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Additional file 1.

Additional file1: Table S1. Characteristics of the included studies (detailed). Table S2. Baseline characteristics of participants with CD. Table S3. Baseline characteristics of participants with UC. Figure S1. Forest plots showing the proportion of patients with Crohn’s disease achieving a CDAI-70 response during the induction phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S2. Forest plots showing the proportion of with Crohn’s disease achieving a CDAI-100 response during the induction phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S3. Forest plots showing the proportion of patients with Crohn’s disease achieving a CDAI-70 response during the maintenance phase with infliximab. Figure S4. Forest plots showing the proportion of patients with Crohn’s disease achieving a CDAI-100 response during the maintenance phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S5. Forest plots showing the proportion of patients with Crohn’s disease experiencing any adverse event with infliximab (upper plot) or vedolizumab (lower plot). Figure S6. Forest plots showing the proportion of patients with Crohn’s disease experiencing any serious adverse event with infliximab (upper plot) or vedolizumab (lower plot). Figure S7. Forest plots showing the proportion of patients with Crohn’s disease experiencing any infection with infliximab (upper plot) or vedolizumab (lower plot). Figure S8. Forest plots showing the proportion of patients with Crohn’s disease experiencing any serious infection with infliximab (upper plot) or vedolizumab (lower plot). Figure S9. Forest plots showing the proportion of patients with Crohn’s disease who discontinued due to adverse events in the infliximab (upper plot) or vedolizumab (lower plot) treatment arms. Figure S10. Forest plots showing the proportion of patients with Crohn’s disease who discontinued due to lack of efficacy in the infliximab treatment arm. Figure S11. Forest plots showing the proportion of patients with ulcerative colitis achieving a clinical response during the induction phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S12. Forest plot showing the proportion of patients with ulcerative colitis achieving mucosal healing during the induction phase with infliximab. Figure S13. Forest plots showing the proportion of patients with ulcerative colitis achieving a clinical response during the maintenance phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S14. Forest plots showing the proportion of patients with ulcerative colitis achieving mucosal healing during the maintenance phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S15. Forest plots showing the proportion of patients with ulcerative colitis experiencing any adverse event with infliximab (upper plot) or vedolizumab (lower plot). Figure S16. Forest plots showing the proportion of patients with ulcerative colitis experiencing any serious adverse event with infliximab (upper plot) or vedolizumab (lower plot). Figure S17. Forest plots showing the proportion of patients with ulcerative colitis experiencing any infection with infliximab (upper plot) or vedolizumab (lower plot). Figure S18. Forest plots showing the proportion of patients with ulcerative colitis experiencing any serious infection with infliximab (upper plot) or vedolizumab (lower plot). Figure S19. Forest plots showing the proportion of patients with ulcerative colitis who discontinued due to adverse events with infliximab (upper plot) or vedolizumab (lower plot). Figure S20. Forest plots showing the proportion of patients with ulcerative colitis who discontinued due to lack of efficacy with vedolizumab.

Severe acute respiratory syndrome coronavirus 2, the disease-causing pathogen of the coronavirus disease 2019 pandemic, has resulted in morbidity and mortality worldwide. Pregnant women are more susceptible to severe coronavirus disease 2019 and are at higher risk of preterm birth than uninfected pregnant women. Despite this evidence, the immunologic effects of severe acute respiratory syndrome coronavirus 2 infection during pregnancy remain understudied.This study aimed to assess the impact of severe acute respiratory syndrome coronavirus 2 infection during pregnancy on inflammatory and humoral responses in maternal and fetal samples and compare antibody responses to severe acute respiratory syndrome coronavirus 2 among pregnant and nonpregnant women.Immune responses to severe acute respiratory syndrome coronavirus 2 were analyzed using samples from pregnant (n=33) and nonpregnant (n=17) women who tested either positive (pregnant, 22; nonpregnant, 17) or negative for severe acute respiratory syndrome coronavirus 2 (pregnant, 11) at Johns Hopkins Hospital. We measured proinflammatory and placental cytokine messenger RNAs, neonatal Fc receptor expression, and tetanus antibody transfer in maternal and cord blood samples. In addition, we evaluated antispike immunoglobulin G, antispike receptor-binding domain immunoglobulin G, and neutralizing antibody responses to severe acute respiratory syndrome coronavirus 2 in serum or plasma collected from nonpregnant women, pregnant women, and cord blood.Pregnant women with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection expressed more interleukin-1 beta, but not interleukin 6, in blood samples collected within 14 days vs14 days after performing severe acute respiratory syndrome coronavirus 2 test. Pregnant women with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection also had reduced antispike receptor-binding domain immunoglobulin G titers and were less likely to have detectable neutralizing antibody than nonpregnant women. Although severe acute respiratory syndrome coronavirus 2 infection did not disrupt neonatal Fc receptor expression in the placenta, maternal transfer of severe acute respiratory syndrome coronavirus 2 neutralizing antibody was inhibited by infection during pregnancy.Severe acute respiratory syndrome coronavirus 2 infection during pregnancy was characterized by placental inflammation and reduced antiviral antibody responses, which may impact the efficacy of coronavirus disease 2019 treatment in pregnancy. In addition, the long-term implications of placental inflammation for neonatal health require greater consideration.

BackgroundOutpatient COVID-19 has been insufficiently characterized.ObjectiveTo determine the progression of disease and subsequent determinants of hospitalization.DesignA prospective outpatient cohort.SettingOutpatients were recruited by phone between April 21 to June 23, 2020 after receiving outpatient or emergency department testing within a large health network in Maryland, USA.ParticipantsOutpatient adults with positive RT-PCR results for SARS-CoV-2.MeasurementsSymptoms, portable pulse oximeter oxygen saturation (SaO2), heart rate, and temperature were collected by participants on days 0, 3, 7, 14, 21, and 28 after enrollment. Baseline demographics, comorbid conditions were evaluated for risk of subsequent hospitalization using negative binomial, logistic, and random effects logistic regression.ResultsAmong 118 SARS-CoV-2 infected outpatients, the median age was 56.0 years (IQR, 50.0 to 63.0) and 50 (42.4%) were male. Among those reporting active symptoms, the most common symptoms during the first week since symptom onset included weakness/fatigue (67.3%), cough (58.0%), headache (43.8%), and sore throat (34.8%). Participants returned to their usual health a median of 20 days (IQR, 13 to 38) from the symptom onset, and only 65.5% of respondents were at their usual health during the fourth week of illness. Over 28 days, 10.9% presented to the emergency department and 7.6% required hospitalization. Individuals at the same duration of illness had a 6.1 times increased adjusted odds of subsequent hospitalization per every percent decrease in home SaO2(95% confidence interval [CI]: 1.41 to 31.23, p=0.02).LimitationsSeverity and duration of illness may differ in a younger population.ConclusionSymptoms often persisted but uncommonly progressed to hospitalization. Home SaO2might be an important adjunctive tool to identify progression of COVID-19.RegistrationClinicaltrials.gov NCT number:NCT04496466Funding SourceThe Sherrilyn and Ken Fisher Center for Environmental Infectious Diseases Discovery Program and the Johns Hopkins University School of Medicine

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic control will require widespread access to accurate diagnostics. Salivary sampling circumvents swab supply chain bottlenecks, is amenable to self-collection, and is less likely to create an aerosol during collection compared with the nasopharyngeal swab. Methods We compared real-time reverse-transcription polymerase chain reaction Abbott m2000 results from matched salivary oral fluid (gingival crevicular fluid collected in an Oracol device) and nasal-oropharyngeal (OP) self-collected specimens in viral transport media from a nonhospitalized, ambulatory cohort of coronavirus disease 2019 (COVID-19) patients at multiple time points. These 2 sentences should be at the beginning of the results. Results There were 171 matched specimen pairs. Compared with nasal-OP swabs, 41.6% of the oral fluid samples were positive. Adding spit to the oral fluid percent collection device increased the percent positive agreement from 37.2% (16 of 43) to 44.6% (29 of 65). The positive percent agreement was highest in the first 5 days after symptoms and decreased thereafter. All of the infectious nasal-OP samples (culture positive on VeroE6 TMPRSS2 cells) had a matched SARS-CoV-2 positive oral fluid sample. Conclusions In this study of nonhospitalized SARS-CoV-2-infected persons, we demonstrate lower diagnostic sensitivity of self-collected oral fluid compared with nasal-OP specimens, a difference that was especially prominent more than 5 days from symptom onset. These data do not justify the routine use of oral fluid collection for diagnosis of SARS-CoV-2 despite the greater ease of collection. It also underscores the importance of considering the method of saliva specimen collection and the time from symptom onset especially in outpatient populations.