Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol

Clowse, Megan E.B.; Wolf, Douglas C.; Förger, Frauke; Cush, John J.; Golembesky, Amanda; Shaughnessy, Laura; Cuyper, Dirk De; M, Uma

doi:10.3899/jrheum.140189

Cited by 76 publications

(47 citation statements)

References 32 publications

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“…Reports of CZP‐exposed pregnancies were obtained from the UCB Pharma safety database from the start of CZP clinical development through the cutoff date of March 6, 2017. We report the totality of the data up to the cutoff date, including those given in the previous data cut 18. Information on pregnancy dating, CZP exposure, congenital malformations, and other pregnancy outcomes, maternal comorbidities, and concomitant medications was extracted.…”

Section: Methodsmentioning

confidence: 99%

Pregnancy Outcomes After Exposure to Certolizumab Pegol

Clowse

Scheuerle

Chambers

et al. 2018

Arthritis & Rheumatology

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143

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ObjectiveAnti–tumor necrosis factor (anti‐TNF) medications are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti‐TNF agents are often discontinued early in gestation. Certolizumab pegol (CZP), a PEGylated, Fc‐free anti‐TNF agent approved for the treatment of rheumatic diseases and/or Crohn's disease, has minimal to no active placental transfer. This analysis was undertaken to evaluate pregnancy outcomes in women receiving CZP, especially those exposed during early pregnancy.MethodsProspective and retrospective data on maternal CZP exposure were extracted from the UCB Pharma safety database through March 6, 2017. Analysis was limited to prospective reports to avoid potential bias associated with retrospective submissions. The numbers of live births, miscarriages, elective abortions, stillbirths, and major congenital malformations were ascertained.ResultsOf 1,137 prospectively reported pregnancies with maternal exposure to CZP, 528 (including 10 twin pregnancies) had 538 known outcomes: 459 live births (85.3%), 47 miscarriages (8.7%), 27 elective abortions (5.0%), and 5 stillbirths (0.9%). There were 8 major congenital malformations (1.7%) among the 459 infants. First trimester exposure occurred in 367 (81.2%) of 452 pregnancies resulting in 459 live births. Exposure during all 3 trimesters occurred in 201 (44.5%) of 452 pregnancies.ConclusionThis analysis represents the largest cohort of pregnant women exposed to an anti‐TNF agent for management of chronic inflammatory diseases. Analysis of pregnancy outcomes does not indicate a teratogenic effect of CZP, compared to the general population, nor an increased risk of fetal death. The data are reassuring for women of childbearing age considering treatment with CZP.

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Section: Methodsmentioning

confidence: 99%

Pregnancy Outcomes After Exposure to Certolizumab Pegol

Clowse

Scheuerle

Chambers

et al. 2018

Arthritis & Rheumatology

Self Cite

143

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“…[23][24][25][26][27][28]34,35,39,41,[43][44][45][46][47][48][49][50][51] Also excluded were case reports or small case series (n < 10), or manuscripts where there was incomplete information on birth outcomes such that ORs could not be calculated. [79][80][81][82][83][84][85][86] Of the studies with repeat population groups, 27,29,30,36,45,46,49,51,79,80,82,[84][85][86][87][88][89][90][91] the most recent study was selected for inclusion provided data could be extracted. A total of six studies met the final selection criteria for inclusion in the meta-analysis.…”

Section: Studies Retrievedmentioning

confidence: 99%

Anti-Tumour Necrosis Factor α Therapies and Inflammatory Bowel Disease Pregnancy Outcomes: A Meta-analysis

Shihab

Yeomans

Cruz

2016

ECCOJC

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Background and Aims: Inflammatory bowel disease (IBD) commonly affects women during their reproductive years, leading to concerns regarding pregnancy outcomes and therapeutic safety. The aim of this study was to assess the risks associated with anti-tumour necrosis factor α (anti-TNFα) therapy for pregnancy outcomes, including rates of congenital abnormality, based on published studies. Methods: Published studies were screened from on-line databases and international meeting abstracts. A meta-analysis was performed for adverse pregnancy outcomes (APOs), congenital abnormalities (CAs), preterm birth (PTB) and low birth weight (LBW). The prevalence of CAs was compared with whole-population pooled registry data. Results: In women exposed to anti-TNFα the pooled odds ratio for APOs was 1.14 (95% confidence interval [CI] 0.73-1.78; p = 0.55) compared with disease-matched controls. The pooled odds ratios for CAs, PTB and LBW were 0.89 (0.37-2.13; p = 0.79), 1.21 (0.74-2.00; p = 0.45) and 1.36 (0.77-2.38; p = 0.29) respectively. The rate of CAs in TNFα-exposed women was not statistically different from that in population-wide registries (difference 0.4%, 95% CI −2.0 to +2.7). Conclusions: Anti-TNFα therapy does not increase the risk of APOs, CAs, PTB or LBW compared with disease-matched controls. Furthermore, the risk of CAs is not increased when published prevalence data are compared with data for the general population. These findings may offer some reassurance for women and physicians regarding the safety profile of anti-TNFα during pregnancy in IBD.

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“…С учетом этого применение ИНФ может быть безо-пасно, по данным Европейской антиревматической лиги (EULAR,) до 20-й недели беременности, по данным British Society for Rheumatology/British Health Professionals in Rheumatology (BSR/BHPR) -до 16-й не-дели; АДА и ЭТЦ -в течение первых двух триместров, их применение в III триместре возможно лишь по жизнен-ным показаниям; данных по голимумабу и ТЦЗ в насто-ящее время недостаточно, чтобы судить о возможности их использования при беременности [16,17]. На настоя-щий момент ГИБП с наилучшим профилем безопасно-сти на всем протяжении беременности, а также при лак-тации является ЦЗП [16,17,26], который относится к группе ингибиторов ФНОα и представляет собой пэги-лированные антитела класса IgG1, лишенные, в отличие от других ингибиторов ФНОα, Fc-фрагмента, который, как известно, отвечает за способность антител проникать через плацентарный барьер за счет связывания со специ-фическим Fc-рецептором (FcRn) [18,27,28]. В исследо-вании U. Mahadevan и соавт.…”

Section: Discussionunclassified

“…В связи с этим, несмотря на то что частота врожденных дефектов при их применении минимальна и нет явных признаков тератогенности, сохраняется риск компрометированности иммунной системы плода, что отражено, в частности, в рекомендациях Британского общества [17], которое указывает на необходимость стро-го избегать вакцинирования детей живыми вакцинами до 7 мес. Данные UCB Pharma о случаях применения ЦЗП при беременности свидетельствуют об отсутствии повы-шенного риска врожденных аномалий плода [27]. Таким образом, ЦЗП может являться перспективным препара-том в терапии молодых пациенток (а они составляют большинство пациентов с артериитом Такаясу), позволяя не прерывать лечение ни при планировании, ни при ве-дении беременности вплоть до родоразрешения, а также при лактации.…”

Section: Discussionunclassified

Certolizumab Pegol in the Treatment of Takayasu Arteritis: The First Experience and Prospects

Novikov¹,

Smitienko²,

Соколова³

et al. 2018

rsp

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Certolizumab pegol (CZP) is the only pegylated biological agent (BA) that does not contain an Fc fragment, which minimizes its transplacental transfer. Takayasu arteritis mostly occurs in reproductive-aged women.Objective: to evaluate the efficacy and safety of CZP used to treat standard immunosuppressive therapy-resistant Takayasu arteritis.Subjects and methods. The retrospective study enrolled 6 female patients aged 18 to 35 years with Takayasu arteritis who received CZP. The median disease duration before BA usage was 66 months (24 to 204 months). The median duration of immunosuppressive therapy prior to CZP treatment was 92 months (14 to 132 months). All the female patients had taken glucocorticoids and methotrexate before and during CZP therapy. Only four patients had received two to five immunosuppressive drugs at different times prior to BA administration. Three patients had previously used other BAs. The disease activity was determined by the National Institute of Health (NIH) criteria. The Indian Takayasu Clinical Activity Score (ITAS2010) was used. The disease activity was recorded in all the patients prior to CZP therapy.Results and discussion. The median duration of CZP treatment was 17 months (6 to 24 months). The median erythrocyte sedimentation rate after CZP usage decreased from 22.5 to 10.5 mm/h; the median C-reactive protein level dropped from 7.8 to 0.39 mg/dl (p<0.05), the median daily dose of prednisolone was reduced from 20 to 8.75 mg (p<0.05). All the patients achieved complete remission an average of 4 months after starting CZP therapy. Three patients were still in remission after 12–24 months. One relapse of the disease was recorded following 24 months. ITAS2010 reduced from 1–4 to 0 in five patients and to 2 in one patient with recurrence. There was a good tolerance in five female patients. The adverse events were herpes labialis in two cases, community-acquired pneumonia in one case, and postoperative abscess in one case too.Conclusion. CZP in Takayasu arteritis was shown to be an effective drug for remission induction and maintenance. The presented results of the first experience in treating this disease with CZP are indicative of its promising further investigation as a steroid-sparing drug in patients with refractory vasculitis. One of the important advantages of CZP is its supposed high safety throughout pregnancy.

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Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol

Cited by 76 publications

References 32 publications

Pregnancy Outcomes After Exposure to Certolizumab Pegol

Pregnancy Outcomes After Exposure to Certolizumab Pegol

Anti-Tumour Necrosis Factor α Therapies and Inflammatory Bowel Disease Pregnancy Outcomes: A Meta-analysis

Certolizumab Pegol in the Treatment of Takayasu Arteritis: The First Experience and Prospects

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