Early escape (week 16–104)* Crossover (week 24–104)† Randomised patients (n) ASAS20 Week 28 Week 52 Week 104 ASAS40 Week 28 Week 52 Week 104 BASDAI50 Week 28 Week 52 Week 104 Change in BASDAI§ Week 28 Week 52 Week 104 Change in BASFI§ Week 28 Week 52 Week 104 Change in BASMI§ Week 52 Week 76 Week 104 Change in SF-36 PCS¶ Week 52 Week 76 Week 104 Change in SF-36 MCS¶ Week 52 Week 76 Week 104 41 23/40 (57.5) 25/34 (73.5) 24/31 (77.4) 15/40 (37.5) 19/34 (55.9) 21/31 (67.7) 17/41 (41.5) 17/35 (48.6) 21/33 (63.6) −2.4±2.49 −3.4±2.60 −3.6±2.25 −1.5±2.86 −3.0±3.07 −3.2±3.20 −0.7±0.87 −0.7±0.96 −0.6±1.04 12.3±8.78 12.7±10.87 13.6±7.80 4.3±11.51 3.9±12.27 5.2±10.94 35 26/35 (74.3) 29/34 (85.3) 28/31 (90.3) 21/35 (60.0) 27/34 (79.4) 28/31 (90.3) 21/35 (60.0) 27/34 (79.4) 27/32 (84.4) −3.3±2.47 −4.4±2.02 −4.6±2.42 −1.5±2.30 −2.3±2.24 −2.6±2.23 −0.8±0.90 −0.7±0.94 −0.8±0.95 14.1±9.40 15.2±8.65 15.5±9.32 3.7±8.80 3.9±9.12 2.0±9.55 Clinical and epidemiological research 50 mg only‡ 113 85/102 (83.3) 85/98 (86.7) 77/90 (85.6) 66/102 (64.7) 73/98 (74.5) 74/90 (82.2) 65/103 (63.1) 70/99 (70.7) 72/91 (79.1) −3.8±2.15 −4.0±2.09 −4.2±2.19 −2.4±2.12 −2.5±2.12 −2.7±2.07 −0.7±0.90 −0.8±0.78 −0.8±0.79 12.8±10.63 13.4±10.70 14.2±11.28 3.7±7.90 2.9±9.00 3.8±8.75 Early escape (week 16–104) 50 mg →100 mg* 25 6/25 (24.0) 9/21 (42.9) 7/16 (43.8) 3/25 (12.0) 2/21 (9.5) 5/16 (31.3) 3/25 (12.0) 1/21 (4.8) 5/16 (31.3) −0.8±1.88 −1.3±1.58 −2.0±2.33 −0.3±1.52 −0.9±1.59 −1.7±2.19 −0.4±0.79 −0.4±0.92 −0.4±0.98 4.8±8.96 7.3±10.82 7.6±8.83 1.8±9.80 1.2±8.58 1.5±13.82 100 mg only‡ 107 78/100 (78.0) 86/99 (86.9) 77/93 (82.8) 70/100 (70.0) 73/99 (73.7) 64/93 (68.8) 66/100 (66.0) 76/99 (76.8) 65/93 (69.9) −3.9±2.41 −4.4±2.24 −4.4±2.25 −2.5±2.26 −2.9±2.14 −2.9±2.21 −0.7±0.88 −0.7±0.88 −0.8±0.96 13.0±8.14 13.5±8.73 13.9±9.28 6.4±11.75 7.3±10.81 7.6±10.86 100 mg → 100 mg* 33 3/32 (9.4) 10/28 (35.7) 14/25 (56.0) 2/32 (6.3) 8/28 (28.6) 7/25 (28.0) 1/32 (3.1) 6/29 (20.7) 6/25 (24.0) −0.5±1.55 −1.3±1.96 −1.8±1.93 0.6±2.48 −0.5±2.63 −1.2±2.64 0.0±1.07 −0.2±0.92 −0.3±0.86 5.4±8.62 6.6±7.49 6.5±7.77 1.3±9.93 2.8±11.26 5.0±9.86 Table 1 Efﬁcacy measures through week 104 by early escape status: observed data presented without imputation Placebo → golimumab 50 mg (group 1) Golimumab 50 mg (group 2) Golimumab 100 mg (group 3) Values are mean±SD change from baseline for continuous outcomes or n (%) of patients achieving the end point for dichotomous outcomes. *Patients in these groups met the early escape criteria at week 16. †Patients in this group did not discontinue study agent prior to week 24 and crossed over at week 24. ‡Patients in these groups did not meet the early escape criteria at week 16. §Negative change indicates improvement. ¶Positive change indicates improvement. ASAS, Assessment in SpondyloArthritis international Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; MCS, mental component summary; PCS, physical component summary; SF-36, 36-item Short-Form health survey. and patient disposition through week 24 have been previously published.1 At baseline, 28 (35.9%) patients in group 1, 43 (29.1%) patients in group 2 and 44 (31.4%) patients in group 3 used concomitant DMARDs. At week 52, a total of 313 patients (group 1, n=70; group 2, n=118; group 3, n=125) were still receiv- ing treatment, and 290 patients (group 1, n=65; group 2, n=109; group 3, n=116) completed the study through week 104. At week 16, 41 (53%) patients in group 1 and 25 (18%) patients in group 2 had less than 20% improvement in total back pain and morning stiffness and entered early escape. Thirty- three (24%) patients in group 3 met the criteria for early escape at week 16, but as speciﬁed in the protocol, they did not have their dose adjusted. Through week 104, 13 (17%) patients in group 1, 28 (20%) patients in group 2 and 24 (17%) patients in group 3 discontinued treatment. The most common reasons for discontinuation of the study agent were unsatisfactory therapeutic effect (27 patients: 8 in group 1, 11 in group 2 and 8 in group 3) and adverse events (19 patients: 2 in group 1, 7 in group 2 and 10 in group 3). Ann Rheum Dis 2012;71:661–667. doi:10.1136/ard.2011.154799 Efﬁcacy The intention to treat analysis revealed that 38.5% of patients in group 1, 60.1% in group 2 and 71.4% in group 3 had an ASAS20 response at week 104. In addition, 38.5% of patients in group 1, 55.8% in group 2 and 54.3% in group 3 had an ASAS40 response, and 21.8%, 31.9% and 30.7%, respectively, were in partial remission. Actual observed efﬁcacy outcomes at weeks 28, 52 and 104, without data imputation, are summarised in table 1 according to early escape status. Patients who required early escape at week 16 generally had lower response rates than those in the same group who did not require early escape. However, of the patients in group 2 who met the early escape criteria, 42.9% and 43.8% achieved ASAS20 responses at weeks 52 and 104, respectively, after receiving a dose escalation from 50 to 100 mg (table 1). Of the patients in group 3 who met the early escape criteria, 35.7% and 56.0% achieved ASAS20 responses at weeks 52 and 104, respectively, even though they did not receive dose adjustments. 663