ABSTRACT
Background: The utilization and reimbursement of technology-based health care services has drastically increased, especially in the era of COVID-19. However, they are not universally accessible and are disproportionately utilized, which can exacerbate already existing disparities Objective: To evaluate differences in technology-based health care usage in an academic pediatric gastroenterology practice based on demographic characteristics and the Area Deprivation Index (ADI), a validated composite index of socioeconomic status (SES). Design/Methods: We conducted a retrospective cohort study of new patients seen in the Pediatric Gastroenterology Clinic at the Children's Hospital Colorado for constipation from 1/1/2019-12/31/2020. Demographic variables and number of secure messages, telephone calls, telehealth visits, and emergency department (ED) visits for constipation were extracted for up to one year. We assigned each patient a state and national ADI based on home address. Univariate negative binomial regression models were used to determine significance. We also used a Poisson regression model to better understand the interplay between ED visits, technology-based health care usage, and SES. Result(s): 2087 patients were included in our study. The predicted mean number of patient-initiated secure messages (P=0.04) and phone calls (P=0.03) were significantly less in those with lower socioeconomic status (higher state ADI) (Figure 1). Socioeconomic status based on both state and national ADI did not significantly affect telehealth video usage. The predicted mean number of telehealth video visits and patient-initiated secure messages were significantly lower in Hispanic patients (P<0.001 and P<0.001), non-English speakers (P<0.001 and P<0.001), and those with government insurance (P=0.02 and P<0.001) (Table 1). The predicted mean number of patient-initiated phone calls was also significantly lower in Non-English speakers (P=0.02). The Poisson regression model showed that when the number of patient-initiated secure messages and telephone calls is small, lower SES is associated with more ED visits. As the number of patient-initiated secure messages and telephone calls increase, the extent of the positive association between low SES and ED visits attenuated gradually and eventually became negatively associated (P=0.04 and P=<0.001). This relationship was not significant for telehealth video visits. Conclusion(s): Patients with lower socioeconomic status, non-English speakers, and Hispanic patients utilize technology-based health care services significantly less. Thus, while technology-based health care services may help to increase access to care for some patients, it is important to minimize barriers and prevent the worsening of already-existing inequities in health care access. Improving access to secure messaging and telephone calls in patients with low SES may help to prevent constipation-related ED visits as well as reduce healthcare costs.
ABSTRACT
Background. Severe coronavirus disease 2019 (COVID-19) often results from the immune-mediated cytokine storm, triggered by granulocyte macrophage-colony stimulating factor (GM-CSF), potentially leading to respiratory failure and death. Lenzilumab, a novel anti-human GM-CSF monoclonal antibody, neutralizes GM-CSF and demonstrated potential to improve clinical outcomes in a matched case-cohort study of patients with severe COVID-19 pneumonia. This Phase 3 randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of lenzilumab to improve the likelihood of survival without invasive mechanical ventilation (SWOV), beyond available treatments. Methods. Hypoxic patients, hospitalized with COVID-19 (n=520), requiring supplemental oxygen, but not invasive mechanical ventilation, were randomized on Day 0 to receive lenzilumab (1800mg, n=261) or placebo (n=259), and available treatments, including remdesivir and/or corticosteroids;and were followed through Day 28. Results. Baseline demographics were comparable between groups: male, 64.7%;mean age, 60.5 years;median CRP, 79.0 mg/L. Patients across both groups received steroids (93.7%), remdesivir (72.4%), or both (69.1%). Lenzilumab improved the primary endpoint, likelihood of SWOV in the mITT population, by 1.54-fold (HR: 1.54;95%CI: 1.02-2.32, p=0.0403). Lenzilumab improved SWOV by 1.91-fold (nominal p=0.0073) and 1.92-fold (nominal p=0.0067) in patients receiving remdesivir or remdesivir and corticosteroids, respectively. A key secondary endpoint of incidence of IMV, ECMO or death was also improved in patients receiving remdesivir (p=0.020) or remdesivir and corticosteroids (p=0.0180). Treatment-emergent serious adverse events were similar across both groups. Conclusion. Lenzilumab significantly improved SWOV in hypoxic COVID-19 patients upon hospitalization, with the greatest benefit observed in patients receiving treatment with remdesivir and corticosteroids. NCT04351152.
ABSTRACT
Autologous stem cell transplantation (ASCT) is an effective procedure for the treatment of multiple myeloma (MM) and lymphoma patients, but an adequate hematopoietic stem cell (HSC) yield is essential. In some patients (poor mobilizers, PM), stem cell mobilization is difficult leading to repeated apheresis sessions and increased patients' burden. Plerixafor (PLX), in combination with granulocyte colony stimulating factor (G-CSF) has been shown to effectively mobilize HSCs in PM patients. The OPTIMOB study is a prospective, multi-center, non-interventional, observational study to evaluate the current approach of HSC mobilization and collection regimen as well as ASCT procedures in German MM and lymphoma patients with special focus on PM patients. It is expected to enroll at least 210 poor mobilizers in this study. This prespecified interim analysis was performed after the complete documentation of the first 100 poor mobilizers. Until data cut-off in November 2020, 461 patients from 28 sites were enrolled. 66% of the patients suffered from MM, 63% were male and mean age was 59 years (SD: ±9.55). In total, 38% of the patients were classified as PM. PLX was used in 83% of the PM patients during mobilization, mainly due to low CD34+ cell content in peripheral blood (72% of the patients). Collection target was reached in 72% of patients receiving PLX versus 50% of PM who did not receive PLX. In total, 87% of PM patients underwent apheresis. Mean collection result of the first day of apheresis was 7.2 cells x106/kg bw (SD: ± 28.13) in PM patients with PLX versus 3.7 cells x106/ kg bw [SD: ±3.44]) in PM patients without PLX. ASCT was performed in 67% of the PM patients at the data cut-off. Adverse events occurred in 39% of the study population but were not related to PLX use. Mean number of induction cycles and apheresis days as well as the elapsed time between start of mobilization and transplantation did not seem to change in the study population during the SARS-CoV-2 pandemic. However, there was a tendency towards more frequently use of G-SCF for mobilization instead of chemotherapeutic based mobilization regimes. In Germany, a high number of MM and lymphoma patients appear to be PMs. This interim analysis of the OPTIMOB study shows that adding PLX to standardized mobilization strategies is associated with an adequate mobilization of CD34+ cells in 3 out of 4 PMs, allowing them to undergo ASCT.
ABSTRACT
BackgroundThe hyperinflammatory cytokine storm (CS) of COVID-19 is mediated by GM-CSF leading to release of downstream inflammatory chemokines, cytokines, and markers of systemic inflammation (C-reactive protein, CRP). The LIVE-AIR study demonstrated that lenzilumab, an anti-GM-CSF monoclonal antibody in patients hospitalized with COVID-19, safely improved the likelihood of achieving the primary endpoint, survival without ventilation (SWOV) by 1.54-fold (HR: 1.54;95%CI: 1.02–2.32, p=0.0403) compared with placebo. An exploratory analysis in patients with CRP<150 mg/L and age<85 years was conducted to determine lenzilumab efficacy when administered prior to advanced inflammation.MethodsLIVE-AIR was a phase 3 randomized, double-blind, placebo-controlled trial. Patients with COVID-19 (n=520), >18 years, and ≤94% oxygen saturation on room air and/or requiring supplemental oxygen, but not invasive mechanical ventilation (IMV), were randomized to receive lenzilumab (600 mg, n=261) or placebo (n=259) via three intravenous infusions administered 8 hours apart. Participants were followed through Day 28 following treatment.ResultsOverall, baseline demographics were comparable between treatment groups: male, 64.7%;mean age, 60.5 years;mean BMI, 32.5 kg/m2;median CRP, 79 mg/L;CRP was <150 mg/L in 78% of participants. Participants received steroids (93.7%), remdesivir (72.4%), or both (69.1%). Lenzilumab (n=159) improved the likelihood of SWOV by 3.04-fold in participants with CRP<150 mg/L and age<85 years (3.04;1.68–5.51, nominal p=0.0003) compared with placebo (n=178). Response to lenzilumab was observed in the first through third quartiles of baseline CRP (<41 mg/L, HR:8.33;41<79 mg/L, HR:1.60;79<137 mg/L, HR: 2.12;>137 mg/L, HR: 1.17). The incidence of IMV, ECMO, or death was reduced (OR: 0.31;95%CI: 0.15–0.63, p=0.002) and mortality was improved by 2.22-fold (OR: 2.22;95%CI: 1.07–4.67, p=0.034). In these participants, lenzilumab decreased CRP as early as Day 2 following treatment, compared with placebo which was further decreased by 38% on Day 28 compared with placebo (24.4±3.4 mg/L vs 39.1±4.9 mg/L).ConclusionLenzilumab significantly improved SWOV in hospitalized, hypoxic participants with COVID-19 pneumonia with the greatest benefits in SWOV and survival in patients with CRP<150 mg/L and age <85 years. Inhibition of GM-CSF, an orchestrator of CS, early in the hyperinflammatory response improved outcomes in COVID-19. NCT04351152