- Rheumatoid Arthritis Research and Therapies
- Xenotransplantation and immune response
- Autoimmune and Inflammatory Disorders Research
- Pancreatic function and diabetes
- Chronic Lymphocytic Leukemia Research
- Systemic Lupus Erythematosus Research
- T-cell and B-cell Immunology
- Virus-based gene therapy research
- Diabetes and associated disorders
- Cutaneous lymphoproliferative disorders research
- SARS-CoV-2 and COVID-19 Research
- Animal Genetics and Reproduction
- COVID-19 Clinical Research Studies
- Pharmacological Effects of Natural Compounds
- Lymphoma Diagnosis and Treatment
- Immune Cell Function and Interaction
- Liver physiology and pathology
- Organ Transplantation Techniques and Outcomes
- Long-Term Effects of COVID-19
- Transplantation: Methods and Outcomes
- Pregnancy and Medication Impact
- Neutrophil, Myeloperoxidase and Oxidative Mechanisms
- Tuberculosis Research and Epidemiology
- Phagocytosis and Immune Regulation
- Statistical Methods in Clinical Trials
Pfizer (United States)
2013-2023
Uppsala University
1996-2003
Abstract Objective The purpose of this 24‐month phase III study was to examine structural preservation with tofacitinib in patients rheumatoid arthritis (RA) an inadequate response methotrexate (MTX). Data from a planned 12‐month interim analysis are reported. Methods In double‐blind, parallel‐group, placebo‐controlled study, receiving background MTX were randomized 4:4:1:1 at 5 mg twice daily, 10 placebo and daily. At month 3, nonresponder placebo‐treated advanced blinded manner receive as...
Based on primary results from ORAL Surveillance, an event-driven clinical trial of risk-enriched patients, identify subpopulations with different relative risk (ie, 'high-risk' and 'low-risk') tofacitinib versus tumour necrosis factor inhibitors (TNFi).
Objective To describe characteristics and coronavirus disease 2019 (COVID-19) clinical outcomes of patients with rheumatoid arthritis (RA), psoriatic (PsA), or ulcerative colitis (UC) receiving systemic therapies vs the general population. Methods This descriptive retrospective cohort study used data from United States Optum deidentified COVID-19 electronic health record dataset (2007–2020). Adults were stratified into 3 cohorts (patients RA, PsA, UC who had received therapy) a comparator...
The aim of the present study was to evaluate role xenoreactive antibodies in islet-like cell cluster (ICC) xenograft rejection. For this purpose, normal mice, mice with a targeted disruption Fc-receptor (FcR) γ-chain, or membrane exon immunoglobulinμ-chain gene, were transplanted fetal porcine ICC under kidney capsule. Mice lacking FcR γ have no functional for IgG IgE. immunoglobulin μ-chain cannot produce antibodies, because B development is arrested at stage preB cells. All animals,...
The aim of the present study was to evaluate role T-cell cytokine interferon (IFN)-gamma in mediating macrophage activation xenograft rejection.For this purpose, fetal porcine islet-like cell cluster (ICC) transplants were placed under renal capsule normal mice and with a homozygous targeted disruption IFN-gamma or receptor gene. Some continuously infused cyclosporine (CsA, 12.4 mg/kg body weight/day) CsA vehicle by subcutaneously implanted osmotic pumps. Histological evaluation xenografts...
A new murine model of porcine islet-like cell cluster (ICC) xenograft rejection, avoiding interference unspecific inflammation, was introduced and used to investigate rejection mechanisms. Athymic (nu/nu) mice were transplanted with syngeneic, allogeneic, or xenogeneic islets under the kidney capsule. After original transplantation, immune cells in ICC xenografts undergoing native immunocompetent transferred peritoneal cavity athymic mice. At defined time points after transfer, primary...
Background. The aim of the present study was to evaluate nature T cells involved in and, presumably, critical fetal porcine islet-like cell cluster (ICC) xenograft rejection. Methods. Normal mice and receptor (TCR)-β-, TCR-δ-, or TCR-β×δ-deficient were transplanted with ICC under kidney capsule. Perforin- granzyme B (GraB)-deficient used further characterize cell-dependent pathways. For evaluation role activation process macrophages, TCR-β×δ mutants treated recombinant mouse tumor necrosis...
Previous work has demonstrated that short-term systemic administration of cytotoxic T lymphocyte antigen-4 (CTLA-4) Ig blocks human pancreatic islet xenograft rejection in mice and induces long-term, donor-specific tolerance, whereas studies on pig have failed to demonstrate a role for CTLA4Ig preventing rejection. Treatment with anti-CD40 ligand (L) monoclonal antibodies alone is somewhat effective prolonging the survival xenografts, but ineffective when applied skin xenografts. However,...
Abstract: To investigate the role of interferon (IFN)‐γ and tumor necrosis factor (TNF)‐α their potential to replace each other in process fetal porcine islet‐like cell cluster (ICC) xenograft rejection, mice with a targeted disruption IFN‐γ receptor gene wild‐type controls were transplanted ICCs under kidney capsule given post‐transplant treatment TNF‐α‐inhibiting agent MDL 201,449A. Some 201,449A‐treated receptor‐deficient received additional cyclosporinee (CsA). Evaluation xenografts was...
<h3>Background</h3> Tofacitinib is a novel oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). Phase (P) 2 and 3 studies demonstrated tofacitinib effective has manageable safety profile as both monotherapy in combination with nonbiologic disease-modifying antirheumatic drugs (DMARDs). <h3>Objectives</h3> To assess whether there are relative differences efficacy or between mono- therapy RA patients (pts) an inadequate response (IR) to DMARDs. <h3>Methods</h3>...
<h3>Background</h3> Tofacitinib is a novel, oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). <h3>Objectives</h3> An evaluation malignancies in tofacitinib RA programme from Phase (P) 2, P3, and long-term extension (LTE) studies based on data up to April 2013. <h3>Methods</h3> Data were pooled 6 P2 P3 randomised 2 open-label LTE (ongoing at time analysis; databases not locked). Patients (pts) (LTE pts rolled over studies) treated with 5 or 10 mg twice daily (BID);...
<h3>Background</h3> Tofacitinib is a novel oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). <h3>Objectives</h3> To assess efficacy tofacitinib monotherapy in patients (pts) with early RA (eRA), as defined by disease duration (i.e., time since diagnosis) <6 months, Phase 3, 24-month (Mo) study (ORAL Start, NCT01039688) vs methotrexate (MTX) MTX-naïve pts active RA. Primary analyses have been reported.<sup>1</sup> <h3>Methods</h3> Pts were randomised 2:2:1...
<h3>Background</h3> Tofacitinib is a novel oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). <h3>Objectives</h3> Describe efficacy and safety adalimumab (ADA) patients (pts) transitioning to tofacitinib open label extension (OLE) without washout. <h3>Methods</h3> In Phase 3 randomised controlled trial (RCT, NCT00853385) ORAL Standard, pts on background MTX received 5 mg BID, 10 ADA 40 sc injections (Q2 Wk), placebo (PBO) or PBO BID (4:4:4:1:1). Primary results were...
<h3>Background</h3> In the 21st century, with availability of effective therapies for rheumatoid arthritis (RA), conduct double-blind placebo (PBO)-controlled studies has changed dramatically. PBO therapy is continued shorter periods time, especially if patients (pts) have an inadequate clinical response. many these trials, pts are "rescued" after a finite period time (usually around 3 months) they do not meet minimum response criteria, although usual primary endpoint at month 6. The...
<h3>Background</h3> Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). inhibits JAK3 and/or JAK1 with functional selectivity over JAK2. <h3>Objectives</h3> To characterise changes in haemoglobin (Hb) and incidence anaemia following tofacitinib evaluate relationship between fatigue or vitality. <h3>Methods</h3> Changes Hb as defined by OMERACT criteria were analysed from five randomised controlled Phase (P) 3 (N=3314) two open-label...