Taltz ® (ixekizumab)

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Taltz® (ixekizumab): Key Inclusion and Exclusion Criteria for Axial Spondyloarthritis Clinical Trials

This response provides inclusion and exclusion criteria for axSpA clinical trials COAST-V, COAST-W, and COAST-X.

Key Inclusion and Exclusion Criteria

  • COAST-V (N=341) is a phase 3, 16-week double-blind, placebo-controlled trial with an active reference arm and an extension period to 52 weeks in patients with active AS/r-axSpA who are naive to bDMARDs.1

  • COAST-W (N=316) is a phase 3, 16-week double-blind, placebo-controlled trial with an extension period to 52 weeks in patients with active AS/r-axSpA and an inadequate response or intolerance to 1 or 2 TNF inhibitors.2

  • COAST-X (N=305) is a phase 3, 52-week double-blind, placebo-controlled trial in patients with nr-axSpA who are naive to bDMARDs.3

Key inclusion and exclusion criteria for the Phase 3 COAST clinical trials are summarized in Table 1

Table 1. 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 Criteria1,2,4,5

-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.

-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 therapya, and
-pregnancy or breastfeeding.

Patients were allowed to continue the medications 

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

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 Criteria5

-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,
-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.

a Patients 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

1. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. 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

2. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. 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

3. A study of ixekizumab (LY2439821) in participants with nonradiographic axial spondyloarthritis (COAST-X). ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT02757352. Updated August 27, 2019. Accessed November 1, 2019.

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5. A study of ixekizumab (LY2439821) in participants with nonradiographic axial spondyloarthritis (COAST-X). ClinicalTrials.gov identifier: NCT027575352. Updated July 3, 2018. Accessed July 31, 2019. https://clinicaltrials.gov/ct2/show/NCT02757352.

Glossary

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

bDMARD = biologic disease-modifying antirheumatic drug

nr-axSpA = nonradiographic axSpA

TNF = tumor necrosis factor

Date of Last Review: January 10, 2019


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