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2.
Clin Rheumatol ; 41(12): 3661-3673, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-1990657

ABSTRACT

INTRODUCTION: To describe clinical characteristics of patients in Japan with coronavirus disease 19 (COVID-19) and pre-existing rheumatic disease and examine the possible risk factors associated with severe COVID-19. METHODS: Adults with rheumatic disease and a COVID-19 diagnosis who were registered in the COVID-19 Global Rheumatology Alliance (C19-GRA) physician-reported registry from Japan between 15 May 2020 and 12 May 2021 were included. Multivariable logistic regression models were used to assess factors associated with severe COVID-19 progression, defined as death or requiring oxygen inhalation. RESULTS: In total, 222 patients were included in the study. Rheumatoid arthritis (48.2%), gout (14.4%), and systemic lupus erythematosus (8.1%) were the most common types of rheumatic disease, 55.1% of patients were in remission and 66.2% had comorbid disease. Most patients were hospitalised (86.9%) for COVID-19, 43.3% received oxygen, and 9.0% died. Older age (≥ 65 years), corticosteroid use, comorbid diabetes, and lung diseases are associated with higher risk for severe COVID-19 progression (odds ratio (OR) 3.52 [95% confidence interval (CI) 1.69-7.33], OR 2.68 [95% CI 1.23-5.83], OR 3.56 [95% CI 1.42-8.88], and OR 2.59 [95% CI 1.10-6.09], respectively). CONCLUSIONS: This study described clinical characteristics of COVID-19 patients with rheumatic diseases in Japan. Several possible risk factors for severe COVID-19 progression were suggested. Key points • Clinical characteristics of 222 adult patients in Japan with coronavirus disease 19 (COVID-19) and pre-existing rheumatic diseases were described. • Most patients were hospitalised (86.9%) for COVID-19 in Japan, 43.3% received oxygen, and 9.0% died. • The COVID-19 characteristics of patients with rheumatic diseases did not show any obvious different pattern from those of the general population in Japan. • In this study, older age (≥ 65 years), corticosteroid use, comorbid diabetes, and lung diseases are associated with higher risk for severe COVID-19 progression.


Subject(s)
Antirheumatic Agents , COVID-19 , Diabetes Mellitus , Physicians , Rheumatic Diseases , Rheumatology , Adult , Humans , COVID-19/epidemiology , SARS-CoV-2 , Japan/epidemiology , COVID-19 Testing , Antirheumatic Agents/therapeutic use , Rheumatic Diseases/complications , Rheumatic Diseases/epidemiology , Rheumatic Diseases/drug therapy , Registries , Diabetes Mellitus/epidemiology , Oxygen , Adrenal Cortex Hormones/therapeutic use
3.
Pharmaceuticals (Basel) ; 14(12)2021 Dec 02.
Article in English | MEDLINE | ID: covidwho-1554881

ABSTRACT

Coronavirus disease 2019 (COVID-19) remains a global threat to humanity. Its pathogenesis and different phases of disease progression are being elucidated under the pandemic. Active viral replication activates various immune cells and produces large amounts of inflammatory cytokines, which leads to the cytokine storm, a major cause of patient death. Therefore, viral inhibition is expected to be the most effective early in the course of the disease, while immunosuppressive treatment may be useful in the later stages to prevent disease progression. Based on the pathophysiology of rheumatic diseases, various immunomodulatory and immunosuppressive drugs are used for the diseases. Due to their mechanism of action, the antirheumatic drugs, including hydroxychloroquine, chloroquine, colchicine, calcineurin inhibitors (e.g., cyclosporine A and tacrolimus), glucocorticoids, cytokines inhibitors, such as anti-tumor necrosis factor-α (e.g., infliximab), anti-interleukin (IL)-6 (e.g., tocilizumab, sarilumab, and siltuximab), anti-IL-1 (e.g., anakinra and canakinumab) and Janus kinase inhibitors (e.g., baricitinib and tofacitinib), cytotoxic T lymphocyte-associated antigen 4 blockade agents (e.g., abatacept), and phosphodiesterase 4 inhibitors (e.g., apremilast), have been tried as a treatment for COVID-19. In this review, we discuss the mechanisms of action and clinical impact of these agents in the management of COVID-19.

4.
JPRN; 29/03/2021; TrialID: JPRN-jRCT2071200117
Clinical Trial Register | ICTRP | ID: ictrp-JPRN-jRCT2071200117

ABSTRACT

Condition:

coronavirus disease 2019(COVID-19)

Intervention:

IV Cohort : A single IV dose of Casirivimab(Genetical Recombination)1200mg and Imdevimab(Genetical Recombination)1200mg, a single IV dose of Casirivimab(Genetical Recombination)4000mg and Imdevimab(Genetical Recombination)4000mg or a single IV dose of placebe
SC Cohort : A single SC dose of Casirivimab(Genetical Recombination)600mg and Imdevimab(Genetical Recombination)600mg or a single SC dose of placebo

Primary outcome:

Safety, Phamacokinetics
Safety and Tolerability Endpoints
- Adverse events that occurred after the initial dose of the study drug, including serious adverse events (SAEs)
- Vital signs
- Physical Findings
- Laboratory Findings
- 12-lead electrocardiography
Evaluation items for PK
- Concentrations and PK parameters of casirivimab and imdevimab in Serum

Criteria:

Inclusion criteria: - Absence of findings suggestive of active disease
- For subjects with chronic diseases, maintaining stable state at least 6 months prior to screening
- Willingness and ability to comply with the requirements of the study protocol
- Consent to contraception

Exclusion criteria: - Positive diagnostic test results for SARS-CoV-2 infection using samples collected within 72 hours prior to enrollment
- A History of positive diagnostic tests for SARS-CoV-2 infection
- Medically attended acute disease, systemic administration of antibiotics, or hospitalization at least one night for any reason within 30 days prior to screening
- One or more clinically significant abnormal laboratory results at screening
- A severe allergy, anaphylactic reaction or hypersensitivity to chimeric, human, humanized antibodies or fusion protein or drug (including additives)

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