OBJECTIVE: To evaluate the effects of etanercept treatment on patient-reported outcomes (PRO) in patients with psoriatic arthritis (PsA). METHODS: A 24-week double-blind comparison to placebo was followed by a 48-week open-label phase in which all eligible patients received etanercept. PRO were measured using the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), the Medical Outcomes Study Short-Form (SF-36), the EQ-5D visual analog scale (VAS), and the American College of Rheumatology (ACR) patient pain assessment. RESULTS: Beginning at Week 4 and continuing through Week 24 of double-blind treatment, patients treated with etanercept had significantly higher mean percentage improvement in HAQ-DI relative to baseline than patients given placebo (53.6% vs 6.4% at Week 24; p < 0.001). After 48 weeks of open-label treatment with etanercept, the mean percentage change from study baseline was 52.8% for the original etanercept group and 46.9% for the original placebo group, with 41.2% of patients overall achieving a HAQ-DI of 0. Mean changes relative to baseline for SF-36 physical component summary scores, EQ-5D VAS, and ACR pain assessment were also significant in the double-blind period for etanercept compared with placebo (p < 0.001 for all 3 measures). Patients taking placebo achieved similar improvements once they began treatment with etanercept in the open-label period. CONCLUSION: Patients with PsA treated with etanercept reported significant improvements in physical function that were almost 10 times the improvement seen with placebo and were maintained for up to 2 years. Almost half of patients treated with etanercept reported no disability by the end of the study.
RCT Entities:
OBJECTIVE: To evaluate the effects of etanercept treatment on patient-reported outcomes (PRO) in patients with psoriatic arthritis (PsA). METHODS: A 24-week double-blind comparison to placebo was followed by a 48-week open-label phase in which all eligible patients received etanercept. PRO were measured using the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), the Medical Outcomes Study Short-Form (SF-36), the EQ-5D visual analog scale (VAS), and the American College of Rheumatology (ACR) patientpain assessment. RESULTS: Beginning at Week 4 and continuing through Week 24 of double-blind treatment, patients treated with etanercept had significantly higher mean percentage improvement in HAQ-DI relative to baseline than patients given placebo (53.6% vs 6.4% at Week 24; p < 0.001). After 48 weeks of open-label treatment with etanercept, the mean percentage change from study baseline was 52.8% for the original etanercept group and 46.9% for the original placebo group, with 41.2% of patients overall achieving a HAQ-DI of 0. Mean changes relative to baseline for SF-36 physical component summary scores, EQ-5D VAS, and ACR pain assessment were also significant in the double-blind period for etanercept compared with placebo (p < 0.001 for all 3 measures). Patients taking placebo achieved similar improvements once they began treatment with etanercept in the open-label period. CONCLUSION:Patients with PsA treated with etanercept reported significant improvements in physical function that were almost 10 times the improvement seen with placebo and were maintained for up to 2 years. Almost half of patients treated with etanercept reported no disability by the end of the study.
Authors: Philip Mease; Ernest Choy; Peter Nash; Chrysostomos Kalyvas; Matthias Hunger; Luminita Pricop; Kunal K Gandhi; Steffen M Jugl; Howard Thom Journal: Eur J Rheumatol Date: 2018-07-01
Authors: Jasvinder A Singh; Gordon Guyatt; Alexis Ogdie; Dafna D Gladman; Chad Deal; Atul Deodhar; Maureen Dubreuil; Jonathan Dunham; M Elaine Husni; Sarah Kenny; Jennifer Kwan-Morley; Janice Lin; Paula Marchetta; Philip J Mease; Joseph F Merola; Julie Miner; Christopher T Ritchlin; Bernadette Siaton; Benjamin J Smith; Abby S Van Voorhees; Anna Helena Jonsson; Amit Aakash Shah; Nancy Sullivan; Marat Turgunbaev; Laura C Coates; Alice Gottlieb; Marina Magrey; W Benjamin Nowell; Ana-Maria Orbai; Soumya M Reddy; Jose U Scher; Evan Siegel; Michael Siegel; Jessica A Walsh; Amy S Turner; James Reston Journal: Arthritis Rheumatol Date: 2018-11-30 Impact factor: 10.995
Authors: Jasvinder A Singh; Gordon Guyatt; Alexis Ogdie; Dafna D Gladman; Chad Deal; Atul Deodhar; Maureen Dubreuil; Jonathan Dunham; M Elaine Husni; Sarah Kenny; Jennifer Kwan-Morley; Janice Lin; Paula Marchetta; Philip J Mease; Joseph F Merola; Julie Miner; Christopher T Ritchlin; Bernadette Siaton; Benjamin J Smith; Abby S Van Voorhees; Anna Helena Jonsson; Amit Aakash Shah; Nancy Sullivan; Marat Turgunbaev; Laura C Coates; Alice Gottlieb; Marina Magrey; W Benjamin Nowell; Ana-Maria Orbai; Soumya M Reddy; Jose U Scher; Evan Siegel; Michael Siegel; Jessica A Walsh; Amy S Turner; James Reston Journal: Arthritis Care Res (Hoboken) Date: 2018-11-30 Impact factor: 4.794
Authors: Ia Khmaladze; Tiina Kelkka; Simon Guerard; Kajsa Wing; Angela Pizzolla; Amit Saxena; Katarina Lundqvist; Meirav Holmdahl; Kutty Selva Nandakumar; Rikard Holmdahl Journal: Proc Natl Acad Sci U S A Date: 2014-08-18 Impact factor: 11.205