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
N1 - Funding Information:
Funding: This study was sponsored by Pfizer Inc. Medical writing support was provided by Complete Medical Communications and funded by Pfizer Inc.
Funding Information:
Medical writing support under the guidance of the authors was provided by Christina Viegelmann, PhD, at Complete Medical Communications, Glasgow, UK, and was funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015; 163: 461–464).
Funding Information:
The authors thank the patients and their families, investigators, and study teams involved in OPT Pivotal 1, OPT Pivotal 2, OPT Compare, and OPT Retreatment. The authors would also like to thank Dr Tim Crook of Pfizer Inc for his intellectual input and critical review, during the development of this manuscript. Medical writing support under the guidance of the authors was provided by Christina Viegelmann, PhD, at Complete Medical Communications, Glasgow, UK, and was funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015; 163: 461–464). Funding: This study was sponsored by Pfizer Inc. Medical writing support was provided by Complete Medical Communications and funded by Pfizer Inc. Conflict of interest: SS is a member of the advisory board of, conducted clinical trials for, or received honoraria from Astellas, Beiersdorf, Celgene, Chugai Pharma, Creabilis, Dermasence, Hel-sinn, Kneipp, Menlo Therapeutics, Merz, Nerre, Novartis, Trevi, Vanda, and Ziarco. TL conducted clinical trials for, or received honoraria for serving as a member of the Scientific Advisory Board of, AbbVie, Biogen-IDEC, Celgene, CERIES, Eli Lilly, Galderma, Janssen-Cilag, La Roche Posay, Maruho, Meda, MSD, Mundip-harma, Novartis, Pfizer Inc, Sandoz, Sanofi-Aventis, Symrise, and Wolff. GY conducted clinical trials for, or received honoraria for serving as a member of the Scientific Advisory Board of, Celgene, Eli Lilly, Galderma, Menlo Therapeutics, Novartis, Opko, Pfizer Inc., Regeneron Sanofi, Sienna, and Trevi, and received research funds from Allergan, GSK/Stiefel, the Leo Foundation, and Pfizer Inc. AGB, JCC, CM, MAZ, and AMT are shareholders and employees of Pfizer Inc.
Publisher Copyright:
© 2018 Acta Dermato-Venereologica.
PY - 2018
Y1 - 2018
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
C2 - 29182790
AN - SCOPUS:85043339333
VL - 98
SP - 340
EP - 345
JO - Acta Dermato-Venereologica
JF - Acta Dermato-Venereologica
SN - 0001-5555
IS - 3
ER -