Use of Biologic Therapy by Pregnant Women With Inflammatory Bowel Disease Does Not Affect Infant Response to Vaccines

Beaulieu, Dawn B.; Ananthakrishnan, Ashwin N.; Martin, Christopher F.; Cohen, Russell D.; Kane, Sunanda V.; M, Uma

doi:10.1016/j.cgh.2017.08.041

Cited by 108 publications

(89 citation statements)

References 24 publications

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“…It is generally recommended that live vaccines should not be given to infants exposed to biologic agents in utero for at least 6 months after birth, because of a theoretical concern about the response to vaccination. Although there are no published data following exposure to IL‐23p19 inhibitors, the Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes (PIANO) registry found use of other biologic therapies by pregnant women with inflammatory bowel disease did not affect infant response to Haemophilus influenzae B or tetanus vaccines . In adult patients, long‐term (≥3 years) treatment with ustekinumab was not found to compromise immune response to pneumococcal or tetanus vaccines, but there are no data on vaccine response during treatment with IL‐23p19 inhibitors .…”

Section: Unmet Needsmentioning

confidence: 99%

Safety of selective IL‐23p19 inhibitors for the treatment of psoriasis

Crowley

Warren

Cather³

2019

Acad Dermatol Venereol

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Psoriasis is a chronic disease that requires long‐term treatment. Consequently, understanding the safety and tolerability of any potential treatment over time is critical to effective prescribing. The biologic agents currently available for the treatment of psoriasis target a number of different inflammatory cytokines involved in psoriasis disease pathogenesis. The monoclonal antibodies tildrakizumab, guselkumab and risankizumab target the p19 subunit that is specific to interleukin (IL)‐23. This article reviews published data on the safety of these IL‐23p19 inhibitors in patients with psoriasis compared with other currently available biologic therapies. Data from randomized, placebo‐ and active‐controlled phase 3 clinical trials show tildrakizumab, guselkumab and risankizumab to have a favourable risk–benefit profile in patients with moderate to severe psoriasis. No significant safety concerns have been observed for any of these IL‐23p19 inhibitors in the data published to date. The most commonly reported adverse events (AEs) associated with these agents in phase 3 studies were upper respiratory tract infections. No increase was seen in rates of serious infections, malignancies or major adverse cardiovascular events, with no signals suggestive of an elevated risk of opportunistic infections, active tuberculosis or reactivation of latent tuberculosis infection, mucocutaneous Candida infections, triggering or worsening of inflammatory bowel disease, demyelinating disorders or suicidal ideation. Selectively targeting IL‐23p19 may help avoid AEs that have been associated with biologic agents with other mechanisms of action. Data from long‐term extension studies and patient registries will further establish the safety profile of IL‐23p19 inhibitors for the treatment of moderate to severe psoriasis in routine practice.

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Section: Unmet Needsmentioning

confidence: 99%

Safety of selective IL‐23p19 inhibitors for the treatment of psoriasis

Crowley

Warren

Cather³

2019

Acad Dermatol Venereol

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“…There are no reports to evidence IFX-associated child immunodeficiencies or developmental disorders. Normal development of T and B cells, normal Ig concentrations and adequate vaccination responses have been observed [57, 58]. however, there is one case report on a fatal disseminated Bacillus Calmette-Guérin (BCG) infection in a child exposed to IFX in utero, who had received a tuberculosis vaccination [59].…”

Section: Biologics: Tnf-α Inhibitorsmentioning

confidence: 99%

“…A most recent study with children exposed to anti-TNF-α during pregnancy has indicated that responses to tetanus and Hemophilus influenzae B vaccines were not affected and that T‑helper cell and B cell responses were to be assumed [58]. …”

Section: Biologics: Tnf-α Inhibitorsmentioning

confidence: 99%

“…The recommendation remains valid to avoid LAV within the first 6 months of life (if treatment with anti-TNF-α antibodies was continued by the end of the second trimester) or within the first year of life (with continuous therapy of this kind); however, no clinical consequences seem to result from detectable anti-TNF-α levels in children [58, 62, 63]. …”

Section: Biologics: Tnf-α Inhibitorsmentioning

confidence: 99%

“…Neither for IFX nor for ADA do the data indicate a negative effect on children’s immune systems, although long-term investigations are lacking for ADA [58]. …”

Section: Biologics: Tnf-α Inhibitorsmentioning

confidence: 99%

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Immunosuppressives and biologics during pregnancy and lactation

Puchner

Gröchenig

Sautner

et al. 2019

Wien Klin Wochenschr

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SummaryAn increasing and early-onset use of immunosuppressives and biologics has become more frequently seen among patients with inflammatory bowel diseases (IBD) and rheumatic disorders. Many women in their childbearing years currently receive such medications, and some of them in an interdisciplinary setting. Many questions arise in women already pregnant or wishing to conceive with respect to continuing or discontinuing treatment, the risks borne by the newborns and their mothers and long-term safety. Together with the Austrian Society of Rheumatology and Rehabilitation, the IBD working group of the Austrian Society of Gastroenterology and Hepatology has elaborated consensus statements on the use of immunosuppressives and biologics in pregnancy and lactation. This is the first Austrian interdisciplinary consensus on this topic. It is intended to serve as a basis and support for providing advice to our patients and their treating physicians.

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2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases

Bass

Chakravarty

Akl

et al. 2023

Arthritis Care & Research

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To provide evidence-based recommendations on the use of vaccinations in children and adults with rheumatic and musculoskeletal diseases (RMDs).Methods. This guideline follows American College of Rheumatology (ACR) policy guiding management of conflicts of interest and disclosures and the ACR guideline development process, which includes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. It also adheres to the Appraisal of Guidelines for Research and Evaluation (AGREE) criteria. A core leadership team consisting of adult and pediatric rheumatologists and a guideline methodologist drafted clinical population, intervention, comparator, outcomes (PICO) questions. A review team performed a systematic literature review for the PICO questions, graded the quality of evidence, and produced an evidence report. An expert Voting Panel reviewed the evidence and formulated recommendations. The panel Guidelines and recommendations developed and/or endorsed by the American College of Rheumatology (ACR) are intended to provide guidance for patterns of practice and not to dictate the care of a particular patient. The ACR considers adherence to the recommendations within this guideline to be voluntary, with the ultimate determination regarding their application to be made by the clinician in light of each patient's individual circumstances. Guidelines and recommendations are intended to promote beneficial or desirable outcomes but cannot guarantee any specific outcome. Guidelines and recommendations developed and endorsed by the ACR are subject to periodic revision as warranted by the evolution of medical knowledge, technology, and practice. ACR recommendations are not intended to dictate payment or insurance decisions, and drug formularies or other third-party analyses that cite ACR guidelines should state this. These recommendations cannot adequately convey all uncertainties and nuances of patient care.

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Use of Biologic Therapy by Pregnant Women With Inflammatory Bowel Disease Does Not Affect Infant Response to Vaccines

Abstract: Vaccination of infants against HiB and tetanus toxin, based on antibody titers measured when infants were at least 7 months old, does not appear to be affected by in utero exposure to biologic therapy.

Cited by 108 publications

References 24 publications

Safety of selective IL‐23p19 inhibitors for the treatment of psoriasis

Safety of selective IL‐23p19 inhibitors for the treatment of psoriasis

Immunosuppressives and biologics during pregnancy and lactation

2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases

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