Impact of Obesity on Response to Biologic Therapies in Patients with Inflammatory Bowel Diseases
AbstractApproximately 20 –40% of patients with inflammatory bowel disease (IBD) are obese. Obesity is associated with inferior outcomes in patients with IBD, with lower rates of achieving remission, poor quality of life, and higher burden of unplanned healthcare utilization. Multiple cohort studies in patients with immune -mediated inflammatory diseases, including IBD, treated with biologic agents like tumor necrosis factor-α antagonists have suggested that obesity is associated with inferior response to biologic therapy. This may be related to the negative impact of obesity on the pharmacokinetics of biologic agen ts....
Source: BioDrugs - March 23, 2022 Category: Drugs & Pharmacology Source Type: research

Enhancing the Response Rate to Recombinant Uricases in Patients with Gout
AbstractRefractory, or uncontrolled, gout is a chronic, progressive, inflammatory arthropathy resulting from continued urate deposition after failed attempts to lower serum uric acid below the therapeutic threshold with oral urate-lowering therapies such as allopurinol and febuxostat. Recombinant uricase is increasingly being used to treat refractory gout; however, the immunogenicity of uricase-based therapies has limited the use of these biologic therapies. Antidrug antibodies against biologic therapies, including uricase and PEGylated uricase, can lead to loss of urate-lowering response, increased risk of infusion reacti...
Source: BioDrugs - March 22, 2022 Category: Drugs & Pharmacology Source Type: research

Qualitative Analysis of the Design and Implementation of Benefit-Sharing Programs for Biologics Across Europe
ConclusionsTo realize the full potential of benefit-sharing programs, we identify the importance of (i) setting up and timely monitoring success indicators for these programs; (ii) including quality of care and access to care parameters as success indicators; (iii) establishing clear pathways for the transparent redistribution/reinvestment of savings and (iv) transparently communicating with patients about the outcomes of benefit-sharing programs. (Source: BioDrugs)
Source: BioDrugs - March 18, 2022 Category: Drugs & Pharmacology Source Type: research

A Tale of Two New Targets for Hypertriglyceridaemia: Which Choice of Therapy?
AbstractAngiopoietin-like protein 3 (ANGPTL3) and apolipoprotein C-III (apoC-III) are novel metabolic targets for correcting hypertriglyceridaemia (HTG). As a background to their potential clinical use, we review the metabolic aetiology of HTG, particular abnormalities in triglyceride-rich lipoproteins (TRLs) and their role in atherosclerotic cardiovascular disease (ASCVD) and acute pancreatitis. Molecular and cardiometabolic aspects of ANGPTL3 and apoC-III, as well as inhibition of these targets with monoclonal antibody and nucleic acid therapies, are summarized as background information to descriptions and analyses of re...
Source: BioDrugs - March 14, 2022 Category: Drugs & Pharmacology Source Type: research

Antisense Oligonucleotide Therapy: From Design to the Huntington Disease Clinic
AbstractHuntington disease (HD) is a fatal progressive neurodegenerative disorder caused by an inherited mutation in the huntingtin (HTT) gene, which encodes mutant HTT protein. Though HD remains incurable, various preclinical studies have reported a favorable response to HTT suppression, emphasizing HTT lowering strategies as prospective disease-modifying treatments. Antisense oligonucleotides (ASOs) lower HTT by targeting transcripts and are well suited for treating neurodegenerative disorders as they distribute broadly throughout the central nervous system (CNS) and are freely taken up by neurons, glia, and ependymal ce...
Source: BioDrugs - March 7, 2022 Category: Drugs & Pharmacology Source Type: research

Effect Modification by Indication to the Risks of Major Thromboembolic Adverse Events in Patients Receiving Intravitreal Anti-Vascular Endothelial Growth Factor Treatment: A Population-Based Retrospective Cohort Study
ConclusionsPatients treated with aflibercept or ranibizumab for different indications may be associated with varying risk of TAEs. The findings provide evidence to support treatment selection, taking indications and TAE risk into consideration. (Source: BioDrugs)
Source: BioDrugs - March 1, 2022 Category: Drugs & Pharmacology Source Type: research

First-Line Treatment of Advanced Non-Small-Cell Lung Cancer with Immune-Checkpoint Inhibitors: New Combinations and Long-Term Data
AbstractTreatment of metastatic non-small-cell lung cancers (NSCLCs) has long been based on cytotoxic chemotherapy. Immune checkpoint inhibitors (ICIs), notably monoclonal antibodies directed against programmed cell death protein-1 (PD-1) or its ligand (PD-L1), have transformed therapeutic standards in thoracic oncology. These ICIs are now the reference first-line therapy, and numerous phase III trials have established their efficacy in treatment-na ïve patients. First-line pembrolizumab monotherapy was validated for patients with ≥ 50% of tumor cells expressing PD-L1 and, in the USA, for patients with ≥ 1% PD-L1 ...
Source: BioDrugs - February 11, 2022 Category: Drugs & Pharmacology Source Type: research

Long-Term Safety and Effectiveness of PF-05280014 (a Trastuzumab Biosimilar) Treatment in Patients with HER2-Positive Metastatic Breast Cancer: Updated Results of a Randomized, Double-Blind Study
ConclusionLong-term safety and OS were consistent with previous results and demonstrated no clinically meaningful differences between treatment groups.Trial registrationClinicalTrials.gov: NCT01989676 (21 November 2013); and EudraCT: 2013-001352-34 (18 December 2013). (Source: BioDrugs)
Source: BioDrugs - February 8, 2022 Category: Drugs & Pharmacology Source Type: research