for Premedication in the Clinical Trials
to the protocols for psoriasis and psoriatic arthritis, and axSpA
(including AS/r-axSpA and nr-axSpA) trials, if a patient experienced
an acute allergic/hypersensitivity reaction after injection of
investigational product, consideration for any premedication for
future injections was agreed upon between the investigator and
sponsor and/or its designee.
considered appropriate for premedication included but were not
restricted to acetaminophen/paracetamol up to 1000 mg and
antihistamines (for example, oral diphenhydramine 50 mg), given 30
to 60 minutes prior to investigational product injection.
were permitted to self-premedicate at home prior to administration
of investigational product as directed by the investigator.1,2
of potential allergic/hypersensitivity reactions that might merit
generalized pruritus or urticaria, and
ISRs (eg, injection-site erythema, injection-site pruritus, etc).1,2
note that ixekizumab is contraindicated in patients with serious
hypersensitivity to the active substance or to any of the
in Clinical Trials
patients experiencing an ISR during the induction period of
UNCOVER-1, -2, and -3, one patient who received ixekizumab used
premedication for ISR when taking future injections.2
patients who received ixekizumab during the 24-week double-blind
treatment periods of SPIRIT-P1 and SPIRIT-P2 used premedication for
ISR with future injections.2
analysis has been conducted on patients who used premedication for
ISR with future injections in axSpA trials.
Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab
in moderate-to-severe plaque psoriasis. N Engl J Med.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
= ankylosing spondylitis/radiographic axial spondyloarthritis
= axial spondyloarthritis
= injection site reaction
= nonradiographic axial spondyloarthritis