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

Author:

Goteti Kosalaram1ORCID,French Jonathan2ORCID,Garcia Ramon2,Li Ying1,Casset‐Semanaz Florence1,Aydemir Aida1,Townsend Robert1,Mateo Cristina Vazquez1,Studham Matthew1,Guenther Oliver3,Kao Amy1,Gastonguay Marc2ORCID,Girard Pascal4,Benincosa Lisa1,Venkatakrishnan Karthik1ORCID

Affiliation:

1. EMD Serono Research and Development Institute, Inc (an affiliate of Merck KGaA, Darmstadt Germany) Billerica Massachusetts USA

2. Metrum Research Group Tariffville Connecticut USA

3. Merck KGaA Darmstadt Germany

4. Merck Institute of Pharmacometrics Lausanne Switzerland

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Reference49 articles.

1. Measures of adult systemic lupus erythematosus: updated version of British Isles lupus assessment group (BILAG 2004), European consensus lupus activity measurements (ECLAM), systemic lupus activity measure, revised (SLAM‐R), systemic lupus activity questionnaire for population studies (SLAQ), systemic lupus erythematosus disease activity index 2000 (SLEDAI‐2K), and systemic lupus international collaborating clinics/American College of Rheumatology Damage Index (SDI);Romero‐Diaz J;Arthritis Care Res,2011

2. The Systemic Lupus Erythematosus Responder Index (SRI); A new SLE disease activity assessment

3. What Does It Mean to Be a British Isles Lupus Assessment Group–Based Composite Lupus Assessment Responder? Post Hoc Analysis of Two Phase III Trials

4. Definition and initial validation of a Lupus Low Disease Activity State (LLDAS)

5. A critical review of clinical trials in systemic lupus erythematosus

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