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Tofacitinib improves pruritus and health-related quality of life up to 52 weeks: Results from 2 randomized phase III trials in patients with moderate to severe plaque psoriasis - 14/11/16

Doi : 10.1016/j.jaad.2016.07.040 
Steven R. Feldman, MD, PhD a, Diamant Thaçi, MD, PhD b, Melinda Gooderham, MD, MSc c, Matthias Augustin, MD d, Claudia de la Cruz, MD e, Lotus Mallbris, MD, PhD f, , Marjorie Buonanno, MSN g, Svitlana Tatulych, MD g, Mandeep Kaur, MD, MS f, Shuping Lan, MS, MPH g, Hernan Valdez, MD h, Carla Mamolo, PhD g,
a Wake Forest University School of Medicine, Winston-Salem, North Carolina 
b Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany 
c Skin Center for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada 
d Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany 
e Clinica Dermacross, Santiago, Chile 
f Pfizer Inc, Collegeville, Pennsylvania 
g Pfizer Inc, Groton, Connecticut 
h Pfizer Inc, New York, New York 

Reprint requests: Carla Mamolo, PhD, Pfizer Inc, 445 Eastern Point Rd, Groton, CT 06340.Pfizer Inc445 Eastern Point RdGrotonCT06340

Abstract

Background

Tofacitinib is an oral Janus kinase inhibitor that improves clinical measures of psoriasis.

Objective

We sought to assess patient-reported outcomes in tofacitinib-treated patients with moderate to severe plaque psoriasis over 52 weeks.

Methods

In 2 identical, phase III studies (Oral treatment for Psoriasis Trial Pivotal 1 [NCT01276639], n = 901, and Pivotal 2 [NCT01309737], n = 960), patients were randomized 2:2:1 to receive 5 or 10 mg of tofacitinib or placebo, twice daily. At week 16, placebo-treated patients were re-randomized to tofacitinib. Dermatology Life Quality Index score, Itch Severity Item score, Patient Global Assessment score, and patient satisfaction were assessed.

Results

Baseline Dermatology Life Quality Index score indicated substantial health-related quality of life impairment. At week 16, a greater proportion of patients achieved Dermatology Life Quality Index score of 1 or less (no effect of psoriasis on health-related quality of life) with tofacitinib 5 and 10 mg twice daily versus placebo (Oral treatment for Psoriasis Trial Pivotal 1/2: 26.7%/28.6% and 40.2%/48.2% vs 4.6%/6.0%, respectively; P < .0001); improvements were maintained through week 52. Similar patterns were observed with Patient Global Assessment. Improvements in itch were particularly rapid, observed 1 day after treatment initiation for both tofacitinib doses versus placebo (P < .05). At week 16, more patients were satisfied with tofacitinib versus placebo (P < .0001).

Limitations

Clinical nonresponders discontinued at week 28.

Conclusions

Tofacitinib demonstrated improvement in health-related quality of life and patient-reported symptoms that persisted over 52 weeks.

Le texte complet de cet article est disponible en PDF.

Key words : health-related quality of life, patient-reported outcomes, plaque psoriasis, pruritus, tofacitinib, treatment satisfaction

Abbreviations used : BID, DLQI, FAS, HRQoL, ISI, JPA, OPT, OPT 1, OPT 2, PASI, PGA, PRO, PtGA


Plan


 This study was sponsored by Pfizer Inc. Editorial support was provided by Alice Palmer, PhD, of Complete Medical Communications and was funded by Pfizer Inc.
 Disclosure: Dr Feldman has participated in advisory boards for AbbVie, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, and Pfizer Inc; has served as a consultant for AbbVie, Amgen, Celgene, Eli Lilly, Galderma, Mylan, Novartis, and Pfizer Inc; and is a member of the speaker's bureau for Celgene, Janssen, and Novartis. Dr Thaçi has served as a consultant, investigator, and speaker, and has participated in advisory boards for AbbVie, Amgen, Baxalta, Biogen-Idec, Celgene, Dignity, Eli Lilly, Janssen, Leo Pharma, MSD, Novartis, Pfizer Inc, UCB, and Xenoport; and has received research/educational grants from AbbVie, Novartis, and Pfizer Inc. Dr Gooderham has participated in advisory boards for AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, and Pfizer Inc; has served as a consultant for Kyowa Hakko Kirin; has received research grants from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Kyowa Hakko Kirin, Leo Pharma, Merck, Novartis, Pfizer Inc, and Takeda; and is a member of the speaker's bureau for AbbVie, Amgen, Celgene, Eli Lilly, Janssen, and Novartis. Dr Augustin has received grants and/or honoraria as a consultant, speaker, and/or advisory board member from AbbVie, Almirall, Amgen, Astellas, Biogen, Celgene, Eli Lilly, Janssen, Leo Pharma, Merck, MSD, Mundipharma, Novartis, Pfizer Inc, Pohl-Boskamp, UCB, and Xenoport. Dr de la Cruz has participated in advisory boards for AbbVie, Janssen, Novartis, and Pfizer Inc; has received research grants from AbbVie, Eli Lilly, and Pfizer Inc; and is a member of the speaker's bureau for AbbVie and Novartis. Dr Mallbris is a previous employee of Pfizer Inc. Ms Buonanno; Drs Tatulych, Kaur, Valdez, and Mamolo; and Ms Lan are employees and shareholders of Pfizer Inc.
 Supplemental materials are available at www.jaad.org.


© 2016  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 75 - N° 6

P. 1162 - décembre 2016 Retour au numéro
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