PMID- 34967916
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220217
IS  - 2193-8210 (Print)
IS  - 2190-9172 (Electronic)
VI  - 12
IP  - 2
DP  - 2022 Feb
TI  - Ixekizumab 80 mg Every 2 Weeks Treatment Beyond Week 12 for Japanese Patients 
      with Generalized Pustular Psoriasis and Erythrodermic Psoriasis.
PG  - 481-494
LID - 10.1007/s13555-021-00666-x [doi]
AB  - INTRODUCTION: In 2018, ixekizumab (80 mg every 2 weeks [Q2W] beyond Week 12) 
      received approval in Japan for patients with generalized pustular psoriasis (GPP) 
      and erythrodermic psoriasis (EP). This open-label study evaluated the efficacy 
      and safety of ixekizumab (80 mg Q2W from Week 12 to Week 20) in Japanese patients 
      with GPP and EP. METHODS: Seven patients with GPP and five patients with EP were 
      enrolled. An initial dose of 160 mg (subcutaneous [SC] injection) was followed by 
      80 mg Q2W SC until Week 12. Primary endpoint assessed global improvement score 
      (GIS) by comparing psoriatic findings, Static Physician Global Assessment, 
      Psoriasis Area and Severity Index score, and other evaluations with those at the 
      baseline and were graded as 1 = resolved, 2= improved, 3 = unchanged, and 4 = 
      worsened. Patients who showed GIS = 1 (resolved) at Week 12 completed the study. 
      Patients with GIS >/= 2 continued to receive ixekizumab 80 mg Q2W until Week 20. 
      RESULTS: At Week 12, four of seven patients with GPP showed "resolved," two 
      showed "improved," and one showed "worsened." Of five patients with EP, one 
      showed "resolved" and four showed "improved." Two patients with GPP and four 
      patients with EP continued ixekizumab treatment until Week 20. At Week 20, one of 
      the two patients with GPP showed "resolved" and one patient showed "improved." 
      All four patients with EP showed "improved." One non-drug related serious adverse 
      event was reported by one patient with EP at Week 12. From Week 12 to Week 20, no 
      adverse events (AEs) were reported in patients with GPP, but two mild AEs were 
      reported in one of the four patients with EP. CONCLUSIONS: This study indicates 
      that ixekizumab continuous Q2W dosing is efficacious and safe for patients with 
      GPP and EP. CLINICAL TRIAL REGISTRATION: NCT03942042.
CI  - (c) 2021. The Author(s).
FAU - Morita, Akimichi
AU  - Morita A
AD  - Department of Geriatric and Environmental Dermatology, Nagoya City University 
      Graduate School of Medical Sciences, Nagoya, Japan.
FAU - Okubo, Yukari
AU  - Okubo Y
AD  - Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
FAU - Morisaki, Yoji
AU  - Morisaki Y
AD  - Eli Lilly Japan K.K., 5-chome-1-28, Isogamidori, Chuo Ward, Kobe, Hyogo, 
      651-0086, Japan.
FAU - Torisu-Itakura, Hitoe
AU  - Torisu-Itakura H
AD  - Eli Lilly Japan K.K., 5-chome-1-28, Isogamidori, Chuo Ward, Kobe, Hyogo, 
      651-0086, Japan. itakura_hitoe@lilly.com.
FAU - Umezawa, Yoshinori
AU  - Umezawa Y
AD  - Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT03942042
PT  - Journal Article
DEP - 20211229
PL  - Switzerland
TA  - Dermatol Ther (Heidelb)
JT  - Dermatology and therapy
JID - 101590450
PMC - PMC8717693
OAB - Ixekizumab is an anti-interleukin-17 treatment for a skin condition with thick 
      and scaly patches called psoriasis. Ixekizumab (initial dose of 160 mg followed 
      by 80 mg administered every 2 weeks [Q2W] from Week 2 through Week 12 and 
      thereafter 80 mg every 4 weeks [Q4W]) has been approved in Japan; people who have 
      not achieved 100% clear skin after taking ixekizumab for 12 weeks can continue to 
      receive ixekizumab Q2W rather than monthly. However, this approval partially 
      lacked data from people with rare types of psoriasis, generalized pustular 
      psoriasis (GPP) and erythrodermic psoriasis (EP). The aim of this study was to 
      look at the effectiveness and safety of continuous Q2W dosing of ixekizumab in 
      Japanese people with GPP and EP beyond Week 12. Researchers aimed to find out 
      whether psoriasis symptoms in this population improved if they continued Q2W 
      treatment for > 12 weeks. Seven people with GPP and 5 with EP participated in the 
      study (12 in total). Participants initially received 160 mg under-the-skin 
      injection of ixekizumab, followed by 80 mg injections Q2W. Two GPP and four EP 
      participants continued to receive ixekizumab after 12 weeks up to Week 20. One 
      GPP participant achieved 100% clear skin, and another GPP participant and all 4 
      EP participants showed improvement. No participants died, and safety findings 
      were similar to previous ixekizumab studies from both Japanese and non-Japanese 
      people. This study suggests that people with GPP and EP who continue to take 
      ixekizumab Q2W after 12 weeks may show improvements in their psoriasis with a 
      well-tolerated safety profile.
OABL- eng
OTO - NOTNLM
OT  - Erythrodermic psoriasis
OT  - Generalized pustular psoriasis
OT  - Ixekizumab
OT  - Q2W
EDAT- 2021/12/31 06:00
MHDA- 2021/12/31 06:01
PMCR- 2021/12/29
CRDT- 2021/12/30 12:47
PHST- 2021/09/29 00:00 [received]
PHST- 2021/12/10 00:00 [accepted]
PHST- 2021/12/31 06:00 [pubmed]
PHST- 2021/12/31 06:01 [medline]
PHST- 2021/12/30 12:47 [entrez]
PHST- 2021/12/29 00:00 [pmc-release]
AID - 10.1007/s13555-021-00666-x [pii]
AID - 666 [pii]
AID - 10.1007/s13555-021-00666-x [doi]
PST - ppublish
SO  - Dermatol Ther (Heidelb). 2022 Feb;12(2):481-494. doi: 10.1007/s13555-021-00666-x. 
      Epub 2021 Dec 29.