Consent in writing was obtained from each patient in advance. 2.2 Treatment Patients received combination

therapy with GLM plus MTX, with GLM administered at a dose of 50 mg or 100 mg every 4 weeks plus MTX administered at a dose of up to 8 mg/week; or GLM monotherapy, with GLM administered at 100 mg every 4 weeks, for a total of 24 weeks. All patients were prescribed MTX if it was not contraindicated. GLM was administered subcutaneously in accordance with the Japanese package insert #find more randurls[1|1|,|CHEM1|]# [14]. 2.3 Outcome Measures The primary endpoint of this retrospective analysis of effectiveness was to evaluate the proportion of patients achieving remission defined as a DAS28-CRP <2.3 or a simplified disease activity index (SDAI) score <3.3. Mean changes in the DAS28-CRP from baseline to 4 weeks were also evaluated. Safety was evaluated on the basis of adverse events and laboratory test data. For each parameter, additional stratified analyses were conducted, dividing the patients OICR-9429 mw into two groups; that is, bio-naïve patients who had not received biological agents prior to receiving GLM, and patients who had received prior biological agents (i.e., those switching from other biological agents to GLM). 2.4 Statistical Analysis All data were included for efficacy and safety analyses. The last observation carried forward (LOCF) method was used to allow for missing data. Comparison of groups was performed

using the Student’s t test with statistical significance set at p < 0.05. 3 Results 3.1 Patient Baseline Demographics and Clinical Characteristics Of all patients studied, 18 were bio-naïve cases and 25 had received prior

biological agents, including infliximab (n = 4), etanercept (n = 10), adalimumab (n = 6), and tocilizumab (n = 5). Of the 25 patients previously treated with biological agents, 19 had received one prior biological agent and 6 had received two or more agents. Table 1 shows the baseline demographics and disease characteristics of the patients enrolled into the study. Patient characteristics were generally well balanced between bio-naïve patients and those who had received a prior biological agent, except the proportion of women was slightly greater (96.0 vs 83.3 %) and disease duration Urease was slightly longer (122.6 vs 105.3 months) in the bio-switching group. Table 1 Baseline demographics and disease characteristics in bio-naïve patients and patients who had received prior biological agents   Total (n = 43) Bio-naïve (n = 18) Prior biologicals (n = 25) Sex [n (%)]  Female 39 (90.7) 15 (83.3) 24 (96.0)  Male 4 (9.3) 3 (16.7) 1 (4.0) Age [years] 59.1 (32–79) 55.8 (37–79) 61.4 (32–76) Disease duration [months] 115.3 (7–708) 105.3 (7–708) 122.6 (12–252) DAS28-CRP 4.14 (1.28–7.04) 4.16 (2.61–6.39) 4.12 (1.28–7.04) SDAI 22.2 (2.81–62.30) 22.30 (6.70–56.29) 22.20 (2.81–62.30) CDAI 20.