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Taltz ® (ixekizumab)
Can Taltz® (ixekizumab) be used in patients with lupus?
The use of ixekizumab in patients with lupus has not been studied by Lilly.
Use in Patients with Lupus
Exclusion and Discontinuation Criteria Related to Lupus
In the ixekizumab phase 3 clinical trials in psoriasis and PsA, patients developing symptoms suggestive of a lupus-like syndrome and testing positive for antibodies against double-stranded DNA were required to discontinue from the studies.1,2
- Rationale: In accordance with potential risks associated with immunosuppressive agents, a discontinuation rule for patients who develop symptoms suggestive of lupus-like syndrome and are positive for antibodies against double-stranded DNA was added to limit potential safety risks to these patients.2
In the ixekizumab phase 3 clinical trials in axSpA (including AS/r-axSpA and nr-axSpA), patients with a history of lupus were excluded.3-5
Treatment-Emergent Adverse Events During Clinical Trials
In ixekizumab clinical trials, TEAEs were evaluated using MedDRA. This response includes TEAEs reported that include the term "lupus."2
Lupus-Related Treatment-Emergent Adverse Events
Within the overall safety database across 16 psoriasis trials as of March 19, 2020 (N=6645 patients exposed to ixekizumab accounting for 17902.0 PYs of exposure), there was 1 report of chronic cutaneous lupus erythematosus that led to study drug discontinuation.2
Psoriatic Arthritis Trials
Within the overall safety database across 4 PsA trials as of March 19, 2020 (N=1401 patients exposed to ixekizumab accounting for 2247.7 PYs of exposure), there were no TEAE reports of any of the MedDRA preferred terms containing the term "lupus."2
Axial Spondyloarthritis Trials
Within the overall safety database across 4 axSpA (including AS/r-axSpA and nr-axSpA) trials as of March 19, 2020 (N=932 patients exposed to ixekizumab accounting for 1792.2 PYs of exposure), there were no TEAE reports of any of the MedDRA preferred terms containing the term "lupus."2
Anti-Double-Stranded DNA Antibodies
Screening and testing for double-stranded DNA antibody during ixekizumab trials were not routinely done.1,2 Within the overall safety database as of March 19, 2020 for psoriasis, psoriatic arthritis and axial spondyloarthritis there were no TEAE reports of any MedDRA preferred term that included "double-stranded DNA antibody."2
Laboratory tests for antinuclear antibodies were not routinely performed in ixekizumab trials, although antinuclear antibody was listed in the study protocols as a hepatic monitoring test for treatment emergent abnormalities.1,2 Within the overall psoriasis safety database as of March 19, 2020 there was 1 TEAE report of "antinuclear antibody positive."2
Within the overall PsA and axSpA databases as of March 19, 2020, there were no reports of any MedDRA preferred term that included "antinuclear antibody."2
Post-Marketing Adverse Event Reporting Information
Adverse events related to lupus that have been reported to Lilly during postmarketing as of March 22, 2020 include
- cutaneous lupus erythematosus
- lupus-like syndrome
- systemic lupus erythematosus, and
- systemic lupus erythematosus rash.
These adverse events have been reported very rarely.2
Spontaneous reporting of adverse events can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product caused an event.
Spontaneous reporting is also limited in usage due to bias in reporting, including incomplete information concerning the patient (that is, unknown medical history), unknown concomitant medications and disease states, and under-reporting.
1Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3van 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
4Deodhar 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
5Deodhar 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
AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis
axSpA = axial spondyloarthritis
Lilly = Eli Lilly and Company
MedDRA = Medical Dictionary for Regulatory Activities
nr-axSpA = nonradiographic axial spondyloarthritis
PsA = psoriatic arthritis
PY = patient-years
TEAE = treatment-emergent adverse event
Date of Last Review: January 02, 2020