RESEARCH - Efficacy and safety of certolizumab pegol monotherapy every 4 weeks for RA: FAST4WARD

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Ann Rheum Dis. Published Online First: 17 November 2008.

doi:10.1136/ard.2008.099291

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Extended Report

Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in

patients with rheumatoid arthritis failing previous disease-modifying

antirheumatic therapy: the FAST4WARD study

Roy Fleischmann 1*, Jiri Vencovsky 2, van Vollenhoven 3,

Borenstein 4, Jane Box 5, Geoffroy Coteur 6, Niti Goel 7, Hans-

Brezinschek 8, Alison Innes 8 and Vibeke Strand 9

1 University of Texas Southwestern Medical Center, United States

2 Institute of Rheumatology, Czech Republic

3 Karolinska Institute, Sweden

4 Washington University Medical Center, United States

5 Carolina Bone and Joint, United States

6 UCB, Belgium

7 UCB, United States

8 UCB, United Kingdom

9 Stanford University, United States

Abstract

Background: Tumour necrosis factor alpha (TNF) is a proinflammatory

cytokine involved in the pathogenesis of rheumatoid arthritis (RA).

Treatment with TNF inhibitors reduces disease activity and improves

outcomes for RA patients. This study evaluated the efficacy and safety

of certolizumab pegol 400 mg, a novel, PEGylated, Fc-free TNF

inhibitor, as monotherapy in patients with active RA.

Methods: In this 24-week, multicentre, randomised, double-blind,

placebo-controlled study, 220 patients previously failing 1 DMARDs

were randomised 1:1 to receive subcutaneous certolizumab pegol 400 mg

(n = 111) or placebo (n = 109) every 4 weeks (q4w). The primary

endpoint was ACR20 response at week 24. Secondary endpoints included

ACR50/70 response, ACR component scores, (DAS28[ESR]-3),

patient-reported outcomes (including physical function, HRQoL, pain

and fatigue) and safety.

Results: At week 24, the ACR20 response rates were 45.5% for

certolizumab pegol 400 mg q4w vs 9.3% for placebo (p<0.001).

Differences for certolizumab pegol vs placebo in the ACR20 response

were statistically significant as early as week 1 through to week 24

(p<0.001). Significant improvements in ACR50, ACR components,

DAS28(ESR)-3 and all patient-reported outcomes were also observed

early with certolizumab pegol and were sustained throughout the study.

Most adverse events were mild or moderate and no deaths or cases of

tuberculosis were reported.

Conclusions: Treatment with certolizumab pegol 400 mg monotherapy

every 4 weeks effectively reduced the signs and symptoms of active RA

in patients previously failing 1 DMARDs compared with placebo, and

demonstrated an acceptable safety profile (ClinicalTrials.gov

identifier: NCT00548834).

http://ard.bmj.com/cgi/content/abstract/ard.2008.099291v1?papetoc

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