Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.


Golimumab, ANew, Human, TNF Alpha Antibody, Administered Subcutaneously Every 4 Weeks in Psoriatic Arthritis Patients: 104-Week Efficacy and Safety Results of the Randomized, Placebo-Controlled GO-REVEAL Study

Kavanaugh1,  A., Mease2,  P., Krueger3,  G.G., Gladman4,  D., Zrubek5,  J., Beutler5,  A., Hsu5,  B.

UCSD, San Diego, CA,
Swedish Med Ctr/U of Washington, Seattle, WA,
U of Utah Hlth Sciences Ctr, Salt Lake City, UT,
The Toronto Western Hosp., Toronto, ON,
Centocor R&D, Inc, Malvern, PA,
University of Glasgow, Glasgow, United Kingdom

Purpose:

To assess long-term efficacy & safety of golimumab (GLM) in active PsA.

Methods:

PsA pts with >=3 swollen and >=3 tender joints and psoriasis were randomized to SC PBO or GLM (50 or 100 mg) q4wks. At wk 16, pts with inadequate arthritis response entered early escape (EE). All pts received GLM from wk 24. Investigators could dose-escalate pts receiving GLM 50 mg to 100 mg based on clinical judgement after all pts reached wk 52. The results for pts who remained on the same dose of GLM 50 to 100 mg are described. Analyses were based on observed data.

Results:

405 pts with active PsA were randomized (113 PBO, 146 GLM 50 mg, 146 GLM 100 mg). GLM was significantly better than PBO in improving signs and symptoms of PsA at wk 24, and GLM efficacy was maintained through wk 52.Through wk 104, pts continuing on the same dose of GLM 50 or 100 mg maintained high levels of response. GLM 50 mg pts who switched to 100 mg in EE or via dose escalation also achieved clinically meaningful responses (Table). 8.6% (34/394) of GLM-treated pts experienced SAEs through wk 104. Injection site reactions occurred in 8.9% (35/394) of pts. There was 1 case of histoplasmosis in a pt (GLM 100 mg) that was successfully treated. Malignancies reported through wk 104 include basal cell skin (1 pt), colon (1 pt), and small cell lung cancer (1 pt) in pts receiving GLM 50 mg, and basal cell skin (3 pts), prostate (1 pt), and small cell lung cancer (1 pt; fatal) in pts receiving GLM 100 mg. An additional pt died due to a climbing accident (GLM 50 mg).

Table. Summary of efficacy in GO-REVEAL through wk 104

 GLM 50mg only1GLM 50 >=100mg2GLM 100mg only3
Wk 52 ACR2080/102 (78.4%)11/26 (42.3%)93/115 (80.9%)
HAQ score, mean (SD) improvementn=100, 0.49 (0.55)n=26, 0.20(0.49)n=113, 0.50 (0.54)
ACR5058/102 (56.9%)7/26 (26.9%)68/115 (59.1%)
ACR7044/102 (43.1%)3/26 (11.5%)41/115 (35.7%)
PASI75444/71 (62.0%)17/23 (73.9%)60/86 (69.8%)
Wk 104 ACR2064/70 (91.4%)43/76 (56.6%)95/130 (73.1%)
HAQ score, mean(SD) improvementn=69, 0.54 (0.55)n=76, 0.36 (0.57)n=127, 046 (0.57)
ACR5046/70 (65.7%)27/76 (35.5%)70/130 (53.8%)
ACR7031/70 (44.3%)17/76 (22.4%)48/130 (36.9%)
PASI7533/48 (68.8%)35/56 (62.5%)73/96 (76.0%)
1Includes pts randomized to GLM 50mg and did not change dose;2Includes pts on PBO at baseline who entered EE or crossed over to GLM 50mg and later dose escalated to GLM 100mg and pts randomized to GLM 50mg who entered EE or dose escalated to GLM 100mg;3Includes pts randomized to GLM100 mg and did not change dose;4Among pts with >=3% body surface area psoriasis involvement at baseline.

Conclusion:

Pts with active PsA treated with GLM 50 and 100mg SC q4 wks maintained high levels of improvement through wk 104. GLM was generally well-tolerated, with a safety profile similar to that observed for other anti-TNF agents.

To cite this abstract, please use the following information:
Kavanaugh, A., Mease, P., Krueger, G.G., Gladman, D., Zrubek, J., Beutler, A., et al; Golimumab, ANew, Human, TNF Alpha Antibody, Administered Subcutaneously Every 4 Weeks in Psoriatic Arthritis Patients: 104-Week Efficacy and Safety Results of the Randomized, Placebo-Controlled GO-REVEAL Study [abstract]. Arthritis Rheum 2009;60 Suppl 10 :512
DOI: 10.1002/art.25594

Abstract Supplement

Meeting Menu

2009 ACR/ARHP