Exclusion
criteria in Phase 3 Clinical Trials
Exclusion
criteria related to immunodeficiency in ixekizumab phase 3 clinical
trials included
testing
positive for HIV serology (HIVAb)
having
a known immunodeficiency, and
having
had an infection typical of an immunocompromised host or that occurs
with increased incidence in an immunocompromised host, including but
not limited to
References
1.
Gordon 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
2.
Deodhar 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
3.
van 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
4.
Nash P, Kirkham B, Okada M, et al; SPIRIT-P2 Study Group. Ixekizumab
for the treatment of patients with active psoriatic arthritis and an
inadequate response to tumour necrosis factor inhibitors: results
from the 24-week randomised, double-blind, placebo-controlled period
of the SPIRIT-P2 phase 3 trial. Lancet.
2017;389(10086):2317-2327.
http://dx.doi.org/10.1016/S0140-6736(17)31429-0
5.
Mease PJ, van der Heijde D, Ritchlin CT, et al; SPIRIT-P1 Study
Group. Ixekizumab, an interleukin-17A specific monoclonal antibody,
for the treatment of biologic-naive patients with active psoriatic
arthritis: results from the 24-week randomised, double-blind,
placebo-controlled and active (adalimumab)-controlled period of the
phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76(1):79-87.
http://dx.doi.org/10.1136/annrheumdis-2016-209709
6.
Deodhar 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
Glossary
HIV
= human immunodeficiency virus
HIVAb
= human immunodeficiency virus antibody
nr-axSpA
= nonradiographic axial spondyloarthritis