Thematic stream: inflammatory arthritis: BPP1. Golimumab in Rheumatoid Arthritis Patients Previously Treated with Anti-Tnf Alpha Agents: 2 Year Results from go-after Study

Abstract

Objective: To evaluate 2yr efficacy and safety of golimumab(GLM) in patients with active RA treated with anti-TNF agent(s). Methods: Patients were randomized to placebo(PBO) (Grp1), GLM50mg (Grp2), or GLM100mg (Grp3) subcutaneously q4wks. Patients could have received ≥1 anti-TNFα agent(s) and discontinued for any reason(s). Patients with<20% improvement in tender and swollen joint counts at wk16 entered early escape(EE) in a doubleblinded fashion:patients in the PBO grp received GLM50mg q4wks, those in GLM 50mg received GLM100mg q4wks, and those in GLM100mg grp remained on 100mg q4wks. At wk24, all patients still on PBO crossed over to GLM50mg q4wks. The study was unblinded after the last patient completed the wk24 visit. After the study was unblinded (after last patient completed wk24 evaluation), patients who received GLM50mg could have a dose increase to GLM100mg at the physician's discretion. Efficacy analyses are based on intent-totreat( ITT) population. Results: Improvement in signs and symptoms of RA and physical function observed with GLM at wk24, as assessed by ACR and EULAR(DAS) response criteria, was maintained through wk100. Improvement in ACR20 and ACR50 was observed in patients who increased the dose of GLM from 50mg to 100mg at the physician's discretion during the open-label, long-term extension. Through 2yrs, 16.1% and 16.6% of pts receiving GLM50-and 100 mg, respectively, had 31serious adverse event. Serious infections were reported in 5.0% and 5.7% of patients(no cases of tuberculosis), and injections with injection-site reactions were reported in 0.8% and 1.3%, of patients receiving GLM50mg and 100 mg, respectively. There were 6 malignancies: one patient in the PBO grp(pancreatic ca), 2 in the GLM 50mg grp(cervical ca and squamous cell ca), 3 in the GLM 100mg grp(basal cell ca, lymphoma, and breast ca). The patient in the PBO grp died from pancreatic ca. Conclusions: Efficacy was maintained through 2yrs in patients previously treated with anti-TNF. The long-term safety of GLM is consistent with other anti-TNF agents.