Table 2.

Main outcome parameters of the CONSUL study

Efficacy	Safety
Primary endpoint Radiographic spinal progression measured by the change in the mSASSS after 2 years of treatment.	AEs, serious AE and AE of interest until week 112
Secondary endpoints New syndesmophyte formation or progression of existing syndesmophytes after 2 years of treatment Improvement of disease activity, function, axial mobility and quality of life measures at week 12 and week 108 in comparison to baseline according to: BASDAI ASDAS CRP and ESR BASFI BASMI and chest expansion Global assessment (patient/physician), general pain and nocturnal pain on the NRS ASAS Health Index PhASS PASS Percentage of subjects who achieve an ASAS20, ASAS40, ASAS partial remission, BASDAI50 responses and ASDAS inactive disease state in comparison to baseline Change of the bone and cartilage biomarkers serum levels at week 108 in comparison to baseline and their relevance for the prediction of radiographic progression Change of the enteric microbiome profile at week 108 in comparison to baseline Change of osteitis score and scores for the chronic post-inflammatory changes in the spine and sacroiliac joints on MRI by Berlin MRI scoring method at week 12 and week 108 in comparison to baseline (MRI substudy only)

AEs, adverse events ASDAS, Ankylosing Spondylitis Disease Activity Score; ASAS, Assessment of SpondyloArthritis International Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; mSASSS, modified Stoke Ankylosing Spondylitis Spine Score; NRS, numeric rating scale; PASS, Patient Acceptable Symptom State; PhASS, Physician Acceptable Symptom State.