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Effect of traditional therapeutics on prevalence and clinical outcomes of coronavirus disease 2019 in Chinese patients with autoimmune diseases

Huang et al., Journal of Translational Autoimmunity, doi:10.1016/j.jtauto.2023.100227
Dec 2023  
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Hospitalization 43% Improvement Relative Risk Case -6% HCQ for COVID-19  Huang et al.  Prophylaxis Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? Retrospective 432 patients in China (January - February 2023) Lower hospitalization with HCQ (not stat. sig., p=0.085) Huang et al., J. Translational Autoimm.., Dec 2023 FavorsHCQ Favorscontrol 0 0.5 1 1.5 2+
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
*, now with p < 0.00000000001 from 411 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments.
Retrospective 432 autoimmune disease patients in China showing lower hospitalization with HCQ without statistical significance (OR 0.566, p=0.085) in unadjusted results, slightly higher COVID-19 cases without statistical significance, and increased cough compared with CNI.
risk of hospitalization, 43.4% lower, OR 0.57, p = 0.09, treatment 141, control 291, RR approximated with OR.
risk of case, 6.3% higher, RR 1.06, p = 0.25, treatment 118 of 141 (83.7%), control 229 of 291 (78.7%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Huang et al., 12 Dec 2023, retrospective, China, peer-reviewed, 9 authors, study period 1 January, 2023 - 28 February, 2023. Contact:,,
This PaperHCQAll
Effectiveness of Casirivimab-Imdevimab and Sotrovimab During a SARS-CoV-2 Delta Variant Surge
MD, MPH David T Huang, PharmD Erin K Mccreary, MD J Ryan Bariola, MS Tami E Minnier, MD Richard J Wadas, BSN Judith A Shovel, Debbie Albin, MD Oscar C Marroquin, PhD Kevin E Kip, MBA Kevin Collins, MD Mark Schmidhofer, MA Mary Kay Wisniewski, MD David A Nace, MHA Colleen Sullivan, BS Meredith Axe, MBA Russell Meyers, MD; Alexandra Weissman, PhD William Garrard, PhD Octavia M Peck-Palmer, MD, DMSc Alan Wells, MD Robert D Bart, MD Anne Yang, PhD Lindsay R Berry, PhD Scott Berry, PhD Amy M Crawford, PhD Anna Mcglothlin, PharmD Tina Khadem, MS Kelsey Linstrum, MS Stephanie K Montgomery, MET; Daniel Ricketts, MS Jason N Kennedy, BS Caroline J Pidro, MS Anna Nakayama, PhD Rachel L Zapf, PhD Paula L Kip, MD; Ghady Haidar, MD Graham M Snyder, MD; Bryan J Mcverry, MD Donald M Yealy, MD, MPH Derek C Angus, MD, MSc Christopher W Seymour
JAMA Network Open, doi:10.1001/jamanetworkopen.2022.20957
IMPORTANCE The effectiveness of monoclonal antibodies (mAbs), casirivimab-imdevimab and sotrovimab, is unknown in patients with mild to moderate COVID-19 caused by the SARS-CoV-2 Delta variant. OBJECTIVE To evaluate the effectiveness of mAb against the Delta variant compared with no mAb treatment and to ascertain the comparative effectiveness of casirivimab-imdevimab and sotrovimab. DESIGN, SETTING, AND PARTICIPANTS This study comprised 2 parallel studies: (1) a propensity score-matched cohort study of mAb treatment vs no mAb treatment and (2) a randomized comparative effectiveness trial of casirivimab-imdevimab and sotrovimab. The cohort consisted of patients who received mAb treatment at the University of Pittsburgh Medical Center outpatient infusion centers and emergency departments from July 14 to September 29, 2021. Participants were patients with a positive SARS-CoV-2 test result who were eligible to receive mAbs according to emergency use authorization criteria. EXPOSURE For the trial, patients were randomized to either intravenous casirivimab-imdevimab or sotrovimab according to a system therapeutic interchange policy. MAIN OUTCOMES AND MEASURES For the cohort study, risk ratio (RR) estimates for the primary outcome of hospitalization or death by 28 days were compared between mAb treatment and no mAb treatment using propensity score-matched models. For the comparative effectiveness trial, the primary outcome was hospital-free days (days alive and free of hospitalization) within 28 days after mAb treatment, where patients who died were assigned −1 day in a bayesian cumulative logistic model adjusted for treatment location, age, sex, and time. Inferiority was defined as a 99% posterior probability of an odds ratio (OR) less than 1. Equivalence was defined as a 95% posterior probability that the OR was within a given bound. RESULTS A total of 3069 patients (1023 received mAb treatment: mean [SD] age, 53.2 [16.4] years; 569 women [56%]; 2046 had no mAb treatment: mean [SD] age, 52.8 [19.5] years; 1157 women [57%]) were included in the prospective cohort study, and 3558 patients (mean [SD] age, 54 [18] years; 1919 women [54%]) were included in the randomized comparative effectiveness trial. In propensity score-matched models, mAb treatment was associated with reduced risk of hospitalization or death (RR, 0.40; 95% CI, 0.28-0.57) compared with no treatment. Both (continued) Key Points Question Is monoclonal antibody (mAb) treatment effective in nonhospitalized patients with COVID-19 caused by the Delta variant? Findings In this propensity scorematched cohort study (n = 3069) and randomized comparative effectiveness trial (n = 3558), mAb treatment
Adverse Events Among the 2454 patients who received casirivimab-imdevimab, 17 (<1%) reported adverse events and 7 (<1%) reported severe adverse events, making them rare. Similarly, for the 1104 patients who received sotrovimab, 6 (<1%) reported adverse events and 4 (<1%) reported severe adverse events. The most commonly reported adverse events were flushing, itching, breathing difficulties, and chest tightness or pain. Discussion During the Delta variant surge, we found that casirivimab-imdevimab and sotrovimab were each associated with a reduced risk-adjusted hospitalization and death among patients with mild to moderate COVID-19 compared with no mAb treatment. In a randomized comparative effectiveness trial, no primary analysis met a prespecified trigger for conclusions of inferiority or equivalence, although the subgroup analysis of patients who received mAb treatment in an infusion center showed superiority of casirivimab-imdevimab over sotrovimab. The Delta variant of SARS-CoV-2 was observed in late 2020 and became the dominant strain worldwide by July 2021. Yet, early evidence of the efficacy of mAb was reported before the emergence of the Delta variant. The present study extended previous work 5 and found that mAbs were associated with improved outcomes in patients with the Delta variant in a cohort with a robust sample size and methods to adjust for treatment selection and confounding. Future work is needed to ascertain the effectiveness of mAbs..
Acquisition, Huang, Mccreary, Bariola, Wadas et al., Critical revision of the manuscript for important intellectual content
Administrative, Bariola, Minnier, Wadas, Shovel et al., Supervision: Huang, Bariola, Minnier
Bariola, Mccreary, Khadem, Establishing a distribution network for COVID-19 monoclonal antibody therapy across a large health system during a global pandemic, Open Forum Infect Dis, doi:10.1093/ofid/ofab151
Cicchitto, Cardillo, De Martinis, Effects of casirivimab/imdevimab monoclonal antibody treatment among vaccinated patients infected by SARS-CoV-2 Delta variant, Viruses, doi:10.3390/v14030650
Falcone, Tiseo, Valoriani, Efficacy of bamlanivimab/etesevimab and casirivimab/imdevimab in preventing progression to severe COVID-19 and role of variants of concern, Infect Dis Ther, doi:10.1007/s40121-021-00525-4
Huang, Mccreary, Bariola, Effectiveness of casirivimab and imdevimab, and sotrovimab during Delta variant surge: a prospective cohort study and comparative effectiveness randomized trial. medRxiv, doi:10.1101/2021.12.23.21268244
Huang, Mccreary, Bariola, Minnier, Shovel et al., Concept and design
Huang, Mccreary, Bariola, The UPMC OPTIMISE-C19 (OPtimizing Treatment and Impact of Monoclonal antIbodieS through Evaluation for COVID-19) trial: a structured summary of a study protocol for an open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization, Trials, doi:10.1186/s13063-021-05316-3
Mader, Tydykov, Glück, 2. Propensity Scores for Unmatched and Matched Patients eTable 1. Comparison of Characteristics of Unmatched and Propensity Matched Patients eTable 2. Primary and Secondary Outcomes in an Unmatched Cohort of Patients Receiving Monoclonal Antibody Treatment and an At-Risk Population of Patients Not Receiving Monoclonal Antibody Treatment eTable 3. Subgroup Analyses of the Randomized Comparative Effectiveness Trial, Comparing Sotrovimab to Casirivimab and Imdevimab SUPPLEMENT 3, doi:10.1016/j.isci.2022.104076
Mccreary, Bariola, Minnier, A learning health system randomized trial of monoclonal antibodies for COVID-19. medRxiv, doi:10.1101/2021.09.03.21262551
Mccreary, Bariola, Minnier, Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days, Contemp Clin Trials, doi:10.1016/j.cct.2021.106652
Mccreary, Bariola, Wadas, Association of subcutaneous or intravenous administration of casirivimab and imdevimab monoclonal antibodies with clinical outcomes in adults with COVID-19, JAMA Netw Open, doi:
Zwarenstein, Treweek, Gagnier, Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement, BMJ, doi:10.1136/bmj.a2390
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