TY - JOUR
T1 - Maternal and neonatal antibody levels on pertussis vaccination in pregnant women on immune-modulating therapy for rheumatic disease
AU - Ghalandari, Nafise
AU - Immink, Maarten M
AU - Röder, Esther
AU - Bruijning-Verhagen, Patricia C J
AU - Smeele, Hieronymus
AU - Crijns, Hubertina
AU - van der Maas, Nicoline A T
AU - Bekker, Mireille N
AU - Sanders, Elisabeth A M
AU - Dolhain, Radboud J E M
N1 - Funding Information:
RJEMD received an unrestricted grant from Galapagos, UCB Pharma B.V., Dutch Arthritis Association and ZonMw and consultancy fees, speaker fees, honoraria advisory boards from AbbVie, AstraZeneca, Eli Lily, Galapagos, Novartis, Roche, UCB. NG received a Ph.D scholarship from Dutch Medicine Evaluation Board (CBG-MEB) and was employed by UCB pharma B.V. as medical science liaison from June 2022 to February 2023. Other authors have no competing interests to declare.
Funding Information:
This Investigator Initiated Study (PreCARA) was supported by Union Chimique Belge (UCB), where UCB provided financial support and the Dutch Arthritis Foundation (ReumaNederland) (project number: LLP-26), a non-profit organisation. The historical comparison study was supported by the Dutch Ministry of Health, Welfare and Sport.
Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/8
Y1 - 2023/8
N2 - OBJECTIVES: While protection against pertussis following maternal tetanus-diphtheria-and-acellular-pertussis (Tdap) vaccination was demonstrated in healthy term-born infants, no evidence is available on Tdap vaccination in combination with immune-modulating therapy during pregnancy. In this pilot study, we explored whether treatment with tumour necrosis factor alpha inhibitors (TNFis) in pregnant patients with rheumatic disease interferes with Tdap vaccine responses and affects maternal anti-pertussis IgG antibody levels in newborns.METHODS: Patients were included by a rheumatologist during pregnancy in case they received maternal Tdap vaccination in the late-second or early-third trimester of pregnancy. Blood samples were obtained from mothers during the first pregnancy trimester, 3 months after delivery and from the umbilical cord. IgG antibody levels against Tdap-included antigens were measured using a bead-based multiplex immunoassay. Findings on patients exposed to TNFis were compared with those from TNFi-unexposed patients and with data from a historical comparator study among healthy Tdap vaccinated mother-infant pairs (n=53).RESULTS: 66 patients (46 exposed and 20 unexposed to TNFIs) were enrolled. No major differences in IgG antibody levels were observed between TNFi-exposed and unexposed mothers before maternal Tdap vaccination and 3 months after delivery. In cord sera, however, antibody levels against pertussis toxin were significantly lower after TNFi-treatment (35.94 IU/mL, 95% CI 20.68 to 62.45) compared with no TNFi-treatment of mothers with rheumatic disease (94.61 IU/mL, 95% CI 48.89 to 183.07) and lower compared with a cohort of healthy mothers (125.12 IU/mL, 95% CI 90.75 to 172.50). We observed similar differences for filamentous haemagglutinin, pertactin, tetanus toxoid and diphtheria toxoid.CONCLUSION: These preliminary data indicate no major differences in IgG antibody levels on maternal Tdap vaccination in pregnant women with or without immune-modulating treatment, although our findings suggest that TNFis during pregnancy induce lower maternal anti-pertussis-specific protective antibody levels in newborns.
AB - OBJECTIVES: While protection against pertussis following maternal tetanus-diphtheria-and-acellular-pertussis (Tdap) vaccination was demonstrated in healthy term-born infants, no evidence is available on Tdap vaccination in combination with immune-modulating therapy during pregnancy. In this pilot study, we explored whether treatment with tumour necrosis factor alpha inhibitors (TNFis) in pregnant patients with rheumatic disease interferes with Tdap vaccine responses and affects maternal anti-pertussis IgG antibody levels in newborns.METHODS: Patients were included by a rheumatologist during pregnancy in case they received maternal Tdap vaccination in the late-second or early-third trimester of pregnancy. Blood samples were obtained from mothers during the first pregnancy trimester, 3 months after delivery and from the umbilical cord. IgG antibody levels against Tdap-included antigens were measured using a bead-based multiplex immunoassay. Findings on patients exposed to TNFis were compared with those from TNFi-unexposed patients and with data from a historical comparator study among healthy Tdap vaccinated mother-infant pairs (n=53).RESULTS: 66 patients (46 exposed and 20 unexposed to TNFIs) were enrolled. No major differences in IgG antibody levels were observed between TNFi-exposed and unexposed mothers before maternal Tdap vaccination and 3 months after delivery. In cord sera, however, antibody levels against pertussis toxin were significantly lower after TNFi-treatment (35.94 IU/mL, 95% CI 20.68 to 62.45) compared with no TNFi-treatment of mothers with rheumatic disease (94.61 IU/mL, 95% CI 48.89 to 183.07) and lower compared with a cohort of healthy mothers (125.12 IU/mL, 95% CI 90.75 to 172.50). We observed similar differences for filamentous haemagglutinin, pertactin, tetanus toxoid and diphtheria toxoid.CONCLUSION: These preliminary data indicate no major differences in IgG antibody levels on maternal Tdap vaccination in pregnant women with or without immune-modulating treatment, although our findings suggest that TNFis during pregnancy induce lower maternal anti-pertussis-specific protective antibody levels in newborns.
KW - Arthritis, Rheumatoid
KW - Biological Therapy
KW - Tumor Necrosis Factor Inhibitors
KW - Vaccination
UR - http://www.scopus.com/inward/record.url?scp=85168964732&partnerID=8YFLogxK
U2 - 10.1136/rmdopen-2023-002985
DO - 10.1136/rmdopen-2023-002985
M3 - Article
C2 - 37640516
SN - 2056-5933
VL - 9
SP - 1
EP - 10
JO - RMD Open
JF - RMD Open
IS - 3
M1 - e002985
ER -