Head-to-head (H2H) studies enable the direct comparison of several alternative therapeutic approaches and thus provide the evidence-based foundation for the relative position of one treatment as compared to others for a specific indication. These trials constitute an important addition to placebo-controlled clinical trials. Among the controlled clinical trials not performed by the pharmaceutical industry, there are a relevant number of H2H trials for connective tissue diseases (CTDs) and vasculitides, particularly for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). This article encompasses a review of the H2H trials for CTDs and vasculitides and discusses their relevance for current treatment algorithms. For SLE the H2H trials were predominantly performed for the treatment of lupus nephritis, demonstrating the impact of low-dose cyclophosphamide and mycophenolate as well as azathioprine for maintenance therapy. In recent H2H trials rituximab could be established as induction and maintenance therapy for AAV, which has now been incorporated into current treatment guidelines. Further comparative trials will be necessary in order to select the most effective and safest treatment for every patient, in the sense of personalized medicine.
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http://dx.doi.org/10.1007/s00393-024-01537-4 | DOI Listing |
Abdom Radiol (NY)
December 2024
The Seventh Affiliated Hospital of Sun Yat-sen University, Shenzhen, China.
Purpose: To investigate whether a low-calorie, reduced-fat diet affects liver attenuation imaging (ATI) measurements.
Methods: A total of 320 participants were enrolled in this prospective study. They were randomly assigned to four groups: a fasting group, a postprandial 0.
PLoS One
November 2024
Pediatric Intensive Care Unit, Instituto da Criança, Universidade de São Paulo, São Paulo, São Paulo, Brazil.
Objective: To assess a comparative analysis of the ROX index, Wood-Downes-Ferrés score (WDF), p-ROXI, and the SpO2/FiO2 ratio as predictors of high-flow nasal cannula (HFNC) failure in children hospitalized for bronchiolitis.
Methods: Data were extracted from the clinical trial "Comparison between HFNC and NIV in children with acute respiratory failure caused by bronchiolitis" conducted at a tertiary Brazilian hospital (Emergency Department and PICU). The inclusion criteria were children under 2 years of age admitted for bronchiolitis who developed mild to moderate respiratory distress and were eligible for HFNC therapy.
Indian J Surg Oncol
December 2024
Department of Onco-Anesthesia and Palliative Medicine, AIIMS, Dr BRAIRCH, New Delhi, India.
Expert Opin Biol Ther
December 2024
Hexal AG (A Sandoz company), Holzkirchen, Germany.
Background: To support an interchangeability designation for Sandoz adalimumab biosimilar (GP2017), antidrug antibody (ADA) signal-to-noise (S/N) ratios were assessed in the GP2017 ADACCESS trial to directly assess potential changes in immunogenicity.
Research Design And Methods: ADACCESS was a 51-week trial in patients with moderate-to-severe plaque psoriasis that included patients treated continuously with reference adalimumab (cH), and patients who experienced four switches between reference adalimumab and GP2017 (H2H). ADAs were measured every 6 weeks during the switching phase using an electrochemiluminescence assay.
J Breath Res
November 2024
LRM Statistical Consulting, LLC, West Orange, NJ, United States of America.
Oral malodor negatively impacts a person's quality of life and may affect up to 50% of the population. The aim of this randomized, placebo and no-product controlled, evaluator-blind, proof-of-concept study was to evaluate the effectiveness and safety of the single use of two experimental lozenges containing the laccase enzyme and green coffee extract (with and without flavor) in reducing intrinsic oral malodor. Following 12-16 h of avoidance of oral hygiene,156 generally healthy subjects presented at screening and baseline visits with a mean organoleptic odor intensity (OI) score of ⩾2 and an OralChromareading of ⩾125 parts per billion (ppb) hydrogen sulfide (HS) gas and were randomly assigned to receive either one of the two experimental lozenges, a placebo lozenge, or no-product.
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