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
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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. / Feldman, Steven R; Thaçi, Diamant; Gooderham, Melinda; Augustin, Matthias; de la Cruz, Claudia; Mallbris, Lotus; Buonanno, Marjorie; Tatulych, Svitlana; Kaur, Mandeep; Lan, Shuping; Valdez, Hernan; Mamolo, Carla.
in: J AM ACAD DERMATOL, Jahrgang 75, Nr. 6, 12.2016, S. 1162-1170.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - 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
AU - Feldman, Steven R
AU - Thaçi, Diamant
AU - Gooderham, Melinda
AU - Augustin, Matthias
AU - de la Cruz, Claudia
AU - Mallbris, Lotus
AU - Buonanno, Marjorie
AU - Tatulych, Svitlana
AU - Kaur, Mandeep
AU - Lan, Shuping
AU - Valdez, Hernan
AU - Mamolo, Carla
N1 - Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
PY - 2016/12
Y1 - 2016/12
N2 - 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.
AB - 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.
U2 - 10.1016/j.jaad.2016.07.040
DO - 10.1016/j.jaad.2016.07.040
M3 - SCORING: Journal article
C2 - 27692733
VL - 75
SP - 1162
EP - 1170
JO - J AM ACAD DERMATOL
JF - J AM ACAD DERMATOL
SN - 0190-9622
IS - 6
ER -
