ABSTRACT
INTRODUCTION: More women with autoimmune and inflammatory conditions are being treated with monoclonal antibody biologics (mAbs) during their pregnancy, to maintain clinical remission. The use of anti-tumor necrosis factor alpha agents in pregnancy appears to be safe but less is known regarding other mAbs, such as anti-integrins and anti-cytokine agents. There are currently no comprehensive guidelines on how to manage the exposed infants. Areas covered: We review recent literature to assess the impact of mAbs on birth and early infant outcomes, including what is currently known about maternal and infant drug levels at birth and drug clearance in the infant. We describe the potential risks of infections and reported hematological and immunological effects of antenatal mAbs exposure on the infant and provide guidance on the management of the exposed infant. Expert opinion: Exposed infants should be monitored closely. Certain mAb exposures require specific testing and management. Safety monitoring should be done in a multidisciplinary approach and should include pediatric care providers. The current clinical experience with anti-tumor necrosis factor agents in pregnancy cannot be extrapolated to other mAbs. Long-term observational studies and a multicenter international registry are needed to better appreciate the impact of exposure, especially to newer mAbs.
Subject(s)
Antibodies, Monoclonal/adverse effects , Autoimmune Diseases/drug therapy , Immunosuppressive Agents/adverse effects , Pregnancy Complications/drug therapy , Prenatal Exposure Delayed Effects , Biological Products/adverse effects , Female , Humans , Infant, Newborn , PregnancyABSTRACT
Despite a large body of literature testing interventions to improve heart failure care, care is often suboptimal. This scoping study assesses organizational interventions to improve heart failure outcomes in ambulatory settings. Fifty-two studies and systematic reviews assessing multicomponent, self-management support, and eHealth interventions were included. Studies dating from the 1990s demonstrated that multicomponent interventions could reduce hospitalizations, readmissions, mortality, and costs and improve quality of life. Self-management support appeared more effective when included in multicomponent interventions. The independent contribution of eHealth interventions remains unclear. No studies addressed management of comorbidities, geriatric syndromes, frailty, or end of life care. Few studies addressed risk stratification or vulnerable populations. Limited reporting about intervention components, implementation methods, and fidelity presents challenges in adapting this literature to scale interventions. The use of standardized reporting guidelines and study designs that produce more contextual evidence would better enable application of this work in health system redesign.
