A5051940562- Immune Cell Function and Interaction
- Immunotherapy and Immune Responses
- T-cell and B-cell Immunology
- Pregnancy and Medication Impact
- Rheumatoid Arthritis Research and Therapies
- Systemic Lupus Erythematosus Research
- Reproductive System and Pregnancy
- Monoclonal and Polyclonal Antibodies Research
- Eosinophilic Esophagitis
- Immunodeficiency and Autoimmune Disorders
- Inflammatory Bowel Disease
- Autoimmune and Inflammatory Disorders Research
- Immune cells in cancer
- Lymphoma Diagnosis and Treatment
- Microscopic Colitis
- Pharmaceutical studies and practices
- T-cell and Retrovirus Studies
- Immune Response and Inflammation
- Reproductive Biology and Fertility
- CAR-T cell therapy research
- Biosimilars and Bioanalytical Methods
- Pharmacovigilance and Adverse Drug Reactions
- Reproductive Health and Contraception
- Cervical Cancer and HPV Research
- Endometriosis Research and Treatment
Janssen (Netherlands)
2014-2025
Janssen (Belgium)
2020
Vrije Universiteit Brussel
1995-2008
Vlaams Instituut voor Biotechnologie
1995-2008
Flemish Community
2004-2005
University of Oxford
2003
Université Libre de Bruxelles
1998
Abstract Recruitment of myeloid cells during inflammatory reactions plays an important role in the propagation and resolution inflammation. However, identification characterization these mice has been hampered by cellular heterogeneity at functional phenotypic level. We have defined criteria for rapid flow‐cytometric monocytes (M o ), macrophages (MΦ), neutrophils (N eu ) eosinophils (E os murine tissues using novel established markers. These were applied to study naive with experimentally...
Abstract Most of the mice bearing a s.c. BW-Sp3 lymphoma tumor mount CD8+ T cell-mediated response resulting in regression. Nonetheless, progression occurs some recipients and is associated with CTL inactivity. We demonstrated that cell-activating APC were induced regressors whereas cell suppressive myeloid cells predominated spleen progressors. Indeed, vitro depletion either adherent or CD11b+ populations restored cytotoxicity proliferation these mice. This inhibition was cell-to-cell...
Abstract This study is based on an expanded access program in which 511 patients suffering from active refractory rheumatoid arthritis (RA) were treated with intravenous infusions of infliximab (3 mg/kg+methotrexate (MTX)) at weeks 0, 2, 6 and every 8 thereafter. At week 22, 474 still follow-up, whom 102 (21.5%), who not optimally responding to treatment, received a dose increase 30 onward. We aimed build model discriminate the decision give increase. was treating rheumatologist's clinical...
Characterization of the spontaneous immune response that frequently occurs in tumor-bearing animals, as well immunization using dendritic cells pulsed with tumor antigens, suggests a limiting factor tumor-specific may be defect co-stimulatory signal is required for optimal activation T cells. In this work, we describe new approach to improve antigen-presenting capacity cells, which does not require source purified tumor-associated antigen. We fused P815 mastocytoma bone marrow-derived...
Summary Background Ustekinumab, a human immunoglobulin G1 monoclonal antibody that binds to and inhibits interleukin (IL)‐12/IL‐23, is indicated for multiple immune‐mediated diseases. Ustekinumab actively transported across the placenta theoretically could impact pregnancy outcomes. Limited data on outcomes with ustekinumab exposure are available. Aim To assess in patients exposed during Methods Cumulative medically confirmed ustekinumab‐exposed pregnancies from manufacturer's Global Safety...
Abstract Data on the use of golimumab (GLM) during pregnancy are limited. This study evaluated outcomes in women treated with GLM pregnancy. Cumulative data GLM‐exposed pregnancies from Company's global safety database (GSD) summarized. Cases were medically confirmed maternal exposures to or within 3 months prior conception a reported outcome. Pregnancy (e.g., live births) and congenital anomalies prospectively cases (i.e., outcome not known when first company) presented descriptive manner....
Although there is strong evidence supporting the short-term efficacy and safety of anti-tumour necrosis factor-alpha agents, few studies have examined long-term effects. We evaluated 511 patients with long-standing refractory rheumatoid arthritis treated intravenous infusions infliximab 3 mg/kg at weeks 0, 2, 6, 14 every 8 thereafter for 4 years. Among initial included in study, 479 could be evaluated; these, 295 (61.6%) were still receiving treatment year follow-up. The most common reasons...
Women of childbearing potential are often treated with monoclonal antibodies to control chronic and debilitating inflammatory diseases. Remicade® (innovator infliximab [IFX]) may cross the placenta after first trimester pregnancy. Hence, evidence is needed optimize treatment while carefully weighing benefits risks mother child. Here, we report on birth infant outcomes (up 2 years) following gestational exposure IFX based a summary cumulative pregnancy reports in women exposed during from...
In the European Union (EU), a Risk Management Plan (RMP) is submitted as part of dossier for initial marketing authorization medicinal product or with an application involving significant change to existing authorization. A comprehensive revision EU Guideline on Good Pharmacovigilance Practices (GVP) Module V-Risk Systems (Revision [Rev] 2), adopted in March 2017, provides framework developing more focused, actionable, and risk-proportionate RMPs. This paper describes Janssen experience...
Studies focusing on safety outcomes typically require large populations to comprehensively characterise the patient groups exposed medicines under investigation. However, there is often less information for subpopulations, such as pregnant or breastfeeding women, particularly when new are considered. It important understand what can be obtained from drug utilization studies (DUS) involving women in early years postmarketing provide supportive studies. The aims of this literature review (1)...
ABSTRACT Purpose To present the main findings of a post‐authorization safety study assessing pregnancy and infant outcomes after prenatal golimumab exposure in real‐world setting. Methods This observational population‐based cohort included data from pregnancies ending 2006–2018 (Finland) or 2019 (Denmark, Sweden). Infants born to women with rheumatic diseases ulcerative colitis diagnoses were identified. Based on prescription fills 90 days prior until delivery, infants assigned one four...
We previously reported on a murine T lymphoma cell line, BW-Sp3, with inherent immunogenicity. BW-Sp3 tumors can elicit an anti-tumor CD8(+) CTL response capable of mediating regression subcutaneous tumors. However, this immune is inadequate to eliminate cancer cells completely in significant percentage the recipients, resulting progressing In tumor model, progression correlated tolerization tumor-reactive and cellular immunotherapy bearing animals, or without B7-mediated costimulation, even...
Abstract Background Ustekinumab (UST) is indicated for psoriasis (PSO), psoriatic arthritis (PsA), Crohn’s disease (CD), and ulcerative colitis (UC). The recommended dose in CD/UC generally higher than PSO/PsA. No adverse pregnancy outcomes were observed preclinical studies.1 Here we present from spontaneous reporting, clinical studies registries. Methods This dataset includes pregnancies with maternal exposure to UST during or within 3 months prior conception reported the manufacturer...
<h3>Background</h3> Rheumatologic conditions and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for the treatment rheumatoid arthritis (RA), psoriatic (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC). GLM should be used during pregnancy only if clearly needed. For RA patients some PsA patients, administered with methotrexate (MTX), an agent teratogenic abortifacient properties. <h3>Objectives</h3> To characterize outcomes in...