PMID- 27358210
OWN - NLM
STAT- MEDLINE
DCOM- 20170414
LR  - 20191210
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Linking)
VI  - 30
IP  - 11
DP  - 2016 Nov
TI  - Long-term clinical safety and efficacy of brodalumab in the treatment of Japanese 
      patients with moderate-to-severe plaque psoriasis.
PG  - 1957-1960
LID - 10.1111/jdv.13785 [doi]
AB  - BACKGROUND: Brodalumab (KHK4827) is a human anti-interleukin-17-receptor A 
      monoclonal antibody. In Japanese patients with moderate-to-severe plaque 
      psoriasis, brodalumab showed rapid and robust efficacy and a favourable safety 
      profile in a 12-week, phase 2, double-blind, randomized controlled trial. 
      OBJECTIVES: To evaluate the long-term safety and efficacy of brodalumab, an 
      extension of a phase 2 trial of Japanese patients with moderate-to-severe 
      psoriasis was performed. METHODS: Patients received open-label brodalumab 210 or 
      140 mg subcutaneously every 2 weeks for 52 weeks. Efficacy was measured using the 
      Psoriasis Area and Severity Index (PASI) score and the static physician global 
      assessment (sPGA) instrument. The endpoint of psoriatic arthritis was 20% 
      improvement in American College of Rheumatology response criteria (ACR 20). The 
      patients were also monitored for treatment-emergent adverse events (AEs), 
      including serious AEs (SAEs). RESULTS: Of 145 patients, 133 completed the study. 
      The percentage of patients with >/=75% reduction of PASI scores (PASI 75), >/=90% 
      (PASI 90) and 100% (PASI 100) at Week 52 (the last observation carried forward) 
      were 94.4%, 87.5% and 55.6%, respectively, in the 210-mg group, and the 
      corresponding values in the 140-mg group were 78.1%, 71.2% and 43.8%. At Week 52, 
      75.0% patients in 210-mg group achieved ACR 20, compared with 37.5% patients in 
      140-mg group. The most commonly reported AEs were nasopharyngitis (35.2%), upper 
      respiratory tract inflammation (10.3%) and contact dermatitis (9.7%). CONCLUSION: 
      Brodalumab showed a sustained clinical response and an acceptable safety profile 
      through 52 weeks in Japanese patients with moderate-to-severe plaque psoriasis in 
      this open-label extension study.
CI  - (c) 2016 European Academy of Dermatology and Venereology.
FAU - Umezawa, Y
AU  - Umezawa Y
AD  - Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan. 
      yoshinori.umezawa@jikei.ac.jp.
FAU - Nakagawa, H
AU  - Nakagawa H
AD  - Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
FAU - Niiro, H
AU  - Niiro H
AD  - Clinical Education Center, Kyushu University Hospital, Fukuoka, Japan.
FAU - Ootaki, K
AU  - Ootaki K
AD  - Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan.
CN  - Japanese Brodalumab Study Group
LA  - eng
PT  - Journal Article
DEP - 20160629
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 6ZA31Y954Z (brodalumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Clinical Trials, Phase II as Topic
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/*drug therapy
MH  - Severity of Illness Index
EDAT- 2016/10/25 06:00
MHDA- 2017/04/15 06:00
CRDT- 2016/07/01 06:00
PHST- 2015/11/04 00:00 [received]
PHST- 2016/03/11 00:00 [accepted]
PHST- 2016/10/25 06:00 [pubmed]
PHST- 2017/04/15 06:00 [medline]
PHST- 2016/07/01 06:00 [entrez]
AID - 10.1111/jdv.13785 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2016 Nov;30(11):1957-1960. doi: 10.1111/jdv.13785. 
      Epub 2016 Jun 29.