P509 Vedolizumab levels in breast milk: Results from a prospective, postmarketing, milk-only lactation study in nursing mothers with inflammatory bowel disease

Abstract Background The safety of inflammatory bowel disease (IBD) medications during lactation is of significant interest and relevance to female patients of childbearing potential. Available data regarding the safety and transfer of biologic agents via breast milk are limited to case reports. Vedolizumab has a well-established, positive benefit-risk profile in adult IBD patients. Literature data show that vedolizumab is detectable in human milk. Methods A prospective, postmarketing, phase 4, open-label, milk-only lactation study was conducted to assess vedolizumab concentrations in breast milk from lactating women with IBD who were on an established vedolizumab maintenance regimen (300 mg intravenous [IV] every 8 weeks [Q8W] or an alternative dose frequency). Maternal milk samples were serially collected throughout the dosing interval on Days 1 (predose and 1 h after the end of vedolizumab infusion), 4, 8, 15, 29, and 57 to allow the estimation of drug excreted in milk relative to the maternal dosage. Maternal safety data were also collected. Results A total of 11 patients were enrolled in the study. Vedolizumab was detectable in the majority of milk samples collected on Days 1 and 57, and in all samples collected at other time points. Following receipt of vedolizumab 300 mg IV on Day 1, the vedolizumab milk concentration increased with a median time to peak concentration (Cmax) of 3–4 days, and subsequently decreased exponentially. For the 9 patients on the Q8W regimen, median Cmax was 0.213 µg/ml (range, 0.098–0.561 µg/ml); the geometric mean daily infant dosage, calculated using average concentration over 8-week dosing interval (0.13 µg/ml), was 0.02 mg/kg/day with a corresponding geometric mean percentage of maternal dosage consumed in breast milk by infants of 21%. The maternal safety profile was acceptable and similar to that observed in previous adult studies. Leveraging the mean trough serum concentration of 11.2 µg/ml from historical studies of vedolizumab, the ratio of mean milk concentration (trough, 0.05 µg/ml; peak, 0.25 µg/ml) to serum concentration was approximately 0.4%-2.2%, which is consistent with published data for vedolizumab and comparable with several other monoclonal antibody therapeutics for IBD. Published vedolizumab studies also showed no increase in general or gastrointestinal tract infections in the infants exposed to vedolizumab in breast milk, and exposed infants reached their acceptable development milestones through up to 10 months of follow-up. Conclusion Vedolizumab was found to be present in human breastmilk at a low level. The impact of vedolizumab IV administration during breastfeeding is expected to be minimal.

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P065 Conservation of breast milk cytokine profiles in consecutive pregnancies of women with inflammatory bowel disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.194 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S170-S171

Author(s):

M Agrawal ◽

L Tarassishin ◽

A Rendon ◽

A Debebe ◽

C Hillenbrand ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Pilot Study ◽

Breast Milk ◽

Bowel Disease ◽

Preliminary Evidence ◽

Immune Functions ◽

Milk Samples ◽

Cytokine Profiles ◽

Study Results ◽

Inflammatory Bowel

Abstract Background Preliminary evidence suggests changes in breast milk cytokines in women with inflammatory bowel disease (IBD) compared to healthy controls, with potential implications toward offspring immunological development. However, changes in breast milk cytokine profiles in consecutive pregnancies are not known. Methods In this pilot study, we prospectively enrolled 11 pregnant women with, and 10 without IBD during two consecutive pregnancies and collected clinical data during each pregnancy and post birth. We collected breast milk samples at two weeks post birth and obtained the expression levels of 92 cytokines using the Olink proteomic platform. We further analyzed the correlation of cytokine profiles within each sample, in paired breast milk samples from consecutive pregnancies, and in random two unpaired breast milk samples, of women with and without IBD. Results The baseline characteristics of women with and without IBD were comparable (Table). The cytokine profiles were significantly correlated between paired breast milk samples from consecutive pregnancies compared to unpaired breast milk samples from women with or without IBD. The overall correlations of cytokine profiles in paired IBD pregnancies were significantly higher than the controls (Figure). Conclusion Our pilot study results suggest that the breast milk cytokine signatures are more conserved in consecutive pregnancies of women with IBD compared to those without IBD. Future analysis will test if our findings have implications toward familial clustering of immune functions in offspring.

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The impact of inflammatory bowel disease on hard teeth tissues – preliminary results from POLIBD study

10.26226/morressier.59a6b34bd462b80290b5599d ◽

2017 ◽

Author(s):

Rafa Filip

Keyword(s):

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Preliminary Results ◽

Inflammatory Bowel ◽

The Impact

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Exploitation of Marine-Derived Robust Biological Molecules to Manage Inflammatory Bowel Disease

Marine Drugs ◽

10.3390/md19040196 ◽

2021 ◽

Vol 19 (4) ◽

pp. 196

Author(s):

Muhammad Bilal ◽

Leonardo Vieira Nunes ◽

Marco Thúlio Saviatto Duarte ◽

Luiz Fernando Romanholo Ferreira ◽

Renato Nery Soriano ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Bioactive Compounds ◽

Bowel Disease ◽

Clinical Translation ◽

Biologically Active ◽

Naturally Occurring ◽

Inflammatory Bowel ◽

Functional Features ◽

Biological Entities ◽

The Impact

Naturally occurring biological entities with extractable and tunable structural and functional characteristics, along with therapeutic attributes, are of supreme interest for strengthening the twenty-first-century biomedical settings. Irrespective of ongoing technological and clinical advancement, traditional medicinal practices to address and manage inflammatory bowel disease (IBD) are inefficient and the effect of the administered therapeutic cues is limited. The reasonable immune response or invasion should also be circumvented for successful clinical translation of engineered cues as highly efficient and robust bioactive entities. In this context, research is underway worldwide, and researchers have redirected or regained their interests in valorizing the naturally occurring biological entities/resources, for example, algal biome so-called “treasure of untouched or underexploited sources”. Algal biome from the marine environment is an immense source of excellence that has also been demonstrated as a source of bioactive compounds with unique chemical, structural, and functional features. Moreover, the molecular modeling and synthesis of new drugs based on marine-derived therapeutic and biological cues can show greater efficacy and specificity for the therapeutics. Herein, an effort has been made to cover the existing literature gap on the exploitation of naturally occurring biological entities/resources to address and efficiently manage IBD. Following a brief background study, a focus was given to design characteristics, performance evaluation of engineered cues, and point-of-care IBD therapeutics of diverse bioactive compounds from the algal biome. Noteworthy potentialities of marine-derived biologically active compounds have also been spotlighted to underlying the impact role of bio-active elements with the related pathways. The current review is also focused on the applied standpoint and clinical translation of marine-derived bioactive compounds. Furthermore, a detailed overview of clinical applications and future perspectives are also given in this review.

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Vedolizumab Concentrations in Breast Milk: Results from a Prospective, Postmarketing, Milk-Only Lactation Study in Nursing Mothers with Inflammatory Bowel Disease

Clinical Pharmacokinetics ◽

10.1007/s40262-021-00985-4 ◽

2021 ◽

Author(s):

Wan Sun ◽

Blair Fennimore ◽

Dawn B. Beaulieu ◽

Razvan Arsenescu ◽

Adam C. Stein ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Breast Milk ◽

Bowel Disease ◽

Nursing Mothers ◽

Inflammatory Bowel

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Impact of COVID-19 on the diagnosis, assessment and management of children with inflammatory bowel disease in the UK: implications for practice

BMJ Paediatrics Open ◽

10.1136/bmjpo-2020-000786 ◽

2020 ◽

Vol 4 (1) ◽

pp. e000786

Author(s):

Abbie Maclean ◽

James J Ashton ◽

Vikki Garrick ◽

R Mark Beattie ◽

Richard Hansen

Keyword(s):

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Delayed Diagnosis ◽

High Standard ◽

Current Evidence ◽

Faecal Calprotectin ◽

Paediatric Patients ◽

Inflammatory Bowel ◽

Working Practices ◽

The Impact

The assessment and management of patients with known, or suspected, paediatric inflammatory bowel disease (PIBD) has been hugely impacted by the COVID-19 pandemic. Although current evidence of the impact of COVID-19 infection in children with PIBD has provided a degree of reassurance, there continues to be the potential for significant secondary harm caused by the changes to normal working practices and reorganisation of services.Disruption to the normal running of diagnostic and assessment procedures, such as endoscopy, has resulted in the potential for secondary harm to patients including delayed diagnosis and delay in treatment. Difficult management decisions have been made in order to minimise COVID-19 risk for this patient group while avoiding harm. Initiating and continuing immunosuppressive and biological therapies in the absence of normal surveillance and diagnostic procedures have posed many challenges.Despite this, changes to working practices, including virtual clinic appointments, home faecal calprotectin testing kits and continued intensive support from clinical nurse specialists and other members of the multidisciplinary team, have resulted in patients still receiving a high standard of care, with those who require face-to-face intervention being highlighted.These changes have the potential to revolutionise the way in which patients receive routine care in the future, with the inclusion of telemedicine increasingly attractive for stable patients. There is also the need to use lessons learnt from this pandemic to plan for a possible second wave, or future pandemics as well as implementing some permanent changes to normal working practices.In this review, we describe the diagnosis, management and direct impact of COVID-19 in paediatric patients with IBD. We summarise the guidance and describe the implemented changes, evolving evidence and the implications of this virus on paediatric patients with IBD and working practices.

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