PMID- 35624407
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2193-8210 (Print)
IS  - 2190-9172 (Electronic)
VI  - 12
IP  - 6
DP  - 2022 Jun
TI  - Safety of Ixekizumab in Adult Patients with Moderate-to-Severe Psoriasis: Data 
      from 17 Clinical Trials with Over 18,000 Patient-Years of Exposure.
PG  - 1431-1446
LID - 10.1007/s13555-022-00743-9 [doi]
AB  - 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.
CI  - (c) 2022. The Author(s).
FAU - Griffiths, Christopher E M
AU  - Griffiths CEM
AD  - The Dermatology Centre, Salford Royal Hospital, University of Manchester, NIHR 
      Manchester Biomedical Research Centre, Manchester, UK.
FAU - Gooderham, Melinda
AU  - Gooderham M
AD  - SKiN Centre for Dermatology, Peterborough, ON, Canada.
FAU - Colombel, Jean-Frederic
AU  - Colombel JF
AD  - Icahn School of Medicine at Mount Sinai, New York, NY, USA.
FAU - Terui, Tadashi
AU  - Terui T
AD  - Department of Dermatology, Nihon University School of Medicine, Tokyo, Japan.
FAU - Accioly, Ana P
AU  - Accioly AP
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Gallo, Gaia
AU  - Gallo G
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Zhu, Danting
AU  - Zhu D
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Blauvelt, Andrew
AU  - Blauvelt A
AUID- ORCID: 0000-0002-2633-985X
AD  - Oregon Medical Research Center, 9495 SW Locust Street, Suite G, Portland, OR, 
      USA. ablauvelt@oregonmedicalresearch.com.
LA  - eng
PT  - Journal Article
DEP - 20220527
PL  - Switzerland
TA  - Dermatol Ther (Heidelb)
JT  - Dermatology and therapy
JID - 101590450
PMC - PMC9209552
OTO - NOTNLM
OT  - Ixekizumab
OT  - Long-term
OT  - Psoriasis
OT  - Safety
EDAT- 2022/05/28 06:00
MHDA- 2022/05/28 06:01
PMCR- 2022/05/27
CRDT- 2022/05/27 23:28
PHST- 2022/03/16 00:00 [received]
PHST- 2022/05/05 00:00 [accepted]
PHST- 2022/05/28 06:00 [pubmed]
PHST- 2022/05/28 06:01 [medline]
PHST- 2022/05/27 23:28 [entrez]
PHST- 2022/05/27 00:00 [pmc-release]
AID - 10.1007/s13555-022-00743-9 [pii]
AID - 743 [pii]
AID - 10.1007/s13555-022-00743-9 [doi]
PST - ppublish
SO  - Dermatol Ther (Heidelb). 2022 Jun;12(6):1431-1446. doi: 
      10.1007/s13555-022-00743-9. Epub 2022 May 27.