scholarly journals Real World Evidence of Neutralizing Monoclonal Antibodies for Preventing Hospitalization and Mortality in COVID-19 Outpatients

Author(s):  
Matthew K Wynia ◽  
Laurel E Beaty ◽  
Tellen D Bennett ◽  
Nichole E Carlson ◽  
Christopher B Davis ◽  
...  

Background: Neutralizing monoclonal antibodies (mAbs) are authorized for early symptomatic COVID-19 patients. Whether mAbs are effective against the SARS-CoV-2 Delta variant, among vaccinated patients, or for prevention of mortality remains unknown. Objective: To evaluate the effectiveness of mAb treatment in preventing progression to severe disease during the Delta phase of the pandemic and based on key baseline risk factors. Design, Setting, and Patients: Observational cohort study of non-hospitalized adult patients with SARS-CoV-2 infection from November 2020-October 2021, using electronic health records from a statewide health system plus state-level vaccine and mortality data. Using propensity matching, we selected approximately 2.5 patients not receiving mAbs for each patient who received mAbs. Exposure: Neutralizing mAb treatment under emergency use authorization Main Outcomes: The primary outcome was 28-day hospitalization; secondary outcomes included mortality and severity of hospitalization. Results: Of 36,077 patients with SARS-CoV-2 infection, 2,675 receiving mAbs were matched to 6,677 not receiving mAbs. Compared to mAb-untreated patients, mAb-treated patients had lower all-cause hospitalization (4.0% vs 7.7%; adjusted OR 0.48, 95%CI 0.38-0.60) and all-cause mortality (0.1% vs. 0.9%; adjusted OR 0.11, 95%CI 0.03-0.29) to day 28; differences persisted to day 90. Among hospitalized patients, mAb-treated patients had shorter hospital length of stay (5.8 vs. 8.5 days) and lower risk of mechanical ventilation (4.6% vs. 16.6%). Relative effectiveness was similar in preventing hospitalizations during the Delta variant phase (adjusted OR 0.35, 95%CI 0.25-0.50) and across subgroups. Lower number-needed-to-treat (NNT) to prevent hospitalization were observed for subgroups with higher baseline risk of hospitalization (e.g., multiple comorbidities (NNT=17) and not fully vaccinated (NNT=24) vs. no comorbidities (NNT=88) and fully vaccinated (NNT=81). Conclusion: Real-world evidence demonstrated mAb effectiveness in reducing hospitalization among COVID-19 outpatients, including during the Delta variant phase, and conferred an overall 89% reduction in 28-day mortality. Early outpatient treatment with mAbs should be prioritized, especially for individuals with highest risk for hospitalization.

2021 ◽  
Vol 14 (7) ◽  
pp. 700
Author(s):  
Theodoros Mavridis ◽  
Christina I. Deligianni ◽  
Georgios Karagiorgis ◽  
Ariadne Daponte ◽  
Marianthi Breza ◽  
...  

Now more than ever is the time of monoclonal antibody use in neurology. In headaches, disease-specific and mechanism-based treatments existed only for symptomatic management of migraines (i.e., triptans), while the standard prophylactic anti-migraine treatments consist of non-specific and repurposed drugs that share limited safety profiles and high risk for interactions with other medications, resulting in rundown adherence rates. Recent advances in headache science have increased our understanding of the role of calcitonin gene relate peptide (CGRP) and pituitary adenylate cyclase-activating polypeptide (PACAP) pathways in cephalic pain neurotransmission and peripheral or central sensitization, leading to the development of monoclonal antibodies (mAbs) or small molecules targeting these neuropeptides or their receptors. Large scale randomized clinical trials confirmed that inhibition of the CGRP system attenuates migraine, while the PACAP mediated nociception is still under scientific and clinical investigation. In this review, we provide the latest clinical evidence for the use of anti-CGRP in migraine prevention with emphasis on efficacy and safety outcomes from Phase III and real-world studies.


Author(s):  
Marta Torres-Ferrús ◽  
Victor J. Gallardo ◽  
Alicia Alpuente ◽  
Edoardo Caronna ◽  
Eulalia Gine-Cipres ◽  
...  

2016 ◽  
Vol 19 (7) ◽  
pp. A488 ◽  
Author(s):  
H Stegenga ◽  
M Chambers ◽  
P Jonsson ◽  
R Thwaites ◽  
S Garner

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
WY Ding ◽  
JM Rivera-Caravaca ◽  
F Marin ◽  
G Li ◽  
V Roldan ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background The benefit of oral anticoagulation (OAC) in atrial fibrillation (AF) must be balanced against any potential risk of harm. We aimed to evaluate the "NNT for net effect" (NNTnet) using CARS in anticoagulated patients with AF. Methods We used patient-level data from the real-world Murcia AF Project and AMADEUS clinical trial. Baseline risk of stroke was calculated using CARS while major bleeding was estimated from prior studies. Stroke and major bleeding events at 1-year were determined. NNTnet was calculated as a reciprocal of the net effect of ARR with OAC (NNTnet= 1 / (ARRstroke - ARIbleeding)). Results 3,511 patients were included (1,306 [37.2%] real-world patients and 2,205 [62.8%] clinical trial). The absolute 1-year stroke risk was similar across both cohorts and the main results are presented in the Table. In both cohorts, the NNTnet was significantly lower in patients with an excess stroke risk of ≥2% by CARS. Among real-world patients with a very high (>10%) baseline stroke risk, the use of OAC was associated with an ARRstroke of 10.9% and ARIbleeding of 1.2%, generating an overall NNTnet of 11. In the clinical trial, the use of OAC was associated with an ARRstroke of 11.0% and ARIbleeding of 0.6%, generating an overall NNTnet of 10. Conclusion Overall, the NNTnet approach in AF incorporates information regarding baseline risk of stroke and major bleeding, and relative effects of OAC with the potential to include multiple additional outcomes and weighting of events based on their perceived effects by individual patients. This simple and intuitive metric may be useful to improve communication and optimise the patient-centred management of AF. NNT in Real-World and Clinical Trial Real-World Clinical Trial Ischaemic stroke risk at 1-year Baseline risk without anticoagulation (%) 5.7% (95% CI 5.5 - 6.0) 5.1% (95% CI 4.9 - 5.3) Anticoagulation-mediated risk (%) 1.7% (95% CI 1.1 - 2.6) 1.3% (95% CI 0.8 - 1.8) Absolute risk reduction (%) 4.0% 3.8% NNTbenefit 25 27 Major bleeding risk at 1-year Baseline risk without anticoagulation (%) 2.3% 2.3% Anticoagulation-mediated risk (%) 3.3% (95% CI 2.4 - 4.4) 3.9% (95% CI 3.1 - 4.8) Absolute risk increase (%) 1.0% 1.6% NNTharm 100 63 NNTnet 34 46


2021 ◽  
Author(s):  
Michael J. Ahlers ◽  
Hilary J. Aralis ◽  
Wilson L. Tang ◽  
Jeremy B. Sussman ◽  
Gregg C. Fonarow ◽  
...  

ABSTRACTBackgroundNon-pharmaceutical interventions (NPIs) are mitigation strategies used to reduce the spread of transmissible diseases. The relative effectiveness of specific NPIs remains uncertain.MethodsWe used state-level Coronavirus disease 2019 (COVID-19) case and mortality data between January 19, 2020 and March 7, 2021 to model NPI policy effectiveness. Empirically derived breakpoints in case and mortality velocities were used to identify periods of stable, decreasing, or increasing COVID-19 burden. The associations between NPI adoption and subsequent decreases in case or death velocities were estimated using generalized linear models accounting for weekly variability shared across states. State-level NPI policies included: stay at home order, indoor public gathering ban (mild >10 or severe ≤10), indoor restaurant dining ban, and public mask mandate.Results28,602,830 cases and 511,899 deaths were recorded. The odds of a decrease in COVID-19 case velocity were significantly elevated for stay at home (OR 2.02, 95% CI 1.63-2.52), indoor dining ban (OR 1.62, 95% CI 1.25-2.10), public mask mandate (OR 2.18, 95% CI 1.47-3.23), and severe gathering ban (OR 1.68, 95% CI 1.31-2.16). In mutually adjusted models, odds remained elevated for stay at home (AOR 1.47, 95% CI 1.04-2.07) and public mask mandate (AOR = 2.27, 95% CI 1.51-3.41). Stay at home (OR 2.00, 95% CI 1.53-2.62; AOR 1.89, 95% CI 1.25-2.87) was also associated with greater likelihood of decrease in death velocity in unadjusted and adjusted models.ConclusionsNPIs employed in the U.S. during the COVID-19 pandemic, most significantly stay at home orders, were associated with decreased COVID-19 burden.


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