BioDrugs journal

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BioDrugs journal

BioDrugs is a Medline-indexed, Springer Nature journal (2023 Impact Factor 5.4, CiteScore 12.6)

17/11/2024

This population-based, nationwide cohort study found that treatment of psoriasis with interleukin (IL) inhibitors, particularly IL-23 inhibitors, was associated with a lower risk of psoriatic arthritis compared with TNF inhibitor treatment.

Background Evidence comparing the impact of various biologics for psoriasis on the progression to psoriatic arthritis (PsA) is limited. We therefore assessed the risk of PsA associated with interleukin (IL)-23 inhibitor, IL-17 inhibitor, or IL-12/23 inhibitor use compared with tumor necrosis factor....

03/11/2024

This study assessed the safety, efficacy, and cost effectiveness of trastuzumab originators and their biosimilars in real-world clinical settings, analyzing two large and diverse datasets from multiple perspectives.

Background Despite the global use of trastuzumab biosimilars, concerns remain regarding their efficacy and safety. In particular, when used concurrently with pertuzumab, trastuzumab biosimilars lack extensive real-world data and safety information. Additionally, as cancer drug expenditures continue....

28/10/2024

Amberley D. Stephens & Trevor Wilkinson review progress and emerging themes in defining discovery strategies for generation of antibodies that target complex multi-spanning membrane proteins.

Complex integral membrane proteins, which are embedded in the cell surface lipid bilayer by multiple transmembrane spanning polypeptides, encompass families of proteins that are important target classes for drug discovery. These protein families include G protein-coupled receptors, ion channels, tra...

28/10/2024

This review identifies and synthesizes evidence characterizing adverse outcomes associated with PEGylation of protein-based therapeutics on immunogenicity, pharmacologic properties including pharmacokinetics, and safety.

The beneficial effects of polyethylene glycol (PEG)-conjugated therapeutics, such as increased half-life, solubility, stability, and decreased immunogenicity, have been well described. There have been concerns, however, about adverse outcomes with their use, but understanding of those adverse outcom...

21/10/2024

This study analysed the availability, access and expenditure of advanced therapy medicinal products (ATMPs) in the period from 2016 to 2023 in Italy.

Background Advanced therapy medicinal products (ATMPs) are an innovative output of biomedical research, characterized by a high level of uncertainty on long-term efficacy and safety, elevated price tags and often complex administration. All these elements compounded make their European authorization...

21/10/2024

This study investigates the impact of eblasakimab, a first-in-class anti-IL‑13Rα1 antibody, on type 2 inflammatory biomarkers in patients with moderate-to-severe atopic dermatitis.

Introduction Eblasakimab, a first-in-class monoclonal antibody with a unique mechanism to target the interleukin (IL)-13 receptor alpha 1 (IL-13Rα1), inhibits IL-4/IL-13 signaling in the pathophysiology of atopic dermatitis (AD). This study investigates the impact of eblasakimab on type 2 inflammat...

03/10/2024

Malte Lenders and colleagues conclude that the optimal time for enzymatic AGAL activity measurement in migalastat-treated patients appears to be 24 h after the last migalastat intake.

Aim Current recommendations for Fabry disease include α-galactosidase A (AGAL) activity measurements to assess the biochemical response in migalastat-treated patients. Owing to contradictory data from laboratories, we aimed to analyze why AGAL activity measures from dried blood spots (DBS) often fa...

30/09/2024

This observational study explored patient experience and satisfaction after switching to CT-P17, a high-concentration, citrate-free adalimumab biosimilar.

Background and Objectives Biosimilars are cost-effective alternatives to reference products for patients with inflammatory bowel diseases (IBD) and chronic inflammatory rheumatic diseases (CIRD), but patient beliefs can affect adherence to the transition. This study aimed to explore patient experien...

30/09/2024

This review presents the totality of evidence that confirmed the biosimilarity of biosimilar natalizumab (PB006) to its reference medicine, which supported its approval by the FDA and the EMA.

A biosimilar medicine is a successor to a reference (‘originator’/’original-brand’) biologic medicine brought to market once the patent and exclusive marketing rights for the reference have expired. Biosimilar natalizumab (PB006 [biosim-NTZ]; developed by Polpharma Biologics S.A. and markete...

26/09/2024

This phase I study aimed to establish the pharmacokinetic equivalence between LY01015 and the original investigational nivolumab (Opdivo®) in healthy Chinese male subjects. Safety and immunogenicity were also assessed.

Background Nivolumab (Opdivo®) is the first anti-PD-1 antibody approved in the world. LY01015 is a potential biosimilar of nivolumab. Objectives This phase I study aimed to establish the pharmacokinetic equivalence between LY01015 and the original investigational nivolumab (Opdivo®) in healthy Chi...

26/09/2024

Lark L. Coffey and colleagues summarize published data from pre-clinical and clinical trials for the IXCHIQ and PXVX0317 chikungunya virus vaccines and discuss outstanding questions.

Chikungunya virus is an emerging mosquito-borne alphavirus that causes febrile illness and arthritic disease. Chikungunya virus is endemic in 110 countries and the World Health Organization estimates that it has caused more than 2 million cases of crippling acute and chronic arthritis globally since...

25/09/2024

Benjamin Stump & Aaron Waxman review the molecular mechanisms and signaling pathways that have culminated in the development of sotatercept in the treatment of pulmonary arterial hypertension, including TGF- β superfamily signaling, and the findings of the completed RCTs, and discuss future directions for the treatment of PAH.

Pulmonary arterial hypertension (PAH) is a rare and progressive disease that continues to remain highly morbid despite multiple advances in medical therapies. There remains a persistent and desperate need to identify novel methods of treating and, ideally, reversing the pathologic vasculopathy that....

02/09/2024

The September issue of BioDrugs is now online.
See our articles on:
* Local Interventions and CAR T Cell Therapy in Solid Tumors
* Targeting Neurological Aspects of Mucopolysaccharidosis type II
* Genetic Substrate Reduction Therapy in Lysosomal Storage Diseases
* Stapokibart in Adults with Moderate-to-Severe Atopic Dermatitis
* Infliximab Dose Intensification Strategies in Inflammatory Bowel Disease
* Intravenous vs Subcutaneous Tocilizumab Plasma Exposure in Kidney Transplant Patients
* Insulin Icodec: First Approval

Volume 38, issue 5 articles listing for BioDrugs

02/09/2024

This review summarizes the most significant brain-targeted approaches evaluated in recent years for mucopolysaccharidosis type II.

Mucopolysaccharidosis type II (MPS II) is a rare, pediatric, neurometabolic disorder due to the lack of activity of the lysosomal hydrolase iduronate 2-sulfatase (IDS), normally degrading heparan sulfate and dermatan sulfate within cell lysosomes. The deficit of activity is caused by mutations affec...

26/08/2024

This systematic review by Marina Beraza-Millor and colleagues analyzes the application of genetic substrate reduction therapy for the treatment of lysosomal storage diseases.

Background Genetic substrate reduction therapy (gSRT), which involves the use of nucleic acids to downregulate the genes involved in the biosynthesis of storage substances, has been investigated in the treatment of lysosomal storage diseases (LSDs). Objective To analyze the application of gSRT to th...

25/08/2024

This PK simulation-based analysis highlights the potential of using post-intensification infliximab trough thresholds associated with aspirational treatment targets in Crohn’s disease and ulcerative colitis to guide choice of infliximab dose intensification strategy.

Background The optimal infliximab dose intensification strategy to address loss of response associated with subtherapeutic infliximab trough levels remains uncertain, as does whether post-intensification trough and treatment targets should influence this decision. Objectives This pharmacokinetic sim...

15/08/2024

This study compared plasma exposure of tocilizumab with intravenous vs. subcutaneous administration regimens in kidney transplant recipients with chronic active antibody-mediated rejection (CAAMR).

Background Tocilizumab prevents the clinical worsening of chronic active antibody-mediated rejection (CAAMR) in kidney transplant recipients. Following a global shortage of the intravenous pharmaceutical form in 2022, patients were switched from monthly intravenous administration of 8 mg/kg to weekl...

30/07/2024

This review highlights the synergistic potential of local therapies and CAR T cell treatment to overcome challenges posed by solid tumors and provides an overview of current research combining these two strategies.

Chimeric antigen receptor T cell therapy has been established in the treatment of various B cell malignancies. However, translating this therapeutic effect to treat solid tumors has been challenging because of their inter-tumoral as well as intratumoral heterogeneity and immunosuppressive microenvir...

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