RESEARCH - Certolizumab pegol plus MTX is more effective than placebo plus MTX in active RA

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Arthritis Rheum. 2008 Oct 30;58(11):3319-3329.

Certolizumab pegol plus methotrexate is significantly more effective

than placebo plus methotrexate in active rheumatoid arthritis:

Findings of a fifty-two-week, phase III, multicenter, randomized,

double-blind, placebo-controlled, parallel-group study.

Keystone E, Heijde DV, Mason D Jr, Landewé R, Vollenhoven RV, Combe B,

Emery P, Strand V, Mease P, Desai C, Pavelka K.

University of Toronto, Toronto, Ontario, Canada.

OBJECTIVE: To evaluate the efficacy and safety of 2 dosage regimens of

lyophilized certolizumab pegol (a novel PEGylated anti-tumor necrosis

factor agent) as adjunctive therapy to methotrexate (MTX) in patients

with active rheumatoid arthritis (RA) with an inadequate response to

MTX therapy alone.

METHODS: In this 52-week, phase III, multicenter, randomized,

double-blind, placebo-controlled, parallel-group trial, 982 patients

were randomized 2:2:1 to receive treatment with subcutaneous

certolizumab pegol at an initial dosage of 400 mg given at weeks 0, 2,

and 4, with a subsequent dosage of 200 mg or 400 mg given every 2

weeks, plus MTX, or placebo plus MTX. Co-primary end points were the

response rate at week 24 according to the American College of

Rheumatology 20% criteria for improvement (ACR20) and the mean change

from baseline in the modified total Sharp score at week 52.

RESULTS: At week 24, ACR20 response rates using nonresponder

imputation for the certolizumab pegol 200-mg and 400-mg groups were

58.8% and 60.8%, respectively, as compared with 13.6% for the placebo

group. Differences in ACR20 response rates versus placebo were

significant at week 1 and were sustained to week 52 (P < 0.001). At

week 52, mean radiographic progression from baseline was reduced in

patients treated with certolizumab pegol 200 mg (0.4 Sharp units) or

400 mg (0.2 Sharp units) as compared with that in placebo-treated

patients (2.8 Sharp units) (P < 0.001 by rank analysis). Improvements

in all ACR core set of disease activity measures, including physical

function, were observed by week 1 with both certolizumab pegol dosage

regimens. Most adverse events were mild or moderate.

CONCLUSION: Treatment with certolizumab pegol 200 or 400 mg plus MTX

resulted in a rapid and sustained reduction in RA signs and symptoms,

inhibited the progression of structural joint damage, and improved

physical function as compared with placebo plus MTX treatment in RA

patients with an incomplete response to MTX.

PMID: 18975346

http://www.ncbi.nlm.nih.gov/pubmed/18975346

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