Use of B-Cell–Depleting Therapy in Women of Childbearing Potential With Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder

Purposeof Review: There is considerable heterogeneity in the use of B cell depletion in women of childbearing age, likely driven at least in part by the discrepancy between the product labels and what is known about the physiology of IgG1, including breastmilk and placental transfer.Recent Findings:We provide practical considerations on the use of this medication class in women of childbearing potential. We discuss pre-pregnancy planning including vaccinations, safety of B cell depletion during pregnancy as well as postpartum considerations including breastfeeding.Summary:B cell depleting monoclonal antibodies have shown to be effective for pre-pregnancy and postpartum prevention of inflammatory activity in multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD). B cell depleting therapies are large IgG1 monoclonal antibodies which have minimal transfer across the placenta and into breastmilk. Consideration of risks and benefits of these therapies should be considered in counseling women planning pregnancy and postpartum.

Certolizumab Pegol: A New Therapeutic Approach for Acrodermatitis Continua of Hallopeau

<b><i>Introduction:</i></b> Acrodermatitis continua of Hallopeau (ACH) is a rare, chronic, and recurrent form of pustular psoriasis (PP) localized to one or more digits. Due to the rarity of ACH, no clear treatment guidelines are currently available, making the therapeutic approach more complex. <b><i>Case Presentation:</i></b> We report the first case of a young woman with ACH who was successfully treated with certolizumab pegol (CZP). <b><i>Discussion/Conclusion:</i></b> PP and ACH are difficult to treat, and biologics may be an option more manageable than cyclosporine. CZP is the safest biologic therapy during pregnancy, so there is low risk in prescribing it in women with childbearing potential. However, continuing biological therapy during pregnancy always involves an assessment of the clinical benefits, which must outweigh the risks.

Sodium valproate prescribing safety in women of childbearing potential

AimsThe purpose of this audit was to identify all women being prescribed Sodium Valproate under the Bassetlaw Local Mental Health Team (LMHT) caseload to see how well latest prescribing guidelines are being met, and help set up a system allowing efficient monitoring of Sodium Valproate prescribing in the future.BackgroundDespite early concerns regarding potential teratogenicity, Sodium Valproate became a widely used anticonvulsant and mood stabiliser and is licensed for use in Epilepsy, Migraine prophylaxis and Bipolar affective disorder. Research evidence now shows its use in pregnancy increases risk of neurodevelopmental disorders to 40%, and serious birth defects to 10%. Despite research finding these risks prescribing practice did not significantly change. To better reflect these findings in clinical practice in 2018 the Pharmacovigilance Risk Assessment Committee recommended Sodium Valproate should not be used in pregnancy unless they have a form of epilepsy unresponsive to other anti-epileptic drugs, and all with childbearing potential should be enrolled in a pregnancy prevention programme (PPP). This was endorsed by UK Medicines and Healthcare Devices Regulatory Agency in April 2018 with launch of the PPP.Standards:Must be offered counselling about risks of valproate to unborn child and importance of effective contraception.Annual specialist Review by a specialist now mandatoryRisk acknowledgement form must be updated at least annually.MethodThe electronic RiO records for all female patients on the Bassetlaw LMHT caseload in the year 2019 were checked to identify those prescribed Valproate. For those prescribed Valproate, evidence of annual risk acknowledgement form, date of last appointment, underlying diagnosis and contraceptive method was checked. This data was stored together on an excel file and used to create a patient list to help allow future monitoring.ResultFrom 594 female patients identified, 27 (4.5%) were prescribed Sodium Valproate. Of these, 14 (52%) had PPP documentation uploaded, 24 (89%) had been reviewed within the last 12 months, and 13 (48%) had no documentation of contraceptive method.ConclusionThis audit helped highlight there is likely a large population of patients not yet on the Pregnancy Prevention Programme. Creating a monitoring system in excel for female patients being prescribed Valproate can help improve adherence to latest guidelines, with a colour coding system to highlight those needing risk acknowledgement forms/appointments within the next three or six months. Educating patients and other healthcare professionals about risks will also help improve prescribing practice and avoid use in pregnancy.

AB0918-PARE FAMILY PLANNING AND RMDS: A SURVEY

Background:It is well known and universally aknowledged that RMDs are not related to old age, as those who are affected by these illness between 30 and 45 years old are a big number, perhaps the biggest one. Therefore, family planning and pregnancy are topics even more actual and their management is certainly one of the biggest source of distress and troubles in people affected by RMDs and their spouses.Objectives:to define and deeply understand the problem’s dimension, ANMAR made a survey according to the CAPIRE Observatory.Methods:an pposite questionnaire was given to patients waiting for a rheumatological consultation, during 6 months in 2020.Results:Over 300 women with an RMD fulfilled the questionnaire:7 on 10 women are trying to become pregnant51% of them did not notice it to their Rheumatologist.57% of them has been already pregnant.Conclusion:In Italy, women with RMDs are over 3.5 millions and the a lot of them are women of childbearing potential.As therapies actually used are really effective, but may induce side effects on the reproductive system, it is absolutely needed to inform the Rheumatologist about the intent to procreate and to have suggestions about the correct chice of contracception models.Communication between patient and Rheumatologist must be improoved, even in this important topic.Disclosure of Interests:None declared

Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV

Background/Purpose Use of tenofovir disoproxil fumarate (TDF) improves patient outcomes in preventing mother-to-child transmission (pMTCT) of the hepatitis B virus (HBV) in mothers with chronic HBV and high viral loads. Given the lack of data for tenofovir alafenamide (TAF) in pMTCT, rates of early viral suppression with TAF and TDF were evaluated in women of childbearing potential (WOCBP) participating in 2 randomized, double-blind, Phase 3 studies in chronic HBV. Methods In a patient subset meeting WOCBP criteria and with baseline HBV DNA >200,000 IU/mL, rates of viral suppression with TAF or TDF in achieving the target of HBV DNA <200,000 IU/mL at weeks 12 and 24 were assessed. Multivariate logistic regression was used to identify factors predictive of failure to suppress HBV DNA to the target level. Results In 275 of 1298 (21%) patients meeting WOCBP criteria with high viral load, 93% and 96% had HBV DNA <200,000 IU/mL at weeks 12 and 24, respectively. Results for TAF (n = 194) vs TDF (n = 81) treatment were similar at weeks 12 and 24 (94% vs. 90% and 97% vs. 93%), respectively. High baseline HBV DNA level, genotype D infection, and prior interferon (week 24 only) were predictive of failure to achieve the target level. Both treatments were well tolerated with TAF showing less impact on renal and bone parameters. Conclusions In WOCBP with high VL, no differences were found between TAF and TDF in reducing HBV DNA to levels associated with lower transmission risk. These data support ongoing studies of TAF for pMTCT.

Appropriateness for SARS-CoV-2 vaccination for otolaryngologist and head and neck surgeons in case of pregnancy, breastfeeding, or childbearing potential: Yo-IFOS and CEORL-HNS joint clinical consensus statement

Purpose SARS-CoV-2 vaccines are a key step in fighting the pandemic. Nevertheless, their rapid development did not allow for testing among specific population subgroups such as pregnant and breastfeeding women, or elaborating specific guidelines for healthcare personnel working in high infection risk specialties, such as otolaryngology (ORL). This clinical consensus statement (CCS) aims to offer guidance for SARS-CoV-2 vaccination to this high-risk population based on the best evidence available. Methods A multidisciplinary international panel of 33 specialists judged statements through a two-round modified Delphi method survey. Statements were designed to encompass the following topics: risk of SARS-Cov-2 infection and use of protective equipment in ORL; SARS-Cov-2 infection and vaccines and respective risks for the mother/child dyad; and counseling for SARS-CoV-2 vaccination in pregnant, breastfeeding, or fertile healthcare workers (PBFHW). All ORL PBFHW were considered as the target audience. Results Of the 13 statements, 7 reached consensus or strong consensus, 2 reached no consensus, and 2 reached near-consensus. According to the statements with strong consensus otorhinolaryngologists—head and neck surgeons who are pregnant, breastfeeding, or with childbearing potential should have the opportunity to receive SARS-Cov-2 vaccination. Moreover, personal protective equipment (PPE) should still be used even after the vaccination. Conclusion Until prospective evaluations on these topics are available, ORL-HNS must be considered a high infection risk specialty. While the use of PPE remains pivotal, ORL PBFHW should be allowed access to SARS-CoV-2 vaccination provided they receive up-to-date information.

Appropriateness for SARS-CoV-2 Vaccination for Otolaryngologist and Head and Neck Surgeons in case of Pregnancy, Breastfeeding or Childbearing potential: YO-IFOS and CEORL-HNS joint clinical consensus statement

Purpose: SARS-CoV-2 vaccines are a key step in fighting the pandemic. Nevertheless, their rapid development did not allow for testing among specific population subgroups such as pregnant and breastfeeding women, or elaborating specific guidelines for healthcare personnel working in high infection risk specialties, such as otolaryngology (ORL). This clinical consensus statement (CCS) aims to offer guidance for SARS-CoV-2 vaccination to this high-risk population based on the best evidence available.Methods: A multidisciplinary international panel of 33 specialists judged statements through a 2-rounds modified Delphi method survey. Statements were designed to encompass the following topics: risk of SARS-Cov-2 infection and use of protective equipment in ORL; SARS-Cov-2 infection and vaccines and respective risks for the mother/child dyad; and counseling for SARS-CoV-2 vaccination in pregnant, breastfeeding, or fertile healthcare workers (PBFHW). All ORL PBFHW were considered as the target audience.Results: Of the 13 statements, 7 reached consensus or strong consensus, 2 reached noConsensus and 2 reached near-consensus. According to the statements with strong consensus Otorhinolaryngologists – Head & Neck Surgeons who are pregnant, breastfeeding or with childbearing potential should have the opportunity to receive SARS-Cov-2 vaccination. Moreover, personal protective equipment (PPE) should still be used even after the vaccination.Conclusion: Until prospective evaluations on these topics are available, ORL-HNS must be considered a high infection risk specialty. While the use of PPE remains pivotal, ORL PBFHW should be allowed access to SARS-CoV-2 vaccination provided they receive up-to-date information.