Clinical and epidemiological research Figure 3 The proportions of patients who had an ASAS20 or ASAS40 response through week 104. Treatment regimen 1 consisted of patients who were originally assigned to placebo at baseline and either entered early escape at week 16 to receive golimumab 50 mg through week 104 or crossed over at week 24 to receive golimumab 50 mg through week 104. Treatment regimen 2 consisted of patients who were originally assigned to golimumab 50 mg at baseline and either entered early escape at week 16 to receive golimumab 100 mg through week 104 or continued 50 mg through week 104. Treatment regimen 3 consisted of patients who were originally assigned to golimumab 100 mg at baseline and did not receive study medication adjustments. Observed data are presented without imputation. ASAS20, at least 20% improvement in the Assessment of SpondyloArthritis international Society (ASAS) criteria; ASAS40, at least 40% improvement in the criteria. tuberculosis (one patient for each event) and pelvic inﬂamma- tory disease and endometriosis of the appendix (both in the same patient) in group 3. The patient with tuberculosis was negative at screening according to QuantiFERON and tubercu- lin testing. No opportunistic infections were reported through week 104. However, one patient in group 2 had coccidiomycosis after week 104. As previously noted,1 two patients, one each from groups 1 and 3, had basal cell carcinoma reported prior to week 24. No additional malignancies were reported past week 24. Injection-site reactions occurred in 7.3% of patients in group 1 who entered early escape, 8.8% of patients in group 1 who crossed over to active treatment at week 24, 24.0% of patients in group 2 who entered early escape, 8.0% of patients in group 2 who did not enter early escape and 11.4% of patients in group 3 (table 2) and mostly comprised injection-site erythema and swelling. No injection-site reactions were considered to be seri- ous or resulted in discontinuation of study agent. Liver enzyme elevations were more common in patients who received golimumab 100 mg than in those who received the 50 mg dose. While 2.8% of all patients had markedly abnor- mal elevations of alanine aminotransferase levels, no patient had Ann Rheum Dis 2012;71:661–667. doi:10.1136/ard.2011.154799 Figure 4 Mean BASDAI, BASMI and BASFI scores through week 104. Treatment regimen 1 consisted of patients who were originally assigned to placebo at baseline and who either entered early escape at week 16 to receive golimumab 50 mg through week 104 or crossed over at week 24 to receive golimumab 50 mg through week 104. Treatment regimen 2 consisted of patients who were originally assigned to golimumab 50 mg at baseline and who either entered early escape at week 16 to receive golimumab 100 mg through week 104 or continued 50 mg through week 104. Treatment regimen 3 consisted of patients who were originally assigned to golimumab 100 mg at baseline and who did not receive study medication adjustments. Observed data are presented without imputation. BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index. concomitant markedly abnormal postbaseline elevations of ala- nine/aspartate aminotransferase (at least three times the upper limit of normal) and total bilirubin (at least two times the upper limit of normal). Ten patients were found to be positive for antibodies to goli- mumab through week 24. Of these, ﬁve (50%) patients changed from positive to negative between weeks 24 and 104. It is unclear if antibodies to golimumab had an effect on treatment response. DISCUSSION The 2-year results of the GO-RAISE trial indicate that the improvements in signs and symptoms, physical function, range of motion and health-related quality of life achieved at week 241 by patients with AS who received golimumab were sustained 665