Perceived benefits and cost savings of liquid formulation of intravenous infliximab: perspectives of seven European countries.

Background: Following the approval of intravenous (IV) infliximab (IFX) in the 1990s, Celltrion developed the first monoclonal antibody biosimilar for IV IFX (Remsima®: Celltrion, South Korea), followed by the first and only subcutaneous IFX, (Remsima® SC). A liquid formulation of IV IFX has been developed that eliminates the need for reconstitution and introduces a 350 mg vial size not previously available with the powder formulation. This study evaluated the operational benefits and cost savings of the liquid formulation of IV IFX compared to the powder formulation, from the perspective of healthcare professionals across seven European countries.

Efficacy and Safety of Infliximab and Vedolizumab Maintenance Therapy in Patients with Crohn's Disease and Ulcerative Colitis: A Systematic Review and Meta-Analysis.

Direct comparative data for infliximab and vedolizumab are limited due to lack of head-to-head trials. This systematic review and meta-analysis compared the efficacy and safety of infliximab and vedolizumab as intravenous or subcutaneous maintenance treatments for adults with moderately to severely active Crohn's disease or ulcerative colitis. Medical databases, PubMed, Embase, and the Cochrane Library were systematically searched from January 2010 to May 2024 to identify Phase 1 to 3 randomized controlled trials.

Advanced QbD-Based Process Optimization of Clopidogrel Tablets with Insights into Industrial Manufacturing Design.

: Traditional Quality by Testing (QbT) strategies rely heavily on end-product testing and offer limited insight into how critical process parameters (CPPs) influence product quality. This increases the risk of variability and inconsistent outcomes. To overcome these limitations, this study aimed to implement a Quality by Design (QbD) approach to optimize the manufacturing process of clopidogrel tablets.

Radiosurgery versus radiation therapy for long term local control rate of craniopharyngioma: a meta-analysis.

Introduction: Craniopharyngiomas are challenging benign tumors arising from Rathke's pouch remnants, often requiring multidisciplinary management due to their proximity to critical neurovascular structures. This meta-analysis systematically compares conventional radiation therapy (RT) and stereotactic radiosurgery (RS) in treating residual or recurrent craniopharyngiomas.

Method: A comprehensive literature search identified 44 studies, including 46 reports, meeting inclusion criteria such as progression-free survival (PFS) and post-radiotherapy complications.

Factors influencing discharge against medical advice (DAMA) in traumatic brain injury patients requiring decompressive surgery: a comprehensive analysis.

raumatic brain injury (TBI) is a significant global health concern, particularly affecting young individuals, and is a leading cause of mortality and morbidity worldwide. Despite improvements in treatment infrastructure, many TBI patients choose discharge against medical advice (DAMA), often declining necessary surgical interventions. We aimed to investigate the factors that can be associated with DAMA in TBI patients that were recommended to have surgical treatment.

Comparative efficacy and safety of subcutaneous infliximab and vedolizumab in patients with Crohn's disease and ulcerative colitis included in randomised controlled trials.

Background: While indirect comparison of infliximab (IFX) and vedolizumab (VDZ) in adults with Crohn's disease (CD) or ulcerative colitis (UC) shows that IFX has better effectiveness during induction, and comparable efficacy during maintenance treatment, comparative data specific to subcutaneous (SC) IFX (i.e., CT-P13 SC) versus VDZ are limited.

Comparison of the efficacy in improving trigeminal neuralgia in petroclival meningioma between microsurgery and radiosurgery: a meta-analysis.

The purpose of this study was to systematically review studies in the literature to assess the superiority between microsurgery and radiosurgery regarding the efficacy in improving petroclival meningioma (PCM)-related trigeminal neuralgia (TN). PubMed, Embase, Web of Science, and Cochrane clinical trial databases were systematically searched from the inception until December 08, 2022. The overall proportion of patients with improved TN after treatment in all six included studies was 56% (95% confidence interval [CI], 35-76.

Predictor of the Postoperative Swelling After Craniotomy for Spontaneous Intracerebral Hemorrhage: Sphericity Index as a Novel Parameter.

Objective: Spontaneous intracerebral hemorrhage is a serious type of stroke with high mortality and disability rates. Surgical treatment options vary; however, predicting edema aggravation is crucial when choosing the optimal approach. We propose using the sphericity index, a measure of roundness, to predict the aggravation of edema and guide surgical decisions.

Antibiotics Prophylaxis for Endoscopic Endonasal Approach for Skull Base Tumor Surgery: A Meta-Analysis.

Background: The regimen of prophylactic antibiotic for endoscopic endonasal skull base surgery (EE-SBS) varies considerably depending on surgeons and their institutes. The purpose of the present meta-analysis is to assess the effect of antibiotic regimens on EE-SBS surgery for anterior skull base tumor.

Methods: The PubMed, Embase, Web of Science, and Cochrane clinical trial databases were systematically searched through October 15, 2022.

Efficacy of subcutaneous vs intravenous infliximab in rheumatoid arthritis: a post-hoc analysis of a randomized phase III trial.

Objectives: The primary endpoint of the pivotal phase III study of infliximab (IFX) s.c. demonstrated non-inferiority of s.

Inhaled deep eutectic solvent based-nanoemulsion of pirfenidone in idiopathic pulmonary fibrosis.

Pirfenidone (PRF), the first FDA-approved drug to treat idiopathic pulmonary fibrosis (IPF) and formulated as an oral dosage form, has many side effects. To enhance the therapeutic effect, we discovered a high-load nanoemulsion using a novel deep eutectic solvent (DES) and developed an inhalation drug with improved bioavailability. The DES of PRF and N-acetylcysteine were discovered, and their physicochemical properties were evaluated in this study.

Middle meningeal artery embolization for chronic subdural hematoma in elderly patients at high risk of surgical treatment.

Objective: The purpose of this study was to evaluate the effectiveness of middle meningeal artery embolization (MMAE) in elderly high-risk patients with symptomatic chronic subdural hematoma (CSDH) in terms of reduction in hematoma volume and recurrence rate.

Methods: We retrospectively reviewed data prospectively collected from nine patients who underwent 13 MMAE for CSDH between June 2017 and May 2022. The volume of the subdural hematoma was measured using a computer-aided volumetric analysis program.

Novel Esomeprazole Magnesium-Loaded Dual-Release Mini-Tablet Polycap: Formulation, Optimization, Characterization, and In Vivo Evaluation in Beagle Dogs.

Esomeprazole magnesium (EMP) is a proton pump inhibitor (PPI) that reduces acid secretion. EMP has a short plasma half-life (approximately 1.3 h); hence, nocturnal acid breakthrough (NAB) frequently occurs, disturbing the patient's nighttime comfort and sleep.

Asian Facelift.

The Asian facelift requires an adaptation of current techniques to achieve a desired aesthetic outcome. Cultural differences and differences in anthropomorphologic features alter a patient's vision of beauty and youthfulness. Rejuvenation of the aging Asian face mandates a set of strategies, including understanding cultural aspects of Asian patients, anatomy of Asian patients, and appropriate techniques based on these cultural and anatomic considerations.

Budget Impact Analysis of the Introduction of Subcutaneous Infliximab (CT-P13 SC) for the Treatment of Rheumatoid Arthritis in the United Kingdom.

Background: CT-P13 subcutaneous (SC)-the first and only SC version of infliximab-is approved by the European Medicines Agency for the treatment of rheumatoid arthritis (RA). This new mode of infliximab administration will allow patients to self-inject at home, significantly reducing the number of outpatient visits and costs of intravenous (IV) administration. This paper describes the economic impact of introducing CT-P13 SC to the market from the UK societal perspective.

Oral Commissure Lift: A Retrospective Analysis of Complication Rates and Overall Outcomes.

Background: Downward-turning oral commissures and sagging mouth corners can present an unfavorable impression. We introduced a new oral commissure lift procedure and investigated its effectiveness and complication rates.

Methods: Patients who underwent oral commissure lift in the plastic surgery clinic between January 2010 and December 2017 were enrolled retrospectively.

Clinical features and treatment strategies for vertex epidural hematoma: a systematic review and meta-analysis from individual participant data.

Vertex epidural hematoma (VEDH) is a rare extradural hematoma and often misdiagnosed because of its variety of clinical symptoms and characteristic location. Determining optimal timing and technique for VEDH surgery is difficult because of its midline location and atypical clinical course. This study aims to understand the clinical manifestations and current treatment strategies for VEDH.

Comparative efficacy of subcutaneous (CT-P13) and intravenous infliximab in adult patients with rheumatoid arthritis: a network meta-regression of individual patient data from two randomised trials.

Background: A subcutaneous (SC) formulation of infliximab biosimilar CT-P13 is approved in Europe for the treatment of adult patients with rheumatoid arthritis (RA). It may offer improved efficacy versus intravenous (IV) infliximab formulations.

Methods: A network meta-regression was conducted using individual patient data from two randomised trials in patients with RA, which compared CT-P13 SC with CT-P13 IV, and CT-P13 IV with reference infliximab IV.

Efficacy and safety of subcutaneous infliximab versus adalimumab, etanercept and intravenous infliximab in patients with rheumatoid arthritis: a systematic literature review and meta-analysis.

Objectives: There are few comparative data for tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).

Methods: Historical data for reference product/biosimilar intravenous infliximab, or adalimumab and etanercept, were pooled and compared with phase 3 study results for a subcutaneous (SC) formulation of the infliximab biosimilar CT-P13, in a systematic review and meta-analysis (PROSPERO: CRD42019149621).

Results: The authors identified 13 eligible controlled trials that randomized over 5400 participants to prespecified treatments of interest.

Current Status of Neurosurgical and Neurointensive Care Units in Korea : A Brief Report on Nationwide Survey Results.

Objective: The purpose of this study is identify the operation status of the neurosurgical care units (NCUs) in neurosurgical residency training hospitals nationwide and determine needed changes by comparing findings with those obtained from the Korean Neurosurgical Society (KNS) and Korean Society of Neurointensive Care Medicine (KNIC) survey of 2010.

Method: This survey was conducted over 1 year in 86 neurosurgical residency training hospitals and two neurosurgery specialist hospitals and focused on the following areas : 1) the current status of the infrastructure and operating systems of NCUs in Korea, 2) barriers to installing neurointensivist team systems, 3) future roles of the KNS and KNIC, and 4) a handbook for physicians and practitioners in NCUs. We compared and analyzed the results of this survey with those from a KNIC survey of 2010.

Ectopic Expression of , a Member of the OsDREB1 Subfamily, Confers Cold Stress Tolerance in Rice.

Plants adapt to adverse environmental conditions through physiological responses, such as induction of the abscisic acid signaling pathway, stomatal regulation, and root elongation. Altered gene expression is a major molecular response to adverse environmental conditions in plants. Several transcription factors function as master switches to induce the expression of stress-tolerance genes.

How to Escape Stentriever Wedging in an Open-cell Carotid Stent during Mechanical Thrombectomy for Tandem Cervical Internal Carotid Artery and Middle Cerebral Artery Occlusion.

We present 2 cases of complicated mechanical thrombectomy involving tandem cervical internal carotid artery and middle cerebral artery occlusion using the Solitaire FR stent and simultaneous carotid stent angioplasty. During the procedures, the Solitaire stents containing the thrombus were wedged into the open-cell carotid stents, which were already deployed for proximal flow restoration. We describe the methods used to avoid and overcome such complications.

A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis.

Objective: To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents.

Methods: In this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000 mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration-time curve from time zero to last quantifiable concentration (AUC) and maximum serum concentration after second infusion (C).