Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial

HI Brunner, C Abud-Mendoza, DO Viola… - Annals of the …, 2020 - ard.bmj.com
Objectives This ongoing Phase-2, randomised, placebo-controlled, double-blind study
evaluated the efficacy, safety and pharmacokinetics of intravenous belimumab in childhood …

Methods and strategies for assessing uncontrolled drug–drug interactions in population pharmacokinetic analyses: results from the International Society of …

PL Bonate, M Ahamadi, N Budha, A de la Pena… - … of pharmacokinetics and …, 2016 - Springer
The purpose of this work was to present a consolidated set of guidelines for the analysis of
uncontrolled concomitant medications (ConMed) as a covariate and potential perpetrator in …

Population pharmacokinetics of belimumab following intravenous administration in patients with systemic lupus erythematosus

H Struemper, C Chen, W Cai - The Journal of Clinical …, 2013 - Wiley Online Library
The population pharmacokinetics (PK) of belimumab were characterized in 1,603 patients
with systemic lupus erythematosus receiving belimumab 1, 4, 10, or 20 mg/kg doses in …

Chemoimmunotherapy using pegylated liposomal doxorubicin and interleukin-18 in recurrent ovarian cancer: a phase I dose-escalation study

F Simpkins, A Flores, C Chu, JS Berek, J Lucci III… - Cancer immunology …, 2013 - AACR
Abstract Recombinant interleukin (IL)-18 (SB-485232) is an immunostimulatory cytokine,
with shown antitumor activity in combination with pegylated liposomal doxorubicin (PLD) in …

Abstract CT150: A first-in-human phase I study of the OX40 agonist GSK3174998 (GSK998)+/-pembrolizumab in patients (Pts) with selected advanced solid tumors …

S Postel-Vinay, VK Lam, W Ros, TM Bauer, AR Hansen… - Cancer Research, 2020 - AACR
Background: OX40 is a costimulatory receptor transiently expressed on the surface of
activated T cells and some innate immune cells (eg NK cells). OX40 agonists have been …

A dose-escalation study of recombinant human interleukin-18 in combination with rituximab in patients with non-Hodgkin lymphoma

MJ Robertson, J Kline, H Struemper… - Journal of …, 2013 - journals.lww.com
Abstract Interleukin-18 (IL-18) is an immunostimulatory cytokine with antitumor activity in
preclinical models. Rituximab is a CD20 monoclonal antibody with activity against human B …

Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis

H Struemper, M Sale, BR Patel… - The Journal of …, 2014 - Wiley Online Library
Ofatumumab is a human monoclonal antibody directed at CD20 approved for treatment of
chronic lymphocytic leukemia. The population pharmacokinetics of intravenous ofatumumab …

[HTML][HTML] Population pharmacokinetic and pharmacodynamic analysis of belimumab administered subcutaneously in healthy volunteers and patients with systemic …

H Struemper, M Thapar, D Roth - Clinical pharmacokinetics, 2018 - Springer
Background Intravenous belimumab 10 mg/kg every 4 weeks is indicated in patients with
active, autoantibody-positive systemic lupus erythematosus receiving standard systemic …

Efficacy and safety of intravenous belimumab in Japanese patients with systemic lupus erythematosus: a subgroup analysis of a phase 3 randomized placebo …

Y Tanaka, D Bass, M Chu, S Egginton, B Ji… - Modern …, 2019 - academic.oup.com
Objectives: To assess the efficacy and safety of intravenous (IV) belimumab plus standard
systemic lupus erythematosus (SLE) therapy standard of care (SoC) in Japanese patients …

Reductions in circulating B cell subsets and immunoglobulin G levels with long-term belimumab treatment in patients with SLE

H Struemper, M Kurtinecz, L Edwards… - Lupus science & …, 2022 - lupus.bmj.com
Objective To examine the long-term changes in circulating B cell subsets and IgG levels at
5+ years of continuous belimumab treatment and their correlations with efficacy and safety …