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
To assess efficacy and tolerance of GLM by type, number, or reasons for d/c of prior anti-TNF agent(s).
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.
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 only||Etanercept only||Infliximab only|
|No. of pts||59||81||73|
|ACR20||19 (32.2%)||33 (40.7%)||30 (41.1%)|
|ACR50||10 (16.9%)||13 (16.0%)||16 (21.9%)|
|DAS-CRP responder||33 (55.9%)||45 (55.6%)||49 (67.1%)|
|DAS-ESR responder||26 (44.1%)||44 (54.3%)||49 (67.1%)|
|DAS-CRP remission||11 (18.6%)||13 (16.0%)||16 (21.9%)|
|DAS-ESR remission||5 (8.5%)||9 (11.1%)||8 (11.0%)|
|ACR20||20 (33.9%)||36 (44.4%)||35 (47.9%)|
|ACR50||10 (16.9%)||18 (22.2%)||15 (20.5%)|
|DAS-CRP responder||26 (44.1%)||47 (58.0%)||50 (68.5%)|
|DAS-ESR responder||25 (42.4%)||46 (56.8%)||48 (65.8%)|
|DAS-CRP remission||12 (20.3%)||13 (16.0%)||17 (23.3%)|
|DAS-ESR remission||8 (13.6%)||10 (12.3%)||14 (19.2%)|
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