Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

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


Golimumab Is Efficacious in Anti-TNF Agent Experienced Patients with Active RA Regardless of Type of Agent or Reason for Discontinuation of Prior Anti-TNF Agent: Results From the GO-AFTER Study

Smolen1,  J. S., Doyle2,  M. K., Kay3,  Jonathan, Matteson4,  E. L., Landewe5,  R., Hsia2,  E. C., Zhou6,  Y.

Medical Univ Vienna, Vienna, Austria,
Centocor R&D, Inc/U of Penn School of Med, Malvern, PA,
University of Massachusetts Memorial Medical Center, Worcester, MA,
Mayo Clinic, Rochester, MN,
U Hosp Maastricht, Maastricht, Netherlands,
Centocor R&D, Inc, Malvern, PA

Purpose:

To assess efficacy and tolerance of GLM by type, number, or reasons for d/c of prior anti-TNF agent(s).

Method:

Pts could have received 1 or more anti-TNF agent(s) and may have d/c'd for any reason(s). Concomitant use of DMARDs, methotrexate, sulfasalazine and hydroxychloroquine was allowed. Subgroup analyses were performed for ACR20 response at wk14 across DMARD use, number of prior anti-TNFs and reason for d/c of prior TNF inhibitor, such that odds ratios and 95% confidence intervals were calculated comparing the proportions of ACR20 responders at wk14 in the combined GLM vs PBO groups. We also examined the subset of pts receiving a single prior anti-TNF agent to assess the impact of the type of TNF inhibitor (P75 receptor-fusion protein vs mAb) on GLM response. Overall incidences of AEs were determined for pt subgroups defined by type and number of prior anti-TNF agents.

Results:

Assessed by the proportion of pts achieving an ACR20 at wk14, GLM was effective vs PBO in RA pts previously receiving anti-TNF therapy irrespective of DMARD use (ACR20 40% vs 18%, p<0.001) or the reason for d/c of prior anti-TNF (due to efficacy: 39% vs 18%, p<0.001; all other: 34% vs 20%, p=0.027). This was not the case for pts not receiving DMARDs at baseline (29% vs 19%, p=0.184). A consistent treatment benefit of GLM vs PBO was observed for prior use of 1 (39% vs 20%, p=0.002) or 2 (38% vs 16%, p=0.014) anti-TNF agents; too few pts received 3 prior agents for a meaningful comparison. GLM was also effective regardless of a P75 receptor-fusion protein vs mAb agent. 80% of these subgroup pts received prior anti-TNF therapy for >=12wks, and 49% received anti-TNF therapy for >=48wks. The occurrence of AEs through wk24 was similar among pts previously receiving only adalimumab (76.3%), etanercept (70.4%), and infliximab (78.1%), as well as among pts who received

Table. GLM efficacy among pts who received only 1 prior anti-TNF and discontinued anti-TNF therapy for any reason, by prior anti-TNF agent

 Adalimumab onlyEtanercept onlyInfliximab only
No. of pts598173
Week 14   
ACR2019 (32.2%)33 (40.7%)30 (41.1%)
ACR5010 (16.9%)13 (16.0%)16 (21.9%)
DAS-CRP responder33 (55.9%)45 (55.6%)49 (67.1%)
DAS-ESR responder26 (44.1%)44 (54.3%)49 (67.1%)
DAS-CRP remission11 (18.6%)13 (16.0%)16 (21.9%)
DAS-ESR remission5 (8.5%)9 (11.1%)8 (11.0%)
Week 24   
ACR2020 (33.9%)36 (44.4%)35 (47.9%)
ACR5010 (16.9%)18 (22.2%)15 (20.5%)
DAS-CRP responder26 (44.1%)47 (58.0%)50 (68.5%)
DAS-ESR responder25 (42.4%)46 (56.8%)48 (65.8%)
DAS-CRP remission12 (20.3%)13 (16.0%)17 (23.3%)
DAS-ESR remission8 (13.6%)10 (12.3%)14 (19.2%)

Conclusion:

These data suggest that pts previously treated with adalimumab, etanercept or infliximab responded to, and tolerated GLM regardless of the type, number (although too few pts received 3 prior anti-TNF agents to provide conclusive results) or reason for d/c of prior anti-TNF therapy.

To cite this abstract, please use the following information:
Smolen, J. S., Doyle, M. K., Kay, Jonathan, Matteson, E. L., Landewe, R., Hsia, E. C., et al; Golimumab Is Efficacious in Anti-TNF Agent Experienced Patients with Active RA Regardless of Type of Agent or Reason for Discontinuation of Prior Anti-TNF Agent: Results From the GO-AFTER Study [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1664
DOI: 10.1002/art.26738

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