Key Inclusion Criteria

Patients were eligible to be included in the trials only if they met all of the following criteria

Key Exclusion Criteria

Patients were excluded from the trials if they had any of the following criteria

COAST-V, COAST-W, and COAST-X Common Criteria1-3

• a history of back pain ≥3 months with age at onset <45 years
• an inadequate response, as determined by the investigator, to at least 2 NSAIDs for a total duration of at least 4 weeks or a history of intolerance to NSAIDs
• participants taking NSAIDs must be on a stable dose for at least 2 weeks prior to randomization
• a history of prior therapy for axSpA for at least 12 weeks prior to screening
• are ambulatory male or female patients ≥18 years of age at time of screening, and
• agree to use a reliable method of birth control.

Patients were allowed to continue the medications 

• sulfasalazine
• methotrexate
• hydroxychloroquine
• prednisone or equivalent, and
• NSAIDs, if at a stable dose.

•  total ankylosis of the spine
• received a live vaccine within 12 weeks of baseline or received a vaccination with Bacillus Calmette-Guerin within the past year
• ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis
• a compromised immune system
• a current diagnosis or a recent history of malignant or lymphoproliferative disease
• major surgery within 8 weeks of baseline or will require surgery during the study
• a history of other systemic inflammatory diseases (such as but not limited to lupus, vasculitis, or rheumatoid arthritis) or other chronic pain conditions (such as but not limited to fibromyalgia) that might confound the evaluations of benefit from ixekizumab therapy,a and
• pregnancy or breastfeeding.

Patients with a history of IBD were allowed to be included in the study if they had no exacerbation within 6 months prior to baseline, and, if currently on treatment, were required to be on stable treatment for at least 6 months prior to baseline.

Patients with a history of uveitis were allowed to be included in the study unless they had active uveitis within 4 weeks prior to baseline.

COAST-V (bDMARD-Naive): Additional Criteria1

• established diagnosis of AS/r-axSpA and fulfilling ASAS criteria (sacroiliitis on radiograph by mNY criteria and at least 1 SpA feature), and
• active AS/r-axSpA defined as BASDAI ≥4 and total back pain ≥4 on an NRS at screening and baseline.

previous or current treatment with bDMARDs

COAST-W (TNFi-Experienced): Additional Criteria2

• established diagnosis of AS/r-axSpA and fulfilling ASAS criteria (sacroiliitis on radiograph by mNY criteria and at least 1 SpA feature)
• active AS/r-axSpA defined as BASDAI ≥4 and total back pain ≥4 on an NRS at screening and baseline, and
• prior treatment with at least 1 and not more than 2 TNFis. The patient must have discontinued at least 1 TNFi due to either intolerance or an inadequate response (defined as the patient having had an inadequate response, in the opinion of the investigator, to at least 12 weeks of treatment with a TNFi at an adequate dose).

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COAST-X (nr-axSpA; bDMARD-Naïve ): Additional Criteria3

• diagnosis of nr-axSpA and fulfilling the 2009 ASAS classification criteria
• have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a NRS at screening and baseline, and
• have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated CRP.

• previous or current treatment with bDMARDs, and
• have radiographic sacroiliitis fulfilling the 1984 mNY criteria.