According to the protocols for

• psoriasis,
• psoriatic arthritis, and
• axial spondyloarthritis (axSpA), including ankylosing spondylitis/radiographic axial spondyloarthritis (AS/r-axSpA) and nonradiographic axial spondyloarthritis (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. Examples of potential allergic/hypersensitivity reactions that might merit premedication included

• mild-to-moderate skin rashes
• mild-to-moderate generalized pruritus or urticaria, and
• mild-to-moderate injection site reactions (ISRs) (eg, injection-site erythema, injection-site pruritus, etc.).2,3

Medications 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.
• Patients were permitted to self-premedicate at home prior to administration of investigational product as directed by the investigator.2,3

Please note that Taltz is contraindicated in patients with serious hypersensitivity to the active substance or to any of the excipients.1

Of patients experiencing an ISR during the induction period of UNCOVER-1, -2, and -3, one patient who received ixekizumab (original formulation) used premedication for ISR when taking future injections.3

No 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.3

No analysis has been conducted on patients who used premedication for ISR with future injections in axSpA trials.

In the ixekizumab trials, patients were allowed to use over-the-counter

• analgesics,
• antihistamines,
• topical antihistamines and
• topical steroids.2 

Among those who received treatment, the majority received antihistamines.4

Concomitant Medications Provided for Treatment-Emergent ISRs Across 18 Psoriasis Clinical Trials summarizes the concomitant medications.

Concomitant medication to treat injection site reactions (ISR) was uncommonly used. It was used in

• 1.5% of patients treated with ixekizumab every 2 weeks (Q2W) and
• 1.6% of patients treated with etanercept during the first 12 weeks of the UNCOVER studies.4

In an analysis of patients across 18 psoriasis trials, 55 of the 1096 patients (5.0%) who experienced a treatment-emergent ISR were reported to have received a concomitant medication to treat the ISR.3 Concomitant Medications Provided for Treatment-Emergent ISRs Across 18 Psoriasis Clinical Trials summarizes the concomitant medications used to treat ISRs in the all psoriasis ixekizumab safety population (N=7088 total patients) across 18 clinical trials in adult and pediatric patients with psoriasis.3