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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.
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
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 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 |
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Patients were allowed to continue the medications
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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 |
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previous or current treatment with bDMARDs |
COAST-W (TNFi-Experienced): Additional Criteria2 |
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COAST-X (nr-axSpA; bDMARD-Naïve ): Additional Criteria3 |
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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.
Enclosed Prescribing Information
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