Infliximab, adalimumab and vedolizumab concentrations across pregnancy and vedolizumab concentrations in infants following intrauterine exposure

Flanagan, Emma; Gibson, Peter R; Wright, Emily K; Moore, Gregory T.; Sparrow, Miles P.; Connell, William; Kamm, Michael A.; Begun, Jakob; Christensen, Britt; Cruz, Peter De; Shelton, Edward; Dowling, Damian; Andrews, Jane M.; Brown, Steven J; Niewiadomski, Olga; Ward, Mark; Rosella, Ourania; Rosella, Gennaro; Kiburg, Katerina; Ross, Alyson L; Bell, Sally

doi:10.1111/apt.16102

Cited by 44 publications

(119 citation statements)

References 28 publications

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“…Data from the same region, with overlapping time periods and common co-authors, were concerning for possible duplication, and as such the smaller studies were also excluded. 23,28,37 Our systematic review therefore included four studies (213 pregnancies): three were full manuscripts, 21,22,30 while one was a conference abstract. 26 Study characteristics.…”

Section: Resultsmentioning

confidence: 99%

“…Of the four trials in our systematic review, one was a prospective cohort study, 26 one was a retrospective case-control study, 21 and two were retrospective cohort studies. 22,30 The control group included patients exposed to "disease-matched" controls, 26 or those exposed to at least one of anti-TNF, steroids, immunomodulators, 5ASA or ustekinumab. 21,22,30 Exposure to VDZ varied across studies; within 2 months of conception, 30 at least once during pregnancy, 21 at least once during the first trimester, 26 and throughout pregnancy, 22 were included respectively.…”

Section: Resultsmentioning

confidence: 99%

“…20 Recent studies have reported on the safety of VDZ during pregnancy. 3,[21][22][23][24][25][26][27][28][29][30] However, these studies are often limited by small-sample sizes and lack of standardized control groups. As such, we aimed to systematically assess the safety of VDZ, compared with other therapeutic agents, in pregnant women with IBD.…”

Section: Introductionmentioning

confidence: 99%

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Systematic review and meta‐analysis: Safety of vedolizumab during pregnancy in patients with inflammatory bowel disease

Bell

Tandon

Lentz

et al. 2021

J of Gastro and Hepatol

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Background and Aim: Vedolizumab is a novel monoclonal antibody used in patients with inflammatory bowel disease, often affecting women of child-bearing age. We aimed to compare maternal and fetal adverse outcomes in pregnancies of women with inflammatory bowel disease exposed to vedolizumab versus those on other treatment. Methods: We performed a systematic literature search through December 2020 looking for studies including outcomes from pregnancies of female inflammatory bowel disease patients treated with vedolizumab. Our primary outcome was a composite of adverse pregnancy-related events in pregnancies of female patients on vedolizumab compared with those of disease-matched controls on other medication regimens. Events of interest included preterm births, early loss of pregnancy, late fetal death, elective termination of pregnancy, and congenital anomalies. Results: Four studies were included in our review meeting criteria for our primary analysis. Compared with those with no vedolizumab exposure, pregnancies with vedolizumab exposure had an increase in overall adverse pregnancy-related outcomes (odds ratio [OR] 2.18, 95% confidence interval [CI], 1.52-3.13). The vedolizumab group also had increased preterm births (OR 2.16, 95% CI, 1.28-3.66), and early loss of pregnancies (OR 1.79, 95% CI, 1.06-3.01) but no difference in number of live births (OR 0.60, 95%CI, 0.36-1.00), or congenital malformations (OR 1.56, 95% CI, 0.56-4.37). Conclusions: Our systematic review highlights possible concern with the general safety of vedolizumab in pregnancy, as an increase in overall total unfavorable outcomes was observed. Premature births and early loss of pregnancy were also more prevalent in pregnant female patients on vedolizumab. It is possible these findings are confounded by disease activity, and further prospective cohort studies of vedolizumab and pregnancy outcomes are warranted. contributions were as follows: Conor Bell: literature search, data entry, data interpretation and drafting of the manuscript. Parul Tandon: critical review of the manuscript. Eric Lentz: literature search, data entry, and poster creation. John K Marshall: critical review of manuscript. Neeraj Narula: study concept and design, data acquisition, data analysis and critical review of manuscript.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Systematic review and meta‐analysis: Safety of vedolizumab during pregnancy in patients with inflammatory bowel disease

Bell

Tandon

Lentz

et al. 2021

J of Gastro and Hepatol

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“…The fact that the mother was treated with vedolizumab, a humanized monoclonal antibody to α4β7 integrin detected on a specific subpopulation of memory T-lymphocytes for down-regulation of inflammatory processes in the gastrointestinal tract did not explain the symptoms of our patient according to the information given in the literature ( 37 – 39 ). In addition, studies show that vedolizumab levels assessed in cord blood are lower than maternal levels and clear rapidly, with blood levels below the detection limit at 6 weeks after birth ( 40 ).…”

Section: Discussionmentioning

confidence: 99%

Case Report: Symptomatic Chronic Granulomatous Disease in the Newborn

et al. 2021

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Chronic granulomatous disease (CGD) is a primary immunodeficiency, which is diagnosed in most patients between one and three years of age. Here we report on a boy who presented at birth with extensive skin lesions and lymphadenopathy which were caused by CGD. An analysis of the literature revealed 24 patients with CGD who became symptomatic during the first six weeks of life. Although pulmonary complications and skin lesions due to infection were the leading symptoms, clinical features were extremely heterogenous. As follow-up was not well specified in most patients, the long-term prognosis of children with very early onset of CGD remains unknown.

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“…41,42 Vedolizumab appears to be cleared from the blood within 3 months, based on very small case reports. 16,43,44 Very little has been reported on drug transfer and clearance of newer biologics and further studies are needed in this area. The differential drug transfer has led the American College of Rheumatology to strongly recommend continuation of certolizumab therapy during pregnancy, but to recommend continuation of the other anti-TNF agents only conditionally.…”

Section: What Evidence and Guidance Exists To Support Prescriptions Omentioning

confidence: 99%

The use and impact of monoclonal antibody biologics during pregnancy

Pham‐Huy

Top

Constantinescu

et al. 2021

CMAJ

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Increasingly, pregnant patients with inflammatory or autoimmune diseases use monoclonal antibody biologics before conception, during pregnancy and while breastfeeding. Anti-TNFα Infliximab Chimeric anti-TNFα IgG1 Rheumatoid arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis Adalimumab Recombinant humanized anti-TNFα IgG1 Rheumatoid arthritis, polyarticular JIA, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, uveitis Golimumab Humanized anti-TNFα IgG1 Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, ulcerative colitis Certolizumab pegol Recombinant, humanized antibody to the antigen-binding fragment to anti-TNFα Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis Etanercept Human recombinant TNFα receptor/IgG1-Fc fusion protein Ankylosing spondylitis, rheumatoid arthritis, polyarticular JIA, psoriatic arthritis, plaque psoriasis Anticytokine Ustekinumab Anti-IL-12 and IL-23 humanized IgG1 Plaque psoriasis, psoriatic arthritis, Crohn disease, ulcerative colitis Tocilizumab Anti-IL-6 receptor humanized IgG1 Rheumatoid arthritis, polyarticular and systemic JIA, giant cell arteritis Canakinumab Anti-IL-1β human IgG1 CAPS, TRAPS, HIDS, MKD, FMF, systemic JIA Anti-integrin Vedolizumab Humanized anti-α4β7 integrin IgG1 Ulcerative colitis, Crohn disease Natalizumab Anti-integrin α4 subunit humanized IgG4 Multiple sclerosis Anti-B cell Rituximab Anti-CD20 IgG1 Rheumatoid arthritis, non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis Belimumab Anti-B-cell activating factor human IgG1 Systemic lupus erythematosus Note: CAPS = cryopyrin-associated periodic syndromes, FMF = familial Mediterranean fever, HIDS = hyperimmunoglobulin D syndrome, Ig = immunoglobulin, IL = interleukin, JIA = juvenile idiopathic arthritis, MKD = mevalonate kinase deficiency, TNF = tumour necrosis factor, TRAPS = tumour necrosis factor receptor associated periodic syndrome. *Off-label use not listed. Box 1: Evidence used in this narrative reviewWe conducted a literature review of preclinical and clinical studies in PubMed, published from January 2005 to February 2021. We searched for articles relevant to the use of monoclonal antibody biologics during pregnancy using the following search terms: biologics, monoclonal antibody biologics, pregnancy, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, rituximab and neonatal outcomes. Given the rapid emergence of data pertaining to this topic, we also reviewed selected abstracts, published expert guidelines and case reports. In addition, we reviewed the bibliographies of articles from high-impact journals in the fields of gastroenterology, rheumatology and dermatology. Recently published articles were preferred to reflect the most upto-date evidence for this review.

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Infliximab, adalimumab and vedolizumab concentrations across pregnancy and vedolizumab concentrations in infants following intrauterine exposure

Cited by 44 publications

References 28 publications

Systematic review and meta‐analysis: Safety of vedolizumab during pregnancy in patients with inflammatory bowel disease

Systematic review and meta‐analysis: Safety of vedolizumab during pregnancy in patients with inflammatory bowel disease

Case Report: Symptomatic Chronic Granulomatous Disease in the Newborn

The use and impact of monoclonal antibody biologics during pregnancy

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