RESEARCH - Efficacy and safety of certolizumab pegol plus MTX in active RA: RAPID 2

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

doi:10.1136/ard.2008.101659

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Extended Report

Efficacy and Safety of Certolizumab Pegol Plus Methotrexate in Active

Rheumatoid Arthritis: The RAPID 2 Study

f S Smolen 1*, BM Landewé 2, Philip J Mease 3, Jan

Brzezicki 4, Mason 5, Kristel Luijtens 6, F van

Vollenhoven 7, Arthur Kavanaugh 8, H. Schiff 9, Gerd R

Burmester 10, Vibeke Strand 11, Jiri Vencovsky 12 and Désirée MFM van

der Heijde 13

1 Medica University of Vienna, Austria

2 University of Maastricht, Netherlands

3 Rheumatology, United States

4 Oddzial Reumatologii ul, Wojewodzki Szpital Zespolony, Elblag, Poland

5 Research and Development, UCB Inc, Atlanta, Georgia, United States

6 UCB Inc, Brussels, Belgium

7 Karolinska University Hospital, Sweden

8 Div of Rheumatology, United States

9 Denver Arthritis Clinic, United States

10 Charite University Hospital, Germany

11 Stanford, United States

12 Institute of Rheumatology, Czech Republic

13 Leiden University Medical Center, Netherlands

Abstract

Objective: Certolizumab pegol is a PEGylated tumor necrosis factor

(TNF) inhibitor. The objective of this study was to evaluate the

efficacy and safety of certolizumab pegol versus placebo, plus

methotrexate (MTX), in patients with active rheumatoid arthritis (RA).

Methods: This was an international, multicenter, phase 3, randomized,

double-blind, placebo-controlled study in active adult-onset RA.

Patients (n=619) were randomized 2:2:1 to subcutaneous certolizumab

pegol (liquid formulation) 400 mg at Weeks 0, 2, and 4 followed by 200

mg or 400 mg plus MTX, or placebo plus MTX, every 2 weeks for 24

weeks. The primary endpoint was ACR20 response at Week 24. Secondary

endpoints included ACR50 and ACR70 responses, change from baseline in

modified Total Sharp Score (mTSS), ACR core set variables, and

physical function.

Results: Significantly more patients in the certolizumab pegol 200-

and 400-mg groups achieved an ACR20 response versus placebo (P

0.001); rates were 57.3%, 57.6%, and 8.7%, respectively. Certolizumab

pegol 200 and 400 mg also significantly inhibited radiographic

progression; mean changes from baseline in mTSS at Week 24 were 0.2

and –0.4, respectively, versus 1.2 for placebo (rank analysis P

0.01). Certolizumab pegol-treated patients reported rapid and

significant improvements in physical function versus placebo (P

0.001). Most adverse events were mild or moderate, with low incidence

of withdrawals due to adverse events. Five patients developed

tuberculosis.

Conclusion: Certolizumab pegol plus MTX was more efficacious than

placebo plus MTX, rapidly and significantly improving signs and

symptoms of RA and physical function and inhibiting radiographic

progression.

http://ard.bmj.com/cgi/content/abstract/ard.2008.101659v1?papetoc

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