolinska University Hospital, Sweden

4 Centocor Research and Development, Inc. and University of

Pennsylvania School of Medicine, United States

5 Cabrini Medical Centre, Australia

6 Universidad de Chile and Hospital San de Dios, Chile

7 Instytut Reumatologii, Poland

8 Hanyang University Medical Center, Korea, Republic of

9 Westroads Medical Group, United States

10 Centocor Research and Development, Inc., United States

11 Schering-Plough Research Institute, Inc., United States

Abstract

Objective: The Phase 3 GO-FORWARD study examined the efficacy and

safety of golimumab in patients with active rheumatoid arthritis (RA)

despite methotrexate (MTX) therapy.

Methods: Patients were randomly assigned in a 3:3:2:2 ratio to receive

placebo injections plus MTX capsules (Group 1, n=133), golimumab 100

mg injections plus placebo capsules (Group 2, n=133), golimumab 50 mg

injections plus MTX capsules (Group 3, n=89), or golimumab 100 mg

injections plus MTX capsules (Group 4, n=89). Injections were

administered subcutaneously every 4 weeks. The co-primary endpoints

were the proportion of patients with 20% improvement in the American

College of Rheumatology criteria (ACR20) at week 14 and the change

from baseline in the Health Assessment Questionnaire-disability index

(HAQ-DI) score at week 24.

Results: The proportion of patients who achieved an ACR20 response at

week 14 was 33.1% in the placebo plus MTX group, 44.4% (p=0.059) in

the golimumab 100 mg plus placebo group, 55.1% (p=0.001) in the

golimumab 50 mg plus MTX group, and 56.2% (p<0.001) in the golimumab

100 mg plus MTX group. At week 24, median improvements from baseline

in HAQ-DI scores were 0.13, 0.13 (p=0.240), 0.38 (p<0.001), and 0.50

(p<0.001), respectively. During the placebo-controlled portion of the

study (through week 16), serious adverse events occurred in 2.3%,

3.8%, 5.6%, and 9.0% of patients and serious infections occurred in

0.8%, 0.8%, 2.2%, and 5.6%, respectively.

Conclusion: The addition of golimumab to MTX in patients with active

RA despite MTX significantly reduced the signs and symptoms of RA and

improved physical function.

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http://ard.bmj.com/cgi/content/abstract/ard.2008.099010v1?papetoc

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