Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients.

Autor:	Orbai AM; From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA. aorbai1@jhmi.edu.; A.M. Orbai has received grant support and consulting fees from Novartis. I.B. McInnes has received consulting fees from Novartis. L.C. Coates has received grant support, consulting fees, and speakers bureau fees from Novartis. D.D. Gladman has received grant support and consulting fees from Novartis. L. Gossec has received consulting fees from Novartis. L. Pricop, O. Chambenoit, and X. Meng are employees and stockholders of Novartis. P.J. Mease has received research grants, consulting fees, and speakers bureau fees from Novartis. aorbai1@jhmi.edu.; A.M. Orbai, MD, MHS, Johns Hopkins University School of Medicine; I.B. McInnes, MD, PhD, University of Glasgow; L.C. Coates, MBChB, PhD, University of Oxford; M.E. Husni, MD, MPH, Cleveland Clinic; D.D. Gladman, MD, FRCPC, Toronto Western Research Institute and University of Toronto; L. Gossec, MD, PhD, Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Pitié Salpêtrière Hospital, AP-HP; L. Pricop, MD, Novartis Pharmaceuticals Corp.; O. Chambenoit, PhD, Novartis Pharmaceuticals Corp.; X. Meng, PhD, Novartis Pharmaceuticals Corp.; P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington. aorbai1@jhmi.edu., McInnes IB; From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.; A.M. Orbai has received grant support and consulting fees from Novartis. I.B. McInnes has received consulting fees from Novartis. L.C. Coates has received grant support, consulting fees, and speakers bureau fees from Novartis. D.D. Gladman has received grant support and consulting fees from Novartis. L. Gossec has received consulting fees from Novartis. L. Pricop, O. Chambenoit, and X. Meng are employees and stockholders of Novartis. P.J. Mease has received research grants, consulting fees, and speakers bureau fees from Novartis.; A.M. Orbai, MD, MHS, Johns Hopkins University School of Medicine; I.B. McInnes, MD, PhD, University of Glasgow; L.C. Coates, MBChB, PhD, University of Oxford; M.E. Husni, MD, MPH, Cleveland Clinic; D.D. Gladman, MD, FRCPC, Toronto Western Research Institute and University of Toronto; L. Gossec, MD, PhD, Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Pitié Salpêtrière Hospital, AP-HP; L. Pricop, MD, Novartis Pharmaceuticals Corp.; O. Chambenoit, PhD, Novartis Pharmaceuticals Corp.; X. Meng, PhD, Novartis Pharmaceuticals Corp.; P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington., Coates LC; From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.; A.M. Orbai has received grant support and consulting fees from Novartis. I.B. McInnes has received consulting fees from Novartis. L.C. Coates has received grant support, consulting fees, and speakers bureau fees from Novartis. D.D. Gladman has received grant support and consulting fees from Novartis. L. Gossec has received consulting fees from Novartis. L. Pricop, O. Chambenoit, and X. Meng are employees and stockholders of Novartis. P.J. Mease has received research grants, consulting fees, and speakers bureau fees from Novartis.; A.M. Orbai, MD, MHS, Johns Hopkins University School of Medicine; I.B. McInnes, MD, PhD, University of Glasgow; L.C. Coates, MBChB, PhD, University of Oxford; M.E. Husni, MD, MPH, Cleveland Clinic; D.D. Gladman, MD, FRCPC, Toronto Western Research Institute and University of Toronto; L. Gossec, MD, PhD, Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Pitié Salpêtrière Hospital, AP-HP; L. Pricop, MD, Novartis Pharmaceuticals Corp.; O. Chambenoit, PhD, Novartis Pharmaceuticals Corp.; X. Meng, PhD, Novartis Pharmaceuticals Corp.; P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington., Husni ME; From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.; A.M. Orbai has received grant support and consulting fees from Novartis. I.B. McInnes has received consulting fees from Novartis. L.C. Coates has received grant support, consulting fees, and speakers bureau fees from Novartis. D.D. Gladman has received grant support and consulting fees from Novartis. L. Gossec has received consulting fees from Novartis. L. Pricop, O. Chambenoit, and X. Meng are employees and stockholders of Novartis. P.J. Mease has received research grants, consulting fees, and speakers bureau fees from Novartis.; A.M. Orbai, MD, MHS, Johns Hopkins University School of Medicine; I.B. McInnes, MD, PhD, University of Glasgow; L.C. Coates, MBChB, PhD, University of Oxford; M.E. Husni, MD, MPH, Cleveland Clinic; D.D. Gladman, MD, FRCPC, Toronto Western Research Institute and University of Toronto; L. Gossec, MD, PhD, Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Pitié Salpêtrière Hospital, AP-HP; L. Pricop, MD, Novartis Pharmaceuticals Corp.; O. Chambenoit, PhD, Novartis Pharmaceuticals Corp.; X. Meng, PhD, Novartis Pharmaceuticals Corp.; P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington., Gladman DD; From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.; A.M. Orbai has received grant support and consulting fees from Novartis. I.B. McInnes has received consulting fees from Novartis. L.C. Coates has received grant support, consulting fees, and speakers bureau fees from Novartis. D.D. Gladman has received grant support and consulting fees from Novartis. L. Gossec has received consulting fees from Novartis. L. Pricop, O. Chambenoit, and X. Meng are employees and stockholders of Novartis. P.J. Mease has received research grants, consulting fees, and speakers bureau fees from Novartis.; A.M. Orbai, MD, MHS, Johns Hopkins University School of Medicine; I.B. McInnes, MD, PhD, University of Glasgow; L.C. Coates, MBChB, PhD, University of Oxford; M.E. Husni, MD, MPH, Cleveland Clinic; D.D. Gladman, MD, FRCPC, Toronto Western Research Institute and University of Toronto; L. Gossec, MD, PhD, Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Pitié Salpêtrière Hospital, AP-HP; L. Pricop, MD, Novartis Pharmaceuticals Corp.; O. Chambenoit, PhD, Novartis Pharmaceuticals Corp.; X. Meng, PhD, Novartis Pharmaceuticals Corp.; P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington., Gossec L; From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.; A.M. Orbai has received grant support and consulting fees from Novartis. I.B. McInnes has received consulting fees from Novartis. L.C. Coates has received grant support, consulting fees, and speakers bureau fees from Novartis. D.D. Gladman has received grant support and consulting fees from Novartis. L. Gossec has received consulting fees from Novartis. L. Pricop, O. Chambenoit, and X. Meng are employees and stockholders of Novartis. P.J. Mease has received research grants, consulting fees, and speakers bureau fees from Novartis.; A.M. Orbai, MD, MHS, Johns Hopkins University School of Medicine; I.B. McInnes, MD, PhD, University of Glasgow; L.C. Coates, MBChB, PhD, University of Oxford; M.E. Husni, MD, MPH, Cleveland Clinic; D.D. Gladman, MD, FRCPC, Toronto Western Research Institute and University of Toronto; L. Gossec, MD, PhD, Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Pitié Salpêtrière Hospital, AP-HP; L. Pricop, MD, Novartis Pharmaceuticals Corp.; O. Chambenoit, PhD, Novartis Pharmaceuticals Corp.; X. Meng, PhD, Novartis Pharmaceuticals Corp.; P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington., Pricop L; From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.; A.M. Orbai has received grant support and consulting fees from Novartis. I.B. McInnes has received consulting fees from Novartis. L.C. Coates has received grant support, consulting fees, and speakers bureau fees from Novartis. D.D. Gladman has received grant support and consulting fees from Novartis. L. Gossec has received consulting fees from Novartis. L. Pricop, O. Chambenoit, and X. Meng are employees and stockholders of Novartis. P.J. Mease has received research grants, consulting fees, and speakers bureau fees from Novartis.; A.M. Orbai, MD, MHS, Johns Hopkins University School of Medicine; I.B. McInnes, MD, PhD, University of Glasgow; L.C. Coates, MBChB, PhD, University of Oxford; M.E. Husni, MD, MPH, Cleveland Clinic; D.D. Gladman, MD, FRCPC, Toronto Western Research Institute and University of Toronto; L. Gossec, MD, PhD, Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Pitié Salpêtrière Hospital, AP-HP; L. Pricop, MD, Novartis Pharmaceuticals Corp.; O. Chambenoit, PhD, Novartis Pharmaceuticals Corp.; X. Meng, PhD, Novartis Pharmaceuticals Corp.; P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington., Chambenoit O; From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.; A.M. Orbai has received grant support and consulting fees from Novartis. I.B. McInnes has received consulting fees from Novartis. L.C. Coates has received grant support, consulting fees, and speakers bureau fees from Novartis. D.D. Gladman has received grant support and consulting fees from Novartis. L. Gossec has received consulting fees from Novartis. L. Pricop, O. Chambenoit, and X. Meng are employees and stockholders of Novartis. P.J. Mease has received research grants, consulting fees, and speakers bureau fees from Novartis.; A.M. Orbai, MD, MHS, Johns Hopkins University School of Medicine; I.B. McInnes, MD, PhD, University of Glasgow; L.C. Coates, MBChB, PhD, University of Oxford; M.E. Husni, MD, MPH, Cleveland Clinic; D.D. Gladman, MD, FRCPC, Toronto Western Research Institute and University of Toronto; L. Gossec, MD, PhD, Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Pitié Salpêtrière Hospital, AP-HP; L. Pricop, MD, Novartis Pharmaceuticals Corp.; O. Chambenoit, PhD, Novartis Pharmaceuticals Corp.; X. Meng, PhD, Novartis Pharmaceuticals Corp.; P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington., Meng X; From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.; A.M. Orbai has received grant support and consulting fees from Novartis. I.B. McInnes has received consulting fees from Novartis. L.C. Coates has received grant support, consulting fees, and speakers bureau fees from Novartis. D.D. Gladman has received grant support and consulting fees from Novartis. L. Gossec has received consulting fees from Novartis. L. Pricop, O. Chambenoit, and X. Meng are employees and stockholders of Novartis. P.J. Mease has received research grants, consulting fees, and speakers bureau fees from Novartis.; A.M. Orbai, MD, MHS, Johns Hopkins University School of Medicine; I.B. McInnes, MD, PhD, University of Glasgow; L.C. Coates, MBChB, PhD, University of Oxford; M.E. Husni, MD, MPH, Cleveland Clinic; D.D. Gladman, MD, FRCPC, Toronto Western Research Institute and University of Toronto; L. Gossec, MD, PhD, Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Pitié Salpêtrière Hospital, AP-HP; L. Pricop, MD, Novartis Pharmaceuticals Corp.; O. Chambenoit, PhD, Novartis Pharmaceuticals Corp.; X. Meng, PhD, Novartis Pharmaceuticals Corp.; P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington., Mease PJ; From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.; A.M. Orbai has received grant support and consulting fees from Novartis. I.B. McInnes has received consulting fees from Novartis. L.C. Coates has received grant support, consulting fees, and speakers bureau fees from Novartis. D.D. Gladman has received grant support and consulting fees from Novartis. L. Gossec has received consulting fees from Novartis. L. Pricop, O. Chambenoit, and X. Meng are employees and stockholders of Novartis. P.J. Mease has received research grants, consulting fees, and speakers bureau fees from Novartis.; A.M. Orbai, MD, MHS, Johns Hopkins University School of Medicine; I.B. McInnes, MD, PhD, University of Glasgow; L.C. Coates, MBChB, PhD, University of Oxford; M.E. Husni, MD, MPH, Cleveland Clinic; D.D. Gladman, MD, FRCPC, Toronto Western Research Institute and University of Toronto; L. Gossec, MD, PhD, Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Pitié Salpêtrière Hospital, AP-HP; L. Pricop, MD, Novartis Pharmaceuticals Corp.; O. Chambenoit, PhD, Novartis Pharmaceuticals Corp.; X. Meng, PhD, Novartis Pharmaceuticals Corp.; P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington.
Jazyk:	angličtina
Zdroj:	The Journal of rheumatology [J Rheumatol] 2020 Jun 01; Vol. 47 (6), pp. 854-864. Date of Electronic Publication: 2019 Oct 15.
DOI:	10.3899/jrheum.190507
Abstrakt:	Objective: To compare the efficacy of secukinumab with that of placebo across the updated Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and Outcome Measures in Rheumatology (GRAPPA-OMERACT) individual psoriatic arthritis (PsA) core domains using pooled data from 4 phase III PsA studies and 1 phase III ankylosing spondylitis (AS) study. Methods: Data were pooled from 2049 patients with PsA participating in 4 on-label phase III PsA studies (FUTURE 2-5), and the efficacy of each GRAPPA-OMERACT PsA core domain (musculoskeletal disease activity, skin disease activity, pain, patient's global assessment, physical function, health-related quality of life, fatigue, and systemic inflammation) was assessed using multiple measures and definitions specific to each domain. The MEASURE 2 study, a phase III clinical trial in patients with AS, was used to assess improvement in spine symptoms at Week 16. Results: Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16. Notably, among patients treated with secukinumab 300 mg, 34.3% and 19.5% achieved complete resolution of swollen and tender joint counts, respectively; 53.2% and 61.5% achieved complete resolution of enthesitis and dactylitis, respectively; and 33.2% achieved 100% improvement in Psoriasis Area and Severity Index (all p < 0.05 vs placebo); similar improvements were shown for all other core domains. Conclusion: This analysis suggests that secukinumab can benefit people with PsA across the clinical phenotypic spectrum commonly encountered in this disease.
Databáze:	MEDLINE
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