Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of the relationship to the investigational medicinal product (IMP). SAE was any untoward medical occurrence that at any dose resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the TEAE period (time from first dose of IMP up to the end of follow-up period).

Time frame: Baseline up to the end of study (66 weeks)

Population: Analysis was performed on safety population defined as all participants who received at least one dose of the study treatment after signature of the informed consent.

Treatment response for ASAS20 was defined as: Improvement of ≥ 20% and ≥ 1 unit on a 0 (least) to 10 (worst) numerical rating score (NRS) in at least 3 of the 4 ASAS improvement criteria (ASASIC) domains, and no worsening of ≥ 20% and ≥ 1 unit on 0-10 NRS in the remaining domain. The 4 domains included were participant's global disease activity assessment, total back pain, physical function (Bath Ankylosing Spondylitis Functional Index), and Inflammation (mean of last 2 Bath Ankylosing Spondylitis Disease Activity Index questions on morning stiffness).

Time frame: Baseline up to the end of treatment (60 weeks)

Population: Analysis was performed on safety population. Number of participants analyzed=participants with ASAS20 assessment at specified time-points. Here 'n' signifies number of participants with available data for specified time-point.