Confirmatory Population Pharmacokinetic Analysis for Sirukumab, a Human Monoclonal Antibody Targeting Interleukin‐6, in Patients With Moderately to Severely Active Rheumatoid Arthritis

No abstract is available for this paper.

• Publication year

  2018

• Venue

  Journal of clinical pharmacology

• Publication date

  2018-07-01

• Fields of study

  Medicine

• Identifiers
  DOI 10.1002/jcph.1101PMID 29578578
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

• Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled, parallel-group, multinational, phase 3 study.

  2017cited by this paper
• Sirukumab for rheumatoid arthritis: the phase III SIRROUND-D study

  2017cited by this paper
• Absolute Bioavailability and Pharmacokinetic Comparability of Sirukumab Following Subcutaneous Administration by a Prefilled Syringe or an Autoinjector

  2017cited by this paper
• Profile of sarilumab and its potential in the treatment of rheumatoid arthritis

  2017cited by this paper
• Sirukumab: a promising therapy for rheumatoid arthritis

  2017cited by this paper
• Efficacy and Safety of Monotherapy with Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Compared with Adalimumab Monotherapy in Biologic-Naive Patients with Active Rheumatoid Arthritis: Results of a Global, Randomized, Double-Blind, Parallel-Group, Phase 3 Study

  2016cited by this paper
• Monoclonal Antibody Pharmacokinetics in Type 2 Diabetes Mellitus and Diabetic Nephropathy

  2016influential reference
• Minimal physiologically-based pharmacokinetic (mPBPK) model for a monoclonal antibody against interleukin-6 in mice with collagen-induced arthritis

  2016cited by this paper
• The mechanism of action of tofacitinib - an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis.

  2016cited by this paper
• Rheumatoid arthritis

  2016cited by this paper
• 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis

  2016cited by this paper
• American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis

  2015cited by this paper
• Tocilizumab for treating rheumatoid arthritis: an evaluation of pharmacokinetics/pharmacodynamics and clinical efficacy

  2015cited by this paper
• Confirmatory population pharmacokinetic analysis for bapineuzumab phase 3 studies in patients with mild to moderate Alzheimer's disease

  2015cited by this paper
• Tocilizumab in the treatment of rheumatoid arthritis and beyond

  2014cited by this paper
• Latent variable indirect response joint modeling of a continuous and a categorical clinical endpoint

  2014cited by this paper
• Sirukumab, a human anti-interleukin-6 monoclonal antibody: a randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy

  2014cited by this paper
• Pharmacokinetics and safety of sirukumab following a single subcutaneous administration to healthy Japanese and Caucasian subjects.

  2013cited by this paper
• Confirmatory analysis for phase III population pharmacokinetics

  2011cited by this paper
• Pharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab) in healthy subjects in a first-in-human study.

  2011cited by this paper
• Population Pharmacokinetics of Therapeutic Monoclonal Antibodies

  2010influential reference
• Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies

  2010influential reference
• Population Pharmacokinetic Modeling of Ustekinumab, a Human Monoclonal Antibody Targeting IL‐12/23p40, in Patients With Moderate to Severe Plaque Psoriasis

  2009cited by this paper
• An Improved Approach for Confirmatory Phase III Population Pharmacokinetic Analysis

  2008cited by this paper
• Ways to Fit a PK Model with Some Data Below the Quantification Limit

  2001influential reference
• Learning versus confirming in clinical drug development

  1997influential reference
• Interleukin-6 in biology and medicine.

  1993cited by this paper
• [Rheumatoid arthritis].

  1983cited by this paper

• Combination Therapy With Guselkumab and Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis: Pharmacokinetics, Immunogenicity and Drug–Drug Interactions

  2024cites this paper
• Impact of Chronic Inflammatory Diseases on Clinical Pharmacokinetics of Antibody‐Based Therapeutic Proteins

  2024cites this paper
• Integrated Population Pharmacokinetic Analysis of Ustekinumab Across Multiple Immune-Mediated Inflammatory Disease Populations and Healthy Subjects

  2022cites this paper
• Population pharmacokinetics analysis of guselkumab in healthy subjects and patients with psoriatic arthritis, plaque psoriasis and palmoplantar pustulosis

  2022cites this paper
• Population Pharmacokinetics and Exposure‐Response Modeling Analyses of Ustekinumab in Adults With Moderately to Severely Active Ulcerative Colitis

  2020cites this paper
• Pharmacokinetic Variability of Therapeutic Antibodies in Humans: A Comprehensive Review of Population Pharmacokinetic Modeling Publications

  2020cites this paper
• Exposure‐Response Modeling Analyses for Sirukumab, a Human Monoclonal Antibody Targeting Interleukin 6, in Patients With Moderately to Severely Active Rheumatoid Arthritis

  2018cites this paper
• Population Pharmacokinetics and Exposure‐Response Modeling Analyses of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

  2018cites this paper