PMID- 23294276
OWN - NLM
STAT- MEDLINE
DCOM- 20151117
LR  - 20151119
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Linking)
VI  - 28
IP  - 2
DP  - 2014 Feb
TI  - Tofacitinib (CP-690,550), an oral Janus kinase inhibitor, improves 
      patient-reported outcomes in a phase 2b, randomized, double-blind, 
      placebo-controlled study in patients with moderate-to-severe psoriasis.
PG  - 192-203
LID - 10.1111/jdv.12081 [doi]
AB  - BACKGROUND: Psoriasis is a chronic, inflammatory skin disease with a significant 
      impact on health-related quality of life (HRQoL). Tofacitinib (CP-690,550) is a 
      novel, oral Janus kinase inhibitor that is being investigated as a targeted 
      immunomodulator. OBJECTIVE: This Phase 2b study assessed three tofacitinib dosage 
      regimens vs. placebo to characterize the efficacy and safety of tofacitinib in 
      patients with moderate-to-severe chronic plaque psoriasis. We report the 
      patient-reported outcome (PRO) data. METHODS: A total of 197 patients were 
      randomized to tofacitinib 2, 5, 15 mg twice daily or placebo for 12 weeks. Six 
      PRO questionnaires were completed during the study: Dermatology Life Quality 
      Index, Itch Severity Score (ISS), Short Form-36 questionnaire, version 2 (SF-36), 
      Pain/Discomfort Assessment (PDA), Patient Satisfaction with Study Medication 
      (PSSM) item and Patient Global Assessment of psoriasis. RESULTS: Treatment with 
      tofacitinib resulted in significant, dose-dependent improvements in several PROs 
      vs. placebo from week 2 onwards. At week 12, least squares mean changes from 
      baseline for Dermatology life quality index, ISS and SF-36 mental component 
      scores were significantly greater for all active drug arms vs. placebo 
      (P < 0.05), and significantly greater for tofacitinib 5 and 15 mg for SF-36 
      physical component scores vs. placebo (P < 0.05). At week 12, all dose groups had 
      significantly greater numbers of patients reporting 'Clear' or 'Almost clear' on 
      the PtGA vs. placebo. CONCLUSION: In patients with moderate-to-severe chronic 
      plaque psoriasis, short-term (12-week) treatment with oral twice-daily 
      tofacitinib improves HRQoL outcomes and patient assessment of disease severity 
      and symptoms, with an early onset noted.
CI  - (c) 2013 The Authors Journal of the European Academy of Dermatology and Venereology 
      (c) 2013 European Academy of Dermatology and Venereology.
FAU - Mamolo, C
AU  - Mamolo C
AD  - Pfizer Inc, Groton, CT, USA.
FAU - Harness, J
AU  - Harness J
AD  - Pfizer Inc, Groton, CT, USA.
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Tan, H
AU  - Tan H
AD  - Pfizer Inc, Groton, CT, USA.
FAU - Menter, A
AU  - Menter A
AD  - Baylor Research Institute, Dallas, TX, USA.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130107
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Piperidines)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrimidines)
RN  - 0 (Pyrroles)
RN  - 87LA6FU830 (tofacitinib)
RN  - EC 2.7.10.2 (Janus Kinase 3)
SB  - IM
MH  - Adult
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Janus Kinase 3/antagonists & inhibitors
MH  - Male
MH  - Middle Aged
MH  - Patient Outcome Assessment
MH  - Patient Satisfaction
MH  - Piperidines/adverse effects/*therapeutic use
MH  - Protein Kinase Inhibitors/adverse effects/*therapeutic use
MH  - Psoriasis/*drug therapy
MH  - Pyrimidines/adverse effects/*therapeutic use
MH  - Pyrroles/adverse effects/*therapeutic use
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
EDAT- 2013/01/09 06:00
MHDA- 2015/11/18 06:00
CRDT- 2013/01/09 06:00
PHST- 2012/07/31 00:00 [received]
PHST- 2012/11/26 00:00 [accepted]
PHST- 2013/01/09 06:00 [entrez]
PHST- 2013/01/09 06:00 [pubmed]
PHST- 2015/11/18 06:00 [medline]
AID - 10.1111/jdv.12081 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2014 Feb;28(2):192-203. doi: 10.1111/jdv.12081. 
      Epub 2013 Jan 7.