scholarly journals New Lactiplantibacillus plantarum and Lacticaseibacillus rhamnosus strains: well tolerated and improve infant microbiota

2021 ◽  
Author(s):  
Gunilla Önning ◽  
Ragnhild Palm ◽  
Caroline Linninge ◽  
Niklas Larsson
Keyword(s):  
Adverse Events ◽  
Growth Parameters ◽  
List Type ◽  
Young Infants ◽  
Healthy Infants ◽  
Colony Forming Units ◽  
Gut Function ◽  
Probiotic Strains ◽  
Probiotic Lactobacilli ◽  
Faecal Microbiome

Abstract Background Different microorganisms from the environment will begin to colonise the infant during and immediately after the delivery. It could be advantageous to influence the microbiome early on by giving infants probiotic bacteria. The aim of the study was to investigate the tolerance of two probiotic lactobacilli in infants. The effect on the microbiota was also followed. Methods Thirty-six healthy infants, aged 4–83 days at the start of the study, were given a daily supplementation of probiotics (Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus rhamnosus 271, 109 CFU (colony-forming units)) or placebo for 8 weeks. Adverse events, growth parameters, the faecal microbiome and intestinal performance were followed. Results No differences between the groups in growth parameters, adverse events and intestinal performance were observed. The faecal levels of L. plantarum, L. rhamnosus and lactobacilli increased after the intake of probiotics and were significantly higher compared with the placebo group after 4 and 8 weeks of intake. The faecal microbial diversity was similar in the two groups at the end of the study. Conclusions The intervention with the probiotic formulation was well tolerated and increased the level of lactobacilli in the intestine. The developed probiotic formulation will be further evaluated for clinical efficacy in infants. Impact New data for the development of the gut function and the microbiome in breastfed and/or formula-fed young infants over time and the effect of adding two probiotic strains are presented. Lactiplantibacillusplantarum is a species that seldom has been analysed in infants, but it could be detected in 25% of the subjects before administration (mean age 41 days). Lactiplantibacillusplantarum and L. rhamnosus establish well in the intestine of infants and are well tolerated. The microbiota was positively affected by the intake of probiotics.

Safety and tolerance of three probiotic strains in healthy infants: a multi-centre randomized, double-blind, placebo-controlled trial

2017 ◽  
Vol 8 (4) ◽  
pp. 569-578 ◽  
Author(s):  
S. Manzano ◽  
J. De Andrés ◽  
I. Castro ◽  
J.M. Rodríguez ◽  
E. Jiménez ◽  
...  
Keyword(s):  
Adverse Events ◽  
Head Circumference ◽  
Controlled Trial ◽  
Bifidobacterium Longum ◽  
Lactobacillus Helveticus ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Healthy Infants ◽  
Probiotic Strains

Some strains of species belonging to the genera Bifidobacterium and Lactobacillus are used in order to maintain health. Although these organisms have a long record of safe use, it is important to assess their safety and tolerance in potentially vulnerable populations, such as infants. The objective of this study was to evaluate the safety and tolerance of three probiotic strains (Bifidobacterium longum subsp. infantis R0033, Bifidobacterium bifidum R0071 and Lactobacillus helveticus R0052) in healthy infants aged 3 to 12 months. A multi-centre randomized, double-blind, placebo-controlled intervention study with 221 healthy full-term infants was conducted. Infants received either a placebo or one of the 3 probiotic strains (3×109 cfu) daily during an 8 week intervention period. Growth (weight, height and head circumference), adverse events (AEs)/serious adverse events (SAEs), concentrations of D-lactic acid in urine samples, characteristics of the stools and use of medication were collected for safety evaluation. All 4 groups were homogeneous with respect to age, gender, feeding type, ethnicity, height, weight and head circumference at the start of the study. The results showed that changes in growth (weight, height and head circumference) were equivalent in all 4 groups. No SAEs were reported. Total number of AEs recorded was equivalent in all groups. Thus, the use of B. infantis R0033, L. helveticus R0052 and B. bifidum R0071 in infancy is safe, and well tolerated.

scholarly journals Fecal Calprotectin and Eosinophil-Derived Neurotoxin in Children with Non-IgE-Mediated Cow’s Milk Protein Allergy

2021 ◽  
Vol 10 (8) ◽  
pp. 1595
Author(s):  
María Roca ◽  
Ester Donat ◽  
Ana Rodriguez Varela ◽  
Eva Carvajal ◽  
Francisco Cano ◽  
...  
Keyword(s):  
Milk Protein ◽  
Statistical Significance ◽  
Functional Gastrointestinal Disorders ◽  
Fecal Calprotectin ◽  
Cow’S Milk ◽  
Cow's Milk ◽  
Young Infants ◽  
Healthy Infants ◽  
Ige Mediated ◽  
Cow’S Milk Protein

Our aim is to assess the efficacy of fecal calprotectin (fCP) and fecal eosinophil-derived neurotoxin (fEDN) as diagnostic markers of cow’s milk protein allergy (CMPA) and for monitoring the infants’ response to a non-IgE mediated cow’s milk protein (CMP)-free diet. We prospectively recruited infants aged 0 to 9 months. Stool samples were taken from 30 infants with CMPA, 19 with mild functional gastrointestinal disorders, 28 healthy infants, and 28 children who presented mild infections. Despite the fact that levels of fCP and fEDN in CMPA infants were higher than in healthy infants at month 0, differences for both parameters did not reach statistical significance (p-value 0.119 and 0.506). After 1 month of an elimination diet, no statistically significant differences in fCP with basal levels were found (p-values 0.184) in the CMPA group. We found a high variability in the fCP and fEDN levels of young infants, and discrepancies in individual behavior of these markers after a CMP-free diet was started. It seems that neither fCP nor fEDN levels are helpful to discriminate between healthy infants and those with signs or symptoms related to non-IgE-mediated CMPA. Additionally, it is debatable if on an individual basis, fCP or fEDN levels could be used for clinical follow-up and dietary compliance monitoring. However, prospective studies with larger populations are needed to draw robust conclusions.

395 A first-in-human study of FS118, a tetravalent bispecific antibody targeting LAG-3 and PD-L1, in patients with advanced cancer and resistance to PD-(L)1 therapy

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A420-A420
Author(s):  
Timothy Yap ◽  
Deborah Wong ◽  
Siwen Hu-Lieskovan ◽  
Kyriakos Papadopoulos ◽  
Michelle Morrow ◽  
...  
Keyword(s):  
T Cell ◽  
Adverse Events ◽  
Advanced Cancer ◽  
Bispecific Antibody ◽  
Acquired Resistance ◽  
Human Study ◽  
Clinical Activity ◽  
List Type ◽  
Link Type ◽  
Antibody Targeting

BackgroundUpregulation of immune checkpoints, such as LAG-3, plays an important role in promoting resistance to anti-PD-(L)1 therapy. Targeting PD-L1 and LAG-3 using a bispecific antibody may overcome resistance to PD-(L)1 blockade.1 We report initial data from a first-in-human study evaluating FS118 in patients with advanced cancer and resistance to PD-(L)1 therapy.MethodsThe ongoing Phase I FIH study (NCT03440437) is being conducted to evaluate safety, tolerability, immunogenicity, PK/PD and clinical activity of FS118 administered IV weekly to heavily pre-treated patients who had previously received anti-PD-(L)1 therapy for a minimum of 12 weeks. Adverse events were assessed using CTCAEv4.03 and tumor responses assessed using RECISTv1.1 and iRECIST. Single subject dose escalation cohorts were followed by a 3+3 ascending dose design. Three cohorts (3, 10, 20 mg/kg) were expanded to evaluate PK, PD and clinical activity. Pharmacodynamic studies examined soluble LAG-3 production and peripheral T-cell expansion.ResultsForty-three patients (median 6 lines of prior therapy, including ICB) with solid tumors received FS118 at doses from 0.8 mg up to 20 mg/kg across 8 dose levels. Weekly administration of FS118 was well tolerated and did not result in dose- or treatment-limiting toxicities. An MTD was not reached. No safety signals unexpected for the drug class of immune-checkpoint inhibitors were identified in the early study population. The majority (95%) of treatment-emergent adverse events (TEAE) considered by the Safety Review Committee (SRC) to be treatment-related were Grade 1 and 2. Grade 3 TEAEs toxicities (elevated liver enzymes) were observed in 2 patients (5%). No SAEs or deaths were attributed to FS118 treatment. Anti-drug antibodies, observed in half of patients, were typically transient in nature. The pharmacokinetic profile confirmed preclinical predictions and PD parameters included a dose-dependent increase in serum soluble LAG-3 and expansion of peripheral T cells. Long-lasting disease stabilisation (>6 months) was observed in a subset of patients with acquired resistance (defined as a CR, PR or SD ≥3 months on previous PD-(L)1 treatment), but not in patients with primary resistance. Two patients remain on FS118 treatment as of 2 Jul 2020 (duration 10 and 16 months). Retrospective IHC analysis of PD-L1 and LAG-3 co-expression in the tumor was assessed as a potential biomarker associated with clinical outcome.ConclusionsWeekly treatment with FS118 was well tolerated up to 20 mg/kg and was associated with pharmacodynamic markers of FS118 activity. Encouraging signs of clinical activity were observed in highly pre-treated patients who had acquired resistance to prior PD-(L)1 therapy.Trial RegistrationRegistered at www.clinicaltrials.gov, NCT03440437ReferenceKraman M, Faroudi M, Allen N, Kmiecik K, Gliddon D, Seal C, Koers A, Wydro M, Winnewisser J, Young L, Tuna M, Doody J, Morrow M, Brewis N. FS118, a bispecific antibody targeting LAG-3 and PD-L1, Enhances T-Cell activation resulting in potent antitumor activity. Clin Cancer Res 2020; 26:3333–3344.

scholarly journals pH-, Lactic Acid-, and Non-Lactic Acid-Dependent Activities of Probiotic Lactobacilli against Salmonella enterica Serovar Typhimurium

2005 ◽  
Vol 71 (10) ◽  
pp. 6008-6013 ◽  
Author(s):  
Domitille Fayol-Messaoudi ◽  
Cédric N. Berger ◽  
Marie-Hélène Coconnier-Polter ◽  
Vanessa Liévin-Le Moal ◽  
Alain L. Servin
Keyword(s):  
Lactic Acid ◽  
Growth Phase ◽  
Salmonella Enterica ◽  
Lactobacillus Rhamnosus ◽  
Stationary Growth Phase ◽  
Exponential Growth Phase ◽  
Killing Activity ◽  
Serovar Typhimurium ◽  
Probiotic Strains ◽  
Probiotic Lactobacilli

ABSTRACT The mechanism(s) underlying the antibacterial activity of probiotic Lactobacillus strains appears to be multifactorial and includes lowering of the pH and the production of lactic acid and of antibacterial compounds, including bacteriocins and nonbacteriocin, non-lactic acid molecules. Addition of Dulbecco's modified Eagle's minimum essential medium to the incubating medium delays the killing activity of lactic acid. We found that the probiotic strains Lactobacillus johnsonii La1, Lactobacillus rhamnosus GG, Lactobacillus casei Shirota YIT9029, L. casei DN-114 001, and L. rhamnosus GR1 induced a dramatic decrease in the viability of Salmonella enterica serovar Typhimurium SL1344 mainly attributable to non-lactic acid molecule(s) present in the cell-free culture supernatant (CFCS). These molecules were more active against serovar Typhimurium SL1344 in the exponential growth phase than in the stationary growth phase. We also showed that the production of the non-lactic acid substance(s) responsible for the killing activity was dependent on growth temperature and that both unstable and stable substances with killing activity were present in the CFCSs. We found that the complete inhibition of serovar Typhimurium SL1344 growth results from a pH-lowering effect.

scholarly journals A Randomized Double Blind Controlled Safety Trial Evaluating D-Lactic Acid Production in Healthy Infants Fed a Lactobacillus reuteri-containing Formula

2014 ◽  
Vol 7 ◽  
pp. NMI.S14113 ◽  
Author(s):  
Konstantinos Papagaroufalis ◽  
Aikaterini Fotiou ◽  
Delphine Egli ◽  
Liên-Anh Tran ◽  
Philippe Steenhout
Keyword(s):  
Lactic Acid ◽  
Treatment Effect ◽  
Lactobacillus Reuteri ◽  
Lactic Acid Production ◽  
Fold Increase ◽  
Primary Objective ◽  
Double Blind ◽  
Term Infants ◽  
Healthy Infants ◽  
Colony Forming Units

Background D-Lactic acidosis in infants fed lactic acid bacteria-containing products is a concern. Methods The primary objective of this non-inferiority trial was to compare urinary D-lactic acid concentrations during the first 28 days of life in infants fed formula containing Lactobacillus reuteri (1.2 x 106 colony forming units (CFU)/ml) with those fed a control formula. The non-inferiority margin was set at a two-fold increase in D-lactic acid (0.7 mmol/mol creatinine, log-transformed). Healthy term infants in Greece were enrolled between birth and 72 hours of age, and block randomized to a probiotic ( N = 44) or control ( N = 44) group. They were exclusively fed their formulae until 28 days of age and followed up at 7, 14, 28, 112, and 168 ± 3 days. Anthropometric measurements were taken at each visit and tolerance recorded until 112 days. Urine was collected before study formula intake and at all visits up to 112 days and blood at 14 days. Results D-Lactic acid concentration in the probiotic group was below the non-inferiority margin at 28 days: treatment effect -0.03 (95% confidence interval [CI]: [-0.48 to 0.41]) mmol/mol creatinine but was above the non-inferiority margin at 7 and 14 days–-treatment effect 0.50 (95% CI: [0.05-0.96]) mmol/mol creatinine and 0.45 (95% CI: [0.00-0.90]) mmol/mol creatinine, respectively. Blood acid excess and pH, anthropometry, tolerance, and adverse events (AEs) were not significantly different between groups. Conclusion Intake of L. reuteri-containing formula was safe and did not cause an increase in D-lactic acid beyond two weeks. Trial Registration ClinicalTrials.gov NCT01119170.

scholarly journals 478 COM701 in combination with BMS-986207 (anti-TIGIT antibody) and nivolumab – preliminary results of safety, tolerability and pharmacokinetics in patients with advanced solid tumors (NCT04570839)

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A508-A508
Author(s):  
Ecaterina Dumbrava ◽  
Manish Sharma ◽  
Gini Fleming ◽  
Kyriakos Papadopoulos ◽  
Ryan Sullivan ◽  
...  
Keyword(s):  
Antitumor Activity ◽  
Adverse Events ◽  
Solid Tumors ◽  
Pharmacokinetic Parameters ◽  
Tolerability Profile ◽  
List Type ◽  
Advanced Solid Tumors ◽  
Cancer Data ◽  
Preliminary Results ◽  
Favorable Safety

BackgroundCOM701, a novel first-in-class immune checkpoint inhibitor (ICI) binds to poliovirus receptor related immunoglobulin domain containing (PVRIG) leading to enhanced activation of T and NK-cells. COM701 in combination with nivolumab has a favorable safety profile, is well tolerated and demonstrates antitumor activity.1 We hypothesized that the addition of BMS-986207 as a triplet thereby inhibiting the DNAM axis will have an acceptable safety/tolerability profile. We present preliminary results on safety/tolerability and pharmacokinetics (PK) parameters.MethodsUsing an accelerated titration and 3+3 study design we enrolled 14 patients (pts) with advanced solid tumors. Doses of COM701 were 0.3, 1, 3, 10 or 20 [mg/kg IV Q4 wks]; in combination with nivolumab and BMS-986207 (both 480 mg IV Q4 wks). Key objectives were to evaluate the safety and tolerability, to determine the recommended dose for expansion (RDFE) and to characterize preliminary pharmacokinetic parameters. Key inclusion criteria: Age ≥ 18 yrs, histologically confirmed locally advanced or metastatic solid malignancy and has exhausted all available standard treatments. Key exclusion criteria: history of immune-related toxicities on prior immunotherapy treatment leading to discontinuation.ResultsIn the safety population [N=14], 12 pts reported treatment emergent adverse events (TEAEs). The most frequent TEAES [≥3 pts] were fatigue 5 pts (36%), pyrexia 3 pts (21%), vomiting 3 pts (21%). No DLTs were reported in any of the dose levels. The most frequent tumor types enrolled: CRC (n=3), and prostate, melanoma and OVCA/primary peritoneal cancer (n=2 each). Median number of prior therapies was 10 (range 1–19). Four pts had received prior immunotherapy. Serious adverse events [≥2 pts] were 2 pts (14%) with G3 abdominal pain, 2 pts (14%) with vomiting (1pt with G1/2 vomiting, 1 pt with G3 vomiting) all assessed by the investigator as unrelated to study drug. Preliminary PK profiles of COM701 were generally dose proportional.ConclusionsCOM701 in combination with BMS-986207 and nivolumab demonstrates a favorable safety, tolerability and PK profiles. COM701 20 mg/kg has been selected as the RDFE in combination with BMS-986207 and nivolumab (both 480 mg) all administered IV Q4 wks. The expansion cohorts are enrolling pts with platinum resistant ovarian cancer and endometrial cancer. Data cutoff 28 Jun 2021.AcknowledgementsThis study is in collaboration with Bristol Myers Squibb.Trial RegistrationNCT04570839ReferencesVaena, DA, Fleming GF et al. COM701 with or without nivolumab: Results of an ongoing phase 1 study of safety, tolerability and preliminary antitumor activity in patients with advanced solid malignancies (NCT03667716). J Clin Oncol 2021;39: (suppl 15; abstr 2504).Ethics ApprovalThe study obtained ethics approval form all the participating sites. All study participants gave informed consent before taking part.- 0002: START2020.15- 0003: 20210109- 0005: IRB20-1549- 0006: 21-060- 0007: IRB-AAAT4904- 0012: 2020-0755- 0013: STMW2020.16- 0015: 20210109

Texture Consumption Patterns of 8- to 12-Month-Old Infants: A Reflection of Typical Feeding Development

2021 ◽  
pp. 1-10
Author(s):  
Amy L. Delaney ◽  
Megan Van Hoorn ◽  
Sarah Staskiewicz ◽  
Mary Beth Feuling ◽  
Stephanie Pladies ◽  
...  
Keyword(s):  
Early Childhood ◽  
Consumption Patterns ◽  
List Type ◽  
Typically Developing ◽  
Accurate Identification ◽  
Feeding Disorder ◽  
Healthy Infants ◽  
Age Appropriate ◽  
Pediatric Feeding ◽  
Feeding Development

Purpose The lack of age-appropriate expectations for the acquisition of feeding skills and consumption of textured food in early childhood inhibits early and accurate identification of developmental delay in feeding and pediatric feeding disorder. The objective of this study was to describe texture intake patterns in a cohort of typically developing infants between 8 and 12 months of age, with the aim of informing future research to establish targets for feeding skill acquisition. Method Using cross-sectional methodology, we studied the presence of liquid and solid textures and drinking methods in the diet, consumption patterns by texture and drinking methods, and caloric intake by texture via caregiver questionnaire and 3-day dietary intake record in 63 healthy infants between 8 and 12 months of age. Descriptive statistics and a one-way analysis of variance were conducted to compare the effect of age on texture intake patterns. Results Findings reveal rapid advancement of intake patterns for texture overall and for energy intake by texture between 8 and 12 months of age. Whereas liquids continue to provide a large proportion of total energy through this time, solids contribute an equal proportion of energy by 12 months of age. Conclusions This study describes texture intake patterns in a cohort of typically developing infants between 8 and 12 months of age by examining the presence of texture and drinking methods, liquid and solid consumption patterns, and energy intake by texture. When applied to data from a future population sample, findings will provide a threshold for age expectations for typical and disordered feeding development to aid in the detection of developmental delay in feeding and pediatric feeding disorder. What Is Known: Expectations regarding early feeding development have been focused on nutrition parameters. Lack of standardized, age-appropriate expectations for texture progression in infancy and early childhood inhibits early and accurate identification and treatment of pediatric feeding disorder. What Is New: We have described changes in dietary composition by texture and drinking method in healthy infants. Together with nutritional composition, this study describes a more comprehensive assessment of infant feeding, particularly to clinicians who need to diagnose feeding skill deficits. Supplemental Material https://doi.org/10.23641/asha.16879615

scholarly journals 008 Associations between comorbidities and adverse events of antiepileptic drugs and quality of life: a survey of epilepsy patients in australia

2019 ◽  
Vol 90 (e7) ◽  
pp. A3.2-A3
Author(s):  
Jeremy M Welton ◽  
Christine Walker ◽  
Kate Riney ◽  
Alvin Ng ◽  
Lisa M Todd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Antiepileptic Drugs ◽  
List Type ◽  
Linear Regression Models ◽  
Cross Sectional ◽  
Stepwise Selection ◽  
Memory Problems ◽  
The Impact

IntroductionThis study explored the impact of specific types of comorbidities and adverse events (AEs) from antiepileptic drugs (AEDs) on quality of life (QoL) among adult patients with epilepsy (PwE) in Australia.MethodsCross-sectional surveys were completed by PwE, or caregiver proxies, recruited via the online pharmacy application MedAdvisor and Australian PwE Facebook groups from May–August 2018 Data were collected on demographics, epilepsy severity and management, AEs, comorbidities, and QoL (using QOLIE-10-P total score).1 Multiple linear regression models were constructed to explore associations between AEs or comorbidities and QOLIE-10-P, with possible confounders determined using stepwise selection.Results978 responses were included (mean age 44.5 years, 64% female, 52% employed). 97% reported recent AED use, 47% on AED monotherapy, 35% exposed to ≤2 lifetime AEDs, and 55% seizure-free for >1 year. After stepwise selection, control variables included in both models were: time since diagnosis, employment status, seizure frequency, number of currently prescribed AEDs, and number of general practitioner visits per year. In the model for comorbidities, ‘psychiatric disorders’ was associated with the largest QOLIE-10-P decrease (-23.30, p<0.001). In the model for AEs, which additionally controlled for depression and anxiety disorder, ‘memory problems’ was associated with the largest decrease in QOLIE-10-P (-14.27, p<0.001).ConclusionsIn this survey of Australian PwE, of which many had relatively well-controlled epilepsy, psychiatric and memory problems were common and associated with the greatest detrimental impact on QoL. Further research is needed to understand causality, relationships between possibly interrelated or overlapping symptoms, and management strategies. UCB Pharma-sponsored.ReferenceCramer JA, Perrine K, Devinsky O, Meador K. A brief questionnaire to screen for quality of life in epilepsy: The QOLIE-10. Epilepsia 1996;37:577–582.

scholarly journals Comparative Survey of Holding Positions for Reducing Vaccination Pain in Young Infants

2017 ◽  
Vol 2017 ◽  
pp. 1-7
Author(s):  
Hui-Chu Yin ◽  
Shao-Wen Cheng ◽  
Chun-Yuh Yang ◽  
Ya-Wen Chiu ◽  
Yi-Hao Weng
Keyword(s):  
Facial Expression ◽  
Acute Pain ◽  
Supine Position ◽  
Upright Position ◽  
Optimal Position ◽  
Young Infants ◽  
Healthy Infants ◽  
Significant Difference ◽  
Infant Pain ◽  
Comparative Survey

Background. Infant holding position may reduce vaccination pain. However, the optimal position for young infants remains controversial. Objectives. To compare the effectiveness of holding infants in the supine position and the effectiveness of holding infants in upright position for relieving acute pain from vaccine injection. Methods. This prospective cohort study enrolled 6–12-week-old healthy infants. We examined infant pain responses by evaluating the following three categories: (1) crying, (2) irritability, and (3) facial expression. Results. In total, 282 infants were enrolled, with 103 and 179 held in the supine and upright positions, respectively. At 30 s after vaccination, the infants in the supine position showed a larger decrease in crying (p<0.001), irritability (p=0.002), and pained facial expression (p=0.001) than did those in the upright position. However, there was no significant difference in pain response between two groups at 180 s after intervention. Conclusion. In 2-month-old infants, the supine position may reduce acute pain more effectively than does the upright position. Our findings provide a clinical strategy for relieving vaccination pain in young infants.

scholarly journals Multiple Doses of Icatibant used during Pregnancy

2017 ◽  
Vol 8 (3) ◽  
pp. ar.2017.8.0210 ◽  
Author(s):  
Lauren W. Kaminsky ◽  
Theodore Kelbel ◽  
Fay Ansary ◽  
Timothy Craig
Keyword(s):  
Adverse Events ◽  
Literature Search ◽  
Medical Literature ◽  
Case Reports ◽  
Treatment Options ◽  
Multiple Treatment ◽  
Multiple Doses ◽  
Healthy Infants

Background Hereditary angioedema (HAE) is a life-long disease that often manifests by puberty. Treatment of attacks is essential to improve quality of life and to decrease morbidity and mortality. During pregnancy, treatment is limited because multiple treatment options, including icatibant, are not approved for use during pregnancy. Objective We report the outcomes of three pregnancies during which icatibant was used by a patient with HAE with normal C1-inhibitor for treatment of attacks. We also reviewed the literature for reports of icatibant use during pregnancy for outcomes and adverse events. Methods We report on a patient who treated herself with icatibant during three separate pregnancies. Postpartum follow-up verified the health of the mother and children. We also performed a complete literature search of medical literature data bases on icatibant use during pregnancy. Results The patient in our report administered multiple doses of icatibant during three pregnancies. The child born from the first pregnancy and the child from the third pregnancy were born at term and without congenital anomalies. The child from the second pregnancy was 1-month preterm. All three children were developmentally normal. The literature search identified two case reports and one abstract of limited icatibant use without adverse events during pregnancy in patients with HAE. These pregnancies resulted in the births of healthy infants. Conclusion From a search of the literature, three cases of icatibant use during pregnancy resulted in healthy infants. In addition, we report that from icatibant use in three separate pregnancies, one infant was born prematurely, but there were no birth defects. From follow-up, the children continued meeting developmental milestones. This report adds to the acquisition of knowledge for drug adverse events during postmarketing surveillance for icatibant use during pregnancy.

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