A5101682242- Systemic Lupus Erythematosus Research
- Monoclonal and Polyclonal Antibodies Research
- Rheumatoid Arthritis Research and Therapies
- Autoimmune and Inflammatory Disorders Research
- COVID-19 Clinical Research Studies
- Biosimilars and Bioanalytical Methods
- Long-Term Effects of COVID-19
- Liver Diseases and Immunity
- Chronic Lymphocytic Leukemia Research
- Bone health and treatments
- Immunodeficiency and Autoimmune Disorders
- T-cell and B-cell Immunology
- Inflammasome and immune disorders
- Spondyloarthritis Studies and Treatments
- Bone Metabolism and Diseases
- Bone health and osteoporosis research
- SARS-CoV-2 and COVID-19 Research
- Peripheral Neuropathies and Disorders
- Cytokine Signaling Pathways and Interactions
- Pharmaceutical studies and practices
- Toxin Mechanisms and Immunotoxins
- Atherosclerosis and Cardiovascular Diseases
- Psoriasis: Treatment and Pathogenesis
- Urticaria and Related Conditions
- Management and Organizational Practices
Poznan University of Medical Sciences
2015-2024
Medical University of Lodz
2021
Medical University of Warsaw
2017
Wojewódzki Szpital Specjalistyczny Nr 2
2013
Krakowskie Centrum Rehabilitacji
2013
Wroclaw University of Economics and Business
2012
Grochowski Hospital
2003
University School of Physical Education in Kraków
1994-2001
Heliodor Swiecicki Clinical Hospital
1995
<h3>Objectives</h3> This study compared the efficacy and safety of subcutaneous (SC) versus intravenous (IV) formulations tocilizumab in patients with rheumatoid arthritis an inadequate response to disease-modifying antirheumatic drugs (DMARD). <h3>Methods</h3> Patients (n=1262) were randomly assigned receive tocilizumab-SC 162 mg weekly+placebo-IV every 4 weeks or tocilizumab-IV 8 mg/kg weeks+placebo-SC weekly combination traditional DMARD. The primary outcome was demonstrate...
To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product (ETN) in patients moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.This is a phase III, randomised, double-blind, parallel-group, multicentre study 24-week primary endpoint. Patients RA MTX treatment were randomised receive weekly dose 50 mg subcutaneous or ETN. The endpoint was American College Rheumatology 20% (ACR20) response at week 24. Other endpoints as well...
Objective Epratuzumab, a monoclonal antibody that targets CD22, modulates B cell signaling without substantial reductions in the number of cells. The aim this study was to report results 2 phase III multicenter randomized, double‐blind, placebo‐controlled trials, EMBODY 1 and assessing efficacy safety epratuzumab patients with moderately severely active systemic lupus erythematosus (SLE). Methods Patients met ≥4 American College Rheumatology revised classification criteria for SLE, were...
To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) inadequate response to disease-modifying antirheumatic drugs (DMARDs).Patients (n=1262) were randomised 1:1 receive TCZ-SC 162 mg weekly (qw)+placebo-IV every four weeks (q4w) or TCZ-IV 8 mg/kg q4w+placebo-SC qw combination DMARD(s). After a 24-week double-blind period, receiving re-randomised 11:1...
SB4 (Benepali, Brenzys) is a biosimilar of reference etanercept (ETN). In randomised, double-blind, 52-week study, demonstrated comparable efficacy and safety to ETN in patients with rheumatoid arthritis (RA). The open-label extension period evaluated long-term efficacy, immunogenicity when continuing versus switching from SB4.
Abstract Objective To evaluate the dose–response, efficacy and safety of dapirolizumab pegol (DZP) in patients with SLE. Methods Adults moderately to severely active SLE (SLEDAI-2K score ≥6 ≥1 BILAG A or ≥2 B domain scores), receiving stable CS (≤40 mg/day prednisone-equivalent), antimalarial immunosuppressant drugs were included. Patients LN (proteinuria ≤2 g/day) not high-dose CYC permitted entry. Randomized received placebo i.v. DZP (6/24/45 mg/kg) standard-of-care (SOC) treatment every 4...
To compare the 52-week efficacy and safety of SB4 [an etanercept biosimilar] with reference (ETN) in patients active RA.In a phase 3, randomized, double-blind, multicentre study, moderate to severe RA despite MTX treatment were randomized receive 50 mg/week s.c. or ETN up week 52. Efficacy assessments included ACR response rates, 28-joint DAS, Simplified Clinical Disease Activity Indices changes modified total Sharp score (mTSS). Safety immunogenicity also evaluated.A 596 either (n = 299)...
Hydroxychloroquine (HCQ) is an increasingly popular drug owing to its efficacy, long-term safety, and a wide range of therapeutic effects.Currently, the use goes beyond treatment rheumatic dermatological diseases due numerous benefits it provides.As HCQ shows anti-inflammatory, immunomodulatory, antiproliferative, photoprotective action, has great potential be applied also in oncological diseases, multiple sclerosis, diabetes, cardiovascular or recurrent miscarriages.Nevertheless,...
Objective Previous reports of RAPID-PsA ( NCT01087788 ) demonstrated efficacy and safety certolizumab pegol (CZP) over 24 weeks in patients with psoriatic arthritis (PsA), including prior antitumour necrosis factor (TNF) therapy. We report data from a 96-week cut RAPID-PsA. Methods was placebo-controlled to week 24, dose-blind 48 open-label 216. present American College Rheumatology (ACR)/Psoriasis Area Severity Index (PASI) responses, HAQ-DI, pain, minimal disease activity (MDA), modified...
To evaluate the safety and maintenance of efficacy with ABT-122, a bi-specific monoclonal antibody targeting TNF IL-17A, in patients RA or PsA open-label, 24-week extensions [open-label (OLEs)] 12-week, randomized, double-blind studies.All received ABT-122 (RA, 120 mg; PsA, 240 mg) subcutaneously every other week on background MTX. Safety assessments included adverse events (AEs) laboratory parameters. Efficacy was evaluated ACR responses, 28-joint DAS using high-sensitivity CRP [DAS28...
Clinical activity of ankylosing spondylitis (AS) predicts the natural course disease and response to treatment. Several molecules are involved in new bone formation resulting structural damage patients with AS. However, link between clinical molecular phenomena has not yet been fully established. The aim study was investigate relation markers remodeling inflammation We assessed serum levels sclerostin, Dickkopf-1 protein, Wingless protein-3a, morphogenic protein-7, matrix...
Objective Interleukin‐20 (IL‐20) is implicated in the pathogenesis of rheumatoid arthritis (RA). The efficacy, safety, and tolerability NNC0109‐0012, a selective anti–IL‐20 recombinant human monoclonal antibody (mAb), were assessed patients with active RA who had an inadequate response to methotrexate therapy. Methods Sixty‐seven enrolled randomized (2:1) receive NNC0109‐0012 (3 mg/kg per week, subcutaneously) or placebo phase IIa, double‐blind, 12‐week trial 13‐week followup. primary end...
The primary objective was to assess the long-term safety of repeated courses epratuzumab therapy in patients with moderate-to-severe systemic lupus erythematosus. Secondary objectives were efficacy and health-related quality life (HRQOL).Eligible from 12-week, phase IIb, randomized, placebo-controlled EMBLEM study enrolled into open-label extension (OLE) study, SL0008. In SL0008 received 1,200 mg infusions at weeks 0 2 repeating 12-week cycles, plus standard care. Safety measures included...
Despite direct viral effect, the pathogenesis of coronavirus disease 2019 (COVID-19) includes an overproduction cytokines including interleukin 6 (IL-6). Therefore, tocilizumab (TOC), a monoclonal antibody against IL-6 receptors, was considered as possible therapeutic option. Patients were selected from SARSTer database, containing 2332 individuals with COVID-19. Current study included 825 adult patients moderate to severe course. Analysis performed in 170 treated TOC and 655 alternative...
The pathogenesis of coronavirus disease 2019 (COVID-19) is complicated, and in addition to antiviral therapy combating coagulopathy, treatment should also include inhibition the proinflammatory cytokines overproduction. purpose this study compare effectiveness tocilizumab (TCZ) dexamethasone (DEX) administered alone or combination patients with severe COVID-19.Patients were selected from SARSTer database, containing 3330 individuals COVID-19 treated between 1 March 2020 10 2021. current...
Background: Patients with kidney failure are at an increased risk of progression to a severe form coronavirus disease 2019 (COVID-19) high mortality. The current analysis was aimed assess the impact renal on severity COVID-19 and identify factors fatal outcome in this population. Methods: included patients from SARSTer database, national real-world study evaluating treatment for 30 Polish centers. Data were completed retrospectively submitted online. Results: A total 2322 analysis. Kidney...
Objectives: To examine changes in serum levels of the bone remodelling molecules dickkopf-1 (Dkk-1), sclerostin, wingless-type protein-3a (Wnt-3a), and morphogenetic protein-7 (BMP-7) during 6 months anti-tumour necrosis factor (anti-TNF) treatment ankylosing spondylitis (AS) patients with high disease activity.Method: We included 40 axial AS: 20 activity were assigned to TNF inhibitor low non-steroidal anti-inflammatory drug (NSAID) treatment. Markers inflammation assessed at baseline after...
<h3>Background</h3> SB4 is a biologic agent developed as biosimilar of the etanercept reference product (ETN). Etanercept approved for treatment rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic axial spondyloarthritis, plaque psoriasis, and paediatric psoriasis in EU. <h3>Objectives</h3> To compare efficacy, safety, immunogenicity with ETN patients moderate to severe RA despite methotrexate (MTX) treatment. <h3>Methods</h3> Patients MTX were randomly assigned receive...
<h3>Background:</h3> CD40 ligand (CD40L) regulates interactions between T cells and CD40-expressing including antigen-presenting (APC) B cells, thereby playing a critical role in autoimmune disease pathogenesis. DZP, PEGylated monovalent Fab' antibody fragment with specificity for CD40L, prevents CD40L engagement of thus blocks intracellular signalling APC activation. <h3>Objectives:</h3> To report the 24-week efficacy safety interim data DZP phase IIb, randomised, double-blind,...