Tofacitinib improves pruritus and health-related quality of life up to 52 weeks: Results from 2 randomized phase III trials in patients with moderate to severe plaque psoriasis.
BACKGROUND
Tofacitinib is an oral Janus kinase inhibitor that improves clinical measures of psoriasis.


OBJECTIVE
We sought to assess patient-reported outcomes in tofacitinib-treated patients with moderate to severe plaque psoriasis over 52 weeks.


METHODS
In 2 identical, phase III studies (Oral treatment for Psoriasis Trial Pivotal 1 [NCT01276639], n = 901, and Pivotal 2 [NCT01309737], n = 960), patients were randomized 2:2:1 to receive 5 or 10 mg of tofacitinib or placebo, twice daily. At week 16, placebo-treated patients were re-randomized to tofacitinib. Dermatology Life Quality Index score, Itch Severity Item score, Patient Global Assessment score, and patient satisfaction were assessed.


RESULTS
Baseline Dermatology Life Quality Index score indicated substantial health-related quality of life impairment. At week 16, a greater proportion of patients achieved Dermatology Life Quality Index score of 1 or less (no effect of psoriasis on health-related quality of life) with tofacitinib 5 and 10 mg twice daily versus placebo (Oral treatment for Psoriasis Trial Pivotal 1/2: 26.7%/28.6% and 40.2%/48.2% vs 4.6%/6.0%, respectively; P < .0001); improvements were maintained through week 52. Similar patterns were observed with Patient Global Assessment. Improvements in itch were particularly rapid, observed 1 day after treatment initiation for both tofacitinib doses versus placebo (P < .05). At week 16, more patients were satisfied with tofacitinib versus placebo (P < .0001).


CONCLUSIONS
Clinical nonresponders discontinued at week 28.


CONCLUSIONS
Tofacitinib demonstrated improvement in health-related quality of life and patient-reported symptoms that persisted over 52 weeks.
Wake Forest University School of Medicine, Winston-Salem, North Carolina.
Steven R
SR
Feldman
Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
Diamant
D
Thaçi
Skin Center for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada.
Melinda
M
Gooderham
Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Matthias
M
Augustin
Clinica Dermacross, Santiago, Chile.
Claudia
C
de la Cruz
Pfizer Inc, Collegeville, Pennsylvania.
Lotus
L
Mallbris
Pfizer Inc, Groton, Connecticut.
Marjorie
M
Buonanno
Pfizer Inc, Groton, Connecticut.
Svitlana
S
Tatulych
Pfizer Inc, Collegeville, Pennsylvania.
Mandeep
M
Kaur
Pfizer Inc, Groton, Connecticut.
Shuping
S
Lan
Pfizer Inc, New York, New York.
Hernan
H
Valdez
Pfizer Inc, Groton, Connecticut. Electronic address: carla.m.mamolo@pfizer.com.
Carla
C
Mamolo
D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D017060:Patient Satisfaction; D010880:Piperidines / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011537:Pruritus / Q000188:drug therapy* / Q000209:etiology; D011565:Psoriasis / Q000150:complications / Q000188:drug therapy*; D011743:Pyrimidines / Q000627:therapeutic use*; D011758:Pyrroles / Q000627:therapeutic use*; D011788:Quality of Life; D012720:Severity of Illness Index
D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; C479163:tofacitinib
health-related quality of life; patient-reported outcomes; plaque psoriasis; pruritus; tofacitinib; treatment satisfaction