Steven R Feldman1, Diamant Thaçi2, Melinda Gooderham3, Matthias Augustin4, Claudia de la Cruz5, Lotus Mallbris6, Marjorie Buonanno7, Svitlana Tatulych7, Mandeep Kaur6, Shuping Lan7, Hernan Valdez8, Carla Mamolo9. 1. Wake Forest University School of Medicine, Winston-Salem, North Carolina. 2. Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany. 3. Skin Center for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada. 4. Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 5. Clinica Dermacross, Santiago, Chile. 6. Pfizer Inc, Collegeville, Pennsylvania. 7. Pfizer Inc, Groton, Connecticut. 8. Pfizer Inc, New York, New York. 9. Pfizer Inc, Groton, Connecticut. Electronic address: carla.m.mamolo@pfizer.com.
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, andpatient 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.
RCT Entities:
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.