Clinical and epidemiological research Figure 2 Patient disposition through week 104. AEs, adverse events. The proportions of patients with ASDAS scores <1.1 or <2.1 at week 24, 52 or 104 are summarised according to the original ran- domised treatment groups (table S1). Signiﬁcantly greater propor- tions of patients in group 2 and group 3 had ASDAS scores <1.1 or <2.1 at week 24 when compared with patients in group 1. Observed ASAS20 and ASAS40 responses for each treatment regimen over time through week 104 are shown in ﬁgure 3. Mean BASDAI, BASMI (range of motion) and BASFI values over time through week 104 are shown in ﬁgure 4. By week 104, all treat- ment regimens led to mean BASDAI and BASFI scores that were less than 3. However, scores were reduced earlier in patients who were originally treated with golimumab from week 0 compared with those who initially received placebo and later crossed over to golimumab. Similarly, the mean BASMI score improved to less than 3 at week 104 for patients who received golimumab from week 0 through week 104, compared with a mean BASMI score of 3.17 for those patients who were assigned to placebo initially and who later entered early escape or crossed over to golimumab. Observed proportions of patients achieving a BASDAI50 response, as well as actual changes from baseline in BASFI, BASMI (linear method) and PCS and MCS scores of the SF-36 (health-related quality of life) are summarised in table 1 for patients in each group according to their early escape status. Consistent with clinical efﬁcacy as assessed by ASAS response criteria, patients who required early escape at week 16 gener- ally had lower response rates or less improvement from baseline than those in the same group who did not require early escape. Safety Safety results through week 24 were previously reported.1 Adverse events from baseline through week 104 for patients 664 who received at least one dose of golimumab are summarised in table 2. Adverse events were attributed to the dose that the patients were receiving at the time of the event. Thus, patients are counted in the treatment group in which they were assigned at the time of the event. The proportions of patients with at least one adverse event generally increased with longer average dura- tion of follow-up. More patients who received the 100 mg dose of golimumab at any point during the trial had one or more seri- ous adverse events (24 [14.5%] of 165) and serious infections (7 [4.2%] of 165) compared with patients who received golimumab 50 mg (16 [8.0%] of 213 and 3 [1.4%] of 213, respectively). Through week 104, infections were reported in 37.7% of patients who had received placebo, 62.0% of those who had received golimumab 50 mg and 70.9% of those who had received golimumab 100 mg; serious infections were reported in 1.3%, 1.4% and 4.2% of patients, respectively (table S2). The incidence of infections per 100 patient-years in patients receiv- ing golimumab 50 mg was similar to that for patients receiving placebo. A dose-dependent trend in the rate of infections and serious infections was noted for the two golimumab doses. However, when comparing the incidence per 100 patient-years of infection, serious infection or upper respiratory tract infection, the 95% CIs for the two golimumab doses overlapped and thus showed no apparent dose effect. No patients died through week 104 of the study. Serious infec- tions were similar in nature and frequency to those observed in the ﬁrst 24 weeks of the study. Serious infections that occurred after week 24 included the following events: urosepsis and clostridial infection in group 1 (one patient each); tonsillitis (one patient) and anal abscess (two events in one patient) in group 2; and infectious bursitis, cellulitis, Lyme disease and pulmonary Ann Rheum Dis 2012;71:661–667. doi:10.1136/ard.2011.154799