PMID- 35393269
OWN - NLM
STAT- MEDLINE
DCOM- 20220708
LR  - 20220722
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Print)
IS  - 0003-4967 (Linking)
VI  - 81
IP  - 7
DP  - 2022 Jul
TI  - Safety of ixekizumab in patients with psoriatic arthritis: data from four 
      clinical trials with over 2000 patient-years of exposure.
PG  - 944-950
LID - 10.1136/annrheumdis-2021-222027 [doi]
AB  - OBJECTIVES: Ixekizumab, a high-affinity monoclonal antibody that selectively 
      targets interleukin 17A (IL-17A), has shown significant efficacy in the treatment 
      of psoriatic arthritis (PsA) and sustained long-term clinical response without 
      unexpected new safety outcome for an IL-17A inhibitor. Here, we report the 
      updated safety profile of ixekizumab up to 3 years in patients with PsA. METHODS: 
      This is an integrated safety analysis from four clinical trials in patients with 
      PsA who received at least one dose of ixekizumab. Treatment-emergent adverse 
      events (TEAEs) and selected adverse events (AEs) exposure-adjusted incidence 
      rates (EAIRs) per 100 patient-years up to 3 years of exposure are reported. 
      RESULTS: A total of 1401 patients with a cumulative ixekizumab exposure of 2247.7 
      patient-years were included in this analysis. The EAIR of patients with >/=1 TEAE 
      was 50.3 per 100 patient-years and most TEAEs were mild to moderate in severity. 
      Serious AEs were reported by 134 patients (EAIR=6.0). The most reported TEAEs 
      were nasopharyngitis (EAIR=9.0) and upper respiratory tract infection (EAIR=8.3). 
      Infections in general and injection site reactions were the most common TEAEs; 
      the incidence rates of serious cases were low (EAIR </=1.2). The EAIRs of 
      malignancies (EAIR=0.7), inflammatory bowel disease (EAIR=0.1) including 
      ulcerative colitis and Crohn's disease, depression (EAIR=1.6), and major adverse 
      cerebro-cardiovascular events (EAIR=0.5) were low. As assessed, based on year of 
      exposure, incidence rates were decreasing or constant over time. CONCLUSIONS: In 
      this analysis, the overall safety profile and tolerability of ixekizumab are 
      consistent with the known safety profile in patients with PsA. No new or 
      unexpected safety events were detected. TRIAL REGISTRATION NUMBER: NCT01695239, 
      NCT02349295, NCT02584855, NCT03151551.
CI  - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Deodhar, Atul A
AU  - Deodhar AA
AUID- ORCID: 0000-0002-2130-1246
AD  - Division of Arthritis/Rheumatic Diseases (OPO9), Oregon Health and Science 
      University, Portland, Oregon, USA.
FAU - Combe, Bernard
AU  - Combe B
AD  - Rheumatology, CHU Montpellier, Montpellier, France.
FAU - Accioly, Ana P
AU  - Accioly AP
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Bolce, Rebecca
AU  - Bolce R
AD  - Medical Affairs, Eli Lilly and Company, Cincinnati, Ohio, USA.
FAU - Zhu, Danting
AU  - Zhu D
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Gellett, Amanda M
AU  - Gellett AM
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Sprabery, Aubrey Trevelin
AU  - Sprabery AT
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Burmester, Gerd-Rudiger R
AU  - Burmester GR
AUID- ORCID: 0000-0001-7518-1131
AD  - Universitatsklinikum Charite, Berlin, Germany gerd.burmester@charite.de.
LA  - eng
SI  - ClinicalTrials.gov/NCT02584855
SI  - ClinicalTrials.gov/NCT01695239
SI  - ClinicalTrials.gov/NCT03151551
SI  - ClinicalTrials.gov/NCT02349295
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220407
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Interleukin-17)
RN  - BTY153760O (ixekizumab)
SB  - IM
MH  - *Antibodies, Monoclonal, Humanized/adverse effects/therapeutic use
MH  - *Arthritis, Psoriatic/pathology
MH  - Biological Therapy
MH  - *Crohn Disease/chemically induced
MH  - *Dermatologic Agents/adverse effects/therapeutic use
MH  - Humans
MH  - Interleukin-17
MH  - Treatment Outcome
PMC - PMC9209663
OTO - NOTNLM
OT  - Biological Therapy
OT  - Inflammation
OT  - Psoriatic Arthritis
OT  - Therapeutics
COIS- Competing interests: AAD reports consulting and advisory boards for AbbVie, 
      Amgen, Aurinia, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly 
      and Company, GlaxoSmithKline, Janssen, MoonLake, Novartis, Pfizer and UCB; and 
      research grants from AbbVie, Eli Lilly and Company, GlaxoSmithKline, Novartis, 
      Pfizer and UCB. BC has received grant/research support from Novartis, Pfizer and 
      Roche-Chugai; served as a consultant for AbbVie, Eli Lilly and Company, Gilead 
      Sciences, Janssen, Pfizer, Roche-Chugai and Sanofi; and served on speakers' 
      bureaus for Bristol Myers Squibb, Eli Lilly and Company, Gilead Sciences, Merck 
      Sharp & Dohme, Pfizer and Roche-Chugai. APA, DZ, RB, AMG and ATS are shareholders 
      and employees of Eli Lilly and Company. G-RRB is a consultant for Eli Lilly and 
      Company, Janssen, Novartis and Pfizer; and has received research funding from Eli 
      Lilly and Company.
EDAT- 2022/04/09 06:00
MHDA- 2022/07/09 06:00
PMCR- 2022/06/21
CRDT- 2022/04/08 05:30
PHST- 2021/12/17 00:00 [received]
PHST- 2022/03/15 00:00 [accepted]
PHST- 2022/04/09 06:00 [pubmed]
PHST- 2022/07/09 06:00 [medline]
PHST- 2022/04/08 05:30 [entrez]
PHST- 2022/06/21 00:00 [pmc-release]
AID - annrheumdis-2021-222027 [pii]
AID - 10.1136/annrheumdis-2021-222027 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 
      2022 Apr 7.