Table 2 Efficacy results for patients with investigator-defined total spinal ankylosis or Stage V radiographic criteria during the 24-week, double-blind period
TreatmentEntered early escape therapyWeek 12 responseWeek 24 response
ASAS20ASAS40ASAS 5/6BASDAI 50ASAS20ASAS40ASAS 5/6BASDAI 50
ADA*No
ADANo
ADANo
ADA*No
ADA*Yes0000
ADA*Yes0000
PBO*No
PBOYes+000
PBO*Yes++++
PBO*Yes0000
PBO*Yes++++
  • ADA, adalimumab; ASAS, ASsessment in Ankylosing Spondylitis International Working Group criteria for improvement; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; PBO, placebo; √, Responder on blinded therapy; —, non-responder on blinded therapy; +, responder on early escape, open-label adalimumab; 0, non-responder on early escape, open-label adalimumab.

  • *Patients fulfilling Stage V radiographic criteria for TSA.