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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 340-345 |
| Number of pages | 6 |
| Journal | Acta Dermato-Venereologica |
| Volume | 98 |
| Issue number | 3 |
| DOIs | |
| State | Published - Jan 1 2018 |
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Keywords
- Clinically important difference
- Itch severity item
- Patient global assessment
- Pruritus
- Psoriasis
- Tofacitinib
ASJC Scopus subject areas
- Dermatology
Cite this
Validation of the itch severity item as a measurement tool for pruritus in patients with psoriasis : Results from a phase 3 tofacitinib program. / Ständer, Sonja; Luger, Thomas A.; Cappelleri, Joseph C.; Bushmakin, Andrew G.; Mamolo, Carla; Zielinski, Michael A.; Tallman, Anna M.; Yosipovitch, Gil.
In: Acta Dermato-Venereologica, Vol. 98, No. 3, 01.01.2018, p. 340-345.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Validation of the itch severity item as a measurement tool for pruritus in patients with psoriasis
T2 - Results from a phase 3 tofacitinib program
AU - Ständer, Sonja
AU - Luger, Thomas A.
AU - Cappelleri, Joseph C.
AU - Bushmakin, Andrew G.
AU - Mamolo, Carla
AU - Zielinski, Michael A.
AU - Tallman, Anna M.
AU - Yosipovitch, Gil
PY - 2018/1/1
Y1 - 2018/1/1
N2 - 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.
AB - 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.
KW - Clinically important difference
KW - Itch severity item
KW - Patient global assessment
KW - Pruritus
KW - Psoriasis
KW - Tofacitinib
UR - http://www.scopus.com/inward/record.url?scp=85043339333&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85043339333&partnerID=8YFLogxK
U2 - 10.2340/00015555-2856
DO - 10.2340/00015555-2856
M3 - Article
VL - 98
SP - 340
EP - 345
JO - Acta Dermato-Venereologica
JF - Acta Dermato-Venereologica
SN - 0001-5555
IS - 3
ER -