Metropolitan Atlanta Research Articles

389. Epidemiology of Multiple Recurrent Clostridioides difficile in the Atlanta Metropolitan Area between 2016 and 2019

Abstract Background Patients with multiple recurrences of Clostridioides difficile infection (CDI) have longer hospital stays and lower quality of life. Recent changes in therapies and strains of CDI make understanding recurrent CDI in the general population critical as these patients may benefit from microbiota restoring therapies rather than antibiotics alone. Methods Georgia’s Emerging Infections Program (supported by CDC) conducts CDI surveillance in 8 counties around metropolitan Atlanta, GA (population ∼4 million). CDI is defined as any C. difficile-positive specimen with no positive test in the prior 2 weeks. We evaluated CDI between Jan 2015 through Dec 2019 and captured recurrent CDI (CDI test date 2-52 weeks following previous CDI) for 2016-2019 which were categorized as single episode only, recurrent (2 episodes ≤ 1 year) or multiple recurrent (>2 episodes ≤ 1 year). Year was attributed to date of final episode. Census data was used to determine crude and age-specific incidence. Bivariate and multivariable logistic regression was used to estimate odds for multiple recurrent compared to single recurrent CDI with demographic, comorbidity and treatment related covariates. Results Over 4 years 13,745 patients had at least one episode of CDI, 2,930 (20%) had ≥ 1 recurrence and 916 (30%) of these progressed to multiple recurrence. Between 2016 to 2019, incidence of single CDI decreased 25% from 93/100,000 to 69/100,000 (P< 0.01). Multiple recurrent CDI decreased 45% from 9/100,000 to 5/100,000) (P< 0.01); incidence in the 80+ age group was highest and where decreased incidence was most dramatic during the study period (Figures). Time between 1st and 2nd episode was longer among patients with single recurrent than multiple recurrent CDI (median 12 weeks vs. 9 weeks, P< 0.01).. Independent predictors of multiple recurrence were fewer days (< 90) between episodes (aOR: 1.87 P< 0.01) and chronic renal disease (aOR: 1.59 , P< 0.01). Figure 1:Annual Incidence of CDI by age group. A) Incidence of CDI among patients with only a single episode of CDI within 365 days. B) Incidence of CDI among patients with three or more episodes (two or more recurrence) within 365 days. RR documented compares 2016 to 2018 incidence in the 80+ age group Conclusion Time between 1st and 2nd CDI most strongly predicts likelihood of progression to multiple recurrences. Of all measured comorbid conditions, renal disease was most predictive. These findings may help to identify patients at high risk for progression for advanced interventions such as microbiota modifying therapies. Disclosures Scott Fridkin, MD, Pfizer: Grant/Research Support Colleen Kraft, MD MS, Rebiotix Inc: Advisor/Consultant|SERES: Advisor/Consultant.

System-level factors influencing refugee women's access and utilization of sexual and reproductive health services: A qualitative study of providers' perspectives.

Refugee women have poor outcomes and low utilization of sexual and reproductive health (SRH) services, which may be driven by access to and quality of SRH services at their resettled destinations. While healthcare providers offer valuable insights into these topics, little research has explored United States (U.S.) providers' experiences. To fill this literature gap, we investigate U.S. providers' perspectives of healthcare system-related factors influencing refugee women's access and utilization of SRH services. Between July and December 2019, we conducted in-depth, semi-structured interviews with 17 providers serving refugee women in metropolitan Atlanta in the state of Georgia (United States). We used convenience and snowball sampling for recruitment. We inquired about system-related resources, facilitators, and barriers influencing SRH services access and utilization. Two coders analyzed the data using a qualitative thematic approach. We found that transportation availability was crucial to refugee women's SRH services access. Providers noted a tension between refugee women's preferred usage of informal interpretation assistance (e.g., family and friends) and healthcare providers' desire for more formal interpretation services. Providers reported a lack of funding and human resources to offer comprehensive SRH services as well as several challenges with using a referral system for women to get SRH care in other systems. Culturally and linguistically-concordant patient navigators were successful at helping refugee women navigate the healthcare system and addressing language barriers. We discussed implications for future research and practice to improve refugee women's SRH care access and utilization. In particular, our findings underscore multilevel constraints of clinics providing SRH care to refugee women and highlight the importance of transportation services and acceptable interpretation services. While understudied, the use of patient navigators holds potential for increasing refugee women's SRH care access and utilization. Patient navigation can both effectively address language-related challenges for refugee women and help them navigate the healthcare system for SRH. Future research should explore organizational and external factors that can facilitate or hinder the implementation of patient navigators for refugee women's SRH care.

Equity and Engagement for Neurologic Research Participation at the Goizueta Alzheimer’s Disease Research Center of Emory University

AbstractBackgroundAfrican Americans (AA) are disproportionately affected by Alzheimer’s disease[i], consistently underserved by social and health care systems, and greatly underrepresented in Alzheimer’s research.ObjectivesTo better engage the Metropolitan Atlanta population of African Americans, the Goizueta Alzheimer’s Disease Research Center (ADRC) at Emory University has a dedicated focus on the recruitment and retention of AA individuals into ADRC research and brain donation programs.MethodThe cohort examined for this paper were entered into the National Alzheimer’s Coordinating Center (NACC) Uniform Data Set, a longitudinal registry of NIA‐NIH, between November 2015 and February 2020. Equity in research participation has improved by sustaining relationships in the African American community with an educational outreach that addresses health, healthcare access, and the importance of research participation for the elimination of healthcare disparities.ResultsThis population of research volunteers at the Goizueta ADRC, irrespective of race, were similar in age, educational attainment, marital status, and overall health status. Before consenting to research, the following behaviors were observed in older adults: African Americans (AA) are 10.6 times more likely to attend in‐person community events when compared to European Americans (EA). African American (AA) women require more “touches” (phone calls and attendance at educational outreach events) than both Caucasian women AND men. African American (AA) women are the most distinct group with the longest time from first contact to consent. ConclusionThese findings can be used to create a more specific approach to engaging older African American adults in longitudinal neurologic or other health research.

Abstract 15011: Deriving and Validating Novel Neighborhood Data for Investigation of Adverse Outcomes in Patients Hospitalized for Heart Failure: A Feasibility Study

Introduction: Census-based measures of population-level neighborhood deprivation have been linked to adverse outcomes in patients with heart failure (HF). However, limited data exist to examine the impact of neighborhood environmental characteristics on HF outcomes. Objective: Derive novel measures of the patient built environment using multiple databases and compare their performance with traditional Census-based measure of population deprivation to predict 30-day readmission following hospitalization with HF. Methods: We identified the 17 census tracts in the metropolitan Atlanta area from the lowest, middle, and highest tertiles of the Social Deprivation Index (SDI), a neighborhood deprivation measure derived from US Census data. Three novel data sources—Twitter, Foursquare, and Google Places—were used to compute 6 environmental scores in each census tract: accessibility to parks, pharmacies, grocery stores, restaurants, sports places (e.g., gyms and fields), and health facilities (e.g., clinics and hospitals). We computed Pearson correlations across the data sources. We examined model performance of the 6 environmental scores and the SDI to predict readmissions in 804 patients (mean age 67 y, 52% female, 77% Black) hospitalized for acute HF at Emory Healthcare in 2018 using logistic regression adjusted for patient demographic and clinical characteristics. Results: Correlations across data sources ranged from r =-.45 to .65 (Figure 1a). Compared with SDI, 4 of the 6 environmental measures yielded marginally higher AUC values (discrimination) and 2 yielded higher pseudo R-squared values (calibration) for 30-day readmission (Figure 1b). Conclusion: This study demonstrates the early feasibility of directly measuring the patient built environment using novel data streams, and shows that these data may enhance neighborhood understanding of HF outcomes. Future studies should focus on scaling beyond the metropolitan Atlanta area.

Final results from the ribavirin pregnancy registry, 2004-2020.

Significant teratogenic effects have been demonstrated for ribavirin in animal studies. Ribavirin is prescribed for chronic hepatitis C and is contraindicated in pregnant women and their male sexual partners. Both are advised to avoid pregnancy for 6months after exposure. The registry monitored pregnancy exposures to oral formulations of ribavirin for hepatitis C for signals of possible human teratogenicity from 2004 to 2020. Pregnant women were voluntarily enrolled following direct exposure (ribavirin use during pregnancy or the 6months prior) or indirect exposure (through sexual contact during pregnancy or 6months prior, with a man who has taken ribavirin within 6months). Women were followed until the end of pregnancy. Infants were followed until 1year of age. Birth defect rates were compared with the published rate of 2.67 per 100 live births from the Metropolitan Atlanta Congenital Defects Program (MACDP). The registry enrolled 280 pregnancies resulting in 186 live births: eight birth defect cases among 88 directly exposed [9.09% (8/88, 95% CI: 4.01, 17.13)], and six birth defect cases among 98 indirectly exposed [6.12% (6/98, 95% CI: 2.28, 12.85)]. The 95% CI around the birth defect rate among directly exposed pregnancies exceeds the MACDP rate; however, no patterns suggestive of a teratogenic mechanism or safety signal were detected. Based on the patterns of birth defects reported, the final results from this registry do not suggest a clear signal of human teratogenicity for ribavirin. The registry did not meet sample size requirements; therefore, caution should be exercised when interpreting the results.

Assessing Transit Station Area Redevelopment: A Case Study of the Lindbergh Station in Atlanta

This article assesses the land-use, demographic, circulation, and economic development attributes of transit station area development. Findings from this assessment are applied to the Lindbergh Metropolitan Atlanta Rapid Transit Authority (MARTA) Station area in Atlanta, Georgia, for which a private-public partnership is currently being negotiated. Recommendations for the redevelopment of the Lindbergh Station area are provided, including a schematic design that integrates those recommendations. The resulting recommendations are intended to maximize the likelihood for transit ridership and economic benefit while offsetting traffic congestion and vehicle emissions—in keeping with the objectives of the Federal Transit Administration’s Livable Communities Initiative. A safe and inviting walking environment throughout a station area—extending well beyond the area of physical redevelopment itself—is fundamental to achieving these objectives. Existing barrier effects and lack of pedestrian connectivity associated with major transportation corridors within the Lindbergh Station area will significantly offset transportation and environmental benefits on which public investment in the redevelopment is predicated. Solutions are required that provide not only safer street crossings, but a larger proportion of rights-of-way devoted to pedestrian movement and the development of a “street life. “ Priority should be given to pedestrian improvements that increase access to transit for traditionally underserved populations. Finally, open space is required to effectively compete with other more auto-dependent areas and to draw higher income populations to transit station areas.

Transit Stations and Commercial Property Values: A Case Study with Policy and Land-Use Implications

There is little research about the association between rail transit station proximity and commercial property values. There is even less research on the role of public policy in influencing commercial property markets near transit stations without resorting to supply-side constraints. The research reported in this article helps close these gaps in research.This article develops a theory on commercial property value with respect to both transit station proximity and the role of policies that encourage commercial development around transit stations without discouraging commercial development elsewhere. The theory is applied to the universe of commercial property sales in the area of Atlanta known as “Midtown, “ which is located about 1 kilometer north of the downtown edge. Midtown is served by three heavy rail transit stations operated by the Metropolitan Atlanta Rapid Transit Authority (MARTA). To encourage development around MARTA stations, Atlanta waives parking and floor area ratio requirements in Special Public Interest Districts (SPIDs) located around rail stations. Research shows that commercial property values are influenced positively by both access to rail stations and policies that encourage more intensive development around those stations. This article explores both theoretical and policy implications.

Young-onset colon cancer among people living with HIV in metropolitan Atlanta.

Colon cancer is a leading cause of cancer-related morbidity and mortality in the USA. We sought to better characterize colon cancer among a predominantly Black cohort with and without HIV. We retrospectively reviewed all patients (n = 1482) diagnosed with colon cancer between 2015 and 2019 at a large urban tertiary teaching hospital using ICD-9 and ICD-10 codes. In this cohort, 114 (7.7%) of the patients also had HIV. Descriptive summaries were performed for gender, age, race/ethnicity, insurance status, tobacco/alcohol use, and BMI. Among patients with colon cancer only, 50.51% (n = 691) were men and 49.49% (n = 677) were women. Among patients with both HIV and colon cancer, 78.95% (n = 90) were men and 21.05% (n = 24) were women (p-value < 0.001). The mean age of the colon cancer patient sample was 61.62years for those without HIV and 51.31years for those with HIV (p-value < 0.001). Persons with both HIV and colon cancer were more likely to have a lower BMI (p-value < 0.001) and a history of smoking and alcohol use (p-value < 0.001), compared to patients with colon cancer only. When accounting for BMI, tobacco, and alcohol use, those with HIV were 10years younger than those without HIV, 95% CI, 7.3-13; p < 0.001. In this study, HIV positive status was a risk factor for developing colon cancer at a younger age. Larger observational studies with multivariable analysis should be done to better describe the risk of colon cancer and HIV.

Design and Development of a Bus Stop Inventory to Support an Intelligent Transportation System: The MARTA Experience

Bus stops are a critical element in any transit system. The advent of Intelligent Transportation System (ITS) technologies in the area of transit has developed a need for transit agencies to keep an up-to-date inventory of bus stop data. Unfortunately, most transit agencies do not have a bus stop inventory that can adequately support Advanced Public Transportation System (APTS) applications, and many other transit agencies do not have an inventory at all. The design, development, and maintenance of a bus stop inventory that will support an array of available APTS applications is described in this paper. Procedures used in the development of the Metropolitan Atlanta Rapid Transit Authority bus stop inventory are highlighted. The lessons learned from MARTA’s experience should be valuable to other transit agencies that are planning to or are in the process of implementing an APTS.

Barriers to breast cancer screening in Atlanta, GA: results from the Pink Panel survey at faith-based institutions.

PurposeOur research sought to describe barriers to mammography screening among a sample of predominantly Black women in metropolitan Atlanta, Georgia.MethodsThe Pink Panel project convened community leaders from faith-based institutions to administer an offline survey to women via convenience sampling at fourteen churches in Atlanta in late 2019 and early 2020. With the COVID-19 pandemic, the research team switched to an online survey. The survey included seven questions about breast cancer awareness, barriers to breast cancer screening, and screening status. We used residence information to attain the 9-digit zip code to link to the Area Deprivation Index at the Census Block Group neighborhood level. We report results as descriptive statistics of the barriers to mammography screening.ResultsThe 643 women represented 21 counties in Georgia, predominantly from metropolitan Atlanta, and 86% identified as Black. Among women aged 40 and older, 90% have ever had a mammogram. Among all women, 79% have ever had a mammogram, and 86% indicated that they would get a mammogram if offered in their neighborhood. The top barriers to mammography screening were lack of health insurance and high cost. Barriers to mammography screening did not differ substantially by Area Deprivation Index.ConclusionAmong metropolitan Atlanta women aged 40+ , nearly all reported ever having a mammogram. However, addressing the barriers, including lack of health insurance and high cost, that women reported may further improve mammography screening rates.

Management of Out-of-Hospital Cardiac Arrest during COVID-19: A Tale of Two Cities.

Variations in the impact of the COVID-19 pandemic on out-of-hospital cardiac arrest (OHCA) have been reported. We aimed to, using population-based registries, compare community response, Emergency Medical Services (EMS) interventions and outcomes of adult, EMS-treated, non-traumatic OHCA in Singapore and metropolitan Atlanta, before and during the pandemic. Associations of OHCA characteristics, pre-hospital interventions and pandemic with survival to hospital discharge were analyzed using logistic regression. There were 2084 cases during the pandemic (17 weeks from the first confirmed COVID-19 case) and 1900 in the pre-pandemic period (corresponding weeks in 2019). Compared to Atlanta, OHCAs in Singapore were older, received more bystander interventions (cardiopulmonary resuscitation (CPR): 65.0% vs. 41.4%; automated external defibrillator application: 28.6% vs. 10.1%), yet had lower survival (5.6% vs. 8.1%). Compared to the pre-pandemic period, OHCAs in Singapore and Atlanta occurred more at home (adjusted odds ratio (aOR) 2.05 and 2.03, respectively) and were transported less to hospitals (aOR 0.59 and 0.36, respectively) during the pandemic. Singapore reported more witnessed OHCAs (aOR 1.96) yet less bystander CPR (aOR 0.81) during pandemic, but not Atlanta (p < 0.05). The impact of COVID-19 on OHCA outcomes did not differ between cities. Changes in OHCA characteristics and management during the pandemic, and differences between Singapore and Atlanta were likely the result of systemic and sociocultural factors.

Combined Effect of Changes in Transit Service and Changes in Occupancy on Per-Passenger Energy Consumption

Many transit providers changed their schedules and route configurations during the COVID-19 pandemic, providing more frequent bus service on major routes and curtailing other routes, to reduce the risk of COVID-19 exposure. This research first assessed the changes in Metropolitan Atlanta Rapid Transit Authority (MARTA) service configurations by reviewing the pre-pandemic versus during-pandemic General Transit Feed Specification (GTFS) files. Energy use per route for a typical week was calculated for pre-pandemic, during-closure, and post-closure periods by integrating GTFS data with MOVES-Matrix transit energy and emission rates (MOVES signifying MOtor Vehicle Emission Simulator). MARTA automated passenger counter data were appended to the routes, and energy use per passenger-mile was compared across routes for the three periods. The results showed that the coupled effect of transit frequency shift and ridership decrease from 2019 to 2020 increased route-level energy use for over 87% of the routes and per-passenger-mile energy use for over 98% of the routes. In 2021, although MARTA service had largely returned to pre-pandemic conditions, ridership remained in an early stage of recovery. Total energy use decreased to about pre-pandemic levels, but per-passenger energy use remained higher for more than 91% of routes. The results confirm that while total energy use is more closely associated with trip schedules and routes, per-passenger energy use depends on both trip service and ridership. The results also indicate a need for data-based transit planning, to help avoid inefficiency associated with over-provision of service or inadequate social distancing protection caused by under-provision of service.

Spatial and Temporal Variability of Rail Transit Costs and Cost Effectiveness

Previous research has evaluated the temporal variability of transit costs and shown that peak period service costs more to operate in both gross and net terms. However, research on spatial variability of transit costs, particulalry for modes other than bus transit, is quite limited. Using transit agency data on labor and train allocations in the United States, I develop an accounting cost model that allocates variable and semi-fixed capital costs to times of day and each link and station of two regional rapid rail transit networks—the San Francisco Bay Area Rapid Transit District (BART) and the Metropolitan Atlanta Rapid Transit Authority (MARTA)—to evaluate temporal and spatial variability of costs and average costs per rider. I find that costs per hour are highest, but average costs per rider are lowest, during weekday peak periods in both systems, and that costs are highest and costs per rider are lowest in the urban core area of the BART system, while there is no clear spatial pattern in the MARTA system.

Comparison of sociodemographic characteristics of a phase 1 clinical trial population at an NCI-designated comprehensive cancer center in the Southeast to catchment area.

e18591 Background: Racial and ethnic minority populations are consistently under-represented in oncology clinical trials despite comprising a disproportionate share of cancer burden. Due in part to difficulties associated with participation, phase 1 trials pose a unique challenge and opportunity for minority inclusion. Here we examine the sociodemographics of phase 1 clinical trial patients at an NCI-designated Comprehensive Cancer Center compared to all patients treated at the center, patients with new cancer diagnoses in metropolitan Atlanta, and the state of Georgia (GA). Methods: Patients enrolled on phase 1 trials at the Winship Cancer Institute (WCI) from 2015-2020, identified from a data warehouse, were compared to new patient registrations at WCI from 2015-2019. Patients with cancer in metro Atlanta and GA were identified from the Surveillance, Epidemiology, and End Results (SEER) Program: Nov 2018 Submission. Covariates for the phase 1 and institutional cohort included sex, race, ECOG PS, insurance, and age at consent. Covariates for SEER patients included sex, race, and age at diagnosis. Summary statistics are reported for categorical variables using frequencies and percentages, and for continuous variables using mean, median, standard deviation, and range. One-sample proportion tests were utilized to compare observed demographic proportions on phase 1 trials with proportions calculated from new patient registrations at WCI and from SEER case data. Results: From 2015-2020, 2325 patients (43.4% F, 56.6% M) signed consent for phase 1 trials. Grouped race distribution was 70.3% White, 26.2% Black, 3.5% Other. Insurance distribution was 42.9% private, 48% government, 9.1% uninsured/other. Mean age at consent was 61.7 years (MD 63, ran 19-92). Of new patient registrations at WCI in 2015 ( N= 12358) (49.7% F, 50.3% M), grouped race distribution was 64.0% W, 28.2% B, 8% O. Atlanta 2015 SEER patients ( N= 31101) (50.3%F, 49.7%M) showed grouped race distribution 58.4% W, 37.2% B, 4.3% O. Mean age at diagnosis was 62.9. GA 2015 SEER patients ( N= 99487) (48.6%F, 51.4%M) showed grouped race distribution 71.2% W, 26.7% B, 2.1% O. Mean age at diagnosis was 64.2. The race and sex distribution of phase 1 patients was significantly different than proportions calculated from new patient registrations at WCI and SEER data from patients in Atlanta ( p&lt; 0.001). Sex distribution was significantly different than GA SEER patients. Conclusions: Phase 1 patients were significantly more likely to be white and male, compared with patients treated at the cancer center, as well as patients with cancer in Atlanta. Race distribution was not significantly different from patients with cancer in GA. Our intent is to characterize existing disparities in order to increase representation of patients from racial and ethnic minority backgrounds in phase 1 clinical trials.

Croup Associated With SARS-CoV-2: Pediatric Laryngotracheitis During the Omicron Surge

In this retrospective analysis, we describe weekly croup and corresponding viral prevalence patterns in a pediatric quaternary care system in metropolitan Atlanta. We characterize a series of 24 patients with croup associated with SARS-CoV-2 infection and show that this clinical presentation increased substantially in frequency during the period of high Omicron vs Delta transmission.

Multijurisdictional Analyses of Birth Defects: Considering the Common Data Model Approach.

Multijurisdictional Analyses of Birth Defects: Considering the Common Data Model Approach.

In Case You Haven't Heard…

In a public recognition of death by suicide, Mental Health America of Georgia's Executive Director Abdul Henderson released the following statement Jan. 15 on the passing of Jeff Parker, CEO and manager of the Metropolitan Atlanta Rapid Transit Authority (MARTA): “Jeff Parker was a leader in our community that dedicated his life's work to building better transportation systems. On behalf of Mental Health America of Georgia, we send our deepest condolences to his family, and we mourn a true leader and innovator.” He added, “To learn that Jeff's cause of death was by suicide breaks my heart. We have to keep working to help people in crisis.” He then referred those who may be experiencing a crisis themselves to the Georgia Crisis &amp; Access Line, available toll free, 24/7. MARTA Board of Directors Chairwomen Rita Scott in her statement on the passing of Parker also referred readers to Georgia's crisis line.

Identifying Community-Engaged Translational Research Collaboration Experience and Health Interests of Community-Based Organizations Outside of Metropolitan Atlanta

Identifying Community-Engaged Translational Research Collaboration Experience and Health Interests of Community-Based Organizations Outside of Metropolitan Atlanta

Socioeconomic characteristics of African American women attending community blood pressure screenings

Study objectiveTo examine the associations of education and income and blood pressure (BP) in a socioeconomically diverse cohort of African-American (AA) women attending community BP screenings. Design, setting, and participantsThis cross-sectional analysis used data from AA women (n = 972) 53 ± 14 years, enrolled between 2015 and 2019 in the 10,000-women hypertension community screening project in the metropolitan Atlanta area. OLS linear regression were used to examine the associations between SES (education and income) and BP after adjusting for age, body mass index (BMI), smoking, and lipids. Main outcomes and measuresOutcomes were systolic and diastolic BP (SBP, DBP). Measures of SES included education [high school ≤(HS), some college, and ≥college] and income- [<$24,000, $24,000–<$48,000, $48,000–$96,000, and ≥$96,000]. Sociodemographics, health history, anthropometrics and point of care non-fasting lipids were obtained. ResultsCompared to women earning <$24,000, an income of ≥$96,000 (β = -5.7 mmHg, 95% CI: −9.9, −1.5, p = .01) was associated with a lower SBP in the minimally adjusted model. Subsequent adjustment for cardiovascular risk factors attenuated the association and was no longer significant. College and above versus ≤HS education was associated with a higher DBP in the minimally (ß = 2.7 mmHg, 95% CI: 0.2, 5.2, p = .03) and fully adjusted models (ß = 3.4 mmHg, 95% CI: 0.2, 6.5, p = .04). ConclusionIncome of ≥$96,000 was associated with a lower SBP while a college and above education was associated with a higher DBP. Findings underscore the need for increased cardiovascular risk awareness and education targeting higher SES AA women attending community BP screenings.

Pharmacovigilance pregnancy data in a large population of patients with chronic inflammatory disease exposed to certolizumab pegol.

Introduction:Chronic inflammatory diseases (CIDs), including rheumatic diseases and other inflammatory conditions, often affect women of reproductive age. Tumor necrosis factor inhibitors (TNFi) are widely used to treat CID, but there is limited information on outcomes of TNFi-exposed pregnancies. We evaluated pregnancy outcomes from 1392 prospectively reported pregnancies exposed to certolizumab pegol (CZP), a PEGylated, Fc-free TNFi with no to minimal placental transfer.Methods:CZP-exposed pregnancies in patients with CID from the UCB Pharmacovigilance global safety database were reviewed from the start of CZP clinical development (July 2001) to 1 November 2020. To limit bias, the analysis focused on prospectively reported cases with known pregnancy outcomes.Results:In total, 1392 prospective pregnancies with maternal CZP exposure and known pregnancy outcomes (n = 1425) were reported; 1021 had at least first-trimester CZP exposure. Live birth was reported in 1259/1425 (88.4%) of all prospective outcomes. There were 150/1425 (10.5%) pregnancy losses before 20 weeks (miscarriage/induced abortion), 11/1425 (0.8%) stillbirths, and 5/1392 (0.4%) ectopic pregnancies. Congenital malformations were present in 30/1259 (2.4%) live-born infants, of which 26 (2.1%) were considered major according to the Metropolitan Atlanta Congenital Defects Program criteria. There was no pattern of congenital malformations.Discussion and conclusion:No signal for adverse pregnancy outcomes or congenital malformations was observed in CZP-exposed pregnancies. Although the limitations of data collected through this methodology (including underreporting, missing information, and absence of a comparator group) should be considered, these data provide reassurance for women with CID who require CZP treatment during pregnancy, and their treating physicians.