PMID- 26800231
OWN - NLM
STAT- MEDLINE
DCOM- 20170613
LR  - 20220408
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 174
IP  - 6
DP  - 2016 Jun
TI  - A randomized phase 2b trial of baricitinib, an oral Janus kinase (JAK) 1/JAK2 
      inhibitor, in patients with moderate-to-severe psoriasis.
PG  - 1266-76
LID - 10.1111/bjd.14403 [doi]
AB  - BACKGROUND: Plaque psoriasis is a chronic and often debilitating skin disorder 
      and proinflammatory cytokines are known to play a key role in the disease 
      process. OBJECTIVES: To evaluate the safety and efficacy of baricitinib, an oral 
      Janus kinase (JAK) 1/JAK2 inhibitor, in patients with moderate-to-severe 
      psoriasis in a randomized, double-blind, placebo-controlled, dose-ranging phase 
      2b study. METHODS: Patients were randomized (n = 271) to receive placebo or oral 
      baricitinib at 2, 4, 8 or 10 mg once daily for 12 weeks (Part A). Dose adjustment 
      for 12 additional weeks was based on percentage improvement in the Psoriasis Area 
      and Severity Index (PASI) score. The primary end point was Psoriasis Area and 
      Severity Index (PASI) 75% (PASI-75) at 12 weeks for North American patients (n = 
      238); secondary end points were safety and efficacy measures in the entire 
      population. RESULTS: At week 12, more North American patients in the 8-mg (43%) 
      and 10-mg (54%) baricitinib groups than in placebo group (17%; P < 0.05) achieved 
      PASI-75. All baricitinib-treated groups had greater mean changes from baseline in 
      their PASI scores (P < 0.05) at 12 weeks and (except 2 mg) had higher rates of 
      PASI-50 than the placebo group; statistically significant PASI-90 responses were 
      achieved in the 8-mg and 10-mg groups at 8 and 12 weeks. More than 81% of PASI-75 
      responders maintained their scores through 24 weeks. During Part A, study 
      discontinuations due to adverse events (AEs) were 0%, 0%, 2.8%, 6.3% and 5.8% and 
      treatment-emergent AE rates were 44%, 50%, 47%, 58% and 64% for placebo and 2-, 
      4-, 8- and 10-mg baricitinib groups, respectively. No opportunistic infections 
      were observed in any treatment group. Dose-dependent changes in laboratory values 
      were observed. CONCLUSIONS: Patients with moderate-to-severe psoriasis treated 
      with baricitinib for 12 weeks achieved significant improvements in PASI-75.
CI  - (c) 2016 The Authors. British Journal of Dermatology published by John Wiley & Sons 
      Ltd on behalf of British Association of Dermatologists.
FAU - Papp, K A
AU  - Papp KA
AD  - K.A. Papp Clinical Research and Probity Medical Research, 135 Union Street East, 
      Waterloo, ON, N2J 1C4, Canada.
FAU - Menter, M A
AU  - Menter MA
AD  - Baylor University Medical Center, Dallas, TX, U.S.A.
FAU - Raman, M
AU  - Raman M
AD  - Centre for Dermatology and Probity Medical Research, Richmond Hill, ON, Canada.
FAU - Disch, D
AU  - Disch D
AD  - Eli Lilly and Company, Indianapolis, IN, U.S.A.
FAU - Schlichting, D E
AU  - Schlichting DE
AD  - Eli Lilly and Company, Indianapolis, IN, U.S.A.
FAU - Gaich, C
AU  - Gaich C
AD  - Eli Lilly and Company, Indianapolis, IN, U.S.A.
FAU - Macias, W
AU  - Macias W
AD  - Eli Lilly and Company, Indianapolis, IN, U.S.A.
FAU - Zhang, X
AU  - Zhang X
AD  - Eli Lilly and Company, Indianapolis, IN, U.S.A.
FAU - Janes, J M
AU  - Janes JM
AD  - Eli Lilly and Company, Indianapolis, IN, U.S.A.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160405
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - 0 (Azetidines)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Purines)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonamides)
RN  - EC 2.7.10.2 (JAK1 protein, human)
RN  - EC 2.7.10.2 (JAK2 protein, human)
RN  - EC 2.7.10.2 (Janus Kinase 1)
RN  - EC 2.7.10.2 (Janus Kinase 2)
RN  - ISP4442I3Y (baricitinib)
SB  - IM
MH  - Azetidines/*administration & dosage/adverse effects
MH  - Dermatologic Agents/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Janus Kinase 1/antagonists & inhibitors
MH  - Janus Kinase 2/antagonists & inhibitors
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/*drug therapy
MH  - Purines
MH  - Pyrazoles
MH  - Sulfonamides/*administration & dosage/adverse effects
MH  - Treatment Outcome
EDAT- 2016/01/23 06:00
MHDA- 2017/06/14 06:00
CRDT- 2016/01/23 06:00
PHST- 2016/01/11 00:00 [accepted]
PHST- 2016/01/23 06:00 [entrez]
PHST- 2016/01/23 06:00 [pubmed]
PHST- 2017/06/14 06:00 [medline]
AID - 10.1111/bjd.14403 [doi]
PST - ppublish
SO  - Br J Dermatol. 2016 Jun;174(6):1266-76. doi: 10.1111/bjd.14403. Epub 2016 Apr 5.