Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol

Objective.To provide information on pregnancy outcomes in women receiving certolizumab pegol (CZP).Methods.The UCB Pharma safety database was searched for pregnancies through to September 1, 2014. Reports for maternal and paternal CZP exposure were included and outcomes examined, and data on CZP exposure, pregnancy, comorbidities, and infant events were extracted by 2 independent reviewers. Concomitant medications and disease activity were reviewed for clinical trial patients.Results.Of 625 reported pregnancies, 372 (59.5%) had known outcomes. Paternal exposure pregnancies (n = 33) reported 27 live births, 4 miscarriages, 1 induced abortion, and 1 stillbirth. Maternal exposure pregnancies (n = 339) reported 254 live births, 52 miscarriages, 32 induced abortions, and 1 stillbirth. Almost all reported pregnancies had exposure to CZP in the first trimester, when organogenesis takes place, and a third of them continued the drug into the second and/or third trimesters. The most frequent indications for maternal CZP use were Crohn disease (192/339) and rheumatic diseases (118/339). Twelve cases of congenital malformation and a single neonatal death were reported.Conclusion.Analysis of pregnancy outcomes after exposure to CZP supports previous reports, suggesting a lack of harmful effect of maternal CZP exposure on pregnancy outcomes. However, additional data from a larger number of outcomes after exposure and studies including an unexposed comparison group are required to fully evaluate CZP safety and tolerability in pregnancy.

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POS0022 PHARMACOVIGILANCE PREGNANCY DATA IN A LARGE POPULATION OF PATIENTS WITH CHRONIC INFLAMMATORY DISEASE EXPOSED TO CERTOLIZUMAB PEGOL: PREGNANCY OUTCOMES AND CONFOUNDERS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.577 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 213.2-213

Author(s):

M. Clowse ◽

R. Fischer-Betz ◽

C. Nelson-Piercy ◽

A. Scheuerle ◽

T. Kumke ◽

...

Keyword(s):

Birth Weight ◽

Preterm Birth ◽

Low Birth Weight ◽

Pregnancy Outcomes ◽

Congenital Malformations ◽

Certolizumab Pegol ◽

First Trimester ◽

Research Support ◽

Safety Database ◽

Live Births

Background:Chronic inflammatory diseases (CID) in women of reproductive age are increasingly being treated with tumour necrosis factor inhibitors (TNFi), in line with recent guidelines.1 However, data on TNFi-exposed pregnancy outcomes are still limited. Certolizumab pegol (CZP), a PEGylated, Fc-free TNFi, has no/minimal placental transfer from mother to infant during the third trimester.2Objectives:To assess pregnancy outcomes from the UCB Pharmacovigilance safety database from over 1,300 prospectively reported pregnancies with maternal CZP exposure.Methods:Details of CZP-exposed pregnancies from the UCB Pharmacovigilance safety database were reviewed up to November 1, 2020. Analysis was limited to prospectively reported cases with known pregnancy outcomes to avoid potential reporting bias. Confounders (specific CID, non-biologic medications and maternal infection) were evaluated using a multivariate stepwise regression model; results from the confounders analysis are reported as odds ratios (OR) with 95% confidence intervals (CI). Patients with missing information about presence or absence of confounders were excluded from the model.Results:1,392 prospective pregnancies (1,425 fetuses) with maternal CZP exposure and known outcomes were reported (Figure 1). Mean (SD) maternal age was 31.9 (5.1) years. Of these, 1,021/1,392 (73.3%) pregnancies had at least first-trimester CZP exposure and 547/1,392 (39.3%) were exposed during all trimesters. Overall, there were 1,259/1,425 (88.4%) live births, 150/1,425 (10.5%) abortions (miscarriages and terminations), 11/1,425 (0.8%) stillbirths, and 5/1,425 (0.4%) ectopic pregnancies. Congenital malformations were reported in 35/1,425 fetuses (2.5%) and in 30/1,259 live-born infants (2.4%); 26 (2.1%) congenital malformations were major according to the Metropolitan Atlanta Congenital Defects Program criteria. There was no pattern of specific congenital malformations. Preterm births occurred in 124/1,259 (9.8%) live births, and 101/1,259 (8.0%) of infants had low birth weight (<2.5 kg). In the confounders analysis, reported corticosteroid use was independently associated with increased odds of preterm birth (OR [95% CI]: 2.1 [1.3–3.4]; p<0.005) and low birth weight (OR [95% CI]: 1.7 [1.0–2.9]; p<0.05), but decreased odds of abortion (OR [95% CI]: 0.5 [0.3–0.9]; p<0.05). Reported NSAID use was associated with increased odds of abortion (OR [95% CI]: 2.2 [1.2–4.0]; p<0.05), as was methotrexate/leflunomide use (OR [95% CI]: 3.2 [1.7–6.2]; p<0.0005). Maternal infections were associated with increased odds of preterm birth (OR [95% CI]: 1.9 (1.1–3.5; p<0.05). Finally, there was an association between a diagnosis of Crohn’s disease and odds of abortion (OR [95% CI]: 2.5 [1.5–4.1]; p=0.0005), and between rheumatoid arthritis and low birth weight (OR [95% CI]: 1.9 [1.1–3.3]; p<0.05).Conclusion:This prospective analysis, including more than 1,000 pregnancies with CZP exposure in at least the first trimester, represents one of the largest cohorts of pregnancies with known outcomes in patients with CID. Our data confirm the impact of specific CID, concomitant drugs or comorbidities on pregnancy outcomes. In particular, additional use of corticosteroids was highlighted as a risk factor for preterm birth and low birth weight in our cohort of CZP-treated patients. No increase in adverse pregnancy outcomes or specific congenital malformations was observed in CZP-exposed pregnancies, compared to the general population,3,4 which offers further reassurance for women of childbearing age considering CZP treatment.References:[1]Sammaritano LR. Arthritis Rheum 2020;72:529–56;[2]Mariette X. Ann Rheum Dis 2018;77:228–33;[3]Ventura SJ. Natl Vital Stat Rep 2012;60:1–21;[4]Lee H. BMC Pregnancy Childbirth 2020;20:33.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Megan Clowse Consultant of: UCB Pharma, Grant/research support from: Janssen, Pfizer, Rebecca Fischer-Betz Consultant of: AbbVie, BMS, Celgene, Chugai, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, UCB Pharma, Catherine Nelson-Piercy Consultant of: Alliance Pharma, UCB Pharma, Angela Scheuerle Consultant of: Antiretroviral Pregnancy Registry, Harmony Biosciences, IQVIA, ICON, NovoNordisk, PPD, Roche, Sanofi-Genzyme, Syneos, UCB Pharma, ViiV, Thomas Kumke Shareholder of: UCB Pharma, Employee of: UCB Pharma, Bernard Lauwerys Employee of: UCB Pharma, Rachna Kasliwal Employee of: UCB Pharma, Frauke Förger Speakers bureau: Mepha, Roche, UCB Pharma, Grant/research support from: UCB Pharma.

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Pregnancy Outcomes in Patients Treated with Bosutinib

Blood ◽

10.1182/blood-2018-99-110547 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 1729-1729 ◽

Cited By ~ 4

Author(s):

Jorge E. Cortes ◽

Carlo Gambacorti-Passerini ◽

Michael W. Deininger ◽

Elisabetta Abruzzese ◽

Liza DeAnnuntis ◽

...

Keyword(s):

Spontaneous Abortion ◽

Pregnancy Outcomes ◽

Research Funding ◽

First Trimester ◽

Maternal Exposure ◽

Safety Database ◽

Spontaneous Reports ◽

Dilation And Curettage ◽

Vaginal Deliveries ◽

Induced Abortions

Abstract Introduction: Studies in animals have shown reproductive toxicity with bosutinib exposure, with teratogenic events in maternal exposure, but little is known about its effect during conception or pregnancy in humans. Methods: Here we describe pregnancy outcomes in bosutinib-treated patients from the Pfizer safety database, which includes cases from both clinical trials and spontaneous reports. Pregnancy cases reported up to February 28, 2018 were identified by searching the database using the Standardized MedDRA Query Pregnancy and Neonatal Topics in patients receiving bosutinib. Results: The database search identified 33 relevant pregnancy reports, including 17 cases of exposure via the father and 16 cases of maternal exposure. Among the 16 cases of maternal exposure, 5 vaginal deliveries of healthy babies, 2 patient-requested induced abortions, 1 spontaneous abortion, and 1 partial molar pregnancy requiring a dilation and curettage were reported. In 1 case, the patient was reported to have delivered a baby, but the details of the status of the baby was not provided. Outcomes in 6 cases are unknown. Of the healthy deliveries, 4 pregnancies went to full term (≥39 weeks) and 1 was of unknown duration; bosutinib was discontinued during the first trimester of pregnancy in all 5 cases. The reported spontaneous abortion was due to a suspected ectopic pregnancy in a 34-year-old patient who began taking bosutinib 500 mg once daily while pregnant and was thought to be unrelated to bosutinib exposure. Of the 17 cases of exposure via father, 8 vaginal deliveries of healthy babies, 1 Caesarean section delivery of a healthy baby, 4 induced abortions, and 1 spontaneous abortion were reported. The remaining 3 cases had unknown outcomes. Of the 4 induced abortions, 1 was elective due to an unintended pregnancy, and 2 were due to unknown reasons. In the last case, it was reported that the fetus was not growing properly and that the pregnancy would subsequently be terminated; no confirmation of congenital abnormality or further information is available. The reported spontaneous abortion was thought to be unrelated to bosutinib; fetal biopsy revealed basal deciduitis with necrosis loci and bleeding. Conclusions: Overall, a review of the available experience with bosutinib in pregnancy did not identify any safety signals. However, adverse effects of bosutinib exposure at conception or during pregnancy in humans cannot be ruled out, particularly if therapy is not interrupted upon recognition of pregnancy. Bosutinib is not recommended for use during pregnancy, and patients on bosutinib treatment should use effective contraception. Disclosures Cortes: Astellas Pharma: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Daiichi Sankyo: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Arog: Research Funding. Gambacorti-Passerini:BMS: Consultancy; Pfizer: Consultancy, Honoraria, Research Funding. Deininger:Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Blueprint: Consultancy. Abruzzese:Novartis: Consultancy; Ariad: Consultancy; BMS: Consultancy; Pfizer: Consultancy. DeAnnuntis:Pfizer Inc: Employment, Equity Ownership. Brümmendorf:Janssen: Consultancy; Merck: Consultancy; Novartis: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Takeda: Consultancy.

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886. Pregnancy Outcomes Following Raltegravir Exposure

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz359.045 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S20-S21

Author(s):

Hala Shamsuddin ◽

Casey Raudenbush ◽

Brittany Sciba ◽

Erica N Gooch ◽

Wayne Greaves ◽

...

Keyword(s):

Spontaneous Abortion ◽

Neural Tube ◽

Neural Tube Defects ◽

Pregnancy Outcomes ◽

Congenital Anomalies ◽

Reproductive Potential ◽

First Trimester ◽

Hiv Treatment ◽

Safety Database ◽

Live Births

Abstract Background Safety data are needed regarding HIV treatment in women of reproductive potential and during pregnancy. This review is to evaluate pregnancy outcomes following prospective exposures (exposure report prior to knowledge of pregnancy outcome) to raltegravir during pregnancy. Methods Exposures to raltegravir during pregnancy reported cumulatively through March 26, 2019 to the internal safety database at Merck & Co., Inc. were reviewed. This database includes all reports of pregnancy from clinical trials sponsored by the company, spontaneous post-marketing reports, and noninterventional data sources. Prospective pregnancy reports were evaluated to determine rates of spontaneous abortion, stillbirth, and congenital anomalies, including neural tube defects. Data from two ongoing cohorts of pregnant women with HIV-1 infection, not included in the internal safety database, were also reviewed. Results A total of 2,508 prospective pregnancy reports with reported outcomes were identified among women exposed to raltegravir: 919 from the internal safety database (Table 1) and 1,589 from the UK/Ireland and French pregnancy cohorts. Among the 2,508 prospective pregnancy exposures, 945 were in the first trimester, of which 757 were within the periconception period (within 28 days of conception). Of the 471 documented first trimester exposures identified in the internal safety database, the rates of spontaneous abortion (6.9%), stillbirth (1%), and congenital anomalies (1.5% per live births) were similar to the rates observed in the background populations of the United States Among outcomes following any exposure, the rate of congenital anomalies was 3.4% per live births. There were no reports of neural tube defects identified within the internal safety database or among the cohort data. Conclusion Prospectively collected pregnancy outcome data do not suggest an association between raltegravir exposure and spontaneous abortion, stillbirth, or congenital anomalies, including neural tube defects. These data support the current HIV treatment recommendations for the use of raltegravir 400 mg twice daily in women of reproductive potential and during pregnancy. Disclosures All Authors: No reported Disclosures.

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P599 Trimester exposure and pregnancy outcomes in women exposed to golimumab: Results from the company pharmacovigilance database

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.727 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S500-S501

Author(s):

S Esslinger ◽

M Otero-Lobato ◽

S Gabriel ◽

M Clark ◽

P Sheridan ◽

...

Keyword(s):

Pregnancy Outcome ◽

Birth Outcomes ◽

Pregnancy Outcomes ◽

Spontaneous Abortions ◽

Live Births ◽

Elective Abortion ◽

Induced Abortions ◽

Pharmacovigilance Database ◽

Inflammatory Bowel ◽

Twin Pregnancies

Abstract Background Rheumatologic disorders and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for several rheumatological indications and ulcerative colitis (UC). To characterise pregnancy outcomes in patients treated with GLM, data obtained from maternal exposure to GLM are presented. Methods These dataset includes individual patient cases reported to the manufacturer through 06 April 2019. Cases included in the analysis were medically confirmed cases of maternal exposures to GLM during pregnancy or within 3 months prior to conception, and a reported pregnancy outcome. Both prospectively reported (ie, pregnancy outcome not known when first reported) and retrospectively reported cases (ie, pregnancy outcome known when first reported) were included. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries. Results Two hundred eight pregnancy cases (131 rheumatological; 43 UC; and 34 other) with 211 reported birth outcomes were identified. Three cases reported twin pregnancies. Of the 208 pregnancy cases, 119 were prospective and 89 were retrospective (Table 1). Average maternal age was 31.9 years. Of the 119 prospectively reported pregnancy cases, 89 (74.8%) resulted in live births, 19 (16.0%) resulted in spontaneous abortion (of these, 42.1% (8/19) received GLM in combination with methotrexate [MTX]), 10 (8.4%) resulted in induced/elective abortion, and 1 (0.8%) resulted in ectopic pregnancy. Overall, 9 congenital anomalies were reported (2 prospective/7 retrospective cases). For 183 of the 208 pregnancy cases with-reported outcomes, the trimester of exposure to GLM was known (Table 2). Among the 110 prospectively reported cases, 82 (74.5%) were exposed during trimester 0 or 1. Of these, 19 had concomitant exposure to MTX, with the following birth outcomes: 8 live births, 8 spontaneous abortions, 3 elective/induced abortions. Eighteen of the prospectively reported cases (16.4%) were exposed to GLM throughout pregnancy (first, second and third trimester) and all resulted in live births. Conclusion The rates of congenital malformations and spontaneous abortions were consistent with published background rates for the general population. Persistent exposure throughout pregnancy was rare, but not associated with apparent clinical sequelae. Limitations of this analysis include the lack of a direct comparison group, the variable amount of data available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases.

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Pregnancy Outcomes of Patients Exposed to Adalimumab in Japan

Digestive Diseases ◽

10.1159/000493462 ◽

2018 ◽

Vol 37 (2) ◽

pp. 123-130 ◽

Cited By ~ 5

Author(s):

Yumi Kawai ◽

Tsuyoshi Tsuchiya ◽

Shigeru Aoki

Keyword(s):

Adverse Events ◽

Pregnancy Outcomes ◽

Outcome Data ◽

Full Term ◽

Third Trimester ◽

Serious Adverse Events ◽

Additional Risk ◽

Safety Database ◽

Induced Abortions ◽

Adalimumab Treatment

Background: This is the first retrospective report of pregnancy outcomes after exposure to adalimumab treatment in Japan. Methods: Using the AbbVie safety database, we analyzed pregnancy outcome data from patients who received adalimumab treatment from April 16, 2008, to May 15, 2017. Results: Data were extracted retrospectively for 74 pregnancies in 73 patients. More than half of the patients included in the study received adalimumab for the treatment of Crohn’s disease (37.8%) or ulcerative colitis (20.3%), while 9.5% received adalimumab for rheumatoid arthritis. Of the 53 pregnancies with available outcome data, 45 newborns (45/53 [84.9%]) were delivered. Of these births, 30 were full-term, 2 were preterm, and 13 were unknown. Apgar scores were available for 11 of the 16 newborns whose mothers were exposed to adalimumab in the third trimester; all scores were within the normal range. Low birth weight was observed in 5 infants out of the 30 full-term deliveries. There were also 5 miscarriages (5/53 [9.4%]), 2 induced abortions (2/53 [3.8%]), and 1 stillbirth (1/53 [1.9%]). Eight maternal adverse events were observed in 5 pregnancies; no serious adverse events occurred. Conclusion: Although safety concerns were inconclusive, these data do not report additional risk to pregnancy outcomes with adalimumab exposure.

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SAT0117 TRIMESTER EXPOSURE AND PREGNANCY OUTCOMES IN WOMEN EXPOSED TO GOLIMUMAB – RESULTS FROM THE COMPANY PHARMACOVIGILANCE DATABASE

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2796 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 992.2-992

Author(s):

M. Otero-Lobato ◽

S. Esslinger ◽

S. Gabriel ◽

M. Clark ◽

P. Sheridan ◽

...

Keyword(s):

Pregnancy Outcome ◽

Birth Outcomes ◽

Pregnancy Outcomes ◽

Congenital Anomalies ◽

Spontaneous Abortions ◽

Live Births ◽

Elective Abortion ◽

Induced Abortions ◽

Pharmacovigilance Database ◽

Inflammatory Bowel

Background:Rheumatologic disorders and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for several rheumatologic indications and ulcerative colitis (UC).Objectives:To characterize pregnancy outcomes in patients treated with GLM, data obtained from maternal exposure to GLM are presented.Methods:This dataset includes individual patient cases reported to the manufacturer through 06 April 2019. Cases included in the analysis were medically confirmed cases of maternal exposures to GLM during pregnancy or within 3 months prior to conception, and a reported pregnancy outcome. Both prospectively reported (ie, pregnancy outcome not known when first reported) and retrospectively reported cases (ie, pregnancy outcome known when first reported) were included. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries.Results:Two hundred eight pregnancy cases (131 rheumatologic indications; 43 UC; and 34 other) with 211 reported birth outcomes were identified. Of these 208 pregnancy cases, 119 were prospective and 89 were retrospective. Average maternal age was 31.9 years. Of the 119 prospectively reported pregnancy cases, 89 (74.8%) resulted in live births, 19 (16.0%) resulted in spontaneous abortion (of these, 42.1% (8/19) received GLM in combination with methotrexate [MTX]), 10 (8.4%) resulted in induced/elective abortion, and 1 (0.8%) resulted in ectopic pregnancy. Overall, 9 congenital anomalies were reported (2 prospective and 7 retrospective cases).For 183 of the 208 pregnancy cases with reported outcomes, the trimester of exposure to GLM was known. Among the 110 prospectively reported cases, 82 (74.5%) were exposed during trimester 0 or 1. Of these, 19 had concomitant exposure to MTX, with the following birth outcomes: 8 live births, 8 spontaneous abortions, 3 elective/induced abortions. Eighteen of the prospectively reported cases (16.4%) were exposed to GLM through trimesters 1-3 and all resulted in live births (none with congenital anomalies; 1 infant with exposure to GLM and MTX was born preterm).Conclusion:The rates of congenital malformations and spontaneous abortions were consistent with published background rates for the general population. Persistent exposure throughout pregnancy was rare. Limitations of this analysis include the lack of a direct comparison group, the variable amount of data available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases.Disclosure of Interests:Marijo Otero-Lobato Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Suzan Esslinger Shareholder of: Johnson & Johnson, Consultant of: Johnson & Johnson, Novartis, Eli Lilly and Sandoz, Employee of: Johnson & Johnson, Susan Gabriel Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Merck, GSK, Michael Clark Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Pamela Sheridan Shareholder of: Johnson & Johnson, Roche Pharmaceuticals, Employee of: Johnson & Johnson, Roche, Novartis, Bayer, Anja Geldhof Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson

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Pregnancy outcomes in patients treated with bosutinib

International Journal of Hematologic Oncology ◽

10.2217/ijh-2020-0004 ◽

2020 ◽

Vol 9 (2) ◽

pp. IJH26 ◽

Cited By ~ 2

Author(s):

Jorge E Cortes ◽

Carlo Gambacorti-Passerini ◽

Michael Deininger ◽

Elisabetta Abruzzese ◽

Liza DeAnnuntis ◽

...

Keyword(s):

Adverse Effects ◽

Pregnancy Outcomes ◽

Contraceptive Use ◽

Reproductive Toxicity ◽

Maternal Exposure ◽

Preclinical Studies ◽

Paternal Exposure ◽

Safety Database ◽

Live Births ◽

Potential Risks

Aim: Preclinical studies have shown reproductive toxicity with bosutinib, but little is known about its effects during conception or pregnancy in humans. Methods: Pregnancy cases in patients receiving bosutinib were identified from the Pfizer safety database. Results: Thirty-three pregnancy reports were identified. Sixteen cases of maternal exposure: six live births, four abortions and six with unknown outcomes. Seventeen instances of paternal exposure: nine live births, five abortions and three with unknown outcomes. Conclusion: Adverse effects of bosutinib exposure at conception or during pregnancy in humans cannot be excluded, particularly if therapy is not interrupted upon recognition of pregnancy. Contraceptive use is recommended for female patients receiving bosutinib, and patients should be made aware of the potential risks associated with bosutinib use during pregnancy.

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Pregnancy outcomes in multiple sclerosis following subcutaneous interferon beta-1a therapy

Multiple Sclerosis Journal ◽

10.1177/1352458510394610 ◽

2011 ◽

Vol 17 (4) ◽

pp. 423-430 ◽

Cited By ~ 81

Author(s):

Magnhild Sandberg-Wollheim ◽

Enrica Alteri ◽

Margaretha Stam Moraga ◽

Gabrielle Kornmann

Keyword(s):

Multiple Sclerosis ◽

Pregnancy Outcomes ◽

Congenital Anomalies ◽

Interferon Beta ◽

Safety Data ◽

Individual Case ◽

In Utero ◽

Available N ◽

Safety Database ◽

Live Births

Background: Women with multiple sclerosis (MS) are advised to discontinue interferon-beta therapy before trying to conceive. Unplanned pregnancies occur and risks related to exposure remain unclear. Methods: To determine pregnancy outcomes following interferon-beta therapy, we examined pregnancies from a global drug safety database containing individual case safety reports received in the post-marketing setting and safety data from clinical trials of subcutaneous interferon beta-1a in MS. Results: One thousand and twenty-two cases of exposure to subcutaneous interferon beta-1a during pregnancy were retrieved; 679 had a documented outcome. In cases for which exposure duration was available ( n = 231), mean time of foetal exposure to subcutaneous interferon beta-1a before treatment discontinuation was 28 days; most pregnancies (199/231; 86.1%) were exposed for ≤45 days. To avoid bias, only outcomes for prospective data ( n = 425) in pregnancies exposed to interferon beta-1a in utero were analysed further. Of these, 324 (76.2%) resulted in normal live births and four (0.9%) in live births with congenital anomalies (3 [0.7%] were ‘major’). Four (0.9%) pregnancies resulted in stillbirths (1 [0.2%] with foetal defects). There were 5 (1.2%) ectopic pregnancies, 49 (11.5%) spontaneous abortions and 39 (9.2%) elective terminations. Most pregnancies exposed to subcutaneous interferon beta-1a in utero were associated with normal live births. The rates of spontaneous abortion and major congenital anomalies in live births were in line with those observed in the general population. Conclusions: These data should be taken into account when considering options for women with MS who become pregnant or who are planning pregnancy while on treatment with subcutaneous interferon beta-1a.

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Reproductive health issues in patients with psoriasis (literature review)

Medical alphabet ◽

10.33667/2078-5631-2019-1-7(382)-5-8 ◽

2019 ◽

Vol 1 (7) ◽

pp. 5-8

Author(s):

L. S. Kruglova ◽

A. A. Osina ◽

A. A. Khotko

Keyword(s):

Drug Therapy ◽

Reproductive Health ◽

Literature Review ◽

Pregnancy Outcomes ◽

Adverse Pregnancy Outcome ◽

Certolizumab Pegol ◽

Genetically Engineered ◽

Health Issues ◽

Degree Of Confidence ◽

Adverse Pregnancy

Among patients with psoriasis, approximately 50% are women and almost 75 % of them are under the age of 40 years. Thus, most women with psoriasis have childbearing potential. When pregnancy occurs in 22 % of patients, the activity of psoriasis persists, characteristic of the course before pregnancy, in 23 % of women, the course of the disease worsens. The article provides up-to-date data on the management of pregnant patients with psoriasis. To improve pregnancy outcomes in patients with psoriasis, it is important to prevent exacerbation of the disease. The choice of drug therapy in this case is based on an assessment of the ratio of the risk of undesirable effects of the drugs on the developing fetus and the risk of the development of exacerbation of psoriasis, which can cause an adverse pregnancy outcome. Despite the fact that the available clinical experience of using genetically engineered drugs is still limited, with a certain degree of confidence we can say that there is no increase in the risk of adverse pregnancy outcomes associated with therapy with certolizumab pegol.

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