PMID- 35654647
OWN - NLM
STAT- MEDLINE
DCOM- 20220706
LR  - 20240831
IS  - 1806-4841 (Electronic)
IS  - 0365-0596 (Print)
IS  - 0365-0596 (Linking)
VI  - 97
IP  - 4
DP  - 2022 Jul-Aug
TI  - Icatibant use in Brazilian patients with hereditary angioedema (HAE) type 1 or 2 
      and HAE with normal C1-INH levels: findings from the Icatibant Outcome Survey 
      Registry Study.
PG  - 448-457
LID - S0365-0596(22)00066-6 [pii]
LID - 10.1016/j.abd.2021.09.009 [doi]
AB  - BACKGROUND: Hereditary angioedema can be caused by C1-Inhibitor (C1-INH) 
      deficiency and/or dysfunction (HAE-1/2) or can occur in patients with normal 
      C1-INH (HAE nC1-INH). METHODS: The Icatibant Outcome Survey (IOS; NCT01034969) 
      registry monitors the safety and effectiveness of icatibant for treating acute 
      angioedema. OBJECTIVE: Present findings from Brazilian patients with HAE-1/2 and 
      HAE nC1-INH participating in IOS. RESULTS: 42 patients were enrolled (HAE-1/2, 
      n = 26; HAE nC1-INH, n = 16). Median age at symptom onset was significantly lower 
      with HAE-1/2 vs. HAE nC1-INH (10.0 vs. 16.5y, respectively; p = 0.0105), whereas 
      median age at diagnosis (31.1 vs. 40.9y; p = 0.1276) and the median time between 
      symptom onset and diagnosis (15.0 vs. 23.8y; p = 0.6680) were numerically lower 
      vs. HAE nC1-INH, respectively. One icatibant dose was used for > 95% of HAE 
      attacks. Median (range) time-to-event outcomes were shorter for patients with HAE 
      nC1-INH vs. HAE-1/2, including time to first administration (0.5 [0-96.0] vs. 1.0 
      [0-94.0]h, respectively), time from first administration to complete resolution 
      (1.0 [0-88.0] vs. 5.5 [0-96.0]h, respectively), and total attack duration (7.0 
      [0.3-99.0] vs. 18.5 [0.1-100.0]h, respectively). Mean (SD) time from attack onset 
      to resolution was significantly shorter for patients with HAE nC1-INH vs. HAE-1/2 
      (9.8 [18.7] vs. 19.6 [24.0]h, respectively; p = 0.0174). 83 adverse events (AEs) 
      in 42 patients were reported; most were mild (66.3%) or moderate (13.3%) and 
      non-serious (75.9%). The most common icatibant-related AE was injection site 
      erythema (HAE-1/2, 34.6%; HAE nC1-INH, 18.8%). STUDY LIMITATIONS: This was an 
      observational study without a treatment comparator and that relied on patient 
      recall. CONCLUSIONS: Findings demonstrate effectiveness and tolerability of 
      icatibant in Brazilian HAE patients.
CI  - Copyright (c) 2022. Published by Elsevier Espana, S.L.U.
FAU - Grumach, Anete S
AU  - Grumach AS
AD  - Clinical Immunology, Faculdade de Medicina, Centro Universitario Saude ABC, Santo 
      Andre, SP, Brazil. Electronic address: anete.grumach@fmabc.net.
FAU - Henriques, Marina T
AU  - Henriques MT
AD  - Clinical Immunology, Faculdade de Medicina, Centro Universitario Saude ABC, Santo 
      Andre, SP, Brazil.
FAU - Bardou, Maine L D
AU  - Bardou MLD
AD  - Clinical Immunology, Faculdade de Medicina, Centro Universitario Saude ABC, Santo 
      Andre, SP, Brazil.
FAU - Pontarolli, Daniele A
AU  - Pontarolli DA
AD  - Clinical Immunology, Faculdade de Medicina, Centro Universitario Saude ABC, Santo 
      Andre, SP, Brazil.
FAU - Botha, Jaco
AU  - Botha J
AD  - Takeda Pharmaceuticals International AG, Zurich, Switzerland.
FAU - Correa, Mariangela
AU  - Correa M
AD  - Takeda Distribuidora Ltda, Sao Paulo, SP, Brazil.
CN  - IOS Brazil Study Group
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20220530
PL  - Spain
TA  - An Bras Dermatol
JT  - Anais brasileiros de dermatologia
JID - 0067662
RN  - 0 (Complement C1 Inhibitor Protein)
RN  - 7PG89G35Q7 (icatibant)
RN  - S8TIM42R2W (Bradykinin)
SB  - IM
MH  - *Angioedemas, Hereditary/diagnosis/drug therapy
MH  - *Bradykinin/analogs & derivatives/therapeutic use
MH  - Brazil
MH  - Complement C1 Inhibitor Protein/chemistry
MH  - Humans
MH  - Registries
MH  - Treatment Outcome
PMC - PMC9263662
OTO - NOTNLM
OT  - Bradykinin
OT  - Bradykinin receptor
OT  - Brazil
OT  - Hereditary angioedema
EDAT- 2022/06/03 06:00
MHDA- 2022/07/07 06:00
PMCR- 2022/05/30
CRDT- 2022/06/02 22:04
PHST- 2021/05/21 00:00 [received]
PHST- 2021/08/26 00:00 [revised]
PHST- 2021/09/15 00:00 [accepted]
PHST- 2022/06/03 06:00 [pubmed]
PHST- 2022/07/07 06:00 [medline]
PHST- 2022/06/02 22:04 [entrez]
PHST- 2022/05/30 00:00 [pmc-release]
AID - S0365-0596(22)00066-6 [pii]
AID - 10.1016/j.abd.2021.09.009 [doi]
PST - ppublish
SO  - An Bras Dermatol. 2022 Jul-Aug;97(4):448-457. doi: 10.1016/j.abd.2021.09.009. 
      Epub 2022 May 30.