Safety of Brodalumab in Plaque Psoriasis: Integrated Pooled Data from Five Clinical Trials.

Brodalumab is approved for treatment of moderate-to-severe plaque psoriasis. Here, we assess the safety profile of brodalumab using pooled safety data from 5 phase II/III trials of brodalumab 140 mg or 210 mg. In total, 4,464 patients received brodalumab, representing 8,891.6 patient-years of exposure. During the placebo-controlled 12-week induction period, rates of serious adverse events per 100 patient-years were 10.8 and 9.6 (brodalumab 140 mg and 210 mg, respectively) vs 4.3 and 6.5 (ustekinumab and placebo, respectively); infections were the most frequent serious adverse event. Rates of serious adverse events during the comparator-controlled 52-week period were 14.4, 10.2 and 8.3 per 100 patient-years for brodalumab 210 mg, brodalumab 140 mg, and ustekinumab, respectively. Brodalumab was not associated with increased risks of malignancy, major adverse cardiac events, suicidal ideation and behaviour, or fatal events. Overall, brodalumab demonstrated an acceptable safety profile in short- and long-term treatment.

Caries prevalence in Danish pre-school children delivered vaginally and by caesarean section.

OBJECTIVE: The mode of delivery may significantly influence the diversity and composition of the oral microflora and facilitate early acquisition of mutans streptococci. The aim was to compare caries prevalence and experience in 3-year-old children delivered vaginally and by caesarean section (C-section). MATERIALS AND METHODS: The study had an observational cohort protocol based on extracted information from governmental databases and nationwide registers concerning birth, social and educational levels and dental status. Children born at the Copenhagen University Hospital in 2005 were eligible and the final study group with complete information consisted of 594 children, 443 delivered vaginally and 151 by C-section. RESULTS: The total caries prevalence was 8% and no significant difference was displayed between the groups. When only the children with caries (dmfs > 0) were compared, those delivered by C-section had a higher mean value in comparison with those delivered vaginally (dmfs 6.8 vs 3.2), but the difference was not statistically significant. There was a significant relationship between caries prevalence and low family income in the total study group (OR = 5.8, p < 0.05). CONCLUSIONS: Within the limitations of this observational cohort study, caries prevalence in 3-year-old children was not related to the mode of delivery. However, the tendency of more severe caries in the C-section group justifies further studies, preferably with a prospective design.

Oral microflora in infants delivered vaginally and by caesarean section.

BACKGROUND. Early in life, vaginally delivered infants exhibit a different composition of the gut flora compared with infants delivered by caesarean section (C-section); however, it is unclear whether this also applies to the oral cavity. AIM. To investigate and compare the oral microbial profile between infants delivered vaginally and by C-section. DESIGN. This is a cross-sectional case-control study. Eighty-four infants delivered either vaginally (n = 42) or by C-section (n = 42) were randomly selected from the 2009 birth cohort at the County Hospital in Halmstad, Sweden. Medically compromised and premature children (<32 weeks) were excluded. The mean age was 8.25 months (range 6-10 months), and parents were asked to complete a questionnaire on socioeconomic factors, lifestyle, and hygiene habits. Saliva was collected and analysed using checkerboard DNA-DNA hybridization. RESULTS. A higher prevalence of salivary Streptococcus salivarius, Lactobacillus curvata, Lactobacillus salivarius, and Lactobacuillus casei was detected in infants delivered vaginally (P < 0.05). The caries-associated bacteria Streptococcus mutans and Streptococcus sobrinus were detected in 63% and 59% of all children, respectively. CONCLUSION. A significantly higher prevalence of certain strains of health-related streptococci and lactobacilli was found in vaginally delivered infants compared with infants delivered by C-section. The possible long-term effects on oral health need to be further investigated.

Microbiological profiles in saliva and supragingival plaque from caries-active adolescents before and after a short-term daily intake of milk supplemented with probiotic bacteria - a pilot study.

PURPOSE: The aim of the present pilot study was to investigate the microbial profile in saliva and supragingival plaque samples collected from caries-active adolescents before and after a daily short-term intake of milk supplemented with the probiotic bacteria. MATERIALS AND METHODS: The present study group consisted of 18 caries-active adolescents of both sexes who volunteered for participation giving an informed consent. The study has a randomised placebo-controlled double-blind pilot design with two parallel arms. After a 2-week run-in period, the subjects were instructed to drink 2.5 dl of milk supplemented with Lactobacillus rhamnosus LB21 (107 CFU/ml) (test) or standard control milk (placebo) once daily for a period of 2 weeks (intervention period). Samples of stimulated whole saliva and supragingival plaque were collected at baseline (after run-in) and immediately after the end of the intervention period (follow-up). The salivary levels of mutans streptococci and lactobacilli were estimated by conventional culturing on selective agar plates. The presence and level of 19 oral species associated with the caries process were determined using the checkerboard DNA-DNA hybridisation technique. Differences between the groups were assessed using the non-parametric Wilcoxon­Mann­Whitney and chi-square tests. RESULTS: The mean caries experience was high with an average of 7.0 ± 3.8 proximal enamel lesions. The most prevalent dominating species in the plaque samples were Streptococcus mitis, Veillonella parvula and Streptococcus gordonii. The saliva samples displayed a more mixed profile, with Streptococcus mitis, Rothia dentocariosa, Lactobacillus casei and Lactobacillus curvata being frequently identified species. All of the subjects harboured mutans streptococci in their saliva, with 61% of them colonised with salivary lactobacilli. No statistically significant differences in the microbial profiles or the estimated counts between the baseline and follow-up samples, or between the two study groups, were observed. CONCLUSIONS: The present study showed that a short-term daily intake of milk supplemented with the probiotic bacterium L. rhamnosus LB21 did not significantly affect the microbial profiles or the levels of caries-associated bacteria in saliva and supragingival plaque samples collected from caries-active adolescents.

Whole saliva in X-linked hypohidrotic ectodermal dysplasia.

BACKGROUND: X-linked hypohidrotic ectodermal dysplasia (HED) is the most common type of ectodermal dysplasia. Identification of female carriers of X-linked HED can be difficult because of varying degrees of clinical symptoms due to the X-chromosome inactivation. This is the first study about whole saliva flow and composition in males affected by HED and female carriers all confirmed by molecular genetic analysis. HYPOTHESIS AND AIM: As salivary glands derive from ectoderm, we hypothesized that whole saliva flow and composition are altered in males affected by HED and female carriers. DESIGN: Saliva flow and composition were examined in a group of affected males and in a group of female carriers, all confirmed by molecular genetic analysis, and compared with healthy male and female controls. RESULTS: Affected males and female carriers had reduced whole saliva flow and saliva with high concentrations of most inorganic salivary constituents as well as total protein. However, affected males and female carriers seemed to have reduced amylase activity and concentration relative to their total protein concentration. CONCLUSION: Saliva flow and composition may be used as part of a comprehensive clinical examination to identify potential female carriers of HED.