PMID- 31820485
OWN - NLM
STAT- MEDLINE
DCOM- 20201123
LR  - 20201123
IS  - 1346-8138 (Electronic)
IS  - 0385-2407 (Print)
IS  - 0385-2407 (Linking)
VI  - 47
IP  - 2
DP  - 2020 Feb
TI  - Long-term safety and efficacy of delgocitinib ointment, a topical Janus kinase 
      inhibitor, in adult patients with atopic dermatitis.
PG  - 114-120
LID - 10.1111/1346-8138.15173 [doi]
AB  - Previous studies demonstrated that delgocitinib ointment, a novel topical Janus 
      kinase inhibitor, rapidly improved clinical signs and symptoms of atopic 
      dermatitis (AD) in Japanese adult patients. We sought to evaluate the long-term 
      safety and efficacy of delgocitinib 0.5% ointment in a 52-week study (QBA4-2). 
      Japanese patients aged 16 years or older with AD received delgocitinib 0.5% 
      ointment b.i.d. for up to 52 weeks. Topical corticosteroids for the treatment of 
      worsening of AD could be used at the investigators' discretion during the 
      treatment period. Safety end-points included the incidence and severity of 
      adverse events (AEs). Pooled safety analyses included the data from the other 
      long-term study (QBA4-1). Efficacy end-points included the percentage change from 
      baseline in the modified Eczema Area and Severity Index (mEASI). A total of 506 
      patients were included in the pooled safety population. Overall, AEs were 
      reported in 69.0% of patients; most AEs were mild and unrelated to delgocitinib 
      ointment. The most common AE was nasopharyngitis, followed by contact dermatitis, 
      acne, and application site folliculitis. No skin atrophy or telangiectasia was 
      found at the application sites of delgocitinib ointment. Application site 
      irritation symptoms were infrequent (<2%) and mild. The incidence of AEs did not 
      increase over time, except for seasonal diseases. The improvement effects on AD 
      as assessed by mEASI were maintained throughout the treatment period. 
      Delgocitinib 0.5% ointment was well tolerated and effective when administrated to 
      Japanese adult patients with AD for up to 52 weeks.
CI  - (c) 2019 Japan Tobacco Inc. The Journal of Dermatology published by John Wiley & 
      Sons Australia, Ltd.
FAU - Nakagawa, Hidemi
AU  - Nakagawa H
AD  - The Jikei University School of Medicine, Tokyo, Japan.
FAU - Nemoto, Osamu
AU  - Nemoto O
AD  - Kojinkai Sapporo Skin Clinic, Hokkaido, Japan.
FAU - Igarashi, Atsuyuki
AU  - Igarashi A
AD  - Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.
FAU - Saeki, Hidehisa
AU  - Saeki H
AUID- ORCID: 0000-0002-1095-0355
AD  - Department of Dermatology, Nippon Medical School, Tokyo, Japan.
FAU - Murata, Ryusei
AU  - Murata R
AD  - Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.
FAU - Kaino, Hironobu
AU  - Kaino H
AD  - Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.
FAU - Nagata, Takeshi
AU  - Nagata T
AUID- ORCID: 0000-0003-3300-7922
AD  - Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.
LA  - eng
GR  - Japan Tobacco Inc./
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20191209
PL  - England
TA  - J Dermatol
JT  - The Journal of dermatology
JID - 7600545
RN  - 0 (Janus Kinase Inhibitors)
RN  - 0 (Ointments)
RN  - 0 (Pyrroles)
RN  - 9L0Q8KK220 (delgocitinib)
SB  - IM
MH  - Acne Vulgaris/chemically induced/diagnosis/epidemiology
MH  - Adolescent
MH  - Adult
MH  - Dermatitis, Atopic/*drug therapy
MH  - Dermatitis, Contact/diagnosis/epidemiology/etiology
MH  - Drug Administration Schedule
MH  - Female
MH  - Folliculitis/chemically induced/diagnosis/epidemiology
MH  - Humans
MH  - Incidence
MH  - Janus Kinase Inhibitors/*administration & dosage/adverse effects
MH  - Japan/epidemiology
MH  - Male
MH  - Nasopharyngitis/chemically induced/diagnosis/epidemiology
MH  - Ointments
MH  - Pyrroles/*administration & dosage/adverse effects
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC7028108
OTO - NOTNLM
OT  - Janus kinase inhibitor
OT  - atopic dermatitis
OT  - delgocitinib
OT  - long-term safety
OT  - topical
COIS- H. N. received consulting fees and/or speaker honoraria from AbbVie, Eisai, Eli 
      Lilly Japan, Janssen, Japan Tobacco, Kyowa Hakko Kirin, LEO Pharma, Maruho, 
      Novartis, Torii Pharmaceutical and UCB Japan, and received research grants from 
      AbbVie, Maruho and Tanabe Mitsubishi. O. N. received advisory board honoraria 
      and/or speaker honoraria from Japan Tobacco, Kyowa Hakko Kirin, LEO Pharma and 
      Maruho. A. I. received advisory board honoraria, consulting fees or speaker 
      honoraria from AbbVie, Eli Lilly Japan, Japan Tobacco, Maruho, Novartis, Sanofi 
      and Torii Pharmaceutical, and received research grants from AbbVie, Eli Lilly 
      Japan, Japan Tobacco, Novartis and Sanofi. H. S. received advisory board 
      honoraria and/or speaker honoraria from Japan Tobacco, Kyorin Pharmaceutical, 
      Kyowa Hakko Kirin, Maruho, Sanofi, Taiho Pharma, Tanabe Mitsubishi and Torii 
      Pharmaceutical, and received research grants from AbbVie, Japan Tobacco, LEO 
      Pharma, Maruho, Otsuka Pharmaceutical and Sanofi. R. M., H. K. and T. N. are 
      employees of Japan Tobacco.
EDAT- 2019/12/11 06:00
MHDA- 2020/11/24 06:00
PMCR- 2020/02/18
CRDT- 2019/12/11 06:00
PHST- 2019/08/29 00:00 [received]
PHST- 2019/11/04 00:00 [accepted]
PHST- 2019/12/11 06:00 [pubmed]
PHST- 2020/11/24 06:00 [medline]
PHST- 2019/12/11 06:00 [entrez]
PHST- 2020/02/18 00:00 [pmc-release]
AID - JDE15173 [pii]
AID - 10.1111/1346-8138.15173 [doi]
PST - ppublish
SO  - J Dermatol. 2020 Feb;47(2):114-120. doi: 10.1111/1346-8138.15173. Epub 2019 Dec 
      9.