Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

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


Golimumab in Rheumatoid Arthritis Patients Previously Treated with Anti-TNF Agents (GO-AFTER Study): Week 52 Results

Smolen1,  J. S., Kay2,  Jonathan, Doyle3,  M. K., Landewe4,  R., Matteson5,  E. L., Wollenhaupt6,  J., Gaylis7,  N. B.

Medical Univ Vienna/Hietzing Hosp, Vienna, Austria,
Centocor R&D, Inc, Malvern, PA
U of Mass Med School, Worcester, MA,
Centocor R&D, Inc/U of Penn School of Med, Malvern, PA,
University Hospital Maastricht, Maastricht, Netherlands,
Mayo Clinic, Rochester, MN,
Klinikum Eilbek, Hamburg, Germany,
Arthritis & Rheumatic Disease Specialties, Aventura, FL,
Altoona Ctr for Clin Research, Duncansville, PA,
Arthritis Center of Lexington, Lexington, KY,

Purpose:

To evaluate the efficacy and safety of golimumab (GLM) in patients (pts) with active rheumatoid arthritis (RA) previously treated with anti-TNFa agent(s).

Methods:

Patients in the GO-AFTER study were randomized (1:1:1) to subcutaneous injections of PBO, GLM 50 mg or 100 mg q4wks. Pts could have received >=1 anti-TNFa agent(s) and discontinued for any reason(s). Pts with <20% improvement in tender and swollen joint counts at wk 16 entered early escape (EE) in a double-blinded fashion: PBO group ® GLM 50 mg q4wks, GLM 50 mg ® GLM 100 mg q4wks, GLM 100 mg group remained on 100 mg q4wks. At wk 24, PBO pts crossed over to GLM 50 mg and the study was unblinded after the last pt completed the wk 24 visit, and pts on GLM 50 mg could escalate to 100 mg at physician discretion. Wk 24 data presented previously, data through wk 52 are now presented.

Results:

The significant improvement in signs and symptoms of RA and physical function observed with GLM at wk 24, as assessed by American College of Rheumatology (ACR) response criteria, Disease Activity Score (DAS) response criteria, and the Health Assessment Questionnaire (HAQ), was maintained through and at wk 52. In the table below, the 50 ® 100 mg column includes pts from the GLM 50 mg group who met EE criteria at wk16 and pts from both PBO and GLM 50 mg groups who were receiving GLM 50 mg q4wks after wk 16 and dose escalated to GLM 100 mg q4wks at the discretion of the investigator after wk 24. These patients may have more refractory disease, but they also had a fairly good response after adjusting their dose of GLM.

AssessmentPBO®50 mg50 mg only50®100 mg100 mg
No. patients726496121
Week 52    
ACR 2052.1%62.5%52.6%60.5%
ACR 5033.8%40.6%18.8%31.7%
DAS28 responders*....
CRP72.1%81.0%68.1%79.1%
ESR70.4%79.0%63.0%73.0%
HAQ (median improvement from baseline)0.250.250.250.31
% improvement from baseline in:....
No. swollen joints70.0%61.3%55.6%75.0%
No. tender joints65.9%81.3%52.4%66.7%
* DAS28 Responders (EULAR Moderate-Good)

Conclusion:

The efficacy (signs/symptoms/physical function) of GLM was maintained through wk 52 in this population. The GLM safety profile was similar to that reported for other anti-TNFa agents.

To cite this abstract, please use the following information:
Smolen, J. S., Kay, Jonathan, Doyle, M. K., Landewe, R., Matteson, E. L., Wollenhaupt, J., et al; Golimumab in Rheumatoid Arthritis Patients Previously Treated with Anti-TNF Agents (GO-AFTER Study): Week 52 Results [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1669
DOI: 10.1002/art.26743

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