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Taltz ® (ixekizumab) injection
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Key inclusion and exclusion criteria for the Phase 3 COAST clinical trials are summarized in 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 |
-a history of back pain ≥3 months with age at onset <45 years, |
-total ankylosis of the spine, Patients were allowed to continue the medications -sulfasalazine, 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. |
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 |
-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) |
-- |
COAST-X (nr-axSpA; bDMARD Naïve ): Additional Criteria5 |
|
-diagnosis of nr-axSpA and fulfilling the 2009 ASAS classification criteria, |
-previous or current treatment with bDMARDs, and |
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.
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
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5A 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.
AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis
bDMARD = biologic disease-modifying antirheumatic drug
nr-axSpA = nonradiographic axial spondyloarthritis
TNF = tumor necrosis factor
Date of Last Review: January 10, 2019
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