22 research outputs found
School climate and productivity of teachers in public senior secondary schools, Ogun West Senatorial District, Nigeria
The objective of this study was to explore the potential correlation between school climate and teachers' productivity in public senior secondary schools in Ogun West Senatorial District, Nigeria. The study employed a correlational research design and was guided by four null hypotheses. Data were collected using a self-constructed questionnaire titled âSchool Climate and Teachersâ Productivity in Public Senior Secondary Schools in Ogun West Senatorial District, Nigeriaâ on a Likert Four Point Scale rating. The questionnaire obtained a reliability coefficient of 0.83. A multi-stage sampling technique was used to select the sample, which consisted of 25 schools. In each of the 25 schools, 20 teachers were selected randomly on an equal gender basis, resulting in a total of 500 teachers and 200 hundred school head to include principal and heads of department, totaling 700 participants through a multistage sampling technique and data were analyzed using Pearsonâs Product Moment Correlation Coefficient in the Statistical Packages for Social Sciences (SPSS) version 21.0. The findings indicated a significant relationship between interpersonal relationship and teachersâ productivity: a significant relationship between school safety and teachersâ productivity; a significant relationship between institutional environment and teacherâs productivity; and a significant relationship between school management and teachersâ productivity. By implication, all aspect of school climate identified in this study plays an integral role in teacherâs productivity, hence the needed catalyst for boosting a good atmosphere in school climate becomes the responsibility of all stakeholders in education. It can be concluded that school climate is key to teacherâs productivity. More so, it is recommended that every school should create a climate team comprising representatives from all school community groups, supported by strong and clearly defined climate leadership at all levels
Dupilumab improves lung function in patients with uncontrolled, moderate-to-severe asthma
Background: Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key drivers of type 2 inflammation. In the phase 3 LIBERTY ASTHMA QUEST trial (NCT02414854) in patients with uncontrolled, moderate-to-severe asthma, add-on dupilumab 200 mg or 300 mg every 2 weeks reduced exacerbations and improved forced expiratory volume in 1 s (FEV1) and quality of life over 52 weeks. This analysis evaluates dupilimab's effect on lung function in the overall population, and subgroups with baseline elevated type 2 inflammatory biomarkers.
Methods: Patients were randomised to 52 weeks of subcutaneous dupilumab 200 mg every 2 weeks, 300 mg every 2 weeks, or matched-volume placebos. Lung function outcomes were analysed in the overall population, in patients with â„150 eosinophils·”Lâ1, â„300 eosinophils·”Lâ1, â„25 ppb fractional exhaled nitric oxide (FeNO), and both â„150 eosinophils·”Lâ1 and â„25 ppb FeNO, at baseline.
Results: Dupilumab treatment (200 mg and 300 mg every 2 weeks) resulted in significant improvements versus placebo after 52 weeks in pre-bronchodilator FEV1 (0.20 and 0.13 L, respectively, versus placebo) and post-bronchodilator FEV1 (0.19 and 0.13 L, respectively), forced vital capacity (FVC) (0.20 and 0.14 L, respectively), forced expiratory flow (0.19 and 0.13 L·sâ1, respectively) and pre-bronchodilator FEV1/FVC ratio (1.75% and 1.61%, respectively) in the overall population (p<0.001). Difference versus placebo in post-bronchodilator FEV1 slope of change (weeks 4â52) was significant (0.04 L·yearâ1; p<0.05). Greater improvements were achieved in patients with elevated baseline blood eosinophil and/or FeNO levels for most outcomes.
Conclusions: Dupilumab improves lung function outcomes, including large and small airway measurements and fixed airway obstruction, in patients with uncontrolled, moderate-to-severe asthma; particularly in patients with elevated biomarkers of type 2 inflammation
Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study
BACKGROUND: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD). OBJECTIVE: To assess the long-term safety and efficacy of dupilumab in patients with AD. METHODS: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300Â mg dupilumab weekly for up to 76Â weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated. RESULTS: Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76Â weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life. LIMITATIONS: Lack of control arm, limited number of patients with 76Â weeks or longer of treatment (median follow-up, 24Â weeks), and patients not receiving the approved dose regimen of 300Â mg every 2Â weeks. CONCLUSION: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD
Infections in Dupilumab Clinical Trials in Atopic Dermatitis: A Comprehensive Pooled Analysis
© 2019, The Author(s). Background: Patients with moderate-to-severe atopic dermatitis (AD) have increased infection risk, including skin infections and systemic infections. Immunomodulators (e.g., anti-tumor necrosis factors, anti-interleukin [anti-IL]-23, anti-IL-17, Janus kinase inhibitors) increase risk of infections. Dupilumab (a monoclonal antibody blocking the shared receptor component for IL-4 and IL-13) is approved for inadequately controlled moderate-to-severe AD and for moderate-to-severe eosinophilic or oral corticosteroid-dependent asthma. Objective: The aim was to determine the impact of dupilumab on infection rates in patients with moderate-to-severe AD. Methods: This analysis pooled data from seven randomized, placebo-controlled dupilumab trials in adults with moderate-to-severe AD. Exposure-adjusted analyses assessed infection rates. Results: Of 2932 patients, 1091 received placebo, 1095 dupilumab 300 mg weekly, and 746 dupilumab 300 mg every 2 weeks. Treatment groups had similar infection rates overall per 100 patient-years (placebo, 155; dupilumab weekly, 150; dupilumab every 2 weeks, 156; dupilumab combined, 152), and similar non-skin infection rates. Serious/severe infections were reduced with dupilumab (risk ratio 0.43; p \u3c 0.05), as were bacterial and other non-herpetic skin infections (risk ratio 0.44; p \u3c 0.001). Although herpesviral infection rates overall were slightly higher with dupilumab than placebo, clinically important herpesviral infections (eczema herpeticum, herpes zoster) were less common with dupilumab (risk ratio 0.31; p \u3c 0.01). Systemic anti-infective medication use was lower with dupilumab. Conclusions: Dupilumab is associated with reduced risk of serious/severe infections and non-herpetic skin infections and does not increase overall infection rates versus placebo in patients with moderate-to-severe AD. ClinicalTrials.gov Identifiers: NCT01548404, NCT02210780, NCT01859988, NCT02277743, NCT02277769, NCT02260986, and NCT02755649
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Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials
Prurigo nodularis (PN) is a chronic inflammatory skin disease with intensely pruritic nodules. The LIBERTY-PN PRIME and PRIME2 phase 3 trials enrolled adults with PN with â„20 nodules and severe itch uncontrolled with topical therapies. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13. Patients were randomized 1:1 to 300âmg dupilumab or placebo subcutaneously every 2âweeks for 24âweeks. The primary endpoint was pruritus improvement, measured by proportion of patients with a â„4-point reduction in Worst Itch Numeric Rating Scale (WI-NRS) from baseline at week 24 (PRIME) or week 12 (PRIME2). Key secondary endpoints included nodule number reduction to â€5 at week 24. PRIME and PRIME2 enrolled 151 and 160 patients, respectively. Both trials met all the pre-specified primary and key secondary endpoints. A â„4-point WI-NRS reduction at week 24 in the dupilumab and placebo arms was achieved by 60.0% and 18.4% of patients, respectively, in PRIME (95% confidence interval (CI), 27.8-57.7 for the difference, Pâ<â0.001) and at week 12 by 37.2% and 22.0% of patients, respectively, in PRIME2 (95% CI, 2.3-31.2; Pâ=â0.022). Dupilumab demonstrated clinically meaningful and statistically significant improvements in itch and skin lesions versus placebo in PN. Safety was consistent with the known dupilumab safety profile.ClinicalTrials.gov identifiers: NCT04183335 and NCT04202679
A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis
Background Giant cell arteritis (GCA) is primarily treated with glucocorticoids (GCs), which have substantial toxicity.
Tocilizumab, an interleukin-6-receptor inhibitor (IL-6Ri), showed benefcial efects in GCA, leading to its approval. This
study investigated the efcacy and safety of sarilumab (another IL-6Ri) in GCA.
Methods This Phase 3, double-blind study comprised a 52-week treatment period and a 24-week follow-up phase.
Eligible GCA patients were randomized to receive sarilumab 200 mg (SAR200+26W) or 150 mg (SAR150+26W)
with a 26-week GC taper, or placebo with a 52-week (PBO+52W) or 26-week (PBO+26W) GC taper. The primary
efcacy endpoint was sustained remission (SR) at week 52. Additional endpoints were SR at week 24, cumulative GC
dose, and safety. The study was discontinued prematurely due to protracted recruitment timelines, because of the
impact of COVID-19. Therefore, only descriptive statistics were summarized.
Results Of the planned 360 subjects, only 83 were randomized and 36 were included in the week 52 analysis. At
week 52, 46% (n=6/13) of patients in SAR200+26W, 43% (n=3/7) in SAR150+26W, 30% (n=3/10) in PBO+52W,
and 0 (n=0/6) in PBO+26W taper groups achieved SR. Sensitivity analyses, excluding acute-phase reactants
from the SR defnition, showed similar results for SAR groups, but 60% (n=6/10) in PBO+52W and 17% (n=1/6)
in PBO+26W taper groups achieved SR at week 52. Similar fndings were noted at week 24. The proportions
of patients who adhered to GC taper from week 12 through week 52 in each group were as follows: 46% (n=6/13,
SAR200+26W), 43% (n=3/7, SAR150+26W), 60% (n=6/10, PBO+52W), and 33% (n=2/6, PBO+26W). The median
actual cumulative GC dose received in the SAR200+26W group was lower than other groups. Most patients (80â
100%) experienced treatment-emergent adverse events, with similar incidences reported across groups.
Conclusions Owing to the small sample size due to the early termination, it is difcult to draw clear conclusions
from this study. There were no unexpected safety findings.Funding: This study was funded by Sanof and Regeneron Pharmaceuticals, Inc.
Acknowledgements: Medical writing support for this manuscript was provided by Vasudha Chachra, MPharm of Sanof
Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma
BACKGROUND : Dupilumab is a fully human anti-interleukin-4 receptor alpha monoclonal antibody that blocks both interleukin-4 and interleukin-13 signaling. Its effectiveness in reducing oral glucocorticoid use in patients with severe asthma while maintaining asthma control is unknown.
METHODS : We randomly assigned 210 patients with oral glucocorticoid-treated asthma to receive add-on dupilumab (at a dose of 300 mg) or placebo every 2 weeks for 24 weeks. After a glucocorticoid dose-adjustment period before randomization, glucocorticoid doses were adjusted in a downward trend from week 4 to week 20 and then maintained at a stable dose for 4 weeks. The primary end point was the percentage reduction in the glucocorticoid dose at week 24. Key secondary end points were the proportion of patients at week 24 with a reduction of at least 50% in the glucocorticoid dose and the proportion of patients with a reduction to a glucocorticoid dose of less than 5 mg per day. Severe exacerbation rates and the forced expiratory volume in 1 second (FEV 1) before bronchodilator use were also assessed.
RESULTS : The percentage change in the glucocorticoid dose was -70.1% in the dupilumab group, as compared with -41.9% in the placebo group (P<0.001); 80% versus 50% of the patients had a dose reduction of at least 50%, 69% versus 33% had a dose reduction to less than 5 mg per day, and 48% versus 25% completely discontinued oral glucocorticoid use. Despite reductions in the glucocorticoid dose, in the overall population, dupilumab treatment resulted in a severe exacerbation rate that was 59% (95% confidence interval [CI], 37 to 74) lower than that in the placebo group and resulted in an FEV 1 that was 0.22 liters (95% CI, 0.09 to 0.34) higher. Injection-site reactions were more common with dupilumab than with placebo (9% vs. 4%). Transient blood eosinophilia was observed in more patients in the dupilumab group than in the placebo group (14% vs. 1%).
CONCLUSIONS : In patients with glucocorticoid-dependent severe asthma, dupilumab treatment reduced oral glucocorticoid use while decreasing the rate of severe exacerbations and increasing the FEV 1. Transient eosinophilia was observed in approximately 1 in 7 dupilumab-treated patients