Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy.

Autor: Tortorici MA; CSL Behring, King of Prussia, Pennsylvania, USA., Yuraszeck T; CSL Behring, King of Prussia, Pennsylvania, USA., Cornblath D; Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Bril V; Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Canada.; Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia., Hartung HP; Department of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.; Brain and Mind Centre, University of Sydney, Sydney, Australia.; Medical University of Vienna, Vienna, Austria., Sobue G; Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan., Lewis RA; Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, California, USA., Merkies ISJ; Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.; Curaçao Medical Center, Willemstad, Curaçao., Lawo JP; CSL Behring, Marburg, Germany., Praus M; CSL Behring, Marburg, Germany., Durn BL; CSL Behring, King of Prussia, Pennsylvania, USA., Mielke O; CSL Behring, Marburg, Germany., Ma X; CSL Behring, King of Prussia, Pennsylvania, USA., Jauslin P; Certara, Princeton, New Jersey, USA., Pfister M; University of Basel, Basel, Switzerland., van Schaik IN; Department of Neurology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands.; Spaarne Gasthuis, Haarlem, The Netherlands.

Publikováno v: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2021 Aug; Vol. 10 (8), pp. 839-850. Date of Electronic Publication: 2021 Aug 01.

Placebo effect in chronic inflammatory demyelinating polyneuropathy: The PATH study and a systematic review.

Autor: Lewis RA; Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, California, USA., Cornblath DR; Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Hartung HP; Department of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Heinrich Heine University, Düsseldorf, Germany., Sobue G; Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan., Lawo JP; CSL Behring, Marburg, King of Prussia, Pennsylvania, USA., Mielke O; CSL Behring, Marburg, King of Prussia, Pennsylvania, USA., Durn BL; CSL Behring, Marburg, King of Prussia, Pennsylvania, USA., Bril V; Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada., Merkies ISJ; Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.; Curaçao Medical Center, Willemstad, Curaçao., Bassett P; Meridian HealthComms Ltd, Manchester, UK., Cleasby A; Meridian HealthComms Ltd, Manchester, UK., van Schaik IN; Department of Neurology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.; The Netherlands and Spaarne Gasthuis, Haarlem, The Netherlands.

Publikováno v: Journal of the peripheral nervous system : JPNS [J Peripher Nerv Syst] 2020 Sep; Vol. 25 (3), pp. 230-237. Date of Electronic Publication: 2020 Aug 05.

Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study.

Autor: van Schaik IN; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands., Mielke O; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands., Bril V; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands., van Geloven N; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands., Hartung HP; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands., Lewis RA; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands., Sobue G; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands., Lawo JP; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands., Praus M; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands., Durn BL; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands., Cornblath DR; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands., Merkies ISJ; Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.

Publikováno v: Neurology(R) neuroimmunology & neuroinflammation [Neurol Neuroimmunol Neuroinflamm] 2019 Jul 03; Vol. 6 (5), pp. e590. Date of Electronic Publication: 2019 Jul 03 (Print Publication: 2019).

Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial.

Autor: van Schaik IN; Department of Neurology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands. Electronic address: i.n.vanschaik@amc.uva.nl., Bril V; Department of Medicine (Neurology), University Health Network, University of Toronto, Toronto, ON, Canada., van Geloven N; Department of Biostatistics and Bioinformatics, Leiden University Medical Center, Leiden, Netherlands., Hartung HP; Department of Neurology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany., Lewis RA; Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA., Sobue G; Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan., Lawo JP; CSL Behring, Marburg, Germany., Praus M; CSL Behring, Marburg, Germany., Mielke O; CSL Behring, Marburg, Germany., Durn BL; CSL Behring, King of Prussia, PA, USA., Cornblath DR; Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Merkies ISJ; Department of Neurology, Maastricht University Medical Center, Maastricht, Netherlands.

Publikováno v: The Lancet. Neurology [Lancet Neurol] 2018 Jan; Vol. 17 (1), pp. 35-46. Date of Electronic Publication: 2017 Nov 06.

Safety of a Four-factor Prothrombin Complex Concentrate Versus Plasma for Vitamin K Antagonist Reversal: An Integrated Analysis of Two Phase IIIb Clinical Trials.

Autor: Milling TJ Jr; Seton Clinical Research Institute, Dell University of Texas Medical School, Dell Children's Medical Center, University Medical Center at Brackenridge, Austin, TX., Refaai MA; University of Rochester Medicine, Rochester, NY., Sarode R; UT Southwestern Medical Center, Dallas, TX., Lewis B; St. Joseph Regional Health Center, Bryan, Texas A&M Health Science Center, College Station, TX., Mangione A; CSL Behring, King of Prussia, PA., Durn BL; CSL Behring, King of Prussia, PA., Harman A; CSL Behring, King of Prussia, PA., Lee ML; UCLA School of Public Health, Los Angeles, CA., Goldstein JN; Massachusetts General Hospital, Boston, MA.

Publikováno v: Academic emergency medicine : official journal of the Society for Academic Emergency Medicine [Acad Emerg Med] 2016 Apr; Vol. 23 (4), pp. 466-75. Date of Electronic Publication: 2016 Mar 21.