Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1 Trial.

BioFactura has developed a proposed biosimilar candidate (BFI-751) to ustekinumab reference product. Results are reported for the first-in-human trial designed to compare the pharmacokinetic profiles, safety, and immunogenicity of BFI-751 and ustekinumab reference products from the European Union and United States as well as similarity of the EU and US reference products. This was a multicenter, randomized, double blind, 3-parallel-group study (trial ID: NCT04843631).

Microbiology of acute and chronic maxillary sinusitis in smokers and nonsmokers.

Objectives: We evaluated the microbiology of sinus aspirates of smokers and nonsmokers with acute and chronic maxillary sinusitis.

Methods: Cultures were obtained from 458 patients, 244 (87 smokers and 157 nonsmokers) of whom had acute maxillary sinusitis and 214 (84 smokers and 130 nonsmokers) of whom had chronic maxillary sinusitis, between 2001 and 2007.

Results: A greater number of Staphylococcus aureus, methicillin-resistant S aureus (MRSA), and beta-lactamase-producing bacteria (BLPB) were found in the 87 smokers with acute sinusitis than in the nonsmokers with acute sinusitis (p < 0.

Increase in the frequency of recovery of meticillin-resistant Staphylococcus aureus in acute and chronic maxillary sinusitis.

This study compared the rate of recovery of meticillin-resistant Staphylococcus aureus (MRSA) between the periods 2001-2003 and 2004-2006 in acute and chronic maxillary sinusitis. Cultures were obtained from 458 patients, 244 with acute and 214 with chronic maxillary sinusitis; 215 isolates were recovered in the 2 years between 2001 and 2003 (118 from acute and 97 from chronic sinusitis), and 243 in the 2 years between 2004 and 2006 (126 from acute and 117 from chronic sinusitis). S.

In vitro effects of penicillin and telithromycin on the expression of Streptococcus pneumoniae capsule.

Objective: To evaluate the effects of subinhibitory concentrations of penicillin and telithromycin on capsular formation by Streptococcus pneumoniae.

Methods: A total of 60 isolates of S. pneumoniae, 20 susceptible, 20 intermediately resistant and 20 resistant to penicillin, were studied.

Frequency of recovery of pathogens causing acute maxillary sinusitis in adults before and after introduction of vaccination of children with the 7-valent pneumococcal vaccine.

The objective of the study was to compare the proportions of the recovery of pathogens of acute maxillary sinusitis in adults in the 4-year period prior to the 5-year period that followed the introduction of vaccination of children with the 7-valent pneumococcal vaccine (PCV7). Cultures were obtained through endoscopy from 385 adults with acute maxillary sinusitis, 156 between 1997 and 2000, and 229 between 2001 and 2005. One hundred and seventeen potentially pathogenic organisms were isolated from the cultures obtained between 1997 and 2000.

Effect of telithromycin and azithromycin on nasopharyngeal bacterial flora in patients with acute maxillary sinusitis.

Objective: To explore the efficacy of the ketolide telithromycin compared with azithromycin in eradicating S pneumoniae from the nasopharynx of adults with acute maxillary sinusitis. The growing resistance of Streptococcus pneumoniae to penicillin and macrolides brought about the development of a new class of antibiotics-the ketolides-that are effective against resistant pneumococci.

Setting: Otolaryngology clinic.

Recovery of interfering bacteria in the nasopharynx following antimicrobial therapy of acute maxillary sinusitis with telithromycin or amoxicillin-clavulanate.

The effect on the nasopharyngeal flora of 7 days of amoxicillin-clavulanate or 5 days of 800 mg once a day was studied in 50 adults with acute sinusitis. The numbers of potential pathogens and interfering alpha-hemolytic streptococci were equally reduced after both therapies. However, the number of interfering Prevotella spp.

Eradication of pathogens from the nasopharynx after therapy of acute maxillary sinusitis with low- or high-dose amoxicillin/clavulanic acid.

The growing resistance of Streptococcus pneumoniae to penicillin can be overcome by increasing the dose of the penicillin administered. This generated the recommendation that the adult dose of amoxicillin for the treatment of acute maxillary sinusitis (AMS) be increased from 1.5 g/day to 4.