Pruritus and quality of life in moderate-to-severe plaque psoriasis: post hoc explorative analysis from the PRISTINE study.
BACKGROUND
Pruritus is a clinically important symptom of psoriasis that has a major impact on quality of life (QoL).


OBJECTIVE
The objective of this study was to examine pruritus and QoL in patients with moderate-to-severe psoriasis treated with etanercept (ETN) in the PRISTINE clinical trial.


METHODS
Patients were randomized (1 : 1, double-blind) to ETN 50 mg QW or 50 mg BIW for 12 weeks, followed by 50 mg QW for 12 weeks. Pruritus was reported as 0 (no itching) to 5 (severe itching). Associations were examined between pruritus and Psoriasis Area and Severity Index, Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depression Screening (HADS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Euro-Qol 5D (EQ-5D) and Medical Outcomes Study (MOS) Sleep Index II.


RESULTS
At baseline, patients (n = 270) had a mean pruritus level of 3.6. Itching (level ≥1) was reported by 96% of patients, 62% of whom had severe itching (level ≥4) and 26% had the highest level of itching. DLQI, HADS-Anxiety, HADS-Depression, FACIT-Fatigue, EQ-5D visual analog scale, and MOS Sleep Index II were significantly associated with itch. At week 12, mean pruritus improvement in the ETN BIW/QW group was greater than in the QW/QW group (2.4 vs. 1.6, P < 0.001), but not at week 24 (2.2 vs. 2.0, P = 0.180). Patients with the most severe itching at baseline (score of 5) had a mean score of 1.7 at week 24. Overall, patients with clinically meaningful pruritus improvement at week 24 reported greater improvement in QoL measures than other patients.


CONCLUSIONS
Most patients with moderate-to-severe psoriasis in this study (96%) reported pruritus. Pruritus improved significantly with ETN therapy and was strongly associated with improvements in QoL. These data support the clinical relevance of pruritus as an important symptom of patients with moderate/severe psoriasis.
Psoriasis Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Germany.
U
U
Mrowietz
Hospital General de Agudos, Buenos Aires, Argentina.
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EN
Chouela
Pfizer Inc, Collegeville, PA, USA.
L
L
Mallbris
Pfizer Specialty Care, Medical Affairs Europe, Inflammation, Rome, Italy.
D
D
Stefanidis
Pfizer Italia S.r.l., Rome, Italy.
V
V
Marino
Pfizer Inc, Collegeville, PA, USA.
R
R
Pedersen
Formerly of Pfizer Inc, Collegeville, PA, USA.
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RL
Boggs
D000328:Adult; D001007:Anxiety / Q000209:etiology; D003863:Depression / Q000209:etiology; D004311:Double-Blind Method; D000068800:Etanercept / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011537:Pruritus / Q000150:complications / Q000188:drug therapy / Q000523:psychology*; D011565:Psoriasis / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*; D011788:Quality of Life; D012720:Severity of Illness Index
D007166:Immunosuppressive Agents; D000068800:Etanercept