Nonanaphylactic Hypersensitivity Events Reported at an Incidence Rate ≥0.1 Per 100 Patient-Years in Patients Exposed to Ixekizumab Across 17 Adult Psoriasis Clinical Trials characterizes nonanaphylactic hypersensitivity events across an integrated data set of 17 adult psoriasis clinical trials (N=6892 patients accounting for 18,025.7 patient-years [PY] of ixekizumab exposure through March 19, 2021).2,3

No cases of anaphylaxis were confirmed after medical reviews.2,3

The overall incidence rate of allergic/hypersensitivity reactions across the 17 adult psoriasis clinical trials was 5.6 per 100 PY.2,3

Most hypersensitivity or allergic reactions were mild in severity, and consisted mostly of various skin rashes.5

In the 12-week induction period of the 2 active comparator trials with etanercept (UNCOVER-2 and -3),

• 2 patients receiving ixekizumab experienced a hypersensitivity event considered to be serious
  • One of the serious events (leukocytoclastic vasculitis) resulted in admission to the hospital. This patient, who was being treated with ixekizumab 80 mg every 2 weeks and had recently started taking lansoprazole, did not discontinue the study.5
  • The other serious event (facial angioedema), reported in a patient being treated with ixekizumab 80 mg every 4 weeks, resulted in the patient discontinuing from the study.5
• an additional ixekizumab-treated patient discontinued the study due to nonserious urticaria
• across all treatments, <4% of patients reported experiencing an allergic or hypersensitivity reaction, and
• allergic/hypersensitivity reaction rates were comparable for the ixekizumab 80 mg every 2 weeks and every 4 weeks dosing regimens.5

Hypersensitivity Reactions Through Week 12 in UNCOVER-1, -2, and -3 (Individual Studies, All Treatment Groups) provides the frequency of hypersensitivity reactions through week 12 of UNCOVER-1, -2, and -3.

Nonanaphylactic Hypersensitivity Events Reported at an Incidence Rate ≥0.1 Per 100 Patient-Years in Patients Exposed to Ixekizumab Across 4 Psoriatic Arthritis Clinical Trials characterizes hypersensitivity events across a broader data set of 4 psoriatic arthritis clinical trials (N=1401 patients accounting for 2247.7 PY of ixekizumab exposure through March 19, 2021).7

No cases of anaphylaxis were confirmed after medical reviews.7,8

The overall incidence rate of allergic/hypersensitivity reactions across the 4 psoriatic arthritis clinical trials was 4.5 per 100 PY.7,8

In the 24-week double-blind treatment period of SPIRIT-P1, mild or moderate hypersensitivity events, most commonly manifesting as rash or urticaria, were reported in 7 patients in the total ixekizumab group (ixekizumab 80 mg every 4 weeks and ixekizumab 80 mg every 2 weeks groups combined).

• None were reported as serious.
• One patient treated with ixekizumab 80 mg every 4 weeks discontinued the study due to rash.9

In the 24-week double-blind treatment period of SPIRIT-P2, significantly greater proportions of patients in the ixekizumab 80 mg every 4 weeks group (8 [7%] patients; p=.0358) and ixekizumab every 2 weeks group (9 [7%] patients; p=.0192) had allergic reactions or hypersensitivity events than did patients treated with placebo (1 [1%] patient).

• All events were reported as either mild or moderate and the most common manifestations were angioedema, eczema, rash, or urticaria (2 patients for each manifestation).
• No cases of anaphylaxis were reported.
• One patient taking ixekizumab 80 mg every 4 weeks discontinued treatment due to an allergic or hypersensitivity TEAE, a nonserious pruritic rash.10

Hypersensitivity Reactions Through Week 24 in SPIRIT-P1 and -P2 Trials (Individual Studies, All Treatment Groups) provides the incidence of hypersensitivity reactions through 24 weeks in SPIRIT-P1 and SPIRIT-P2.

Nonanaphylactic Hypersensitivity Events Reported at an Incidence Rate ≥0.1 Per 100 Patient-Years in Patients Exposed to Ixekizumab Across 4 Axial Spondyloarthritis Clinical Trials characterizes hypersensitivity events across a data set of 4 axial spondyloarthritis (axSpA) clinical trials (COAST-V and COAST-W AS/r-axSpA trials, COAST-X nr-axSpA trial, and COAST-Y long-term extension study in patients with axSpA) through March 19, 2021 from 932 patients (2096.2 PY).7

No cases of anaphylaxis were confirmed after medical reviews.7

The overall incidence rate of allergic/hypersensitivity reactions across the 4 axSpA clinical trials was 4.2 per 100 PY.7

During the 16-week double-blinded treatment period of the COAST-V trial, treatment-emergent allergic or hypersensitivity reactions were more frequent in the active treatment groups (3 [4%] of 83 patients in the ixekizumab 80 mg every 2 weeks group, 3 [4%] of 81 patients in the ixekizumab 80 mg every 4 weeks group, 4 [4%] of 90 patients in the adalimumab group) than in the placebo group (1 [1%] of 86 patients) (Hypersensitivity Reactions Through Week 16 in COAST-V and COAST-W Clinical Trials (Individual Studies, All Treatment Groups)). All of these events were nonanaphylactic events.11

During the 16-week double-blinded treatment period of the COAST-W trial, treatment-emergent allergic or hypersensitivity reactions were reported in 6 (6.1%) of 98 patients in the ixekizumab 80 mg every 2 weeks group, 3 (2.6%) of 114 patients in the ixekizumab 80 mg every 4 weeks group, and 1 (1.0%) of 104 patients in the placebo group (Hypersensitivity Reactions Through Week 16 in COAST-V and COAST-W Clinical Trials (Individual Studies, All Treatment Groups)). No anaphylaxis events were reported during the 16-week double-blinded treatment period.12

During the 52-week double-blinded treatment period of the COAST-X trial, treatment-emergent allergic or hypersensitivity reactions were reported in 3 (3.0%) of 102 patients in the ixekizumab 80 mg every 2 weeks group, 4 (4.0%) of 96 patients in the ixekizumab 80 mg every 4 weeks group, and 4 (4.0%) of 104 patients in the placebo group. No anaphylaxis events were reported during the 52-week double-blinded treatment period in patients treated with ixekizumab.13