Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis

Investigator's global assessment

a 11-point scale ranging from -5 (obvious aggravation) to 5(marked improvement) points.

Time frame: up to 12 weeks

Prurigo Activity Score

The PAS is a 7-item questionnaire evaluating the type, distribution and size of pruriginous lesions, the representative body area and exact number of lesions, the activity in the terms of percentage of pruriginous lesions with excoriations/crusts on top and the percentage of healed pruriginous lesions, which is proved to be a useful tool to objectively measure PN patients over time.

Time frame: up to 12 weeks

Visual analogue scale (VAS) at week 12

The VAS is a visual scale for itch on a horizontal 10-cm line, on which the left end is marked as "no itch" and the right end is marked "worst imaginable itch". We defined the average pruritus of the past 24 hours as VAS24h, average, and the worst and average pruritus of the past 4 weeks as VAS4w, worst and VAS4w, average.

Time frame: up to 12 weeks

Numeric rating scale at week 12

The NRS is a similar tool for the measurement of itch ranging from 0 (no itch) to 10 (unbearable itch). Similarly, we defined the average and worst pruritus of the past 24 hours using NRS as NRS24h, average and NRS24h, worst.

Time frame: up to 12 weeks

Verbal rating scale (VRS) at week 12

The VRS is a 5-point questionnaire that indicated different itching intensities as follows: 0=none; 1=mild; 2=moderate; 3=severe; 4= very severe. The VRS24h, average, VRS24h, worst and VRSevening represented 24-hour average, worst as well as average evening pruritus by VRS.

Time frame: up to 12 weeks

Dermatology Life Quality Index (DLQI) at week 12

The DLQI is a questionnaire with scores ranging from 0 to 30. The total scores of 30 points represent the worst possible quality of life due to pruritus and a change of the score of ≥4 points is considered to be clinically important.