Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Efficacy and Safety of Certolizumab Pegol in a Clinically Representative Population of Patients (Pts) with Active Rheumatoid Arthritis (RA): Results of the REALISTIC Phase IIIb Randomized Controlled Study.

Weinblatt2,  Michael, Fleischmann8,  Roy, Emery3,  Paul, Goel11,  Niti, Bingham5,  Clifton O., Pope9,  Janet, Massarotti1,  Elena

Brigham and Women's Hospital, Boston, MA
UCB, Raleigh, NC
UCB, Smyrna, GA
Brigham and Women's Hospital
Chapel Allerton Hospital, Leeds, United Kingdom
Hospital Cochin, Paris, France
Johns Hopkins University, Baltimore, MD
Karolinska Institute, Stockholm, Sweden
Leiden University Medical Centre, Leiden, The Netherlands
MCRC, University of Texas, Dallas, TX
St. Joseph's Health Care, University of Western Ontario, London, ON, Canada

Background:

Certolizumab pegol (CZP) is effective and well tolerated in pts with active RA when used with methotrexate (MTX) or given as monotherapy.1–3 The objective of this study was to further investigate the safety and efficacy of CZP in a broader active RA population more closely resembling routine clinical practice.

Methods:

REALISTIC (RA Evaluation in Subjects Receiving TNF Inhibitor Certolizumab Pegol) was a multicenter (North America and Western Europe) Phase IIIb trial in active RA pts with inadequate response to >=1 DMARD including pts with prior TNF-inhibitor exposure (NCT00717236), stratifying by baseline (BL) MTX use, prior TNF-inhibitor use and disease duration. In the 12-wk double-blind (DB) phase, pts were randomized to CZP 400 mg at Wks 0, 2 and 4 and 200 mg at Wks 6, 8 and 10 or placebo injection (control) every 2 wks (Q2W) added to their current treatment. From Wk 12, open-label (OL) CZP 200 mg Q2W was given for >=16 wks. Primary outcome was ACR20 at Wk 12. ACR responses were determined using NRI, and DAS28(CRP) and HAQ-DI using LOCF.

Results:

Of the 1063 pts aged 19–86 (mean 55.1) years (78.0% female) who were randomized (CZP = 851; control = 212), 37.6% had prior TNF-inhibitor exposure. Mean HAQ-DI and DAS28(CRP) scores at BL were 1.50 and 5.71 for CZP and 1.61 and 5.71 for the control group. Duration of RA was 0.2–52.0 (mean 8.7, SD 8.8) years. Most pts (88.7% overall; CZP: 89.5%, n = 762; control: 85.4%, n = 181) completed 12 wks' therapy and entered the OL phase. The primary objective was met; ACR20 was achieved in 51.1% of CZP vs 25.9% of control pts (p<0.001) at Wk 12. Wk 12 ACR50 and ACR70 responses were 26.6% and 13.0% for CZP pts vs 9.9% and 2.8% for control pts (p<0.001 for both). CZP clinical responses were rapid; ACR20/50 responses were significantly superior to control (31.8% vs 8.5% and 9.6% vs 1.4%, p<0.001 for both) from first time point (Wk 2) onwards. Significant improvements in DAS28(CRP) were reported with CZP vs control from Wk 2 (–1.07 vs –0.42; p<0.001) through to Wk 12 (–1.64 vs –0.79, p<0.001). DAS28(CRP) remission (DAS28 <2.6) was achieved in 16.3% of CZP and 5.7% of controls (p<0.001) at Wk 12. CZP pts also reported rapid and significant improvements in HAQ-DI vs control: mean change from BL at Wk 2: –0.29 vs –0.12; p<0.001 to Wk 12: –0.43 vs –0.21; p<0.001. In CZP pts, BL use of MTX (yes vs no) did not markedly affect ACR20 responses (52.4% vs 48.3%), nor did prior use of TNF-inhibitor (47.2% vs 53.5%) at Wk 12. Similar ACR20 results were seen regardless of disease duration, activity and geographic region. Adverse and serious adverse event rates were comparable between CZP and control groups (65.1% vs 59.3%, and 5.4% vs 6.2%), with no new safety signals and no cases of TB observed.

Conclusion:

In a diverse group of RA pts reflecting those seen in daily clinical practice (including those with prior TNF-inhibitor use), addition of CZP to current therapy was associated with a rapid clinical response consistent in all strata, improved function and reduced disease activity with a favorable risk benefit profile.

1.Keystone, E, et al. Arthritis Rheum 2008;58:3319-3329.

2.Smolen, J, et al. Arthritis Rheum 2009;68:797-804.

3.Fleischmann, R, et al. Ann Rheum Dis 2009;68:805-811.

To cite this abstract, please use the following information:
Weinblatt, Michael, Fleischmann, Roy, Emery, Paul, Goel, Niti, Bingham, Clifton O., Pope, Janet, et al; Efficacy and Safety of Certolizumab Pegol in a Clinically Representative Population of Patients (Pts) with Active Rheumatoid Arthritis (RA): Results of the REALISTIC Phase IIIb Randomized Controlled Study. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1805
DOI: 10.1002/art.29570

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