Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
Golimumab in Rheumatoid Arthritis: GO-FORWARD Week 52 Results
Keystone1, Edward C., Genovese2, M.C., Klareskog3, L., Hsia4, E. C., Hall5, S., Miranda6, P.C., Pazdur7, J.
Professor of Medicine/University of Toronto, Toronto, ON,
Centocor R&D, Inc, Malvern, PA
Stanford U, Palo Alto, CA,
Karolinska Institutet, Stockholm, Sweden,
Centocor R&D, Inc/U of Penn School of Med, Malvern, PA,
Cabrini Medical Center, Malvern, Victoria, Australia,
U of Chile/Hosp San Juan de Dios, Santiago, Chile,
Instytut Reumatologii, Warszawa, Poland,
Hanyang University Hospital, Seoul, South Korea,
Westroads Medical group, Omaha, NE,
To assess efficacy and safety of golimumab (GLM) + MTX vs MTX alone in pts with active RA despite MTX.
Pts were randomized to PBO + MTX (Grp 1), GLM 100mg + PBO (Grp 2), GLM 50mg + MTX (Grp 3), and GLM 100mg + MTX (Grp 4). At wk16, pts in Grps 1, 2, and 3 who had < 20% improvement in tender and swollen joints entered early escape (EE). At wk 24, pts in Grp 1 crossed over to 50mg + MTX.
Through wk52, 4%, 10%, 12%, and 16% had a sustained clinical response (ACR70 at 6 consecutive monthly visits) in Grps 1 to 4, respectively; sustained remission (DAS 28 remission at 6 consecutive monthly visits), was observed in 15%, 16%, 29%, and 28% of the respective grps. SAEs were reported in 11%, 17%, 14%, and 18% of pts in Grps 1 through 4, respectively & 2%, 6%, 2%, and 8%, respectively, had serious infections. Between wks 24 and 52, 9 serious infections were reported: 2 in Grp1 EE, 4 in Grp2, 1 in Grp3, & 2 in Grp4. During this period 4 pts had malignancies: squamous and basal cell cancer (Grp1), basal cell cancer (Grp4), breast cancer (Grp 3 and Grp 4).
GLM efficacy was sustained through 1 yr with many pts achieving sustained remission and sustained clinical response. More pts in grps receiving GLM 100 mg had SAEs and serious infections.
Table. Wk52 Efficacy*
To cite this abstract, please use the following information:
Keystone, Edward C., Genovese, M.C., Klareskog, L., Hsia, E. C., Hall, S., Miranda, P.C., et al; Golimumab in Rheumatoid Arthritis: GO-FORWARD Week 52 Results [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1667