PMID- 27106510
OWN - NLM
STAT- MEDLINE
DCOM- 20171011
LR  - 20191210
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 176
IP  - 3
DP  - 2017 Mar
TI  - Efficacy and safety of brodalumab in patients with generalized pustular psoriasis 
      and psoriatic erythroderma: results from a 52-week, open-label study.
PG  - 741-751
LID - 10.1111/bjd.14702 [doi]
AB  - BACKGROUND: A T-helper (Th) cell subset Th17 preferentially produces interleukin 
      (IL)-17 and plays a pivotal role in the pathogenesis of psoriasis. However, the 
      pathological roles of IL-17 cascades in generalized pustular psoriasis (GPP) and 
      psoriatic erythroderma (PsE) have not been well established. OBJECTIVES: To 
      evaluate the efficacy and safety of brodalumab, a human immunoglobulin G2 
      monoclonal antibody against human IL-17-receptor A (IL-17RA), in Japanese 
      patients with GPP and PsE. METHODS: This was an open-label, multicentre, 
      long-term phase III study in Japanese patients with rare and severe types of 
      psoriasis. Patients received brodalumab 140 mg at day 1 and weeks 1 and 2, and 
      then every 2 weeks until week 52. The primary endpoint was the Clinical Global 
      Impression of Improvement (CGI). Safety evaluations included treatment-emergent 
      adverse events (AEs) and changes in laboratory parameters. RESULTS: A total of 12 
      patients with GPP and 18 with PsE were enrolled. Ten patients with GPP and 16 
      with PsE completed the study. At week 52 (last observation carried forward), CGI 
      remission or improvement was achieved in 11 patients with GPP and 18 with PsE. 
      The most commonly reported AE was nasopharyngitis (33.3%). Five serious AEs 
      occurred during the study. However, none was considered treatment-related. 
      CONCLUSIONS: Brodalumab significantly improved the symptoms of patients with GPP 
      and PsE throughout the 52 weeks, and demonstrated favourable safety profiles 
      without any new safety signals. Inhibition of IL-17RA-mediated signalling by 
      brodalumab is expected to be a promising new treatment option for patients with 
      GPP and PsE.
CI  - (c) 2016 The Authors. British Journal of Dermatology published by John Wiley & Sons 
      Ltd on behalf of British Association of Dermatologists.
FAU - Yamasaki, K
AU  - Yamasaki K
AD  - Department of Dermatology, Tohoku University Graduate School of Medicine, Tohoku 
      University Hospital, 1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
FAU - Nakagawa, H
AU  - Nakagawa H
AD  - Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
FAU - Kubo, Y
AU  - Kubo Y
AD  - Department of Dermatology, Institute of Biomedical Sciences, Tokushima University 
      Graduate School, Tokushima, Japan.
FAU - Ootaki, K
AU  - Ootaki K
AD  - Kyowa Hakko Kirin Co. Ltd, Tokyo, Japan.
CN  - Japanese Brodalumab Study Group
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20161002
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Dermatologic Agents)
RN  - 6ZA31Y954Z (brodalumab)
SB  - IM
CIN - Br J Dermatol. 2017 Mar;176(3):572-573. PMID: 28300318
MH  - Adult
MH  - Antibodies, Monoclonal/*administration & dosage/adverse effects
MH  - Antibodies, Monoclonal, Humanized
MH  - Dermatitis, Exfoliative/*drug therapy
MH  - Dermatologic Agents/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Long-Term Care
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/*drug therapy
MH  - Treatment Outcome
EDAT- 2016/10/22 06:00
MHDA- 2017/10/12 06:00
CRDT- 2016/04/24 06:00
PHST- 2016/04/20 00:00 [accepted]
PHST- 2016/10/22 06:00 [pubmed]
PHST- 2017/10/12 06:00 [medline]
PHST- 2016/04/24 06:00 [entrez]
AID - 10.1111/bjd.14702 [doi]
PST - ppublish
SO  - Br J Dermatol. 2017 Mar;176(3):741-751. doi: 10.1111/bjd.14702. Epub 2016 Oct 2.