ABSTRACT
Background: Although over 100 million pregnant women worldwide are at risk of infection with SARS-CoV-2, little data exists on the impact of COVID-19 and related treatments on maternal/neonatal health. Objective(s): (1) To quantify the prevalence of medication use in pregnancy to treat COVID-19, and (2) To quantify and compare the risk of adverse pregnancy/neonatal outcomes in those with and without COVID-19. Method(s): In the Canadian Mother-Child population-based cohort (CAMCCO), two sub-cohorts were identified using prospective data collection of medical services, prescription drugs, hospitalization archives data, and COVID-19 surveillance testing program (02/28/2020- 2021). The first cohort included all pregnant women during the study period regardless of pregnancy status (delivery, induced/planned or spontaneous abortion);this cohort was further stratified on COVID-19 status. The second cohort included all nonpregnant women (aged 15-45) with a positive COVID-19 test. COVID-19 in pregnant or nonpregnant women was assessed using COVID-19 test results or ICD-10CM code U07.1 from hospital data. COVID-19 severity was categorized based on hospital admission. Women were considered exposed to COVID-19 medications if they filled at least one prescription for a medicine included in the WHO list in the 30 days pre- or 30 days post-COVID-19 positive test/diagnosis. Considering potential confounders, association between COVID-19 during pregnancy, treated vs not, and perinatal outcomes were quantified using log-binomial regression models. Result(s): 150,345 pregnant women (3,464 (2.3%) had COVID-19), and 112,073 nonpregnant women with COVID-19 diagnoses were included. Pregnant women with COVID-19 were more likely to have severe infections compared to nonpregnant women with COVID-19 (11.4% vs 1.6%, p<0.001). The most frequent medications used in pregnancy to treat COVID-19 were antibacterials (13.96%), psychoanaleptics (7.35%), and medicines for obstructive airway disease (3.20%). In pregnancy COVID-19 was associated with spontaneous abortions (adjRR 1.76, 95%CI 1.37, 2.25), gestational diabetes (adjRR 1.52, 95%CI 1.18, 1.97), prematurity (adjRR 1.30, 95%CI 1.01, 1.67), NICU admissions (adjRR 1.32, 95%CI 1.10, 1.59);COVID-19 severity was increasing these risks but exposures to COVID-19 medications reduced all risks. Conclusion(s): COVID-19 severity was higher in pregnancy. Antibacterials, psychoanaleptics, and medicines for obstructive airway disease were the most used overall. COVID-19 was associated with adverse outcomes for mothers and newborns.
ABSTRACT
Background The rapid development and distribution of SARS-CoV-2 vaccines has raised concerns surrounding vaccine safety in immunocompromised populations, such as those with inflammatory bowel disease (IBD). Purpose We described adverse events (AEs) following SARS-CoV-2 vaccination in those with IBD and determined relationships between AEs to post-vaccination antibody titres. Method Individuals with IBD from a prospective cohort in Calgary, Canada (n=670) who received a 1st, 2nd, 3rd, and/or 4th dose of a SARS-CoV-2 vaccine (Pfizer-BioNTech, Moderna, and/or AstraZeneca) were interviewed via telephone for AEs using the Adverse Events Following Immunization form. Subsequently, we assessed injection site reaction as a specific AE outcome. Multivariable logistic regression models were used to assess the association between anti-SARS-CoV-2 spike protein antibody (anti-S) levels within 1–12 weeks of vaccination and injection site reaction following 1st, 2nd, and 3rd dose vaccination. Models were adjusted for age, sex, IBD type, IBD medications, vaccine type, and prior COVID-19 infection. Additionally, we evaluated the risk of flare of IBD within 30 days of vaccination via chart review. Result(s) Table 1 describes AEs in individuals with IBD following 1st dose (n=331), 2nd dose (n=331), 3rd dose (n=195), and 4th dose (n=100) of a SARS-CoV-2 vaccine. AEs were reported in 83.3% of participants after 1st dose, 79.1% after 2nd dose, 77.4% after 3rd dose, and 67.0% after 4th dose. Injection site reaction (pain, redness, etc.) was the most common AE (50.8% of AEs), with fatigue and malaise (18.1%), headache and migraine (8.6%), musculoskeletal discomfort (8.2%), and fever and chills (6.5%) also commonly reported. Multivariable logistic regression determined no associations between anti-S concentration and injection site reaction for all doses. Age above 65 years was associated with decreased injection site reaction following 1st and 3rd doses, while female sex and mRNA vaccine type were associated with increased injection site reaction following 1st and 2nd doses. Prior COVID-19 infection, IBD type, and medication class were not associated with injection site reaction with any dose. Only one participant was diagnosed with a severe AE requiring hospitalization: Immune thrombocytopenic purpura (ITP) following 2nd dose of a Pfizer vaccination. No cases of IBD flare occurred within 30 days of vaccination. Image Conclusion(s) AEs following SARS-CoV-2 vaccination are generally mild and become less common with each consecutive dose. Antibody levels following each dose of the vaccine were not associated with injection site reactions. Females, those under 65 years of age, and those administered mRNA vaccines were more likely to experience an injection site reaction. Prior COVID-19 infection, IBD type, and IBD medication class did not predict injection site reactions. Vaccination was not associated with IBD flare within 30 days of vaccination. Please acknowledge all funding agencies by checking the applicable boxes below Other Please indicate your source of funding;Helmsley Disclosure of Interest A. Markovinovic: None Declared, M. Herauf: None Declared, J. Quan: None Declared, L. Hracs: None Declared, J. Windsor: None Declared, N. Sharifi: None Declared, S. Coward: None Declared, L. Caplan: None Declared, J. Gorospe: None Declared, C. Ma Grant / Research support from: Ferring, Pfizer, , Consultant of: AbbVie, Alimentiv, Amgen, Ferring, Pfizer, Takeda, , Speakers bureau of: AbbVie, Alimentiv, Amgen, Ferring, Pfizer, Takeda, R. Panaccione Grant / Research support from: AbbVie, Ferring, Janssen, Pfizer, Takeda, Consultant of: Abbott, AbbVie, Alimentiv, Amgen, Arena, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Mylan, Oppilan Pharma, Pandion Therapeutics, Pandion Pharma, Pfizer, Progenity, Pro agonist, Roche, Sandoz, Satisfai Health, Schering-Plough, Shire, Sublimity Therapeutics, Takeda, Theravance, UCB, Speakers bureau of: AbbVie, Arena, Celgene, Eli Lilly, Ferring, Gilead Sciences, Janssen, Merck, Pfizer, Roche, Sandoz, Shire, Takeda, R. Ingram: None Declared, J. Kanji: None Declared, G. Tipples: None Declared, J. Holodinsky: None Declared, C. Berstein Grant / Research support from: AbbVie, Amgen, Janssen, Pfizer, Takeda, Speakers bureau of: AbbVie, Janssen, Pfizer, Takeda, D. Mahoney: None Declared, S. Bernatsky: None Declared, E. Benchimol: None Declared, G. Kaplan Grant / Research support from: Ferring, Speakers bureau of: AbbVie, Janssen, Pfizer
ABSTRACT
Introduction: Mental health regional differences during pregnancy through the COVID-19 pandemic is understudied. Objective(s): We aimed to quantify the impact of the COVID-19 pandemic on maternal mental health during pregnancy. Method(s): A cohort study with a web-based recruitment strategy and electronic data collection was initiated in 06/2020. Although Canadian women, >18 years were primarily targeted, pregnant women worldwide were eligible. The current analysis includes data on women enrolled 06/2020-11/2020. Self-reported data included mental health measures (Edinburgh Perinatal Depression Scale (EPDS), Generalized Anxiety Disorders (GAD-7)), stress. We compared maternal mental health stratifying on country/continents of residence, and identified determinants of mental health using multivariable regression models. Result(s): Of 2,109 pregnant women recruited, 1,932 were from Canada, 48 the United States (US), 73 Europe, 35 Africa, and 21 Asia/Oceania. Mean depressive symptom scores were lower in Canada (EPDS 8.2, SD 5.2) compared to the US (EPDS 10.5, SD 4.8) and Europe (EPDS 10.4, SD 6.5) (p<0.05), regardless of being infected or not. Maternal anxiety, stress, decreased income and access to health care due to the pandemic were increasing maternal depression. The prevalence of severe anxiety was similar across country/continents. Maternal depression, stress, and earlier recruitment during the pandemic (June/July) were associated with increased maternal anxiety. Conclusion(s): In this first international study on the impact of the COVID-19 pandemic, CONCEPTION has shown significant country/continent-specific variations in depressive symptoms during pregnancy, whereas severe anxiety was similar regardless of place of residence. Strategies are needed to reduce COVID-19's mental health burden in pregnancy.
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Background: The Coronavirus-2019 (COVID-19) pandemic increased psychosocial distress in the general population and in patients with rheumatic disease. Limited data exists on the impact of COVID-19 in rheumatology patients living in Africa. Objectives: To describe COVID-19 related illness and psychosocial impact in Ethiopian (ET) rheumatology patients attending the only public rheumatology clinic in Ethiopia (Tikur Anbessa Specialized Hospital (TAH) in Addis Ababa). To compare fndings in ET with fndings in Canadian (CA) rheumatology patients. Methods: Between May 1 and Oct 31 2021, 130 patients attending the TAH rheumatology clinic answered questions related to COVID-19 infection, symptoms and testing, and psychosocial impacts of the COVID-19 pandemic. We assessed depression (Patient Health Questionnaire-9), anxiety (General Anxiety Disorder-7;GAD7), COVID-19 stress factors and coping measures, Resilience (Brief Resilience Scale-BRS) and medication compliance (Morisky medication adherence scale-4 item;MAS4). Rheumatic disease severity was assessed with the Routine Assessment of Patient Index Data-3 (RAPID-3). Questionnaires were translated to Amharic. Descriptive statistics are reported [mean (standard deviation), median (25%, 75%) number and percent.)] and compared to data of 97 CA patients with rheumatoid arthritis (RA) and lupus patients from Quebec1. Results: ET patients were mainly female (71%) with a mean (SD) age of 47 (16), and resided in the capital city (Addis Ababa) (72%). Half had RA or lupus. A quarter of patients had moderate to severe rheumatic disease severity desite good medication adherence [MAS4 score of 3(2,4)]. Most (89%) reported no COVID-19 symptoms since the beginning of the pandemic, were not tested for COVID-19 and reported few risk factors for COVID-19 exposure. Eight (6%) ETs were diagnosed with COVID-19;2 required hospitalization. Diagnosed patients reported a median of 2 COVID-19 symptoms (range 0-8;mainly cough, fever and malaise). Within the entire cohort, depression (PHQ9= 10 or above) and anxiety (GAD7=10 or above) were more frequent in ETs than CAs (depression 30% vs 3%;anxiety 16% vs 1%) yet nearly half (47%) of ETs had normal or high resilience levels. The most common COVID-19 stressors were risk of contracting COVID illness personally [ETs vs CAs risk ratio(95% confdence limits-CL);0.67 (0.5, 0.99)] or of loved one [0.56 (0.36, 0.86)]. More ETs reported COVID-19 related stress related to difficulty obtaining food, medicine or other essentials [1.74, (1.00-3.0)], and getting needed supports [1.97 (1.03, 3.77)] (Table 1). CAs and ETs used similar levels of problem solving [median (25%,75%) CA 3.3 (2.8, 3.3), ET 3.5 (3.0, 3.7)] and emotion-focus [CA 2.5 (2.2, 3.1);ET 3.3 (2.8, 3.7)] coping strategies. Conclusion: During the COVID-19 pandemic, depression was more common in ETs compared to CAs with rheumatic disease. COVID-19-related stressors due to insecurity in obtaining the basic essentials and support were more pronounced in ETs. Differences between ETs and CA in these stressors may refect local public health and economic supports. There were no differences in coping strategies.
ABSTRACT
Background: The immune response of SARS-CoV-2 vaccines is uncertain in those with Inflammatory Bowel Disease (IBD) due to a diverse array of immune-modifying therapies that vary in the mechanism of immunosuppression. Aim: We aimed to quantify the serological response to SARS-CoV-2 vaccines in those with IBD and determine antibody levels across varying therapeutic options. Methods: Individuals with IBD who received a first and/or second dose of a COVID-19 vaccine (Pfizer-BioNTech, Moderna, and/or AstraZeneca) were assessed for serological response (1–8 weeks after first dose;1–8 weeks after second dose, 8–18 weeks after second dose, 18+ weeks after second dose) using the SARS-CoV-2 IgG II Quant assay to the receptor-binding domain of the SARS-CoV-2 spike protein. The cohort was stratified based on age, sex, vaccine received, IBD type, IBD therapeutic, and prior confirmed diagnosis of COVID-19. The primary outcome was seroconversion defined as IgG levels of ³50 AU/mL. Secondarily, we evaluated the geometric mean titer (GMT) with 95% confidence intervals (CI). Results: Table 1 describes the characteristics of individuals with IBD (n=466) with serological data following the first dose (n=247) and/or second dose (n=413) of a COVID-19 vaccine. After 1–8 weeks following first dose of the vaccine, 81.4% seroconverted, with the lowest first-dose conversion rates in patients taking anti- TNF monotherapy (80.3%), anti-TNF combination therapy (51.5%), and corticosteroids (50.0%) (Table 1). Overall, 98.4% of the cohort seroconverted within 1–8 weeks of the second dose. Over time, seropositive rates decreased with 95.8% seroconversion within 8– 18 weeks of the second dose and 90.5% after 18 weeks. Seroconversion after second dose was consistently high across all medication classes (range: 94.6%–100.0%), except for oral corticosteroids (62.5%). GMT levels significantly increased (p<0.0001) from first dose (1825 AU/mL [95% CI: 981, 2668 AU/mL]) to second dose at 1–8 week (9059 AU/mL [7698, 10420 AU/mL]) but fell significantly (p<0.0001) to 3649 AU/mL (95% CI: 2562, 4736 AU/ mL) 8–18 weeks from second dose and 2527 AU/mL (95% CI: 883, 4172 AU/mL) 18+ weeks after second dose (Table 1, Figure 1). GMT levels 1–8 weeks after second dose were higher in those with prior COVID-19 (16,770 AU/mL), but lower in those receiving anti- TNF combination therapy (4231 AU/mL) and oral corticosteroids (5996 AU/mL) (Table 1). Conclusion: Seroconversion rates following full-regimen vaccination are high in patients with inflammatory bowel disease across all medication classes except for anti-TNF combination therapy and oral corticosteroids. Antibody titres and seroconversion rates tend to decrease after eight weeks post-full vaccination, which is consistent across medication classes. (Table Presented) Table 1. Patient and vaccine characteristics, seroconversion rates, and geometric mean titres by prior PCR-confirmed COVID-19 status for each medication class. (Figure Presented) Figure 1. Log-transformed anti-SARS-CoV-2 spike antibody concentration per vaccine category. Black points represent GMTs while narrow black bars represent bounds of 95% CI associated with each GMT. Solid blue line represents threshold for positive seroconversion [ln (50 AU/mL)].
ABSTRACT
Background: The immune response to a two-dose regimen of SARS-CoV-2 vaccination in those with Inflammatory Bowel Disease (IBD) has been consistently high in emerging research. Serological responses following a third dose have yet to be established. Aim: We aimed to quantify the serological response to a third dose of SARS-CoV-2 vaccines in those with IBD and compare to responses after a two-dose regimen. Methods: Individuals with IBD who have received at least two doses of a COVID-19 vaccine were assessed for serological response using the SARS-CoV-2 IgG II Quant assay to the receptor-binding domain of the SARSCoV- 2 spike protein at least eight weeks after second dose and then after third dose. The primary outcome was seroconversion defined as IgG levels of ≥50 AU/mL. Secondarily, we evaluated the geometric mean titer (GMT) with 95% confidence intervals (CI). Outcomes were stratified by prior COVID-19 history. A Wilcoxon rank sum test was used to compare antibody titres following 3rd dose vaccination and titres following 2nd dose vaccination. For patients with both post-2nd and post-3rd vaccination serology, the difference in antibody titres between doses was determined and the mean difference was tested using one-sample Student's t-tests. Results: Table 1 describes the characteristics of individuals with IBD (n = 271) with serological data following the corresponding dose for those with 2nd dose vaccination (n = 175) compared to those with a 3rd dose of vaccine (n = 96). Seroconversion following 3rd dose vaccination occurred for all individuals (100.0%), compared to a 94.4% seroconversion rate at least eight weeks following 2nd dose vaccination (range: 8 to 35 weeks post-2nd dose). GMT for the post-3rd dose cohort (16424 AU/mL [13437, 19411 AU/mL]) was significantly higher (p<0.0001) than the post-2nd dose cohort (3261 AU/mL [2356, 4165 AU/mL] (Table 1, Figure 1b). Individual titres as a function of time following 2nd dose vaccination are seen in Figure 1a for both 3rd dose and 2nd dose cohorts. For individuals with serology following both 2nd dose and 3rd dose vaccination (n = 82), seroconversion rates increased from 97.6% to 100.0% after the 3rd dose. GMT following post-3rd dose vaccination also increased with a mean difference in antibody titres between post-3rd dose and post-2nd dose vaccination of 11384 AU/mL (8541, 14228 AU/mL, p < 0.0001). This difference was significant for both individuals with prior COVID-19 history (11682 AU/mL [95% CI: 8618, 14746 AU/mL, p<0.0001]) and individuals without (8194 AU/mL [95% CI: 988, 15400 AU/mL]). Conclusion: Seroconversion rates and antibody response following third dose vaccination are substantially increased as compared to second dose in patients with IBD. Third dose vaccination can counter the decrease in antibody concentration over time following a two-dose regimen. (Table Presented) Table 1. Patient characteristics, vaccine type, seroconversion rates, and geometric mean titres by prior COVID-19 status for post-3rd dose and post-2nd dose cohorts