ABSTRACT
Introduction: Understanding how immunomodulatory therapies influence COVID-19 outcomes in people living with multiple sclerosis (PlwMS) is vital to patients and physicians alike. Aims and Objective: Evaluate COVID-19 outcomes in PlwMS receiving either fingolimod or siponimod. Method(s): The Novartis clinical trial (CT) and safety databases were reviewed to identify confirmed (CT: confirmed if patient is SARS COV-2 positive;post-marketing [PM]: considered as reported) or suspected cases of COVID-19 in PlwMS receiving either fingolimod or siponimod (CT cut-off: fingolimod 04-Aug- 2021, siponimod 29-Oct-2021;PM cut-off: fingolimod 28-Feb- 2022, siponimod 25-Mar-2022). Result(s): For fingolimod, there were 1054 cases comprising of 45 suspected (PM=45) and 1009 confirmed cases (CT=9;PM=1,000) of COVID-19 (mean age in years: 17 [CT], 43 [PM];female: 71% [715/1009;CT=4, PM=711];male: 25% [254/1009;CT=5, PM=249] and not reported: 4% [40/1009;PM=40]). Of these, 35% (358/1009;CT=8, PM=349) were from Europe, 30% (305/1009;PM=305) from the US and 34% (347/1009;CT=1, PM=346) from the rest of the world (ROW). Hospitalisation was required for 13% of patients (130/1009;PM=130);1% (13/1009;PM=13) had a fatal outcome;and 43% (437/1009;CT=9, PM=428) recovered or were recovering at the most recent follow-up. For siponimod there were 321 cases comprising of 6 suspected (CT=1;PM=5) and 315 confirmed cases (CT=53;PM=262) of COVID-19 (mean age in years: 49 [CT], 53 [PM];female: 68% [214/315;CT=34, PM=180];male: 28% [88/315;CT=19, PM=69] and not reported: 4% [13/315;PM=13]). Of these, 53% (168/315;CT=6, PM=162) were from the US;30% (96/315;CT=46, PM=50) from Europe;and 16% (51/315;CT=1, PM=50) from the ROW. Hospitalisation was required for 19% of patients (60/315;CT=15, PM=45);2% (7/315;CT=3, PM=4) had a fatal outcome;and where information was provided 42% (131/315 CT=50, PM=81) recovered or were recovering at the most recent follow-up. Conclusion(s): Available data indicates that most COVID-19 cases among PlwMS treated with fingolimod or siponimod were nonserious. Among PlwMS exposed to disease-modifying therapies (DMTs), the reported hospitalisation and mortality rates are 12.8%-21.5% and 1.62%-3.5%, respectively (Reder et al 2021;Sormani et al 2022). Thus, hospitalisation and fatality rates with siponimod and fingolimod in these series of Novartis reported cases were similar to those observed in PlwMS on other DMTs.
ABSTRACT
Introduction: Per WHO, >190 million people worldwide have been affected by COVID-19 as of 20-Jul-2021. Although people with MS are not at a higher risk of SARS-CoV-2 infection, factors such as age, comorbidity, MS severity and treatment with DMTs may affect COVID-19 severity and outcomes. Understanding the risks, severity and outcomes of COVID-19 in people with MS receiving DMTs, including anti-CD20 DMTs, is important to healthcare practitioners (HCPs) managing MS. Objectives: To report the characteristics and outcomes of COVID- 19 adverse events (AEs) in relapsing MS (RMS) patients taking ofatumumab enrolled in the ongoing, open-label, long-term extension Phase 3b ALITHIOS study and from post-marketing surveillance of people receiving ofatumumab 20 mg subcutaneously. Methods: Patient demographics, baseline characteristics, incidence of COVID-19 AEs, seriousness category (including hospitalization), severity, outcomes, ofatumumab exposure before the start of infection, and action taken with ofatumumab were assessed. Results: As of 29-Jan-2021, 139/1703 (8.2%) patients enrolled in ALITHIOS (mean±SD age at baseline: 37.7±8.7 years;female, 64%) treated with ofatumumab reported COVID-19 AEs (confirmed: 115 [82.7%];suspected: 24 [17.3%]). Of these, 10 (7.2%) experienced COVID-19 serious AEs and all 10 (7.2%) were hospitalized. Most AEs reported were mild (Grade [G] 1;69 [49.6%]) or moderate (G2;62 [44.6%]) in severity. Severe (G3) and life threatening (G4) AEs were reported in 6 (4.3%) and 2 (1.4%) patients, respectively. One (0.7%) patient (48-year-old at COVID- 19 onset;BMI 28.3 kg/m2;recent MS relapse) with confirmed COVID-19 and pneumonia had a fatal outcome. At data cut-off, most patients (128 [92.1%]) had recovered from COVID-19 AEs;2 (1.4%) were recovering, 4 (2.9%) had recovered with sequelae and 4 (2.9%) had not recovered. COVID-19 AEs led to temporary interruption of ofatumumab in 22 (15.8%) patients. As of 31-Jan- 2021, an additional 28 RMS patients with COVID-19 AEs were identified in the Novartis safety database. Further details to be presented. Conclusions: In ALITHIOS, 139 RMS patients on ofatumumab reported COVID-19 AEs (as of 31-Jan-2021). Most (94%) COVID-19 cases were mild or moderate in severity. There were few hospitalizations but one fatal outcome. At data cut-off, most (92%) patients had recovered/resolved from COVID-19. ALITHIOS data extends the understanding of the long-term safety profile of ofatumumab in people living with MS.
ABSTRACT
The SARS-CoV-2 pandemic has revealed the need for rapid and inexpensive diagnostic testing to enable population-based screening for active infection. Neither standard diagnostic testing, the detection and measurement of viral RNA (via polymerase chain reaction), or serological testing (via enzyme-linked immunosorbent assay) has the capability to definitively determine active infection. The former due to a lack of ability to distinguish between replicable and inert viral RNA, and the latter due to varying immune responses (ranging from latent to a complete lack of immune response altogether). Despite many companies producing rapid point-of-care (POC) tests, none will address the global scale of testing needed and few help to combat the ever growing issue of testing resource scarcity. Here we discuss our efforts towards the development of a highly manufacturable, microfluidic device that instantly indicates active viral infection status from ~ 20 μL of nasal mucus or phlegm and requires no external power. The device features a biotin functionalized silicon nanomembrane within an acrylic body containing channels and ports for sample introduction and analysis. Virus capture and target confirmation are done using affinity-based capture and size-based occlusion respectively. Modularity of the device is proven with bead and vaccinia virus capture as we work towards testing with both pure SARS-CoV-2 virus and human samples. With success on all fronts, we could achieve an inexpensive POC diagnostic which can determine an individual’s infection status, aiding containment efforts in the current and future pandemics. In addition to direct viral detection, our method can be used as a rapid POC sample preparation tool that limits the application of PCR reagents to those samples which already display viral size and antigen-based positivity through our device. © 2021 SPIE.
ABSTRACT
The coronavirus disease 2019 (COVID-19) has greatly impacted health-care systems worldwide, leading to an unprecedented rise in demand for health-care resources. In anticipation of an acute strain on established medical facilities in Dallas, Texas, federal officials worked in conjunction with local medical personnel to convert a convention center into a Federal Medical Station capable of caring for patients affected by COVID-19. A 200,000 square foot event space was designated as a direct patient care area, with surrounding spaces repurposed to house ancillary services. Given the highly transmissible nature of the novel coronavirus, the donning and doffing of personal protective equipment (PPE) was of particular importance for personnel staffing the facility. Furthermore, nationwide shortages in the availability of PPE necessitated the reuse of certain protective materials. This article seeks to delineate the procedures implemented regarding PPE in the setting of a COVID-19 disaster response shelter, including workspace flow, donning and doffing procedures, PPE conservation, and exposure event protocols.