Citation

Griffiths CEM, Gooderham M, Colombel JF, Terui T, Accioly AP, Gallo G, Zhu D, Blauvelt A. Dermatol. Ther. (Heidelb) 2022; 12(6): 1431-1446.

Copyright

(Copyright © 2022, Holtzbrinck Springer Nature Publishing Group)

DOI

10.1007/s13555-022-00743-9

PMID

unavailable

Abstract

INTRODUCTION: We report a comprehensive summary of the safety outcomes in adult patients with moderate-to-severe psoriasis with up to 5 years of exposure to ixekizumab.

METHODS: Long-term safety of the IL-17A antagonist ixekizumab was assessed from 17 randomized trials. Treatment-emergent adverse events (TEAEs)-adjusted incidence rates (IRs) per 100 patient-years (PY) within 1-year time periods through 19 March 2021 were calculated for all patients treated with at least one dose of ixekizumab. Reported cases of major adverse cerebro-cardiovascular events (MACE) and inflammatory bowel disease (IBD) were adjudicated.

RESULTS: A total of 6892 adult patients with a cumulative exposure of 18,025.7 PY were included. The IRs per 100 PY for any TEAE and serious adverse events (AEs) were 32.5 and 5.4. IR of discontinuation because of AE was 2.9. A total of 36 deaths were reported. IR of serious infections was low (1.3). There were no confirmed cases of reactivation of tuberculosis (TB). IR of Candida infections (IR 1.9) was low; most cases of Candida were localized, and no systemic cases were reported. IRs of injection site reactions and allergic/hypersensitivity were 5.9 and 5.6, respectively. No confirmed cases of anaphylaxis were observed. IRs were low for malignancies, depression, cytopenia, and MACE (all ≤ 1.2). IBD events were uncommon, although a total of 31 patients (IR 0.2) had confirmed IBD (ulcerative colitis, n = 18; Crohn disease, n = 13). Across safety topics, IRs decreased or remained constant over time.

CONCLUSIONS: The long-term safety profile for ixekizumab is consistent with that previously reported in patients with psoriasis. No new or unexpected safety events were detected. © 2022, The Author(s).

Language: en

Keywords

Safety; adult; disability; human; homicide; female; male; injury; insomnia; depression; Long-term; randomized controlled trial; cause of death; suicide attempt; hospitalization; Psoriasis; obesity; inflammatory bowel disease; major clinical study; controlled study; smoking; controlled clinical trial; double blind procedure; headache; phase 3 clinical trial; anxiety disorder; heart infarction; influenza; treatment withdrawal; drug safety; placebo; fatality; backache; follow up; long term care; risk benefit analysis; diarrhea; multicenter study; asthma; hypercholesterolemia; cardiovascular disease; coronary artery disease; accidental death; bronchitis; rash; hypertension; arthralgia; prostate cancer; adjustment disorder; non insulin dependent diabetes mellitus; dermatitis; disease duration; ulcerative colitis; drug hypersensitivity; urticaria; urinary tract infection; Article; dyslipidemia; contact dermatitis; systemic therapy; Crohn disease; outcome assessment; injection site reaction; medical history; injection site erythema; injection site pain; cytopenia; eczema; septic shock; upper respiratory tract infection; etanercept; sinusitis; opportunistic infection; psoriasis vulgaris; basal cell carcinoma; cholelithiasis; herpes zoster; thrush; rhinopharyngitis; injection site swelling; injection site pruritus; onychomycosis; external otitis; mycosis; invasive candidiasis; non melanoma skin cancer; Medical Dictionary for Regulatory Activities; biological product; Psoriasis Area and Severity Index; adverse event; ixekizumab; major adverse cardiac event; oropharynx candidiasis; squamous cell skin carcinoma; esophagus candidiasis; gastrointestinal candidiasis; Ixekizumab; latent tuberculosis; mucocutaneous candidiasis; senile dementia; skin candidiasis; viral upper respiratory tract infection; vulvovaginitis