scholarly journals Serological Monitoring Is Key To Sustain Progress of the Maternal and Neonatal Tetanus Elimination Initiative

2016 ◽  
Vol 23 (7) ◽  
pp. 532-534 ◽  
Author(s):  
Myron M. Levine ◽  
Marcela F. Pasetti
Keyword(s):  
Disease Control ◽  
Neonatal Tetanus ◽  
Link Type ◽  
Child Bearing ◽  
Tetanus Immunity

In this issue ofClinical and Vaccine Immunology, Scobie and colleagues (H. M. Scobie et al., Clin Vaccine Immunol 23:546–554, 2016,http://dx.doi.org/10.1128/CVI.00052-16) report a nationwide serosurvey of tetanus immunity in >2,000 Cambodian women of child-bearing age to monitor progress toward maternal and neonatal tetanus elimination. This commentary discusses vaccines as interventions for disease control, elimination, and eradication and emphasizes the importance of the tools needed to monitor the effectiveness of initiatives that deliver the vaccines programmatically.

scholarly journals Phase III, multicentre, randomised, double-blind, placebo-controlled, 104-week study of subcutaneous belimumab administered in combination with rituximab in adults with systemic lupus erythematosus (SLE): BLISS-BELIEVE study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025687 ◽  
Author(s):  
Y K Onno Teng ◽  
Ian N Bruce ◽  
Betty Diamond ◽  
Richard A Furie ◽  
Ronald F van Vollenhoven ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Control ◽  
Lupus Erythematosus ◽  
B Lymphocyte ◽  
Activity Index ◽  
Phase Iii ◽  
Systemic Lupus ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Link Type

IntroductionBelimumab, an anti-B-lymphocyte-stimulator antibody, is approved for the treatment of active, autoantibody-positive systemic lupus erythematosus (SLE). Rituximab, a B cell-depleting anti-CD20 antibody, remains in the SLE treatment armamentarium despite failed trials in lupus nephritis and extrarenal lupus. These biologics, which operate through complementary mechanisms, might result in an enhanced depletion of circulating and tissue-resident autoreactive B lymphocytes when administered together. Thus, belimumab and rituximab combination may be a highly effective treatment of SLE. This study aims to evaluate and compare the efficacy, safety and tolerability of subcutaneous (SC) belimumab and a single cycle of rituximab in patients with SLE with belimumab alone.Methods and analysisBLISS-BELIEVE is a three-arm, randomised, double-blind, placebo-controlled, 104-week superiority study. Two hundred adults with SLE will be randomised 1:2:1 to arm A, belimumab SC 200 mg/week for 52 weeks plus placebo at weeks 4 and 6; arm B, belimumab SC 200 mg/week for 52 weeks plus rituximab 1000 mg at weeks 4 and 6; arm C, belimumab SC 200 mg/week plus standard of care for 104 weeks. The 52-week treatment period (arms A and B) is followed by a 52-week observational phase. The primary efficacy endpoint is the proportion of patients with disease control (SLE Disease Activity Index (SLEDAI)−2K≤2, without immunosuppressants and with a prednisone-equivalent dose of ≤5 mg/day) at week 52. Major secondary efficacy endpoints are the proportion of patients in clinical remission (defined as SLEDAI-2K=0, without immunosuppressants and corticosteroids) at week 64, and the proportion of patients with disease control at week 104. Safety endpoints include the incidence of adverse events (AEs), serious AEs and AEs of special interest.Ethics and disseminationWithin 6 months of the study’s primary manuscript publication, anonymised individual participant data and study documents can be requested for further research fromwww.clinicalstudydatarequest.com.Trial registration numberNCT03312907; Pre-results.

Pregnancy and Epilepsy

2018 ◽  
Author(s):  
Trenton Tollefson ◽  
Lynn Liu
Keyword(s):  
United States ◽  
Disease Control ◽  
Seizure Control ◽  
The United States ◽  
Women Of Childbearing Age ◽  
Childbearing Age ◽  
Neurologic Disorder ◽  
Healthy Infants ◽  
Child Bearing ◽  
Active Epilepsy

Epilepsy is the fourth most common neurologic disorder behind migraine, stroke, and Alzheimer’s disease. The Center for Disease Control (CDC) data estimates about 3.4 million people in the United States have active epilepsy. Approximately 1 million women of childbearing age in the United States have epilepsy, and about 2 to 5 infants of 1000 pregnancies are born to mothers with epilepsy. Therefore, providers should consider additional aspects of epilepsy care unique to women with epilepsy (WWE) of childbearing age such as planning for and care during pregnancy; concern how epilepsy may affect pregnancy and how pregnancy may impact seizure control. Fortunately, more than 90% of pregnant WWE will give birth to healthy infants. Providers should maintain these important items in mind when caring for a WWE of child-bearing age. This chapter focuses on the effects of pregnancy on seizures and the effects of seizures on pregnancy in pregnant WWE.

scholarly journals Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis

2019 ◽  
Vol 78 (7) ◽  
pp. 890-898 ◽  
Author(s):  
Yoshiya Tanaka ◽  
Bruno Fautrel ◽  
Edward C Keystone ◽  
Robert A Ortmann ◽  
Li Xie ◽  
...  
Keyword(s):  
Adverse Events ◽  
Disease Control ◽  
Physical Function ◽  
Clinical Outcomes ◽  
Incidence Rates ◽  
Janus Kinase ◽  
Phase Iii ◽  
Open Label ◽  
Serious Adverse Events ◽  
Link Type

ObjectiveTo evaluate clinical outcomes in patients who changed treatment from adalimumab to baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, during a phase III programme.MethodsIn phase III RA-BEAM, patients were randomised 3:3:2 to placebo, baricitinib 4 mg once daily, or adalimumab 40 mg biweekly. At week 16 or subsequent visits, non-responders were rescued to open-label baricitinib 4 mg. At week 52, patients could enter a long-term extension (LTE) and continue on baricitinib or switch from adalimumab to baricitinib 4 mg with no adalimumab washout period. Percentage of patients achieving low disease activity and remission were assessed, along with physical function, patient’s assessment of pain, and safety.ResultsThirty-five (7%) baricitinib-treated and 40 (12%) adalimumab-treated patients were rescued to baricitinib in RA-BEAM; 78% (381/487) of baricitinib-treated and 72% (238/330) of adalimumab-treated patients who were not rescued in RA-BEAM, entered the LTE and continued/were switched to baricitinib. In both baricitinib-rescued and adalimumab-rescued patients, there were significant improvements in all measures up to 12 weeks after rescue compared with the time of rescue. Patients who switched from adalimumab to baricitinib showed improvements in disease control through 12 weeks in the LTE. Exposure-adjusted incidence rates for treatment-emergent adverse events (TEAEs) and infections, including serious events, were similar for patients who switched from adalimumab to baricitinib and those who continued on baricitinib.ConclusionsSwitching from adalimumab to baricitinib (without adalimumab washout) was associated with improvements in disease control, physical function and pain during the initial 12 weeks postswitch, without an increase in TEAEs, serious adverse events or infections.Trial registration numbersNCT01710358, NCT01885078.

scholarly journals Disease Control and Safety of Belimumab Plus Standard Therapy Over 7 Years in Patients with Systemic Lupus Erythematosus

2013 ◽  
Vol 41 (2) ◽  
pp. 300-309 ◽  
Author(s):  
Ellen M. Ginzler ◽  
Daniel J. Wallace ◽  
Joan T. Merrill ◽  
Richard A. Furie ◽  
William Stohl ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Control ◽  
Lupus Erythematosus ◽  
Standard Therapy ◽  
Initial Study ◽  
Systemic Lupus ◽  
Open Label ◽  
Double Blind ◽  
Link Type ◽  
Auto Antibody

Objective.To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with active systemic lupus erythematosus (SLE) treated up to 7 years (n = 177 currently ongoing).Methods.Patients (n = 345) who completed a double-blind, placebo-controlled, 52-week study of belimumab 1, 4, or 10 mg/kg and 24-week extension of belimumab (placebo switched to 10 mg/kg; belimumab same dose or switched to 10 mg/kg) could receive belimumab 10 mg/kg in an open-label continuation study (n = 296). Disease activity was analyzed in patients with active SLE at baseline of the initial study. Biomarker and SLE medication changes were evaluated, and adverse events (AE) were monitored throughout the study.Results.Total belimumab exposure over 7 years (double-blind and open-label periods): 1746 patient-years. SLE Responder Index (SRI) response rates at Week 52 in autoantibody-positive patients: placebo, 29%; belimumab, 46% (p < 0.05). In the continuation study, 57% of auto-antibody-positive patients had an SRI response by Year 2 and 65% by Year 7; severe flares occurred in 19% with placebo and 17% with belimumab during the first year, with the annual rate declining to 2%–9% during years 2–7. Anti-dsDNA autoantibodies in patients positive for them at baseline had a progressive decline of 40%–60% from baseline over 2–7 years with belimumab. Corticosteroid use decreased over time with ≥ 50–55% reduction in median dose during years 5–7. Serious and overall annual AE rates, including infections, were generally stable or decreased during 7-year treatment.Conclusion.Disease control and safety profile were maintained in patients with active SLE taking belimumab plus standard therapy for up to 7 years. [ClinicalTrials.gov numbers: NCT00071487 and NCT00583362]

Implementation of a pedodontic disease control program

1975 ◽  
Vol 39 (2) ◽  
pp. 102-105
Author(s):  
Pinkham ◽  
G Ori ◽  
SH Wei ◽  
CA Full ◽  
FM Parkins
Keyword(s):  
Disease Control ◽  
Control Program ◽  
Disease Control Program

The Speech-Language Pathologists' Role in Mild Traumatic Brain Injury for Middle and High School–Age Children: Viewpoints on Guidelines From the Centers for Disease Control and Prevention

2019 ◽  
Vol 28 (3) ◽  
pp. 1363-1370 ◽  
Author(s):  
Jessica Brown ◽  
Katy O'Brien ◽  
Kelly Knollman-Porter ◽  
Tracey Wallace
Keyword(s):  
High School ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Disease Control ◽  
Mild Traumatic Brain Injury ◽  
School Age Children ◽  
School Age ◽  
Speech Language Pathologists ◽  
Control And Prevention ◽  
Centers For Disease Control

Purpose The Centers for Disease Control and Prevention (CDC) recently released guidelines for rehabilitation professionals regarding the care of children with mild traumatic brain injury (mTBI). Given that mTBI impacts millions of children each year and can be particularly detrimental to children in middle and high school age groups, access to universal recommendations for management of postinjury symptoms is ideal. Method This viewpoint article examines the CDC guidelines and applies these recommendations directly to speech-language pathology practices. In particular, education, assessment, treatment, team management, and ongoing monitoring are discussed. In addition, suggested timelines regarding implementation of services by speech-language pathologists (SLPs) are provided. Specific focus is placed on adolescents (i.e., middle and high school–age children). Results SLPs are critical members of the rehabilitation team working with children with mTBI and should be involved in education, symptom monitoring, and assessment early in the recovery process. SLPs can also provide unique insight into the cognitive and linguistic challenges of these students and can serve to bridge the gap among rehabilitation and school-based professionals, the adolescent with brain injury, and their parents. Conclusion The guidelines provided by the CDC, along with evidence from the field of speech pathology, can guide SLPs to advocate for involvement in the care of adolescents with mTBI. More research is needed to enhance the evidence base for direct assessment and treatment with this population; however, SLPs can use their extensive knowledge and experience working with individuals with traumatic brain injury as a starting point for post-mTBI care.

SIG 15 Perspectives Vol. 20, No. 3, September 2015

2015 ◽  
Vol 20 (3) ◽  
Keyword(s):  
Learning Center ◽  
Link Type

Abstract Download the CE Questions PDF from the toolbar, above. Use the questions to guide your Perspectives reading. When you're ready, purchase the activity from the ASHA Store and follow the instructions to take the exam in ASHA's Learning Center. Available until August 13, 2018.

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