Taltz ® (ixekizumab) injection

80 mg/mL

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What were the inclusion and exclusion criteria for the clinical trials of ixekizumab in axial spondyloarthritis (including AS/r-axSpA and nr-axSpA)?

Key inclusion criteria for clinical trials of ixekizumab in patients with axSpA (including AS/r-axSpA and nr-axSpA) are included in this response.

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Key Inclusion and Exclusion Criteria

  • COAST-V (N=341) was a phase 3, 16-week double-blind, placebo-controlled trial with an active reference arm and a dose double-blind extension period of 52 weeks, conducted in patients with active ankylosing spondylitis/radiographic axial spondyloarthritis (AS/r-axSpA) who were naïve to biologic disease-modifying antirheumatic drugs (bDMARDs).1
  • COAST-W (N=316) was a phase 3, 16-week double-blind, placebo-controlled trial with a dose double-blind extension period of 52 weeks, conducted in patients with active AS/r‑axSpA and an inadequate response or intolerance to 1 or 2 tumor necrosis factor (TNF) inhibitors.2
  • COAST-X (N=303) was a phase 3, 52-week double-blind, placebo-controlled trial, conducted in patients with nonradiographic axial spondyloarthrtis (nr-axSpA) who were naïve to bDMARDs.3
  • COAST-Y (N=773) was a phase 3, 104-week, long-term extension trial including a double-blind, placebo-controlled 40-week randomized withdrawal-retreatment period, is conducted in patients with axial spondyloarthritis who have completed the final study visit in COAST-V, COAST-W, or COAST-X trials.4 

Key Inclusion and Exclusion Criteria in Phase 3 axSpA Clinical Trials summarizes the key inclusion and exclusion criteria for the COAST-V, COAST-W, and COAST-X trials. For additional details on inclusion and exclusion criteria for the COAST trials, see the online supplements for the published manuscripts.1-4

Patients eligible for the COAST-Y trial must have completed the final week-52 visit in the originating study (COAST-V, COAST-W, or COAST-X) without permanently discontinuing the investigational product.4

Patients with a significant uncontrolled safety concern that had developed during the originating study were excluded if the investigator considered it an unacceptable risk to the patient to continue investigational product. However, the investigational product could be resumed and the patient could be enrolled into COAST-Y if the patient recovered from the safety concern within 12 weeks of completing the originating study.4

Key Inclusion and Exclusion Criteria in Phase 3 axSpA Clinical Trials

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).

-- 

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.

Abbreviations: ASAS = assessment of spondyloarthritis international society criteria; AS/r-axSpA = ankylosing spondylitis/radiographic axSpA; axSpA = axial spondyloarthritis; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; bDMARD = biologic disease modifying antirheumatic; CRP = C-reactive protein; IBD = inflammatory bowel disease; mNY = modified New York; MRI = magnetic resonance imaging; nr-axSpA = nonradiographic axial spondyloarthritis; NRS = numeric rating scale; NSAID = nonsteroidal anti-inflammatory drug; SpA = spondyloarthritis; TNFi = tumor necrosis factor inhibitor.

aPatients with psoriasis that have never received and do not require systemic treatment for psoriasis, such as, but not limited to, oral agents or biologic therapies, can be included provided these patients fulfill the entry criteria.

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1van der Heijde D, Cheng-Chung Wei J, Dougados M, et al; COAST-V Study Group. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392(10163):2441-2451. http://dx.doi.org/10.1016/s0140-6736(18)31946-9

2Deodhar A, Poddubnyy D, Pacheco-Tena C, et al; COAST-W Study Group. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71(4):599-611. http://dx.doi.org/10.1002/art.40753

3Deodhar A, van der Heijde D, Gensler LS, et al; COAST-X Study Group. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020;395(10217):53-64. http://dx.doi.org/10.1016/S0140-6736(19)32971-X

4Landewé RBM, Gensler LS, Poddubnyy D, et al; COAST-Y Study Group. Continuing versus withdrawing ixekizumab treatment in patients with axial spondyloarthritis who achieved remission: efficacy and safety results from a placebo-controlled, randomized withdrawal study (COAST-Y). Ann Rheum Dis. 2021;80(8):1022-1030. https://doi.org/10.1136/annrheumdis-2020-219717

Date of Last Review: January 07, 2022


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