Disease trajectory of SLE clinical endpoints and covariates affecting disease severity and probability of response: Analysis of pooled patient‐level placebo (Standard‐of‐Care) data to enable model‐informed drug development

Autor: Kosalaram Goteti, Jonathan French, Ramon Garcia, Ying Li, Florence Casset‐Semanaz, Aida Aydemir, Robert Townsend, Cristina Vazquez Mateo, Matthew Studham, Oliver Guenther, Amy Kao, Marc Gastonguay, Pascal Girard, Lisa Benincosa, Karthik Venkatakrishnan

Publikováno v: CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 2, Pp 180-195 (2023)

Abstract Systemic lupus erythematosus (SLE) is an autoimmune disease affecting multiple organ systems. Many investigational agents have failed or shown only modest effects when added to standard of care (SoC) therapy in placebo‐controlled trials, a

Externí odkaz: https://doaj.org/article/1557da4204d843a4921890da95fb3dbf

Disease trajectory of SLE clinical endpoints and covariates affecting disease severity and probability of response: Analysis of pooled patient-level placebo (Standard-of-Care) data to enable model-informed drug development

Autor: Kosalaram, Goteti, Jonathan, French, Ramon, Garcia, Ying, Li, Florence, Casset-Semanaz, Aida, Aydemir, Robert, Townsend, Cristina Vazquez, Mateo, Matthew, Studham, Oliver, Guenther, Amy, Kao, Marc, Gastonguay, Pascal, Girard, Lisa, Benincosa, Karthik, Venkatakrishnan

Publikováno v: CPT: pharmacometricssystems pharmacologyREFERENCES.

Systemic lupus erythematosus (SLE) is an autoimmune disease affecting multiple organ systems. Many investigational agents have failed or shown only modest effects when added to standard of care (SoC) therapy in placebo-controlled trials, and only two

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::cdadda618742743f6173b6ca6542dbca
https://pubmed.ncbi.nlm.nih.gov/36350330

Comparison of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event suggestive of multiple sclerosis (REFLEX): a phase 3 randomised controlled trial

Autor: Frederik Barkhof, Chris H. Polman, Brian Hennessy, Giancarlo Comi, Nicola De Stefano, Bernard M. J. Uitdehaag, B Stubinski, Mark S. Freedman, Margaretha Stam Moraga, Florence Casset-Semanaz, Ludwig Kappos, Sanda Rocak

Publikováno v: Comi, G, De Stefano, N, Freedman, M S, Barkhof, F, Polman, C H, Uitdehaag, B M J, Casset-Semanaz, F, Hennessy, B, Moraga, M S, Rocak, S, Stubinski, B & Kappos, L 2012, ' Comparison of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event suggestive of multiple sclerosis (REFLEX): a phase 3 randomised controlled trial ', Lancet Neurology, vol. 11, no. 1, pp. 33-41 . https://doi.org/10.1016/S1474-4422(11)70262-9
Lancet Neurology, 11(1), 33-41. Lancet Publishing Group

In patients presenting with a first clinical demyelinating event that is suggestive of multiple sclerosis (MS), treatment with interferon beta can delay the occurrence of further attacks and the onset of MS. We investigated the effects of two dosing

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b46e008a3b48bad23393b0c2d58a7095
https://doi.org/10.1016/s1474-4422(11)70262-9

Factors influencing long-term outcomes in relapsing-remitting multiple sclerosis: PRISMS-15

Autor: Bernard M. J. Uitdehaag, Marcelo Kremenchutzky, Elisabetta Verdun di Cantogno, Juha Multanen, Peter Cornelisse, Lorenz Lehr, Delphine Issard, Jens Kuhle, Ludwig Kappos, Florence Casset-Semanaz

Publikováno v: Journal of Neurology, Neurosurgery and Psychiatry, 86(11), 1202-1207. BMJ Publishing Group
Kappos, L, Kuhle, J, Multanen, J, Kremenchutzky, M, di Cantogno, E V, Cornelisse, P, Lehr, L, Casset-Semanaz, F, Issard, D & Uitdehaag, B M J 2015, ' Factors influencing long-term outcomes in relapsing-remitting multiple sclerosis: PRISMS-15 ', Journal of Neurology, Neurosurgery and Psychiatry, vol. 86, no. 11, pp. 1202-1207 . https://doi.org/10.1136/jnnp-2014-310024

AimAn exploratory study of the relationship between cumulative exposure to subcutaneous (sc) interferon (IFN) β-1a treatment and other possible prognostic factors with long-term clinical outcomes in relapsing–remitting multiple sclerosis (RRMS).Me

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::98e98ce162892644bde9c3d356288be1
https://research.vumc.nl/en/publications/cb3899f8-f220-4a9c-ad91-4361a4dc7519

Du bon usage des tests dans les essays cliniques

Autor: Chrystel Jouan-Flahault, Pascal Minini, Florence Casset-Semanaz

Publikováno v: médecine/sciences. 20:231-235

Les inferences multiples sont presentes dans de nombreux essais cliniques et soulevent des problemes d’analyse et d’interpretation si elles ne sont pas correctement prises en compte. L’ecueil a eviter est de considerer a tort l’existence d’

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0dcd7516fab0647363dbc4e8bb666392
https://doi.org/10.1051/medsci/2004202231