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Validation of the Itch Severity Item as a Measurement Tool for Pruritus in Patients with Psoriasis: Results from a Phase 3 Tofacitinib Program.
- Source :
-
Acta dermato-venereologica [Acta Derm Venereol] 2018 Mar 13; Vol. 98 (3), pp. 340-345. - Publication Year :
- 2018
-
Abstract
- Tofacitinib is an oral Janus kinase inhibitor. This post-hoc analysis aimed to investigate the psychometric properties of the Itch Severity Item (ISI), a numeric rating scale from 0 (no itching) to 10 (worst possible itching) for pruritus in psoriasis, and review the effect of tofacitinib on pruritus in patients with psoriasis participating in Phase 3 studies (N = 3,641). The ISI showed high test-retest reliability (intra-class correlation coefficient: 0.84). The clinically important difference was defined as a 1.48-point change, using Patient Global Assessment as an anchor. Mean changes from baseline in ISI scores with tofacitinib were significantly greater than placebo by Day 2 and exceeded the clinically important difference by Week 4 and Week 2 for tofacitinib 5 and 10 mg twice daily, respectively. The sound psychometric properties of the ISI as an assessment tool for pruritus in psoriasis were confirmed. Tofacitinib provided clinically meaningful improvements in psoriatic pruritus versus placebo.
- Subjects :
- Clinical Trials, Phase III as Topic
Humans
Predictive Value of Tests
Pruritus etiology
Psoriasis complications
Psychometrics
Randomized Controlled Trials as Topic
Remission Induction
Reproducibility of Results
Severity of Illness Index
Time Factors
Treatment Outcome
Antipruritics therapeutic use
Piperidines therapeutic use
Pruritus diagnosis
Pruritus prevention & control
Psoriasis diagnosis
Psoriasis drug therapy
Pyrimidines therapeutic use
Pyrroles therapeutic use
Surveys and Questionnaires
Subjects
Details
- Language :
- English
- ISSN :
- 1651-2057
- Volume :
- 98
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Acta dermato-venereologica
- Publication Type :
- Academic Journal
- Accession number :
- 29182790
- Full Text :
- https://doi.org/10.2340/00015555-2856