Safety of Biologics for Atopic Diseases During Pregnancy.

The high prevalence of atopic diseases in women of childbearing age reveals the need to determine the safety of biologics during pregnancy. This review summarizes the effects of 7 Food and Drug Administration-approved biologics (omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab, and tralokinumab) on maternal and fetal outcomes. For this purpose, we reviewed English-language publications to investigate whether the use of biologics for atopic diseases during pregnancy increased the risk of preterm delivery, stillbirth, low birth weight, or congenital malformations. Most publications found were case reports, case series, or observational studies reporting outcomes in a total of 313 pregnancies. No randomized controlled studies were identified. We found that biologics do not seem to influence maternal or fetal outcomes. Indeed, worsening of the underlying atopic disease during pregnancy appears to be more detrimental to the viability of the pregnancy. Given the small sample size and scarcity of studies, future research should include prospective studies with comparable control groups without exposure to biologics and multicenter registries for long-term follow-up.

Predictors of seroconversion after coronavirus disease 2019 vaccination.

BACKGROUND: Vaccine nonresponse during the coronavirus disease 2019 (COVID-19) pandemic has considerable individual and societal risks. OBJECTIVE: To investigate the clinical characteristics of patients with lack of seroconversion after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS: Demographic and clinical data were collected from 805 patients who had validated antibody assays against the SARS-CoV-2 spike protein at least 14 days after completion of their COVID-19 vaccination. Clinical characteristics from patients with a negative (< 0.4 U/mL) antibody response were assessed and summarized. RESULTS: A total of 622 (77.3%) patients attained seroconversion as defined by a titer of greater than or equal to 0.4 U/mL, whereas 183 out of 805 (22.7%) patients exhibited no seroconversion after vaccination against SARS-CoV-2. Univariately, older age (P = .02) and male sex were associated with a lower likelihood of seroconversion (P = .003). Therapy with immunosuppressive drugs was noted in 93 (50.8%) of seronegative patients with most (n = 83/93, 89.2%) receiving ongoing immunosuppressive therapy at the time of vaccination. Among the 134 (73.2%) seronegative patients with immunodeficiency, 110 (82.1%) had primary immunodeficiency. Cancer (n = 128, 69.9%), B cell depletion therapy (n = 90/115, 78.3%), and immunosuppressant steroid use (n = 71/93 on immunosuppressants, 76.3%) were the other common characteristics among the vaccine nonresponders. More importantly, our study did not evaluate the actual efficacy of COVID-19 vaccination. CONCLUSION: Vaccine responses vary by age and sex, with men showing lower rates of seroconversion as compared with women. Primary immunodeficiency along with active malignancy and ongoing immunosuppression with steroids or B cell depletion therapy appeared to be the most common characteristics for those with a lack of vaccine seroconversion after COVID-19 vaccination.

An unusual presentation of acute deep vein thrombosis after the Moderna COVID-19 vaccine-a case report.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a worldwide pandemic of the multisystem disease coronavirus disease-2019 (COVID-19). Since the development of COVID-19 vaccines, there has been extensive monitoring for potential serious side effects. We report an unusual presentation of acute deep vein thrombosis (DVT) in the right upper extremity of a 27-year-old Caucasian female, 3 days after receipt of her second dose of the Moderna COVID-19 vaccine. Her relevant thrombophilia workup was negative on initial presentation. She was treated with rivaroxaban for 3 months and her symptoms of right upper extremity swelling, and pain improved. Considering our case did not have any evidence of thrombocytopenia, we discuss the possible pathophysiology of acute DVT following Moderna COVID-19 vaccine in contrast to adenoviral vector COVID-19 vaccines (ChAdOx1 nCoV-19 and Ad26.COV2.S), including mRNA COVID-19 vaccine binding to pattern recognition receptors (PRR) in the endosomes and cytosol leading to a pro inflammatory cascade and coagulopathy. We highlight the importance of initial workup for acute DVT post COVID-19 vaccination, that should include complete blood count (CBC) with platelet count, international normalized ratio (INR), prothrombin time (PTT), D-dimer levels, fibrinogen levels, platelet factor 4 (PF4)/heparin enzyme-linked immunosorbent assays (ELISA) followed by a confirmatory PF4 platelet activation assay such as serotonin release assay, P-selectin expression assay, or heparin induced platelet aggregation (HIPA) assay, and imaging for thrombosis.