Table 2

Main outcome parameters of the CONSUL study

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.