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.


Long-Term Radiographic Outcome in Psoriatic Arthritis Patients Treated with Golimumab: 104 Week Results from the GO-REVEAL Study.

Kavanaugh7,  Arthur, Van Der Heijde4,  Desiree M., Gladman6,  Dafna D., Mease5,  Philip J., McInnes8,  Iain B., Krueger9,  Gerald G., Xu3,  Weichun

Centocor Research and Development, Inc, Collegeville, PA
Centocor Research and Development, Inc
Centocor Research and Development, Inc.
Leiden University Medical Center, Meerssen, The Netherlands
Seattle Rheumatology Associate, Seattle, WA
Toronto Western Hospital, Toronto, ON, Canada
University of California-San Diego, La Jolla, CA
University of Glasgow, Glasgow, United Kingdom
University of Utah Health Sciences Center

Objectives:

Golimumab (GLM), a human monoclonal anti-TNFa antibody administered as every 4 weeks subcutaneous injections demonstrated long-term clinical efficacy and acceptable safety through wk104. The effect of GLM on inhibition of progression of structural damage PsA pts has been shown through wk52. Week 104 radiographic results are being reported now.

Methods:

Adult PsA pts with >=3 swollen & >=3 tender joints (SJC/TJC) were randomized to receive SC placebo (PBO) or GLM 50 mg or 100 mg q4 wks. At wk16, pts with <10% improvement in SJC/TJC's entered early escape (EE) in a double-blinded manner to GLM 50 mg (PBO pts) or GLM 100 mg (GLM 50 mg pts). All pts randomized to PBO received GLM 50 mg from wk24 through wk104. Pts on GLM 50 mg could be dose-escalated based on the investigator's judgment to GLM 100 mg after unblinding at wk52. Radiographs of the hands and feet were read at wks 0, 52, and 104. Erosions and joint space narrowing were evaluated by two independent readers unaware of treatment and image time sequence using the van der Heijde-Sharp (vdH-S) method modified for PsA. Data was analyzed based on randomized groups. Due to lack of adequate control arm, no statistical comparisons were performed at wk52 or wk104.

Results:

405 pts were enrolled. Mean age was 46–48 yrs, median SJC/TJC's were 12–14/22–24, HAQ scores were 1.0–1.1, CRP levels were 0.6 mg/dL, and mean (median) total vdH-S scores were 16.34–22.99 (9.00–10.50).

Conclusions:

GLM 50 mg and 100 mg treated patients with active PsA showed no to minimal evidence of radiographic disease progression through wk104.

 PBO*GLM 50 mg**GLM 100 mg***
Change from baseline to wk52 in total scorea   
        N87116128
        Mean ± SD0.10 ± 1.88-0.30 ± 1.65-0.35 ± 1.70
        Median (IQR)0.00 (0.00, 0.50)0.00 (-0.50, 0.00)0.00 (0.00, 0.00)
Change from wk52 to wk104 in total scoreb   
        N87116127
        Mean ± SD-0.03 ± 1.59-0.10 ± 0.100.02 ± 0.71
        Median (IQR)0.00 (0.00, 0.00)0.00 (0.00, 0.00)0.00 (0.00, 0.00)
Change from baseline to wk104 in total scorea   
        N87117128
        Mean ± SD0.08 ± 3.19-0.39 ± 2.04-0.32 ± 1.873
        Median (IQR)0.00 (-0.50, 0.50)0.00 (-0.90, 0.00)0.00 (-0.50, 0.00)
*Includes pts who qualified for EE, crossed-over to GLM 50 mg and pts were dose-escalated from GLM 50 mg to GLM 100 mg,
**Includes pts who qualified for EE and pts who were dose-escalated to GLM 100 mg,
***Includes pts who qualified for EE,
aIncludes pts with baseline and 1 post wk52 score,
bIncludes pts with wk52 and 1 post wk52 score.

To cite this abstract, please use the following information:
Kavanaugh, Arthur, Van Der Heijde, Desiree M., Gladman, Dafna D., Mease, Philip J., McInnes, Iain B., Krueger, Gerald G., et al; Long-Term Radiographic Outcome in Psoriatic Arthritis Patients Treated with Golimumab: 104 Week Results from the GO-REVEAL Study. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1943
DOI: 10.1002/art.29708

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