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Association of Subcutaneous or Intravenous Administration of Casirivimab and Imdevimab Monoclonal Antibodies With Clinical Outcomes in Adults With COVID-19.
McCreary, Erin K; Bariola, J Ryan; Wadas, Richard J; Shovel, Judith A; Wisniewski, Mary Kay; Adam, Michelle; Albin, Debbie; Minnier, Tami; Schmidhofer, Mark; Meyers, Russell; Marroquin, Oscar C; Collins, Kevin; Garrard, William; Berry, Lindsay R; Berry, Scott; Crawford, Amy M; McGlothlin, Anna; Linstrum, Kelsey; Nakayama, Anna; Montgomery, Stephanie K; Snyder, Graham M; Yealy, Donald M; Angus, Derek C; Kip, Paula L; Seymour, Christopher W; Huang, David T; Kip, Kevin E.
  • McCreary EK; Division of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
  • Bariola JR; Division of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
  • Wadas RJ; Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
  • Shovel JA; Wolff Center, University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania.
  • Wisniewski MK; Wolff Center, University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania.
  • Adam M; Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
  • Albin D; Supply Chain Management/HC Pharmacy, UPMC, Pittsburgh, Pennsylvania.
  • Minnier T; Wolff Center, University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania.
  • Schmidhofer M; Division of Cardiology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
  • Meyers R; Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
  • Marroquin OC; Clinical Analytics, UPMC, Pittsburgh, Pennsylvania.
  • Collins K; Clinical Analytics, UPMC, Pittsburgh, Pennsylvania.
  • Garrard W; Clinical Analytics, UPMC, Pittsburgh, Pennsylvania.
  • Berry LR; Berry Consultants, Austin, Texas.
  • Berry S; Berry Consultants, Austin, Texas.
  • Crawford AM; Berry Consultants, Austin, Texas.
  • McGlothlin A; Berry Consultants, Austin, Texas.
  • Linstrum K; Office of Healthcare Innovation, UPMC, Pittsburgh, Pennsylvania.
  • Nakayama A; Office of Healthcare Innovation, UPMC, Pittsburgh, Pennsylvania.
  • Montgomery SK; Office of Healthcare Innovation, UPMC, Pittsburgh, Pennsylvania.
  • Snyder GM; Division of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
  • Yealy DM; Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
  • Angus DC; Office of Healthcare Innovation, UPMC, Pittsburgh, Pennsylvania.
  • Kip PL; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
  • Seymour CW; Office of Healthcare Innovation, UPMC, Pittsburgh, Pennsylvania.
  • Huang DT; Office of Healthcare Innovation, UPMC, Pittsburgh, Pennsylvania.
  • Kip KE; Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
JAMA Netw Open ; 5(4): e226920, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1782544
ABSTRACT
Importance Monoclonal antibody (mAb) treatment decreases hospitalization and death in high-risk outpatients with mild to moderate COVID-19; however, only intravenous administration has been evaluated in randomized clinical trials of treatment. Subcutaneous administration may expand outpatient treatment capacity and qualified staff available to administer treatment, but the association with patient outcomes is understudied.

Objectives:

To evaluate whether subcutaneous casirivimab and imdevimab treatment is associated with reduced 28-day hospitalization and death compared with nontreatment among mAb-eligible patients and whether subcutaneous casirivimab and imdevimab treatment is clinically and statistically similar to intravenous casirivimab and imdevimab treatment. Design, Setting, and

Participants:

This prospective cohort study evaluated high-risk outpatients in a learning health system in the US with mild to moderate COVID-19 symptoms from July 14 to October 26, 2021, who were eligible for mAb treatment under emergency use authorization. A nontreated control group of eligible patients was also studied. Exposures Subcutaneous injection or intravenous administration of the combined single dose of 600 mg of casirivimab and 600 mg of imdevimab. Main Outcomes and

Measures:

The primary outcome was the 28-day adjusted risk ratio or adjusted risk difference for hospitalization or death. Secondary outcomes included 28-day adjusted risk ratios and differences in hospitalization, death, a composite end point of emergency department admission and hospitalization, and rates of adverse events. Among 1959 matched adults with mild to moderate COVID-19, 969 patients (mean [SD] age, 53.8 [16.7] years; 547 women [56.4%]) who received casirivimab and imdevimab subcutaneously had a 28-day rate of hospitalization or death of 3.4% (22 of 653 patients) compared with 7.0% (92 of 1306 patients) in nontreated controls (risk ratio, 0.48; 95% CI, 0.30-0.80; P = .002). Among 2185 patients treated with subcutaneous (n = 969) or intravenous (n = 1216; mean [SD] age, 54.3 [16.6] years; 672 women [54.4%]) casirivimab and imdevimab, the 28-day rate of hospitalization or death was 2.8% vs 1.7%, which resulted in an adjusted risk difference of 1.5% (95% CI, -0.6% to 3.5%; P = .16). Among all infusion patients, there was no difference in intensive care unit admission (adjusted risk difference, 0.7%; 95% CI, -3.5% to 5.0%) or need for mechanical ventilation (adjusted risk difference, 0.2%; 95% CI, -5.8% to 5.5%). Conclusions and Relevance In this cohort study of high-risk outpatients with mild to moderate COVID-19 symptoms, subcutaneously administered casirivimab and imdevimab was associated with reduced hospitalization and death when compared with no treatment. These results provide preliminary evidence of potential expanded use of subcutaneous mAb treatment, particularly in areas that are facing treatment capacity and/or staffing shortages.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Antineoplastic Agents, Immunological / COVID-19 Drug Treatment Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: JAMA Netw Open Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antineoplastic Agents, Immunological / COVID-19 Drug Treatment Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: JAMA Netw Open Year: 2022 Document Type: Article