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 T.; Berry, Lindsay R.; Berry, Scott M.; Crawford, Amy; 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.

doi:10.1001/jamanetworkopen.2022.6920

Cited by 28 publications

(27 citation statements)

References 9 publications

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“…To date, there are only a modest number of case reports/series in the literature where mAbs for treatment of COVID have been used in IMID patients with or without B cell depleting agents ( Table 2 ). Similar to our case, these cases also showed favorable outcomes with no safety concerns ( 13 – 17 ). Yetmar et al ( 16 ) and McCreary et al ( 17 ) have reported the largest case series of treatment with mAbs in immunocompromised patients.…”

Section: Discussionsupporting

confidence: 88%

“…Similar to our case, these cases also showed favorable outcomes with no safety concerns ( 13 – 17 ). Yetmar et al ( 16 ) and McCreary et al ( 17 ) have reported the largest case series of treatment with mAbs in immunocompromised patients. In the work of Yetmar et al, four different mAbs reduced hospitalization rates, mortality rates and persistent infections in 180 patients who received B cell depleting therapy ( 16 ).…”

Section: Discussionsupporting

confidence: 88%

“…McCreary and colleagues compared two routes of administration of casirivimab/imdevimab treatment, also including a subpopulation of 50 patients with rheumatoid arthritis. In this study, mAbs reduced the risk of hospitalization and death regardless of route of administration (17). Comparable results were observed in several other case reports (13-15) reporting 6 patients with various IMIDs (psoriasis, psoriatic arthritis, Sjögren's syndrome/Raynaud disease, and systemic lupus erythematosus).…”

Section: Discussionsupporting

confidence: 86%

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Neutralizing monoclonal antibodies against SARS-CoV-2 for COVID-19 pneumonia in a rituximab treated patient with systemic sclerosis—A case report and literature review

Mutlu

Taubmann²,

Wacker³

et al. 2022

Front. Med.

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Patients with immune-mediated diseases (IMID) such as systemic sclerosis (SSc), who are treated with B cell depleting treatments, are at risk for developing severe COVID-19 due to inadequate humoral immune response. During B cell depletion, therapeutic substitution of neutralizing monoclonal antibodies against the SARS-CoV-2 spike protein (mAbs) might be helpful to prevent severe COVID-19. It has been shown, that in non-IMID patients mABs reduce SARS-CoV-2 viral load and lower the risk of COVID-19 associated hospitalization or death. However, there are limited data on the effect of mAbs in IMID patients after exposure, especially in patients treated with B cell depleting agents. Herein, we report a case of a rituximab treated SSc patient who developed COVID-19 and was successfully treated with a combination of mAbs (casirivimab/imdevimab). With this case we show that IMID patients may benefit from post-exposure administration of mAbs. In our case treatment with neutralizing autoantibodies was safe and a possible contributor in protecting the patient from mechanical ventilation and eventually death. We frame this case within the current evidence from the literature and provide a perspective on the future potential role of mAbs for treating IMID patients suffering from COVID-19.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 86%

See 1 more Smart Citation

Neutralizing monoclonal antibodies against SARS-CoV-2 for COVID-19 pneumonia in a rituximab treated patient with systemic sclerosis—A case report and literature review

Mutlu

Taubmann²,

Wacker³

et al. 2022

Front. Med.

View full text Add to dashboard Cite

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“…The reduction of hospitalization rate with our combination therapy (74%) was better than that of inhaled corticosteroids (36%) (40) and molnupiravir (51%) (41). Although there are other medications such as nirmatrelvir (89%) (42), remdesivir (86%) (43), Paxlovid (88%) (44), and the monoclonal antibodies (70 – 85%) (7,45-47) with slightly better outcomes, the results may not be directly comparable. For example, on average, our patients are sicker than the patients treated with nirmatrelvir, remdesivir, and Paxlovid; this is based on maximum number of days elapsed since symptom onset for eligibility to be part of trials for remdesivir (within 7 days) (43), nirmatrelvir (within 3 days) (42), and Paxlovid (within 5 days) (44).…”

Section: Discussionmentioning

confidence: 99%

Combination of Spironolactone and Sitagliptin Improves Clinical Outcomes of Outpatients with COVID-19: A Prospective Cohort Study

Davarpanah

Adatorwovor

Mansoori

et al. 2022

Preprint

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Background: Coronavirus disease 2019 (COVID-19) leads to hospitalization and death, especially in elderly and those with comorbidities. There are evidences showing that sitagliptin and spironolactone can potentially improve the clinical outcomes of COVID-19 cases. In this observational study on acutely symptomatic outpatient COVID-19 cases, we investigated the effects of spironolactone and sitagliptin on the outcomes of the disease. Methods: This prospective cohort study was conducted at Shiraz University of Medical Sciences Clinics during the fifth wave of the COVID-19 pandemic between July 2021 and September 2021. We followed mild to moderate symptomatic COVID-19 patients, who were treated with either combination (spironolactone 100 mg daily and sitagliptin 100 mg daily) or standard (steroid, antiviral and/or supportive care) therapy up to 30 days. Our primary outcome was hospitalization rate. The secondary outcomes included ER visit, duration of disease, and complications, such as hypoglycemia, low blood pressure or altered mental status. Results: Of the 206 patients referred to clinics, 103 received standard therapy and 103 treated with combination therapy. There were no significant differences in baseline characteristics, except for slightly higher clinical score in control group (6.92 +/- 4.01 control, 4.87 +/- 2.92 combination; P <0.0001). Treatment with combination therapy was associated with lower admission rate (5.8% combination, 22.3% control; P = 0.0011), ER visits (7.8% combination, 23.3% control; P = 0.0021) and average duration of symptoms (6.67 +/- 2.30 days combination, 18.71 +/- 6.49 days control; P =<0.0001). Conclusion: In this prospective cohort study of acutely ill outpatients with COVID-19, the combination of sitagliptin and spironolactone reduced duration of COVID infection and hospital visits better than standard therapeutic approaches. The effects of combination of sitagliptin and spironolactone in COVID-19 patients should be further verified in a double blind, randomized, placebo-controlled trial.

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“…[16][17][18][19] A small minority of patients received subcutaneous casirivimab and imdevimab to accommodate surging patient referrals and staffing shortages. 20 From December 23, 2021 through January 21, 2022, all patients received intravenous sotrovimab due to the emergence of the Omicron variant. Starting September 28, 2021, pregnant patients and patients with immunocompromised conditions were given priority for mAb treatment due to drug scarcity.…”

Section: Methodsmentioning

confidence: 99%

Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy

McCreary

Lemon

Megli

et al. 2022

Preprint

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IMPORTANCEMonoclonal antibody (mAb) treatment decreases hospitalization and death in high-risk outpatients with mild to moderate COVID-19. However, no studies have evaluated adverse events and effectiveness of mAbs in pregnant persons compared to no mAb treatment.OBJECTIVETo determine the frequency of drug-related adverse events and obstetric-associated safety outcomes after treatment with mAb compared to no mAb treatment, and the association between mAb treatment and a composite of 28-day COVID-19-related hospital admission or emergency department visit, COVID-19-associated delivery, or mortality.DESIGN, SETTING, PARTICIPANTSPropensity-score matched cohort study of persons aged 12 years of age or older with a pregnancy episode and any documented positive SARS-CoV-2 test (polymerase chain reaction or antigen test) in the UPMC health system from April 30, 2021 to January 21, 2022.EXPOSURESBamalanivmab and etesevimab, casirivimab and imdevimab, or sotrovimab treatment compared to no mAb treatment.MAIN OUTCOMES AND MEASURESDrug-related adverse events, obstetric-associated safety outcomes among persons who delivered, and a risk-adjusted composite of 28-day COVID-19-related hospital admission or ED visit, COVID-19-associated delivery, or mortality.RESULTSAmong 944 pregnant persons (median [IQR] age 30 [26, 33] years, White (79.5%, N=750), median [IQR] Charlson Comorbidity Index Score 0 (0,0)), 552 persons received mAb treatment (58%). Median gestational age at COVID-19 diagnosis or treatment was 179 days (IQR: 123, 227), and most persons received sotrovimab (69%, N=382). Of those with known vaccination status, 178 (62%) were fully vaccinated. Drug-related adverse events were uncommon (N=8, 1.4%), and there were no differences in any obstetric-associated outcome among 276 persons who delivered. After propensity score matching, the frequency of the composite 28-day COVID-19-associated outcome was 4.0 per 100 persons (95% CI 1.9, 6.2) in mAb-treated compared to 3.7 per 100 persons (95% CI 1.7, 5.8) in non-treated controls (risk difference = 0.31 per 100 persons [95% CI -2.6, 3.3). There were no deaths among mAb-treated patients compared to 1 death in the non-treated controls (p = 0.24). There were more non-COVID-19-related hospital admissions in the mAb-treated persons (risk difference 2.8 per 100 persons (95% CI 1.1, 4.5)).CONCLUSIONS AND RELEVANCEIn pregnant persons with mild to moderate COVID-19, adverse events after mAb treatment were mild and rare. There was no difference in obstetric-associated safety outcomes between mAb treatment and no treatment among persons who delivered. MAb treatment was associated with similar 28-day COVID-19-associated outcomes and more non-COVID-19-related hospital admissions compared to no mAb treatment.Key PointsQUESTIONAmong pregnant persons with COVID-19, is monoclonal antibody (mAb) treatment associated with drug-related adverse events, similar frequency of obstetric-associated safety outcomes, and improved COVID-19-related clinical outcomes compared to no mAb treatment?FINDINGSIn 944 pregnant persons with COVID-19, drug-related adverse events were mild and infrequent. Obstetric-associated safety outcomes were similar between mAb treatment and no treatment. There was no evidence of difference in risk of COVID-19-related hospital admission, COVID-19-associated delivery, or mortality between mAb treatment and no mAb treatment.MEANINGIn pregnant persons with mild to moderate COVID-19, adverse events after mAb treatment were uncommon, and there was no difference in obstetric-associated safety outcomes between mAb treatment and no treatment. MAb treatment was associated with similar 28-day risk of a COVID-19-associated outcome and more non-COVID-19-related hospital admissions compared to no mAb treatment.

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Association of Subcutaneous or Intravenous Administration of Casirivimab and Imdevimab Monoclonal Antibodies With Clinical Outcomes in Adults With COVID-19

Cited by 28 publications

References 9 publications

Neutralizing monoclonal antibodies against SARS-CoV-2 for COVID-19 pneumonia in a rituximab treated patient with systemic sclerosis—A case report and literature review

Neutralizing monoclonal antibodies against SARS-CoV-2 for COVID-19 pneumonia in a rituximab treated patient with systemic sclerosis—A case report and literature review

Combination of Spironolactone and Sitagliptin Improves Clinical Outcomes of Outpatients with COVID-19: A Prospective Cohort Study

Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy

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