Search

Summary: Background: Adalimumab is used to treat several inflammatory diseases, including plaque psoriasis. GP2017 is a proposed adalimumab biosimilar. Objectives: To assess the impact of multiple switches between GP2017 and reference adalimumab (ref‐ADMB) following the demonstration of equivalent efficacy and similar safety and immunogenicity, in adult patients with active, clinically stable, moderate‐to‐severe plaque psoriasis. Methods: This 51‐week double‐blinded, phase III study randomly assigned patients to GP2017 (n = 231) or ref‐ADMB (n = 234) 80 mg subcutaneously at week 0, then 40 mg biweekly from week 1. At week 17, patients were rerandomized to switch (n = 126) or continue (n = 253) treatment. The primary end point was patients achieving ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 16, with equivalence confirmed if the 95% confidence interval (CI) for the difference in PASI 75 between treatments was ± 18%. The key secondary end point was the change from baseline to week 16 in continuous PASI. Other end points were PASI over time; PASI 50, 75, 90 and100; pharmacokinetics; safety; tolerability and immunogenicity for the switched and continued treatment groups. Results: Equivalent efficacy between GP2017 and ref‐ADMB was confirmed for the primary (66·8% and 65·0%, respectively; 95% CI −7·46 to 11·15) and key secondary end points (−60·7% and −61·5%, respectively; 95% CI –3·15 to 4·84). PASI improved over time and was similar between treatment groups at week 16, and the switched and continued groups from weeks 17 to 51. There were no relevant safety or immunogenicity differences between GP2017 and ref‐ADMB at week 16, or the switched and continued groups from weeks 17 to 51. No hypersensitivity to adalimumab was reported upon switching. Conclusions: Following the demonstration of GP2017 biosimilarity to ref‐ADMB, switching up to four times between GP2017 and ref‐ADMB had no detectable impact on efficacy, safety or immunogenicity. [ABSTRACT FROM AUTHOR]

Background Atopic dermatitis (AD) is associated with elevated IgE levels and Th2 responses. The oral administration of nonpathogenic bacteria such as probiotics may improve the course of atopic diseases. It is believed that nonpathogenic bacteria prevent the development of allergic diseases by modulating intestinal immune responses. However, the effects of oral probiotics on AD could not be reproduced in all studies and the direct immunomodulation of the skin-associated immune response by nonpathogenic bacteria has not yet been investigated. Objectives We performed a prospective, double-blind, placebo-controlled clinical study with a cream containing a 5% lysate of the nonpathogenic bacteria Vitreoscilla filiformis. Patients and methods Seventy-five volunteers with AD (6–70 years of age) were randomized to receive either V. filiformis cream 5% or vehicle cream daily for 30 days. Efficacy was evaluated by the SCORe of Atopic Dermatitis (SCORAD), transepidermal water loss (TEWL), assessment of microflora, and the patient’s assessment of itch and loss of sleep. Results Compared with placebo, V. filiformis lysate significantly decreased SCORAD levels ( P = 0·0044) and pruritus ( P = 0·0171). Active cream significantly decreased loss of sleep from day 0 to day 29 ( P = 0·0074). Qualitative and quantitative assessment of cutaneous microbial colonization revealed that V. filiformis lysate reduced Staphylococcus aureus colonization of the skin. The skin barrier as determined by TEWL also improved significantly with the cream alone. Conclusions V. filiformis lysate significantly improved AD. This may be in part due to reduction of S. aureus, but seems to relate in most parts to a direct immunomodulatory effect on skin-associated immune responses. [ABSTRACT FROM AUTHOR]

To evaluate the suitability of a once-a-day dosing regimen of ciprofloxacin using a new extended-release dosage form based on PK/PD principles. Ciprofloxacin’s serum concentrations were measured after administration of 500 mg immediate-release twice-daily, and 1,000 mg extended-release once-daily to 19 healthy volunteers. Pharmacokinetic parameters were determined using non-compartmental and compartmental data analysis. Measured serum concentration profiles were linked to ciprofloxacin’s effect against Escherichia coli (MIC 0.013 mg/l) from in vitro kill curve studies where the pharmacokinetics of ciprofloxacin were simulated and change in number of bacteria (CFU/ml) versus time was monitored. Resulting parameters were used to compare expected kill curves for the two dosing regimens based on measured ciprofloxacin concentrations. Fitting the data using an appropriate PK/PD model resulted in a set of mean pharmacodynamic parameters (bacterial growth rate constant, k0, maximum kill rate constant, Kmax, and EC50). The model included a novel term to account for a change in kill rate after approximately 4 h when Kmax decreased in concentration-dependent matter. The model allowed excellent curve fits of all ciprofloxacin concentrations investigated. Comparison of expected kill curves with the immediate-release versus extended-release treatments showed similar outcome. Both treatments resulted in a decrease in CFU/ml > 5 log units over 24 h. Results indicate that once-a-day dosing of equal total daily doses with the new and more compliance-friendly extended-release dosing form will be therapeutically equivalent to once-a-day dosing with traditional immediate-release dosage forms for treatment of infections with this microorganism. [ABSTRACT FROM AUTHOR]

A new procedure for evaluating dishwashing products has been developed. Good precision and favorable correlation with older methods ar obtained with minimum requirements of manpower, time and materials. Hydrogenated vegetable oil shortening proves to be an ideal soil for dishaashing evaluation if the physical state of the soil is carefully controlled. With such control, it is seen that dishwashing performance is a linear function of detergent concentration. Fatty soil and its effect on foam is discussed and compared with other soils. Variations of evaluation results with water hardness are described. [ABSTRACT FROM AUTHOR]

The article presents the case study of a 42-year-old woman with a medical history of wheat-dependent exercise induced anaphylaxis (WDEIA). Prick testing of the patient showed sensitization to grass pollen and laboratory testing revealed elevated immunoglobulin E and omega-5 Gliadin, the major allergen in WDEIA. Further prognosis of the patient revealed WDEIA mainly during menstruation.

A letter to the editor is presented in response to the article concerning the study on the effects of nonpathogenic gram-negative bacterium Vitreoscilla filiformis lysate on atopic dermatitis.