A5064815302- Endometriosis Research and Treatment
- Rheumatoid Arthritis Research and Therapies
- Uterine Myomas and Treatments
- Chronic Lymphocytic Leukemia Research
- Microscopic Colitis
- Intestinal and Peritoneal Adhesions
- Platelet Disorders and Treatments
- Monoclonal and Polyclonal Antibodies Research
- Systemic Lupus Erythematosus Research
- Pregnancy-related medical research
- Inflammatory Bowel Disease
- Diabetes Treatment and Management
- Immunodeficiency and Autoimmune Disorders
- Parathyroid Disorders and Treatments
- Neonatal Respiratory Health Research
- Biosimilars and Bioanalytical Methods
- Respiratory viral infections research
- Autoimmune Bullous Skin Diseases
- Endometrial and Cervical Cancer Treatments
- Autoimmune and Inflammatory Disorders Research
- Peripheral Neuropathies and Disorders
- Hepatitis B Virus Studies
- Hematopoietic Stem Cell Transplantation
- Gastrointestinal motility and disorders
- Bone health and osteoporosis research
AbbVie (Germany)
2014-2021
AbbVie (United States)
2016-2019
Abbott Fund
2007-2013
Medical University of Silesia
2012
Medical University of Lublin
2012
ChemoCentryx (United States)
2012
Nanjing University
2012
Nanjing General Hospital of Nanjing Military Command
2012
University of Gothenburg
2012
Abbott (Germany)
2009-2011
Upadacitinib is a selective Janus kinase (JAK) 1 inhibitor being developed as an orally administered treatment for patients with moderate to severe rheumatoid arthritis (RA) and other autoimmune disorders. These analyses characterized the population pharmacokinetics of upadacitinib across phase I–III clinical trials using data immediate-release (IR) extended-release (ER) formulations. Pharmacokinetic from 4170 subjects taking IR doses 1–48 mg ER 7.5–30 12 studies spanning trials, total...
Abstract Background Adalimumab is a tumour necrosis factor‐alpha antibody approved for treatment of moderate to severe chronic plaque psoriasis. Objective To characterise population pharmacokinetics adalimumab 40 mg every other week dosing regimen and impact immunogenicity on pharmacokinetics, efficacy safety in psoriasis patients. Methods Patients were enrolled Phase 3 study comprising 16‐week double‐blind, placebo‐controlled period, 17‐week open‐label period Week 16 Psoriasis Area Severity...
Recent guidelines in British Columbia, Canada have suggested that the use of a maximum 3 monthly doses palivizumab 15 mg/kg intramuscularly for RSV immunoprophylaxis high risk infants born prior to season is adequate provide protection against severe disease 5-month season. Efficacy was established, however, with 2 large, randomized controlled clinical studies using 5 immunoprophylaxis. To evaluate differences expected exposures between dosing regimens (3 vs across period), we used...
Exposure–response analyses of upadacitinib (UPA) key efficacy and safety end points (3,685 4,577 subjects for safety, respectively) using data from phase II III rheumatoid arthritis (RA) studies were conducted to support benefit–risk assessment. Percentage achieving American College Rheumatology (ACR)20/50/70, disease activity score 28 (C‐reactive protein) (DAS28‐CRP) ≤ 3.2, DAS28‐CRP < 2.6 increased with increasing UPA plasma exposures. With the small number observed events, no clear...
Elagolix is a novel oral gonadotropin releasing hormone receptor antagonist, that can suppress estradiol in dose-dependent manner. It indicated for management of moderate-to-severe pain associated with endometriosis. A population exposure-response model describing the relationship between elagolix exposure and changes bone mineral density (BMD) was developed using data from four phase III studies premenopausal women endometriosis-associated pain. pharmacokinetic exposure-dependent BMD were...
Abstract Decline of bone mineral density (BMD) during menopause is related to increased risk fractures in postmenopausal women, however, this relationship premenopausal women has not been established. To quantify relationship, real‐world data (RWD) from the National Health and Nutrition Examination Survey (NHANES), longitudinal elagolix phase III clinical trials were modeled across a wide age range, covariates evaluated. The natural changes femoral neck BMD (FN‐BMD) well‐described by...
Abstract Elagolix is a novel, oral gonadotropin‐releasing hormone receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis and heavy menstrual bleeding uterine fibroids. Consistent its mechanism action, elagolix exhibited dose‐dependent suppression estradiol (E2) in clinical studies. A dose‐response model that describes relationship between dosages average E2 levels was combined previously published quantitative systems pharmacology (QSP)...
Elagolix is an orally active, gonadotropin-releasing hormone receptor antagonist approved for the management of endometriosis-associated pain and heavy menstrual bleeding associated with uterine fibroids. population pharmacokinetics factors affecting elagolix exposure in healthy women endometriosis have been reported previously. The purpose this study was to extend model additional modifications incorporate data from phase III studies hormonal add-back therapy Data 13 clinical (a total 2168...
Elagolix is an oral gonadotropin‐releasing hormone antagonist approved by the US Food and Drug Administration (FDA) for management of moderate‐to‐severe pain associated with endometriosis in combination estradiol/norethindrone acetate heavy menstrual bleeding uterine leiomyomas (fibroids) premenopausal women. The objective this work was to characterize relationships between elagolix exposures clinical efficacy response rates dysmenorrhea (DYS) nonmenstrual pelvic (NMPP) women enrolled...
<h3>Background</h3> Low trough levels of the tumour necrosis factor inhibitor, adalimumab (ADL), and anti-ADL antibodies (AAA) were reported to be correlated with lack response at later time points in patients (pts) rheumatoid arthritis (RA).<sup>1</sup> <h3>Objectives</h3> To assess ability ADL clinical assessments Week 12 predict remission (REM) after 24 weeks (wks) treatment ±methotrexate (MTX) established RA pts. <h3>Methods</h3> Data from MTX inadequate responders (MTX-IR) pts available...
<h3>Background</h3> Upadacitinib (UPA), an oral selective JAK1 inhibitor, demonstrated favorable efficacy and acceptable safety in two Phase 2 five 3 global studies subjects with moderately to severely active rheumatoid arthritis (RA). <h3>Objectives</h3> To characterize relationships between UPA plasma exposures different endpoints using data from RA studies. <h3>Methods</h3> Analyses were conducted 3685 (for efficacy) 4577 safety) enrolled the Relationships concentrations selected...
Abstract Background: ABT-263 is a novel small molecule Bcl-2 family protein inhibitor that binds with high affinity to multiple antiapoptotic proteins. The pharmacokinetics, safety and preliminary efficacy of in patients relapsed or refractory lymphoid malignancies, CLL/SLL, SCLC other non-hematological malignancies are being studied three Phase 1/2a studies. Both 14/21-day dosing schedule continuous preceded 7-day lead-in period evaluated these Grade 4 thrombocytopenia has been the most...
Paricalcitol injection and capsules are approved for the prevention treatment of secondary hyperparathyroidism. Exposure‐response analyses were performed to describe paricalcitol pharmacokinetics relationship clinical responses (intact parathyroid hormone [iPTH], serum calcium, phosphorus) following administration or patients with chronic kidney disease (stage 5). similar intravenous oral mean clearance 1.75 L/h bioavailability 75.1%. Exposure—clinical response was best described by an...
Abstract Background: Vascular endothelial growth factor (VEFG) has a pivotal role in tumor angiogenesis, which is required for the of most solid tumors and progression to metastases. Linifanib novel orally active, potent selective inhibitor VEGF platelet derived (PDGF) receptor tyrosine kinases. DCE-MRI non-invasive functional imaging technique that permits indirect measurement hemodynamics, therefore, suitable monitoring inhibition response vasculature. This population PK-PD modeling...