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      A practical approach for vaccinations including COVID-19 in autoimmune/autoinflammatory rheumatic diseases: a non-systematic review

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          Abstract

          The COVID-19 pandemic has occupied the world agenda since December 2019. With no effective treatment yet, vaccination seems to be the most effective method of prevention. Recently developed vaccines have been approved for emergency use only and are currently applied to large populations. Considering both the underlying pathogenic mechanisms of autoimmune/autoinflammatory rheumatological diseases (AIIRDs) and the immunosuppressive drugs used in treatment, vaccination for COVID-19 deserves special attention in such patients. In this article, we aimed to give simple messages to the clinicians for COVID-19 vaccination in patients with AIIRDs based upon the current evidence regarding the use of other vaccines in this patient group. For this purpose, we conducted a “Pubmed search” using the following keywords: Influenza, Hepatitis B, Pneumococcal, and Shingles vaccines and the frequently used conventional and biologic disease-modifying antirheumatic drugs (DMARDs). Likewise, an additional search was performed for the COVID-19 immunization in patients with AIIRDs and considering such drugs. In summary, patients with AIIRDs should also be vaccinated against COVID-19, preferably when disease activity is under control and when there is no concurrent infection. Low-degree immunosuppression does not appear to decrease antibody responses to vaccines. Ideally, vaccinations should be done before the initiation of any biological DMARDs. Patients receiving rituximab should be vaccinated at least 4 weeks before or 6 months after treatment. Since tofacitinib may also reduce antibody responses, especially in combination with methotrexate, it may be appropriate to discontinue this drug before vaccination and to restart after 14 days of immunization.

          Key points

          • COVID-19 vaccinations should preferably be made during remission in patients with autoimmune/autoinflammatory rheumatological diseases.

          • Low-degree immunosuppression may not interfere with antibody response to vaccines.

          • Ideally, vaccinations should be made before the initiation of any biological DMARDs.

          • Timing of vaccination is especially important in the case of rituximab.

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          Most cited references77

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          Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study

          Fei Zhou, Ting Yu, Ronghui Du … (2020)
          Summary Background Since December, 2019, Wuhan, China, has experienced an outbreak of coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Epidemiological and clinical characteristics of patients with COVID-19 have been reported but risk factors for mortality and a detailed clinical course of illness, including viral shedding, have not been well described. Methods In this retrospective, multicentre cohort study, we included all adult inpatients (≥18 years old) with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital (Wuhan, China) who had been discharged or had died by Jan 31, 2020. Demographic, clinical, treatment, and laboratory data, including serial samples for viral RNA detection, were extracted from electronic medical records and compared between survivors and non-survivors. We used univariable and multivariable logistic regression methods to explore the risk factors associated with in-hospital death. Findings 191 patients (135 from Jinyintan Hospital and 56 from Wuhan Pulmonary Hospital) were included in this study, of whom 137 were discharged and 54 died in hospital. 91 (48%) patients had a comorbidity, with hypertension being the most common (58 [30%] patients), followed by diabetes (36 [19%] patients) and coronary heart disease (15 [8%] patients). Multivariable regression showed increasing odds of in-hospital death associated with older age (odds ratio 1·10, 95% CI 1·03–1·17, per year increase; p=0·0043), higher Sequential Organ Failure Assessment (SOFA) score (5·65, 2·61–12·23; p<0·0001), and d-dimer greater than 1 μg/mL (18·42, 2·64–128·55; p=0·0033) on admission. Median duration of viral shedding was 20·0 days (IQR 17·0–24·0) in survivors, but SARS-CoV-2 was detectable until death in non-survivors. The longest observed duration of viral shedding in survivors was 37 days. Interpretation The potential risk factors of older age, high SOFA score, and d-dimer greater than 1 μg/mL could help clinicians to identify patients with poor prognosis at an early stage. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future. Funding Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences; National Science Grant for Distinguished Young Scholars; National Key Research and Development Program of China; The Beijing Science and Technology Project; and Major Projects of National Science and Technology on New Drug Creation and Development.
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            A Novel Coronavirus from Patients with Pneumonia in China, 2019

            Na Zhu, Dingyu Zhang, Wenling Wang … (2020)
            Summary In December 2019, a cluster of patients with pneumonia of unknown cause was linked to a seafood wholesale market in Wuhan, China. A previously unknown betacoronavirus was discovered through the use of unbiased sequencing in samples from patients with pneumonia. Human airway epithelial cells were used to isolate a novel coronavirus, named 2019-nCoV, which formed a clade within the subgenus sarbecovirus, Orthocoronavirinae subfamily. Different from both MERS-CoV and SARS-CoV, 2019-nCoV is the seventh member of the family of coronaviruses that infect humans. Enhanced surveillance and further investigation are ongoing. (Funded by the National Key Research and Development Program of China and the National Major Project for Control and Prevention of Infectious Disease in China.)
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              Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

              Merryn Voysey, Sue Ann Costa Clemens, Shabir Madhi … (2022)
              Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; p interaction =0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. Funding UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D’Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.
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                Author and article information

                Contributors
                Mehmet Soy:
                ORCID: http://orcid.org/0000-0003-1710-7018
                mhmtsoy@gmail.com
                Gökhan Keser:
                ORCID: https://orcid.org/0000-0001-7289-1816
                agkkeser@gmail.com
                Pamir Atagunduz:
                ORCID: https://orcid.org/0000-0002-6393-7461
                pamir.atagunduz@gmail.com
                Melek Yalçin Mutlu:
                ORCID: https://orcid.org/0000-0003-0598-5737
                melekyalcinn@hotmail.com
                Alper Gunduz:
                ORCID: https://orcid.org/0000-0001-9154-844X
                gunduzalper@gmail.com
                Gizem Koybaşi:
                ORCID: https://orcid.org/0000-0003-4730-2025
                gizemkoybasi@gmail.com
                Cemal Bes:
                ORCID: https://orcid.org/0000-0002-1730-2991
                cemalbes@hotmail.com
                Journal
                Journal ID (nlm-ta): Clin Rheumatol
                Journal ID (iso-abbrev): Clin Rheumatol
                Title: Clinical Rheumatology
                Publisher: Springer International Publishing (Cham )
                ISSN (Print): 0770-3198
                ISSN (Electronic): 1434-9949
                Publication date (Electronic): 22 March 2021
                Pages: 1-13
                Affiliations
                [1 ]GRID grid.449305.f, ISNI 0000 0004 0399 5023, Altınbas University (previously Kemerbas University) Faculty of Medicine Department of Internal Medicine, Division of Rheumatology, , Bahcelievler MedicalPark Hospital, ; Istanbul, Turkey
                [2 ]Present Address: Altunizade Mah. Atif Bey sk. Gokdeniz Sitesi, E-3; Usküdar, Istanbul, Turkey
                [3 ]GRID grid.8302.9, ISNI 0000 0001 1092 2592, Ege University Faculty of Medicine Department of Internal Medicine, Division of Rheumatology, ; Bornova, Izmir, Turkey
                [4 ]GRID grid.16477.33, ISNI 0000 0001 0668 8422, Marmara University Faculty of Medicine Department of Internal Medicine, Division of Rheumatology, ; Istanbul, Turkey
                [5 ]University of Health Sciences, Basaksehir Cam and Sakura City Hospital, Basaksehir, Istanbul, Turkey
                [6 ]GRID grid.414177.0, ISNI 0000 0004 0419 1043, Department of Rheumatology, , University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital, ; İstanbul, Turkey
                [7 ]Şişli Hamidiye Etfal Training and Research Hospital, Department of Infectious Diseases, İstanbul, Turkey
                [8 ]GRID grid.414850.c, ISNI 0000 0004 0642 8921, Yedikule Chest Diseases and Chest Surgery Training and Research Hospital, ; İstanbul, Turkey
                [9 ]University of Health Sciences, Başakşehir Çam and Sakura City Hospital, Istanbul, Turkey
                [10 ]GRID grid.414177.0, ISNI 0000 0004 0419 1043, Department of Rheumatology, , University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital, ; İstanbul, Turkey
                Author information
                http://orcid.org/0000-0003-1710-7018
                https://orcid.org/0000-0001-7289-1816
                https://orcid.org/0000-0002-6393-7461
                https://orcid.org/0000-0003-0598-5737
                https://orcid.org/0000-0001-9154-844X
                https://orcid.org/0000-0003-4730-2025
                https://orcid.org/0000-0002-1730-2991
                Article
                Publisher ID: 5700
                DOI: 10.1007/s10067-021-05700-z
                PMC ID: 7982510
                PubMed ID: 33751280
                SO-VID: 50ede3ea-c3d6-4665-baf7-fd0e49f961f4
                Copyright © © International League of Associations for Rheumatology (ILAR) 2021
                License:

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                History
                Date received : 9 February 2021
                Date revision received : 5 March 2021
                Date accepted : 15 March 2021
                Categories
                Subject: Review Article

                ScienceOpen disciplines: Rheumatology
                Keywords: autoimmune/autoinflammatory rheumatological diseases,covid-19,dmards,rituximab,vaccine
                Data availability:
                ScienceOpen disciplines: Rheumatology
                Keywords: autoimmune/autoinflammatory rheumatological diseases, covid-19, dmards, rituximab, vaccine

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