Vibeke Strand1, Philip Mease2, Laure Gossec3, Ori Elkayam4, Filip van den Bosch5, James Zuazo6, Luminita Pricop7, Shephard Mpofu6. 1. Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA. 2. Swedish Medical Center, University of Washington, Seattle, Washington, USA. 3. Department of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), AP-HP, Pitié Salpêtrière Hospital, Paris, France. 4. Department of Rheumatology, Tel Aviv Medical Center, "Sackler" Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 5. Department of Rheumatology, University of Ghent, Ghent, Belgium. 6. Novartis Pharma AG, Basel, Switzerland. 7. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Abstract
OBJECTIVE: To evaluate the effect of secukinumab on patient-reported outcomes (PROs) in subjects with active psoriatic arthritis (PsA) in the FUTURE 1 study. METHODS: Subjects were randomised 1:1:1 to receive intravenous (i.v.) secukinumab 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous secukinumab 150 or 75 mg every 4 weeks or matching placebo until week 24. RESULTS: At week 24, subjects receiving secukinumab i.v.→150 mg or i.v.→75 mg reported greater least squares mean changes from baseline than those receiving placebo in patient global assessment of disease activity (-20.6 and -20.0 vs -7.4, respectively), patient assessment of pain (-20.8 and -20.4 vs -6.7), psoriatic arthritis quality of life (-3.5 and -3.2 vs -0.4), Dermatology Life Quality Index (-8.8 and -7.9 vs 0.7); p<0.0001 vs placebo for both secukinumab groups for above PROs and Functional Assessment of Chronic Illness Therapy-Fatigue (6.74 (p<0.05 vs placebo) and 6.03 vs 4.00); all of which well exceeded minimum clinically important differences. CONCLUSIONS: In subjects with PsA, secukinumab treatment resulted in clinically meaningful improvements in global disease activity, pain, generic and disease-specific measures of health-related quality of life and fatigue. TRIAL REGISTRATION NUMBER: NCT01392326; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
RCT Entities:
OBJECTIVE: To evaluate the effect of secukinumab on patient-reported outcomes (PROs) in subjects with active psoriatic arthritis (PsA) in the FUTURE 1 study. METHODS: Subjects were randomised 1:1:1 to receive intravenous (i.v.) secukinumab 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous secukinumab 150 or 75 mg every 4 weeks or matching placebo until week 24. RESULTS: At week 24, subjects receiving secukinumab i.v.→150 mg or i.v.→75 mg reported greater least squares mean changes from baseline than those receiving placebo in patient global assessment of disease activity (-20.6 and -20.0 vs -7.4, respectively), patient assessment of pain (-20.8 and -20.4 vs -6.7), psoriatic arthritis quality of life (-3.5 and -3.2 vs -0.4), Dermatology Life Quality Index (-8.8 and -7.9 vs 0.7); p<0.0001 vs placebo for both secukinumab groups for above PROs and Functional Assessment of Chronic Illness Therapy-Fatigue (6.74 (p<0.05 vs placebo) and 6.03 vs 4.00); all of which well exceeded minimum clinically important differences. CONCLUSIONS: In subjects with PsA, secukinumab treatment resulted in clinically meaningful improvements in global disease activity, pain, generic and disease-specific measures of health-related quality of life and fatigue. TRIAL REGISTRATION NUMBER: NCT01392326; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Authors: Rieke Alten; P G Conaghan; V Strand; E Sullivan; S Blackburn; H Tian; K Gandhi; S M Jugl; A Deodhar Journal: Clin Rheumatol Date: 2019-02-04 Impact factor: 2.980
Authors: Iain B McInnes; Philip J Mease; Georg Schett; Bruce Kirkham; Vibeke Strand; Nicole Williams; Todd Fox; Luminita Pricop; Steffen M Jugl; Kunal K Gandhi Journal: Arthritis Res Ther Date: 2018-06-07 Impact factor: 5.156
Authors: Giorgio L Colombo; Sergio Di Matteo; Chiara Martinotti; Steffen M Jugl; Praveen Gunda; Mariantonietta Naclerio; Giacomo M Bruno Journal: Clinicoecon Outcomes Res Date: 2018-08-30
Authors: Proton Rahman; Philip J Mease; Philip S Helliwell; Atul Deodhar; Laure Gossec; Arthur Kavanaugh; Alexa P Kollmeier; Elizabeth C Hsia; Bei Zhou; Xiwu Lin; May Shawi; Chetan S Karyekar; Chenglong Han Journal: Arthritis Res Ther Date: 2021-07-14 Impact factor: 5.156
Authors: Iain B McInnes; Philip J Mease; Christopher T Ritchlin; Proton Rahman; Alice B Gottlieb; Bruce Kirkham; Radhika Kajekar; Eumorphia-Maria Delicha; Luminita Pricop; Shephard Mpofu Journal: Rheumatology (Oxford) Date: 2017-11-01 Impact factor: 7.580
Authors: Ana-Maria Orbai; Maarten de Wit; Philip Mease; Judy A Shea; Laure Gossec; Ying Ying Leung; William Tillett; Musaab Elmamoun; Kristina Callis Duffin; Willemina Campbell; Robin Christensen; Laura Coates; Emma Dures; Lihi Eder; Oliver FitzGerald; Dafna Gladman; Niti Goel; Suzanne Dolwick Grieb; Sarah Hewlett; Pil Hoejgaard; Umut Kalyoncu; Chris Lindsay; Neil McHugh; Bev Shea; Ingrid Steinkoenig; Vibeke Strand; Alexis Ogdie Journal: Ann Rheum Dis Date: 2016-09-09 Impact factor: 19.103