{Reference Type}: Clinical Trial, Phase II
{Title}: The relationship between pruritus and the clinical signs of psoriasis in patients receiving tofacitinib.
{Author}: Bushmakin AG;Mamolo C;Cappelleri JC;Stewart M;
{Journal}: J Dermatolog Treat
{Volume}: 26
{Issue}: 1
{Year}: Feb 2015
{Factor}: 3.23
{DOI}: 10.3109/09546634.2013.861891
{Abstract}: <B>OBJECTIVE: </B>Tofacitinib is a novel, oral Janus kinase inhibitor being investigated for psoriasis. This study assessed the relationship between pruritus and clinical signs of psoriasis (assessed by Physician's Global Assessment [PGA]) in patients with moderate-to-severe chronic plaque psoriasis receiving tofacitinib.<BR><B>METHODS: </B>In this 16-week (12-week treatment period, 4-week observation period), double-blind, placebo-controlled, phase IIb study (NCT00678210), 197 patients were randomized to tofacitinib 2, 5 or 15 mg BID, or placebo. Pruritus was patient assessed using the Itch Severity Score (ISS), a 0-10 (10=worst itching) rating scale recorded daily from baseline to week 2 and at study visits. Mediation modeling was used to determine relationships between ISS (average score weeks 2-12), PGA (average score weeks 2-12) and treatment groups.<BR><B>RESULTS: </B>Mediation analysis showed that 70.2-80.5% (p<0.001 versus placebo) of tofacitinib's effect on pruritus was direct, and mostly independent of improvements in erythema, induration and scaling. ISS measurements had acceptable test-retest reliability. Correlation analyses with clinical outcomes supported the validity of the ISS as a pruritus measure.<BR><B>CONCLUSIONS: </B>Tofacitinib has a direct, beneficial effect on patient-reported pruritus independent from improvements in clinician-reported psoriasis severity signs. The ISS demonstrated favorable psychometric characteristics, supporting its use as a pruritus assessment tool.