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1.
Perfusion ; 38(1 Supplement):147-148, 2023.
Artículo en Inglés | EMBASE | ID: covidwho-20243348

RESUMEN

Objectives: We present a case report of medical intensivist driven ECMO program using ECMO as a pre-procedural tool to maintain oxygenation in a patient with critical tracheal stenosis during tracheostomy placement. Method(s): VV ECMO is primarily used to support patients when mechanical ventilation is unable to provide adequate gas exchange. Alternatively, it has been used pre-procedurally when intubation is required in anticipation of a difficult airway. Described here is the first intensivist preformed awake VV ECMO cannulation to facilitate tracheostomy in a patient with severe tracheal stenosis. Result(s): The patient is a 41-year-old female with the relevant background of COVID19 pneumonia status post tracheostomy and subsequently decannulated after prolonged intubation and ICU stay. As a result, the patient developed symptomatic tracheal stenosis and presented two years after her ICU stay for scheduled bronchoscopy and balloon dilation. However, the patient developed worsening stridor and shortness of breath requiring heliox and BPAP. After multidisciplinary discussion between the critical care team ENT teams, the decision was made to cannulate for VV ECMO as a pre-procedural maneuver to allow for oxygenation during open tracheostomy in the OR. Dexmedetomidine and local anesthesia were used for the procedure with the patient sitting at 30 degrees on non-invasive ventilation and heliox. The patient was cannulated with a 21F right internal jugular return cannula and 25F right common femoral drainage cannula by medical intensivists in the intensive care unit using ultrasound guidance. The patient went for operative tracheostomy the next day and was subsequently decannulated from ECMO the following day without complication. She was discharged home on trach collar. Conclusion(s): Intensivist performed ECMO cannulation has been shown to be safe and effective. We anticipate the indications and use will continue to expand. This case is an example that intensivist driven preprocedural ECMO is a viable extension of that practice.

2.
Journal of Crohn's and Colitis ; 17(Supplement 1):i289-i291, 2023.
Artículo en Inglés | EMBASE | ID: covidwho-2277819

RESUMEN

Background: Inflammatory bowel diseases (IBDs) are chronic diseases that require routine hospital visits and long-term medical treatment for control of disease activity. Factors such as gender may impact the use and need for healthcare. This systematic review aimed to summarize what is known about sex differences in the risk of bowel surgery in patients with IBD Methods: Embase, Medline, CINAHL, and Web of Science abstracts (January 2012 to January 2022) were searched systematically for observational studies examining associations between sex and risk of bowel surgery. Screening and data extraction were performed independently by two reviewers using Covidence. Study data were analysed and reported in accordance with the PRISMA guidelines. Quality assessment of included studies was conducted using the Newcastle- Ottawa Scale for cohort studies. Pooled hazard ratios (HRs) were calculated using random effects model meta-analysis for the risk of surgery In addition, meta-analysis was undertaken to assess the risk of surgery by IBD subtype. The between-study heterogeneity was assessed by calculating the tau-squared and the I-squared statistics Results: Of 9,902 screened articles, 36 studies were included in the review Most studies were retrospective by design (74.6%). In total, 21 of 36 studies found statistically significant sex-based differences in the risk of bowel surgery for IBD patients. A pooled estimate of HRs for the 13 studies eligible for meta-analysis showed a statistically significant increased risk of bowel surgery among male patients (HR: 1.43 [95% confidence interval (CI): 1.09;1.86]) compared to female patients. The between-study heterogeneity was high (I2=88.60 [60.60;96.33] and tau2=0.17 [0.03;0.58]) indicating that the pooled estimate should be interpreted with caution. These findings were consistent with the subgroup analysis for ulcerative colitis (HR: 1.78 [1.16;2.72]), but no statistically significant sex difference in the risk of surgery in Crohn's disease patients was found (HR: 1.26 [0.82;1.93]) Conclusion(s): Sex differences exist in the risk of bowel surgery in IBD patients, and further research is needed to address the underlying causes and consequences of these disparities. It is unclear whether differences are due to underlying biologic mechanisms or are associated with healthcare system related factors such as differential access to care. Surgical procedures or the lack or delay thereof, will have consequences for the further disease trajectory.

3.
10th International Workshop on Innovative Simulation for Health Care, IWISH 2021 ; : 84-89, 2021.
Artículo en Inglés | Scopus | ID: covidwho-2156275

RESUMEN

Simulation has, over multiple decades, achieved a remarkable record of improving operational efficiency and effectiveness in many areas - manufacturing, supply chains (including commercial transportation and logistics), health care, public-sector transport, service industries, and military operations. About 2/3 through the twentieth century, simulation's earliest successes appeared in the manufacturing sector. These successes began with attention to value-added operations (e.g., at machines often entailing high capital investments) and rapidly spread to the non-value-added but very necessary material-handling requirements within factories. SARS-CoV-2, (COVID-19) has caused a rapid, widespread change in patient care across the globe. New health and safety guidelines have been established by the Centers for Disease Control and Prevention (CDC) (Health Care Guidelines, 2020). Still, it has been left to individual facilities to address and implement solutions to new standards for social distancing and cleanliness. Here we develop a discrete-event simulation model to simulate an outpatient laboratory clinic, including check-in and patient interaction, to determine if changes lead to increased efficiency and reduce patient wait times, without increasing staffing or additional resources. Under the aegis of the University of Michigan Medical Group (UMMG), this simulation is validated against real data of waiting time at the University of Michigan Canton Health Center (UMCHC) during the height of the pandemic. © 2021 The Authors.

4.
Multiple Sclerosis Journal ; 28(3 Supplement):106-107, 2022.
Artículo en Inglés | EMBASE | ID: covidwho-2138831

RESUMEN

Background: Prospective, deeply phenotyped research cohorts monitoring people with multiple sclerosis (MS) depend on careful participant engagement that was threatened by COVID19- related restrictions to in-clinic visits. Coincidentally, there was forced adoption of televideo-enabled care. Objective(s): To leverage a natural experiment of "going virtual" during the pandemic to evaluate two hypotheses pertaining to remote MS research: that (1) global costs of remote visits are lower, and (2) disability evaluations are non-inferior. Method(s): Between 3/2020 and 12/2021, 207 UCSF EPIC/ ORIGINS MS cohort participants underwent hybrid in-clinic and virtual research visits. Among these, 96 contributed 100 'matched visits', i.e. in-clinic (Neurostatus, NS-EDSS) and remote (televideo-, tele-EDSS;electronic patient-reported, ePR-EDSS) evaluations within 14 days. Clinical and socio/ demographic characteristics were collected. First, visit costs were compared. Then, the quality of data extracted was compared using non-inferiority design with NS-EDSS as primary outcome. Result(s): The 96 participants contributing 100 matched visits had mean age 41.4 years (SD 11.7) and MS duration 1.4 years (SD 3.4);69% were female and 72% White, 8% lived in lowincome zip codes;median driving distance was 70 miles (mean 545). The costs of remote visits to participants (travel, caregiver time), to research (facilities, personnel, parking, participant compensation), and carbon footprint were all lower than in-person visits (p<0.05 for each). Median cohort EDSS was similar, whether evaluated using NS-EDSS (2), tele-EDSS (1.5) or ePREDSS (2), with range 0-6.5. Utilizing a TOST for Non-inferiority, both remote evaluations were non-inferior to NS-EDSS within+/-0.5 EDSS point (p<0.01 for each). Year-to-year, the % of participants with worsening/stable/improved EDSS scores was similar, whether the annual evaluations both used NS-EDSS, or whether the annual evaluation switched from NS-EDSS to tele-EDSS. Discussion(s): "Going virtual" during the pandemic represented a natural experiment in which to test hypotheses about remote research visits. These visits lowered costs for investigators and participants. Further, remote assessments were non-inferior to NS-EDSS and for more precision, could be supplemented with biosensors. Together, these insights support the conduct of research that is more inclusive to participants regardless of geography, race, income, opportunity costs or ability level.

5.
Eur Heart J ; 43(Suppl 2), 2022.
Artículo en Inglés | PubMed Central | ID: covidwho-2107421

RESUMEN

Background: It remains unclear whether COVID-19 infection is associated with increased arrhythmia burden in patients with cardiac implantable electronic devices (CIEDs). Methods: We identified 46 patients tested positive for COVID-19 between 01/03/2020 and 31/05/2021 in our cohort of 1209 patients with CIED (3.8%). Data on arrhythmia burden during a 9 week period (a 4 week “pre-infection” period: P1, the week before the positive Covid-19 test: P2, and the 4 weeks afterwards: P3) was accessible in 35 patients. Results: 83% of patients were not hospitalised. Five patients (14.3%) (all non-hospitalised) had high rate atrial (HRA) events, 4 of which exclusively during P1 and/or P2. Thirty-two non-sustained VT (NSVT) episodes were recorded in 8 patients, one degenerating in VF requiring ICD shock (occurring in P2). One patient had frequent NSVT each week. After exclusion of this outlier, a numerical 4-fold increase in weekly NSVT episodes was observed between P1 and P3 (Patients with NSVT: 0.07±0.12 vs. 0.29±0.17 episodes/week, p=0.057;entire cohort: 0.015±0.060 vs. 0.059±0.138 episodes/week, p=0.16) (Figure 1). In P3, hospitalised patients had a trend towards higher NSVT burden vs. non-hospitalised patients (2/6 (33.3%) vs. 4/29 (13.8%), p=0.27) which was not apparent before the positive Covid-19 test. Conclusion: Our single-centre experience suggests that COVID-19 infection may result in an increase in VA but not atrial arrhythmia burden in patients with CIED. Funding Acknowledgement: Type of funding sources: None.Figure 1

6.
Transfusion ; 62(Supplement 2):164A, 2022.
Artículo en Inglés | EMBASE | ID: covidwho-2088331

RESUMEN

Background/Case Studies: Patients with sickle cell disease (SCD) who have suffered a stroke or frequent vasoocclusive crises benefit from a chronic red blood cell exchange (RBCX) protocol whereby RBCX is performed every four to eight weeks. The American Society for Hematology recommends that these patients receive units that are antigen matched for Rh (D, C, c, E, e) and K. This prevents alloimmunization to these antigens while significantly reducing alloimmunization rates to non-Rh/K antigens. This frequently presents a logistical challenge as the antigen profile of the donor population relative to many patients with SCD differs. Events such as the COVID-19 pandemic or inclement weather present challenges to providing an adequate supply of all blood components, and antigen matching may limit the availability of precious RBC units that may be required elsewhere in the hospital. Over the past two years, blood donations have significantly declined nationwide due to the COVID-19 pandemic. This was exacerbated in North Texas in 2021 following an ice storm that halted operations at our regional blood center for four days. Moreover, genotyping of new Black donors was significantly limited early in the pandemic due to a global shortage of pipette tips. We report our experience providing Rh/K antigenmatched red blood cell (RBC) units for chronic RBCXs during times of marked reduction in the blood supply. Study Design/Methods: RBCXs are scheduled four to eight weeks in advance. Our hospital transfusion service coordinates with the regional blood center to ensure the availability of antigen-matched units for the procedures. We performed a retrospective review of 320 RBCXs among 34 patients with SCD disease in our outpatient apheresis clinic between June 2020 and May 2021. The ABO/Rh types of the units received from the blood supplier were compared to the ABO/Rh types of the patients undergoing RBCX. Results/Findings: 320 RBCXs were conducted between June 2020 and May 2021, requiring 3,180 RBC units to be ordered. Among 1,624 RBC units ordered for Group A or B patients, 372 (23%) Group O RBC units were required to match the antigen profile. Of 3,110 Rh-pos units ordered, 985 (31.7%) were Rh-neg, with 501 being Group O. Among specific Rh-pos phenotypes, D+, C-, E-, C+, E+ patients accounted for 100% of the Rh-neg usage in Rhpos individuals. Conclusion(s): Antigen matching for Rh and K often results in Group O and/or Rh-neg units transfused to non-Group O and/or Rh-pos patients. This places a severe strain on both the blood center and hospital, especially during times of limited supply. One way to lessen this burden is continued genotyping of new Black donors to allow better ABO/Rh matching with patients.

9.
Diabetologia ; 65(SUPPL 1):S190-S191, 2022.
Artículo en Inglés | Web of Science | ID: covidwho-2012635
10.
Journal of Neurology Neurosurgery and Psychiatry ; 93(9), 2022.
Artículo en Inglés | Web of Science | ID: covidwho-2005428
11.
Pediatrics ; 149, 2022.
Artículo en Inglés | EMBASE | ID: covidwho-2002998

RESUMEN

Background: The Mentorship Educational Directive (MED) Program is a medical student-run initiative connecting Black, Indigenous, and People of Color (BIPOC) high school students interested in healthcare with BIPOC medical student mentors. Early health career pipeline programs contribute to achieving health equity by working to assure an adequate and culturally representative health workforce, which is shown to improve access to, and quality of health services for underserved populations. The Health Education Resource Opportunity (HERO) program is a community program focused on increasing the number of underrepresented high school students in STEM fields. The MED program partnered with HERO to add a medical student mentorship component with first- and second- year medical students. Methods: Medical student leaders used a structured virtual platform for mentor/mentee engagement. The HERO program recruited mentees, and student leaders recruited mentors who completed extensive training and were paired via a speed-matching system. Student leaders conducted group sessions on Zoom using breakout rooms and videos as learning tools for demonstrations before students practiced techniques and concepts with their mentors. Mentors and mentees also participated in individual meetings. Following the program, mentors completed reflection questionnaires. We used descriptive and in vivo coding to analyze themes from the questionnaires. Results: Mentors valued the program's structure, created cultural connections, became comfortable having difficult conversations, and felt empowered to mentor students. One of the most common themes was about mentorship;mentors stated they would seek additional opportunities to be mentors and that early mentorship is essential. Shared racial and cultural identities created a deeper connection between mentors and mentees. Mentors found comfort in discussing sensitive topics with their mentees and peers. Conclusion: The MED Program facilitated engagement between medical student mentors and high school mentees using a virtual platform. Three themes emerged from the reflection questionnaires, including cultural connections and shared identities, empowerment of mentors, and comfort with conversations about sensitive topics. These are important findings since studies have shown that sustained relationships and community partnerships enhance students' abilities in higher education. Our findings are a positive step in that direction since mentors expressed satisfaction in their mentoring relationships and felt like they made a positive impact on the students' life and education. The HERO program is currently working with a new set of MED medical student leaders, planning for the coming year and addressing areas for improvement. Overall, we concluded that a virtual BIPOC student mentorship program was a rewarding and meaningful experience for medical students. Areas for further study include analysis of high school student responses and expansion to additional communities. We anticipate that similar programs could potentially expand the network of BIPOC physicians and healthcare leaders, in turn inspiring upcoming generations of potential healthcare providers.

12.
Journal of Adolescent Health ; 70(4):S13, 2022.
Artículo en Inglés | EMBASE | ID: covidwho-1936655

RESUMEN

Purpose: In the wake of the COVID-19 pandemic, marginalized adolescents face new and exacerbated barriers to accessing sexual and reproductive health (SRH) and mental health (MH) care. While telemedicine has adapted to increase access to SRH/MH services, it is less likely to be used by those with limited familiarity or no previous connection to care. We assessed the impact of a novel intervention (AccessKCTeen) that leverages peer outreach leaders and community events on confidence in accessing SRH/MH care and telemedicine. Methods: We engaged and trained teen peer leaders to stimulate healthcare-seeking behaviors by sharing SRH/MH information from our virtual toolkit and mobilizing their peer networks to attend our AccessKCTeen health outreach events. We partnered with community organizations to host events where we demonstrated telemedicine via a mobile van, shared local resources for SRH/MH care, and distributed free over-the-counter emergency contraception (EC), condoms, and pregnancy tests. All services were offered in English and Spanish. Teens completed three surveys: (1) prior to the engaging with AccessKCTeen (demographics, healthcare needs and trust and confidence to access care);(2) immediately post-intervention (health service uptake [e.g., EC, condoms, pregnancy test], satisfaction, healthcare trust, confidence to access care);and (3) one-month after the event (follow-up SRH/MH care utilization). Study staff documented teen engagement and feedback via field notes. Results: We trained five peer leaders. During three community health events, we enrolled 63 teens (mean age 15.9 years;67% female at birth, 27% Genderfluid/Non-Binary/Trans, 27% Hispanic, 30% Black, 45% White, 38% heterosexual). Most (68%) reported no previous vaginal/penile sex. In past week, the majority reported 1 or more days feeling anxious (62%)/depressed (50%)/lonely (59%)/hopeful (71%). Many (44%) had forgone needed care in the previous year, and few (32 %) had previously used telemedicine. Most reported improved understanding of telemedicine after the demonstration. Teens reported these benefits of telemedicine: privacy, ease of use, and increased access to SRH and MH care. Participants felt MH care is “desperately needed” but carries stigma and had friends or classmates with MH concerns. Participants voiced they “need facts” and accurate information on SRH, that education on “abstinence is not enough”, and frequently did not know that EC was available without prescription or the timeframe of effectiveness. Most teens discussed the SRH items directly with the AcessKCTeen. Post-intervention: 82% were satisfied with the intervention and 86% would recommend it to friend. Compared to baseline, more participants reported confidence to access telemedicine (58% vs. 78%) and in-person care: (67% vs. 72%) and trusted “doctors and nurses completely” (70% vs. 79%). Many accepted condoms (27%), pregnancy tests (16%) and EC (27%, 4 of whom were male). Recruitment and follow-up with participants and peer leaders is ongoing Conclusions: As COVID-19 continues to negatively impact SRH/MH care-seeking, the AccessKCTeen pilot offers critical insight on novel methods to increase access to SRH/MH care for marginalized adolescents. Sources of Support: O.5506 (CARES Act Funds), Berkley-Patton (PI), Jackson County, MO [Our Healthy KC Eastside (OHKCE): Addressing COVID-19 and Social Determinants on KC Eastside].

14.
International Journal of Sociology and Social Policy ; 2022.
Artículo en Inglés | Scopus | ID: covidwho-1891337

RESUMEN

Purpose: This paper aims to explore challenges and opportunities of shifting from physical to virtual employment support delivery prompted by the Covid-19 pandemic. It investigates associated changes in the nature and balance of support and implications for beneficiary engagement with programmes and job search. Design/methodology/approach: The study draws on longitudinal interviews conducted with beneficiaries and delivery providers from a neighbourhood-based employment support initiative in an English region with a strong manufacturing heritage between 2019 and 2021. The initiative established prior to the Covid-19 pandemic involved a strong physical presence locally but switched to virtual delivery during Covid-19 lockdowns. Findings: Moving long-term to an entirely virtual model would likely benefit some beneficiaries closer to or already in employment. Conversely, others, particularly lone parents, those further from employment, some older people and those without computer/Internet access and/or digital skills are likely to struggle to navigate virtual systems. The study emphasises the importance of blending the benefits of virtual delivery with aspects of place-based physical support. Originality/value: Previous studies of neighbourhood-based employment policies indicate the benefits of localised face-to-face support for transforming communities. These were conducted prior to the Covid-19 pandemic and the more widespread growth of virtual employment support. This study fills a gap regarding understanding the challenges and opportunities for different groups of beneficiaries when opportunities for physical encounters decline abruptly and support moves virtually. © 2022, Emerald Publishing Limited.

17.
Annals of Emergency Medicine ; 78(4):S91, 2021.
Artículo en Inglés | EMBASE | ID: covidwho-1748259

RESUMEN

Study Objective: Physician representation in emergency medicine (EM) continues to lag despite efforts to advance diversity, equity, and inclusion (DEI). According to a recent report, it could still take the specialty 54 years to achieve Hispanic representation equivalent to the US population. Similar data exists for Black trainees and other underrepresented in medicine (UiM). Mentorship is a key component in supporting UiM, yet physicians of color report having no formal academic mentorship. Furthermore, as different organizations start to develop mentorship programs, the minority tax on mentors becomes more obvious. The American College of Emergency Physicians Diversity, Inclusion, and Health Equity Section (ACEP DIHE) partnered with the Emergency Medicine Residents’ Association (EMRA) to develop the largest virtual diversity mentoring initiative (DMI) in EM to help bridge the gap in representation and inclusion. Methods: ACEP and EMRA obtained a grant from Vituity to sponsor a national mentorship program geared towards advancing racial and ethnic diversity in EM leadership. With only 300 spots for mentors and mentees using the Chronus Mentoring Software, we developed a 6-month virtual mentorship program to cycle through more participants and also provide opportunities to iterate our efforts. The ACEP/EMRA DMI is open to medical students, residents, fellows, and faculty. The virtual format allowed for no geographic restrictions on who could participate. We launched during the unprecedented COVID-19 pandemic with the EM residency recruitment cycle significantly impacted, especially students from programs with no home residency training, including all Historically Black Colleges and Universities (HBCU) programs. Results: Because the pandemic impacted residency recruitment efforts, most of our mentees were medical students. During the first cohort, we recruited 78 mentors and 104 mentees. Unfortunately, because of initial difficulty with the virtual platform and variable commitment due to the pandemic, we only had 29 connections. Notwithstanding, we saw 390 interactions throughout the 6-month period. The ACEP/EMRA DMI team hosted several social events to develop a sense of community including a Match/Mix/Mingle event. We also invited speakers to share their expertise on time management, effective mentorship, and overcoming imposter syndrome. Based on lessons observed in the first cohort, we increased our efforts on recruitment and branding and targeted our outreach to HBCU programs. This led to the recruitment of 98 mentors and 108 mentees for the 2nd cohort with 108 connections. Conclusion: Virtual mentorship offers an effective and efficient way of creating a sense of belonging for trainees and faculty who are underrepresented in medicine. The benefit of virtual mentorship that obscures geographic borders is that it expands the pool of mentors and mentees, allows for cross-collaboration across departments, and decreases the minority tax through dispersed support.

18.
Open Forum Infectious Diseases ; 8(SUPPL 1):S320, 2021.
Artículo en Inglés | EMBASE | ID: covidwho-1746559

RESUMEN

Background. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19), an infection with widely varying clinical severity. Severe COVID-19 was initially proposed to be secondary to cytokine storm syndrome (CSS). However, studies since showed that patients with severe COVID-19 rarely display CSS cytokine phenotypes, and may have more limited inflammatory responses instead. Methods. Prospective cohorts, aged 0-90 years of age who tested positive by polymerase chain reaction (PCR) for SARS-CoV-2 were enrolled from inpatient hospitals and outpatient testing centers in Memphis, TN from May 2020-January 2021. Longitudinal blood samples were obtained including acute, sub-acute and convalescent timepoints. Severity scores of asymptomatic, mild, moderate, and severe COVID-19 were assigned at time of convalescent assessment. Plasma was analyzed with a quantitative human magnetic 38-plex cytokine assay. Results. : 169 participants were enrolled, including 8 asymptomatic, 117 mild, 22 moderate and 17 severe cases, and 5 children with post-COVID-19 multisystem inflammatory syndrome in children (MIS-C). All moderate and severe patients were hospitalized and received treatment (39%). Clear distinctions were seen between asymptomatic-mild cases and moderate-severe cases at acute timepoints and during disease progression for GCSF, IL-8, IL-10, IL-15, IL-1Ra, IP-10, MIP-1a, MIP-1β, and TGFα. There was a significant difference between participants who did and did not require hospitalization for acute timepoint levels of IL-10, IL-15, MIP-1 β and TGFα (p< 0.01). Only 4 participants with active COVID-19 were found to meet criteria for CSS (2%), only 3 of which were severe. MIS-C participants showed nearly universally elevated cytokine levels compared to those with active COVID-19. Conclusion. Moderate and severe acute COVID-19 has a distinct cytokine profile from asymptomatic and mild cases, as detected from acute, subacute and convalescent plasma.

19.
British Journal of Surgery ; 108:1, 2021.
Artículo en Inglés | Web of Science | ID: covidwho-1539387
20.
Multiple Sclerosis Journal ; 27(2 SUPPL):158-160, 2021.
Artículo en Inglés | EMBASE | ID: covidwho-1495981

RESUMEN

Introduction: Inebilizumab is approved in the USA and Japan for aquaporin 4 immunoglobulin (Ig)G seropositive neuromyelitis optica spectrum disorder (NMOSD). Objective: Report final safety and efficacy data from the N-MOmentum trial of inebilizumab in NMOSD. Methods: Participants with NMOSD (aged 18+, EDSS score of ≤8, recent history of attacks) were randomized 3:1 to inebilizumab or placebo monotherapy for 28 weeks or up to attack occurrence;the randomized controlled period (RCP). Primary outcome was time to adjudicated attack. Participants could then enter the inebilizumab open label period (OLP). Final study data are presented, including attack risk and safety outcomes. Results: Of the 230 participants randomized and dosed, 216 (93.9%) entered and 174 (80.6%) completed the OLP. In the RCP, 87.0% were attack free with inebilizumab and 59.9% with placebo (72.8% risk reduction, p<0.001). In the OLP, 87.7% were attackfree in those continuing inebilizumab and 83.4% in those switched from placebo. Regardless of randomization, 225 participants received inebilizumab. Mean (SD) treatment duration was 3.2 (1.4) years;36.8% were treated for >4 years (maximum of 5.5 years). Total exposure was 730.36 person-years (py) with an annualized attack rate of 0.092;40/63 (63.5%) attacks occurred in the first year. Treatment-emergent adverse events (AE) were reported by 89 (39.6%) participants, most frequently urinary tract infection (26.2%), nasopharyngitis (20.9%) and arthralgia (17.3%). Infusion-related reactions with inebilizumab occurred in 28 (12.9%) participants (rate per 100-py: whole study, 11.1;RCP, 37.6). The rate (95% confidence interval) of infections per 100-py did not increase with continued treatment: year 1, 116.3 (102.4-131.6);year 2, 68.1 (57.2-80.6);year 3, 61.9 (50.3-75.5);year 4, 55.1 (41.7-71.4). 105 participants had transient low IgG (<700 mg/dL) during treatment, but no correlations were found between the worst IgG, IgM or IgA levels recorded and the occurrence of any infection or an infection ≥ grade 3 (Fisher exact test, all p>0.05). Three trial participants died: one from complications of NMOSD attack, one from a CNS event of unclear etiology and one due to COVID-19, after 9, 224 and 1225 days of inebilizmab treatment, respectively. Conclusions. During the 5.5 years of N-MOmentum, the risk of attack in participants receiving inebilizumab remained low with no evidence of unexpected serious adverse events, including serious infection.

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