Comparing immunogenicity and safety following transition from reference rituximab to biosimilar rituximab (DRL_RI) in patients with rheumatoid arthritis: a randomized, double-blind, phase 3 study.

Objectives: To assess immunogenicity and safety in patients with active rheumatoid arthritis (RA) transitioning from rituximab [US-licensed rituximab: Reference Product (RP); EU-approved rituximab: Reference Medicinal Product (RMP)] to DRL_RI (proposed rituximab biosimilar), in comparison to those continuing on RP/RMP.

Methods: This double-blind, randomized, Phase 3 study included 140 RA patients having prior exposure to RP/RMP; transitioned to DRL_RI (n = 70) or continued with RP/RMP (n = 70) for two 1000 mg infusions on Days 1 and 15. Assessments included Time-matched Rituximab Concentration (TMRC), anti-drug antibodies (ADAs), neutralizing antibodies (NAbs) and ADA titre over 12 weeks, and safety follow-up till 26 weeks.

Testosterone Therapy for the Treatment of Unexplained Anemia in Men With Hypogonadism.

Decreased testosterone levels are often under-recognized as a cause of anemia in males with hypogonadism. Men, as a subset, are less likely to seek medical care, especially those who struggle with complex psychiatric and social conditions, where they may lack full autonomy. Increasing testosterone levels leads to erythrocytosis by elevating erythropoietin and soluble transferrin receptor levels and suppressing hepcidin and ferritin levels.

Unleashing the Cytokine Storm: A Case of Macrophage Activation Syndrome in Systemic Lupus Erythematosus.

Macrophage activation syndrome (MAS), synonymous with secondary hemophagocytic lymphohistiocytosis (HLH), is a rare and critical complication of rheumatologic disease stemming from the unregulated activation and rapid multiplication of macrophages and T lymphocytes. While it primarily manifests in children diagnosed with systemic juvenile idiopathic arthritis (sJIA), it can arise less frequently in other rheumatologic conditions. Here, we outline the clinical course, treatment, and outcome of MAS diagnosed in an 18-year-old female previously diagnosed with SLE who exhibited a unique clinical presentation.

A nanoscale photonic thermal transistor for sub-second heat flow switching.

Control of heat flow is critical for thermal logic devices and thermal management and has been explored theoretically. However, experimental progress on active control of heat flow has been limited. Here, we describe a nanoscale radiative thermal transistor that comprises of a hot source and a cold drain (both are ~250 nm-thick silicon nitride membranes), which are analogous to the source and drain electrodes of a transistor.

The Metal-Insulator Transition in Vanadium Oxide Nanofilms Enables Microkelvin-Resolution Thermometry.

High-resolution thermometry is critical for probing nanoscale energy transport. Here, we demonstrate how high-resolution thermometry can be accomplished using vanadium oxide (VO), which features a sizable temperature-dependence of its resistance at room temperature and an even stronger dependence at its metal-insulator-transition (MIT) temperature. We microfabricate VO nanofilm-based electrical resistance thermometers that undergo a metal-insulator-transition at ∼337 K and systematically quantify their temperature-dependent resistance, noise characteristics, and temperature resolution.

Time to therapy and safety of testicular tissue cryopreservation in children undergoing gonadotoxic treatment or hematopoietic stem cell transplant.

Background: With the use of multimodal treatments and hematopoietic stem cell transplant, the majority of children diagnosed with malignancies and hematologic diseases are now surviving into adulthood. Due to the gonadotoxic effects and potential for future infertility associated with many of these treatments, fertility counseling with sperm cryopreservation prior to starting therapy is the standard of care for post-pubertal males. Unfortunately, the options are limited for pre-pubertal patients or those unable to provide a specimen.

Comparison of Efficacy and Safety of a Bevacizumab Biosimilar, in Combination with Chemotherapies, in Nonresectable Metastatic Colorectal Cancer and in Advanced Nonsquamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study.

Ranjith K.The objective of this study was to compare the efficacy, safety, pharmacokinetics, and immunogenicity of a proposed bevacizumab biosimilar (DRL_BZ) with the innovator Avastin (reference medicinal product [RMP]) in patients with nonresectable metastatic colorectal cancer (mCRC) over a period of 9 months and advanced nonsquamous non-small cell lung cancer (NSCLC) over 6 months. The study was planned as a randomized, double-blind trial.

Micro-kelvin temperature-stable system for biocalorimetry applications.

Achieving micro-kelvin (µK) temperature stability is critical for many calorimetric applications. For example, sub-nanowatt resolution biocalorimetry requires stabilization of the temperature of the calorimeter to µK levels. Here, we describe how µK temperature stability can be accomplished in a prototypical calorimetric system consisting of two nested shields and a suspended capillary tube, which is well suited for biocalorimetry applications.

Efficacy, Safety, Pharmacokinetics, and Immunogenicity of DRL-Trastuzumab Versus Herceptin in Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: A Randomized Controlled Trial.

Purpose: Dr Reddy's Laboratories Trastuzumab (DRL_TZ) is a biosimilar to Herceptin under development. The present study was conducted to evaluate efficacy, safety, pharmacokinetics (PKs), and immunogenicity of DRL_TZ in comparison with the reference medicinal product (RMP) along with concomitant weekly paclitaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

Methods: This was a randomized, double-blind study in female patients with HER2-positive MBC, randomly assigned in a 1:1 ratio to receive either DRL_TZ or the RMP, that is, an innovator product sourced from the European region, along with additional chemotherapy, as first-line treatment for up to 24 weeks.

A Case of Pernicious Anemia Presenting With Severe Hemolysis.

Vitamin B12 deficiency is a well-known and overall common disease. While the etiology of vitamin B12 deficiency varies from post-surgical changes to inadequate dietary consumption, pernicious anemia should be considered as it is a common cause. Pernicious anemia is an autoimmune atrophic gastritis impairing the absorption of vitamin B12.

Transcription factor Tcf21 modulates urinary bladder size and differentiation.

Urinary bladder organogenesis requires coordinated cell growth, specification, and patterning of both mesenchymal and epithelial compartments. Tcf21, a gene that encodes a helix-loop-helix transcription factor, is specifically expressed in the mesenchyme of the bladder during development. Here we show that Tcf21 is required for normal development of the bladder.

An Insidious Case of Severe Acquired Factor VIII Inhibitor.

Acquired hemophilia occurs when neutralizing antibodies inhibit the activity of coagulation factors, commonly occurring with factor VIII. Most cases are idiopathic; however, autoimmune diseases, certain medications, and malignancies can predispose patients to the development of these inhibitors. Moreover, the initial presentation of the disease is more often catastrophic bleeding, with ecchymosis or mucosal bleeding being less common.

Diffuse Large B-cell Lymphoma of the Orbit With Intracranial Extension: A Rare Entity.

Primary diffuse large B-cell lymphoma of the orbit is a rare diagnosis that accounts for less than 1% of all non-Hodgkin's lymphoma (NHL) cases. We present here the case of a middle-aged woman with a past medical history of intellectual delay and hypothyroidism who presented with a large diffusely infiltrating mass of the left orbit. A biopsy of the lesion during the patient's hospitalization confirmed a diagnosis of diffuse, large B-cell lymphoma.

Pyridoxine Deficiency and Neurologic Dysfunction: An Unlikely Association.

Pyridoxine deficiency is a prevalent condition in the United States that primarily affects patients with alcohol use disorder. The presentation of this condition is very nonspecific and commonly presents with a constellation of symptoms including peripheral neuropathy, stomatitis, dermatitis, confusion, depression, encephalopathy, and seizures. Over half of these patients have associated alcohol use disorder, which causes pyridoxine deficiency due to the breakdown of pyridoxal phosphate during ethanol metabolism in the liver.

Surface Phonon Polariton-Mediated Near-Field Radiative Heat Transfer at Cryogenic Temperatures.

Recent experiments, at room temperature, have shown that near-field radiative heat transfer (NFRHT) via surface phonon polaritons (SPhPs) exceeds the blackbody limit by several orders of magnitude. Yet, SPhP-mediated NFRHT at cryogenic temperatures remains experimentally unexplored. Here, we probe thermal transport in nanoscale gaps between a silica sphere and a planar silica surface from 77-300 K.

One and done: Feasibility and Safety of Primary Ureteroscopy in a Pediatric Population.

Background: Pediatric urolithiasis has been increasing at rate of 4-10 % annually in the United States, most notably within adolescents and females. A significant number of patients will require surgical management of their stones. Primary ureteroscopy (URS) affords the opportunity to treat stones under a single anesthetic with lower re-treatment rates or anatomical and stone characteristic limitations compared to shockwave lithotripsy.

Role of Tranexamic Acid in Palliative Control of Bleeding in End-Stage Head and Neck Cancer: A Case Report.

Tumor-related bleeding is a common manifestation of end-stage head and neck cancer, and it can have a significant impact on a patient's quality of life. Tranexamic acid is an anti-fibrinolytic agent that has been shown to effectively control bleeding and reduce the need for transfusions in various hemorrhagic conditions. Here, we present the case of a patient with end-stage head and neck cancer experiencing recurrent episodes of bleeding, who was able to successfully achieve hemostasis after being treated with tranexamic acid.

Real-world outcomes of diffuse large B-cell lymphoma in the biosimilar era.

Background: Diffuse large B-cell lymphoma (DLBCL) is an aggressive and the most common type of non-Hodgkin lymphoma (NHL). The clinical use of rituximab has improved the treatment response and survival of patients with DLBCL. The introduction of rituximab biosimilar into healthcare system has helped in providing a cost-effective treatment to B-cell lymphoid malignancies as standard of care and has improved access to patients worldwide.

The Double-Edged Sword: Naloxone-Induced Noncardiogenic Pulmonary Edema.

Naloxone-induced noncardiogenic pulmonary edema (NCPE) is a scarcely reported side effect that can occur after naloxone administration. We present a case of a 46-year-old male who presented to the emergency department for further management of an opioid overdose, who developed acute hypoxic respiratory failure after several doses of naloxone. The rapid deterioration of the patient's respiratory status required increased supplemental oxygen, with plane film radiography suggesting diffuse pulmonary edema.