Abstract
Vaccine hesitancy is considered a major barrier to achieving herd immunity against COVID-19. While multiple alternative and synergistic approaches including heterologous vaccination, booster doses, and antiviral drugs have been developed, equitable vaccine uptake remains the foremost strategy to manage pandemic. Although none of the currently approved vaccines are live-attenuated, several reports of disease flares, waning protection, and acute-onset syndromes have emerged as short-term adverse events after vaccination. Hence, scientific literature falls short when discussing potential long-term effects in vulnerable cohorts. The COVAD-2 survey follows on from the baseline COVAD-1 survey with the aim to collect patient-reported data on the long-term safety and tolerability of COVID-19 vaccines in immune modulation. The e-survey has been extensively pilot-tested and validated with translations into multiple languages. Anticipated results will help improve vaccination efforts and reduce the imminent risks of COVID-19 infection, especially in understudied vulnerable groups.
Supplementary Information
The online version contains supplementary material available at 10.1007/s00296-022-05157-6.
Keywords: COVID-19, Registries, Vaccination, Long-term adverse effects, Autoimmune diseases
The future of the COVID-19 pandemic: emerging problems and the way forward
It is unclear when, if and how natural regression of the ongoing coronavirus disease 2019 (COVID-19) pandemic, which has been a cause of unprecedented global morbidity and mortality, will be achieved. Moreover, the progression of COVID-19 to a chronic endemic illness is likely to increase the burden of emerging problems such as post-COVID-19 syndrome [1]. Preventive measures such as vaccination, can help reduce the socioeconomic and health burden associated with COVID-19 [2]. Thus, stringent advocacy for equitable vaccine uptake could help relieve the strain on over-stretched healthcare delivery systems, some of which have been pushed to the brink of collapse [3]. Vaccine efficacy, the longevity of immunity, the potency of booster doses, and the emergence of new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants are considered important determinants in achieving herd immunity against COVID-19 [4].
Scientific ingenuity combined with global collaboration has accelerated the development, licensure, and dissemination of SARS-CoV-2 vaccines at an unprecedented pace. The milestone of 10 billion inoculations worldwide was already achieved in January 2022 [5] although there still remains considerable heterogeneity in the availability and uptake of vaccines across different regions. Nearly ten vaccines have been granted emergency use authorization (EUA), in addition to many vaccine candidates undergoing clinical trials and even more in the pre-clinical phase [6, 7]. Hence, appraising the protective capacity, dynamics, and persistence of immune responses following SARS-CoV-2 infection against different variants warrants rigorous research, especially with scarce evidence-base available.
Navigating uncharted waters: COVID-19 vaccination in patients with autoimmune diseases
Several health organizations have recently authorized booster vaccine doses for previously vaccinated patients [8]. However, the differing administration criteria and scarcity of data on the safety and efficacy profile of these booster doses have led to speculations about booster safety and effectiveness in population groups with altered immunogenic responses. This specifically applies to the immunocompromised, those with autoimmune diseases, and patients undergoing immunotherapy. Heterologous vaccination is also a novel strategy to induce stronger immunogenic responses with acceptable reactogenicity profiles in the face of global vaccine supply interruptions and transmission of emerging variants [9]. Interestingly, this ‘mix and match’ vaccination approach has yielded 20- to 60-fold greater titers of neutralizing antibodies against the SARS-CoV-2 variants by including diverse spike sequences [10].
Recent data from the ongoing COVID-19 vaccination in autoimmune disease (COVAD) study [11] and other large alliance-based research projects have shown the short-term adverse effects of COVID-19 vaccination in patients with autoimmune diseases are comparable to those in healthy controls. Yet, vaccine hesitancy continues to be an impediment to achieving mass immunisation, including vulnerable patient groups [12]. Vaccine hesitancy is mainly contingent on expedited vaccine development and authorization, social media misinformation, distrust in health authorities, perceived adjunctive risks, certain religious beliefs, conspiracy theories, limited research, and assessment, mobilised opposition, and strategic politicisation against mass immunisation efforts [13]. Whilst certain nations, e.g. Brazil, South Africa, Denmark, and the UK are highly receptive to vaccine uptake with approximately 80% vaccination rates, they constitute only 10–20% of the global population [14]. The World Health Organization has rightly identified vaccine hesitancy as one of the top ten global health threats, with discrepancies in confidence, complacency, and convenience as key background players [15]. Vaccine hesitancy is especially a concern in understudied and vulnerable populations, such as pregnant and lactating women, who were largely excluded from the initial vaccine safety trials. While additional data are required to determine the long-term effects of maternal reactogenicity, current evidence strongly suggests that the benefits of maternal vaccination outweigh the theoretical risks [16].
While newer antiviral agents, such as Molnupiravir, Paxlovid, and Sotrivimab, are currently in use, their efficacy in patients with specific autoimmune diseases is yet to be ascertained [17]. Despite the favourable adverse drug event (ADE) profile of SARS-CoV-2 vaccines, there have been concerns regarding the activation of aberrant immune responses. The adjuvants of inoculation can induce hypersensitivity reactions, and those with a heightened immune response or with an immunocompromised status may respond differently [18]. Since none of the currently authorised COVID-19 vaccines are live, the Centers for Disease Control and Prevention (CDC) considers them safe for administration to individuals with modulated immunity although with variable levels of protection [19]. However, skepticism regarding the long-term safety and efficacy of the vaccines, with reports of waning protection over a few months, the emergence of new autoimmune diseases as per several reported cases [20], and the exclusion of susceptible populations from phased vaccine administration have instilled concerns about vaccine safety and tolerability in this group [12]. Preliminary data from recent large-scale alliance-based studies suggest that the short-term effects of vaccination are comparable in patients with autoimmune disease and healthy controls and that the benefits of vaccination in reducing the severity of COVID-19 infection outweigh the risk of post-vaccination adverse effects in cases of immunomodulation [21].
A step towards meaningful data: the COVID-19 vaccination in autoimmune diseases survey
The paucity of evidence-based literature on the short-term safety of COVID-19 vaccines in patients with autoimmune diseases aroused distrust amongst these individuals despite the widely-asserted safety of vaccines [12]. To address this, the COVAD study was conceived, as a patient-reported international electronic survey, to collect meaningful data on the safety and tolerability of COVID-19 vaccines in patients with autoimmune diseases and healthy individuals. The baseline survey featured 36 questions, was hosted on the surveymonkey.com platform, translated into 18 languages, and circulated in early 2021 by the global COVAD study group of 110 physicians in over 94 countries. The initial survey collected over 19,200 responses that helped compile meaningful data on the short-term safety profile of COVID-19 vaccination [11]. However, questions regarding the long-term safety of COVID-19 vaccination remained unanswered.
Unanswered questions: the 2nd COVAD survey
Thereafter, the COVAD-2 survey was formulated with a similar methodology for its development, dissemination, and data collection as the baseline COVAD-1 survey to build on the information previously collected while preserving the original core item set. COVAD-2 will thus serve as a follow-up survey for past respondents and a standalone survey for new participants. The COVAD-2 e-survey has been vetted and extensively pilot-tested by a group of international experts including rheumatologists, neurologists, and internists. It has further undergone testing in patients and lay public and medical students to ensure the questions are simple and easy to understand. It is being translated into several languages and will then be hosted on the online platform surveymonkey.com followed by dissemination by the international expert COVAD study team on social media platforms (e.g. WhatsApp, Facebook, Instagram, and Twitter) and among patient groups in the out patient clinics. Special efforts are being made to cover regions of the world that were relatively under-represented in the current literature and COVAD-1 survey, including Africa, South America, and several countries in Asia.
This ongoing patient-reported study follows the predefined guidelines for survey-based reporting and is conceptualised to gather global data on the long-term efficacy of vaccines [22, 23]. Moreover, it will answer additional questions not previously explored in the baseline survey, such as the potential of vaccine-induced disease flares, de novo emergence of autoimmune diseases, effects of booster vaccine doses, and specific risks of antenatal vaccination. A more in-depth insight into the effects of vaccination on the functional status and quality of life of patients with autoimmune diseases, particularly idiopathic inflammatory myopathies, as well as pregnant and lactating women will also be acquired. Using the Patient-Reported Outcomes Measurement Information System (PROMIS) global and physical function 10A will offer the opportunity to objectively quantify the impact of breakthrough infections and even long COVID-19 [24]. The COVAD-2 survey questionnaire is included in Supplementary File 2.
Data will be downloaded from surveymonkey.com in Microsoft Excel format and imported into statistical analysis packages for further analysis. Descriptive statistics will be used with intergroup comparisons ad hoc using Stata. Open-ended responses will be qualitatively analysed with manual allocation to pre-existent or new categories while incomplete responses will be excluded. The anonymized dataset will be open to future analysis of proposed hypotheses, research questions, and study designs approved by collaborators of the COVAD steering committee for scientific validity and feasibility.
Results will be disseminated in select peer-reviewed journals, on virtual platforms, and at academic conferences. A summary of the study outcomes in plain language will be provided to the respondents upon request. All information about the project, such as study design, project administration, and publication preprints, will be made available upon request. At the conclusion of the study, recruitment materials, project destination links, and online survey media will be deactivated or removed. All data will remain confidential with the principal investigator for a period of five years.
Bridging the gap: bringing patients and healthcare providers closer in the era of COVID-19
Although the switch to remote consultations during the COVID-19 pandemic has widened the communication gap between healthcare providers and patients, it is imperative to address patient concerns and adverse events following vaccination as gathered by this self-reported survey. The results will help improve vaccination efforts and provide future policymakers with valuable data to formulate immunisation guidelines and reduce the imminent risks of COVID-19 in high-risk immunosuppressed groups that are currently understudied. Collaborative efforts toward rebuilding public confidence and community engagement with research-backed communication are essential for improving vaccine acceptance among those now holding views of vaccine hesitancy. The COVAD-2 survey thus follows a similar methodology for its development, dissemination, and data collection as the baseline COVAD-1 survey and aims to promote evidence-based health literacy in immunologically vulnerable populations.
Supplementary Information
Below is the link to the electronic supplementary material.
Acknowledgements
The authors thank all members of the COVAD study group for their invaluable role in the collection of data. The authors thank all respondents for filling the questionnaire. The authors thank The Myositis Association, Myositis India, Myositis UK, Myositis Support and Understanding, the Myositis Global Network, Deutsche Gesellschaft für Muskelkranke e.V. (DGM), Dutch and Swedish Myositis Support Groups, Cure JM, Cure IBM, Sjögren’s India Foundation, Patients Engage, Scleroderma India, Lupus UK, Lupus Sweden, Emirates Arthritis Foundation, EULAR PARE, ArLAR research group, AAAA patient group, APLAR myositis special interest group, Thai Rheumatism association, PANLAR, NRAS, AntiSynthetase Syndrome Support Group and various other patient support groups and organisations for their invaluable contribution in the dissemination of this survey among patients which made the data collection possible. The authors also thank all members of the COVAD study group.
COVID-19 Vaccination in Autoimmune Diseases-2 (COVAD-2) Study Group Author List and Affiliations
India: Dr Bhupen Barman: Department of Medicine, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences(NEIGRIHMS), Shillong-18, Meghalaya, India. Dr Yogesh Preet Singh: Assistant Professor, Division of Rheumatology and Clinical Immunology, Department of General Medicine, Himalayan Institute of Medical sciences, Swami Rama University, Jolly Grant, Dehradun—248140, Uttarakhand, India. Dr Rajiv Ranjan: Clinical Immunology & Rheumatology at Columbia Asia, Palam Vihar, Gurgaon, Haryana, India. Dr Avinash Jain: Department of Clinical Immunology and Rheumatology, SMS Medical College and Hospital, Jaipur, Rajasthan, India. Dr Sapan C Pandya: Rheumatic Disease Clinic, Vedanta Institute of Medical Sciences, Navrangpura, Ahmedabad 380009, Gujarat, India. Dr Rakesh Kumar Pilania: Pediatric Allergy Immunology Unit, Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India. Dr Aman Sharma: Clinical Immunology and Rheumatology Services, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India. Dr Manesh Manoj M: Department of Clinical Immunology and Rheumatology, AKG Memorial Hospital and Dr Shenoy’s CARE (Centre for Arthritis and Rheumatism Excellence), Kannur, Kerala, India. Dr Vikas Gupta: Rheumatology, Dayanand Medical College and Hospital, Ludhiana, Punjab 141001, India. Dr Chengappa G Kavadichanda: Department of Clinical Immunology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India. Dr Pradeepta Sekhar Patro: Department of Clinical Immunology and Rheumatology, Sunshine Hospitals, Plot No. 208, Cuttack Puri Road, Laxmisagar, Bhubaneshwar, Odisha, India. Dr Sajal Ajmani: Arthritis and Rheumatology clinic, New Delhi, Delhi, India. Dr Sanat Phatak: Rheumatology & Immunology, Department of Rheumatology and Immunology, KEM Hospital, Pune, Maharashtra, India. Dr Rudra Prosad Goswami: Department of Rheumatology, All India Institute of Medical Sciences, New Delhi, Delhi, India. Dr Abhra Chandra Chowdhury: Rheumatology, AMRI Hospital, Dhakuria, Kolkata, West Bengal, India. Dr Ashish Jacob Mathew: Department of Clinical Immunology & Rheumatology, Christian Medical College and Hospital, Vellore, Tamil Nadu 632004, India. Dr Padnamabha Shenoy: Dr Shenoy’s CARE (Centre for Arthritis and Rheumatism Excellence), Kannur, Kerala, India. Dr Ajay Asranna: Department of Neurology, NIMHANS, Bengaluru, Karnataka, India. Dr Keerthi Talari Bommakanti: Rheumatology, Yashoda hospital, Behind Hari Hara Kala Bhavan, Secunderabad—500003, T.S. Hyderabad, Telangana, India. Dr Anuj Shukla: Niruj Rheumatology Clinic, 209 Rajvi Complex, Rambaug, Ahmedabad, 380008, Gujarat, India. Dr Arun Kumar R Pandey: LEDTC Clinic, Gomti Nagar, Lucknow, Uttar Pradesh, India. Prithvi Sanjeevkumar Gaur: Smt. Kashibai Navale Medical and General Hospital, Pune, India. Dr Mahabaleshwar Mamadapur: Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. Akanksha Ghodke: Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India. Dr Kunal Chandwar: Department of Clinical Immunology and Rheumatology, King George's Medical University, Lucknow, Uttar Pradesh, India. Kshitij Jagtap: Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Mumbai, Maharastra, India. Pakistan: Zoha Zahid Fazal: Medical College, The Aga Khan University, Karachi, Pakistan. Turkey: Dr Döndü Üsküdar Cansu: Division of Rheumatology, Department of Internal Medicine, Eskişehir Osmangazi University, 26480, Eskişehir, Turkey. Dr Reşit Yıldırım: Division of Rheumatology, Osmangazi University, Turkey. United States of America: Dr Aarat Patel: Bon Secours Rheumatology Center and Division of Pediatric Rheumatology, Department of Pediatrics, University of Virginia School of Medicine , Charlottesville, VA, USA. United Kingdom: Dr John D Pauling: 1. Royal National Hospital for Rheumatic Diseases (at Royal United Hospitals), Upper Borough Walls, Bath, BA1 1RL, UK. 2. Department of Pharmacy and Pharmacology, University of Bath, Bath, UK. Dr Chris Wincup: Department of Rheumatology, Division of Medicine, Rayne Institute, University College London, 5 University Street, London WC1E 6JF, UK; Centre for Adolescent Rheumatology Versus Arthritis at UCL, UCLH, GOSH, London, UK. France: Dr. Margherita Giannini: Explorations fonctionnelles musculaires, service de physiologie, Hôpitaux universitaires de Strasbourg; EA3072, fédération de médecine translationnelle, France. Dr François Maurier: Service de Médecine Interne, Hôpital Robert Schuman, Rue du Champ Montoy, 57070 Vantoux, France. Dr Julien Campagne: Service de Médecine Interne, Hôpital Robert Schuman, Rue du Champ Montoy, 57070 Vantoux, France. Dr Alain Meyer: 1. Centre National de Référence des Maladies Systémiques et Auto-immunes Rares Grand-Est Sud-Ouest (RESO), Service de humatologie, Service de physiologie, Unité d’explorations fonctionnelles musculaires, Hôpitaux Universitaires de Strasbourg, Strasbourg, France; 2. EA3072, Fédération de Médecine Translationelle, Université de Strasbourg, Strasbourg, France. Italy: Dr. Nicoletta Del Papa: Unità operativa complessa (UOC) Day Hospital Reumatologia via Gaetano Pini 9, Centro Specialistico Ortopedico Traumatologico, Gaetano Pini-CTO, Milano, Italy. Dr. Gianluca Sambataro: Medico Immunologia e reumatologia presso, Artoreuma S.R.L., Cors S. Vito 53, 95030 Mascalucia, CT, Italy. Dr. Atzeni Fabiola: Rheumatology Unit, University of Messina, Messina, Italy. Dr. Marcello Govoni: Department of Medical Sciences, Complex Operative Unit and Rheumatology Unit of S.Anna University Hospital, University of Ferrara, Via A. Moro 8, 44124- Cona (FE), Italy. Dr Simone Parisi: Epidemiology Unit, Italian Society for Rheumatology, Milan, Italy; Rheumatology Unit, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, Italy. Dr Elena Bartoloni Bocci: Department of Medicine and Surgery, MED/16- Rheumatology, Università degli studi di Perugia, P.zza Università—06123 – Perugia, Italy. Dr. Gian Domenico Sebastiani: U.O.C. Reumatologia, Ospedale San Camillo-Forlanini, Roma, Italy. Dr Enrico Fusaro: Rheumatology Unit, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy. Dr Marco Sebastiani: Rheumatology Unit, University of Modena and Reggio Emilia, Azienda Ospedaliero-Universitaria Policlinico di Modena, Via del Pozzo, 41125, Modena, Italy. Dr Luca Quartuccio: Clinic of Rheumatology, Department of Medicine (DAME), ASUFC, University of Udine, Udine, Italy. Dr Franco Franceschini: Rheumatology and Clinical Immunology Unit, Department of Clinical and Experimental Sciences, ASST Spedali Civili and University of Brescia, Italy. Dr Pier Paolo Sainaghi: 1. Department of Translational Medicine, Università del Piemonte Orientale UPO, Novara, Italy. 2. Division of Internal Medicine, Immunorheumatology Unit, CAAD (Center for Translational Research on Autoimmune and Allergic Disease) Maggiore della Carità Hospital, Novara, Italy. 3. IRCAD, Interdisciplinary Research Center of Autoimmune Diseases, Novara, Italy. Dr Giovanni Orsolini: Department of Medicine, Rheumatology Unit, University of Verona, Verona, Italy. Dr Rossella De Angelis: Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Italy. Dr Maria Giovanna Danielli: Clinica Medica, Dipartimento di Scienze Cliniche e Molecolari, Università Politecnica delle Marche e Azienda Ospedali Riuniti, Ancona, Italy. Dr Vincenzo Venerito: Department of Emergency and Organ Transplantations-Rheumatology Unit, University of Bari “Aldo Moro”, Bari, Italy. Dr Silvia Grignaschi: Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Università degli studi di Pavia, Pavia, Lombardy, Italy. Dr. Alessandro Giollo. Division of Rheumatology, Department of Medicine, University of Padova Hospital Trust, Padova, Italy. Philippines: Dr Lisa S Traboco: Philippine Rheumatology Association, St Luke’s Medical Center- Global City (Visiting), Philippines. Malaysia: Dr. Syahrul Sazliyana Shaharir- Rheumatology Unit, Department of Internal Medicine, Universiti Kebangsaan Malaysia Medical Centre (UKMMC), Jalan Yaacob Latiff, Kuala Lumpur, Malaysia. Indonesia: Dr Suryo Anggoro Kusumo Wibowo: Rheumatology Division, Department of Internal Medicine, Fakultas Kedokteran, Universitas Indonesia, Indonesia. Mexico: Dr Erick Adrian Zamora Tehozol: Centro Médico Pensiones, Autoimmunity Division, Mérida, Yucatán, Mexico. Dr Jorge Rojas Serrano: Interstitial Lung Disease and Rheumatology Unit, Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico. Dr Ignacio García-De La Torre: Departamento de Inmunología y Reumatología, Hospital General de Occidente and University of Guadalajara, Guadalajara, Jalisco, Mexico. Dr. Iris J. Colunga‑Pedraza: Rheumatology Service, Facultad de Medicina y Hospital Universitario “Dr. JoseE. Gonzalez”, Universidad Autonoma de Nuevo Leon, Av. Francisco I. Madero y Gonzalitos S/N, Colonia Mitras Centro, 64460 Monterrey, Nuevo Leon, Mexico. Dr. Iris J. Colunga‑Pedraza: Rheumatology Service, Facultad de Medicina y Hospital Universitario “Dr. JoseE. Gonzalez”, Universidad Autonoma de Nuevo Leon, Av. Francisco I. Madero yGonzalitos S/N, Colonia Mitras Centro, 64460 Monterrey, Nuevo Leon, Mexico. Dr. Javier Merayo-Chalico: Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición “Salvador Zubirán”, Mexico City, Mexico. Spain: Dr Jesús Loarce-Martos: Rheumatology Department, Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo, 9, 1 km, 28043, Madrid, Spain. Dr Sergio Prieto-González: Department of Internal Medicine, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain. Dr Albert Gil-Vila: Systemic Autoimmune Diseases Unit, Vall d'Hebron General Hospital, Medicine Department, Universitat Autónoma de Barcelona, Barcelona, Spain. Dr Raquel Aranega: Systemic Autoimmune Diseases Unit, Vall d'Hebron General Hospital, Medicine Department, Universitat Autónoma de Barcelona, Barcelona, Spain. Brazil: Dr Leonardo Santos Hoff: School of Medicine, Universidade Potiguar (UnP), Brazil. Japan: Dr Ran Nakashima: Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan. Dr Shinji Sato: Division of Rheumatology, Department of Internal Medicine, Tokai University School of Medicine, 143 Shimokasuya, Isehara, 259-1193, Japan. Dr Naoki Kimura: Department of Lifetime Clinical Immunology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan. Dr Yuko Kaneko: Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. Germany: Dr Stylianos Tomaras: Department of Rheumatology, Helios Clinic Vogelsang-Gommern, 39245 Gommern, Germany. Dr Fabian Nikolai Proft: Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité—Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt- Universität zu Berlin, Berlin, Germany. Dr Marie-Therese Holzer: 1. Department of Pediatrics, Pediatric Rheumatology/Special Immunology, University Hospital Wuerzburg, Josef-Schneider-Str. 2, 97080, Wuerzburg, Germany. 2. Department of Internal Medicine III. (Nephrology and Rheumatology With Section Endocrinology), University Hospital Hamburg- Eppendorf, University Hospital Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. Russian Federation: Dr Margarita Aleksandrovna Gromova: Pirogov Russian National Research Medical University (RNRMU), Moscow, Russian Federation. Israel: Mr Or Aharonov: Department of Gerontology, Faculty of Social Welfare and Health Science, University of Haifa, Haifa, Israel. Hungary: Dr Melinda Nagy-Vincze: 1. Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Móricz Zsigmond út 22, Debrecen, H-4032, Hungary. 2. Gyula Petrányi Doctoral School of Clinical Immunology and Allergology, University of Debrecen, Debrecen, Hungary. Dr Zoltán Griger: 1. Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Móricz Zsigmond út 22, Debrecen, H-4032, Hungary. Morocco: Dr Ihsane Hmamouchi: Laboratoire d'épidémiologie et de recherche clinique, La Faculté de Médecine et de Pharmacie de Rabat, Morocco. Dr Pr Imane El bouchti: Rheumatology Department, Mohammed VI University Hospital, Marrakech, Morocco. Dr. Zineb Baba: Department of Rheumatology, Mohammed VI University Hospital, Marrakech, Morocco. Nigeria: Dr Uyi Ima-Edomwonyi: Consultant, Department of Internal Medicine, Lagos University Teaching Hospital, Lagos, Nigeria. Dr Ibukunoluwa Dedeke: Department of Medicine, University College Hospital Ibadan, Ibadan, Nigeria. Dr Emorinken Airenakho: Consultant Rheumatologist, Irrua Specialist Teaching Hospital, KM 87 Benin Auchi Rd, 310115, Irrua, Nigeria. Dr Nwankwo Henry Madu: Department of Medicine, Nnamdi Azikiwe University, Awka, Nigeria. Dr Abubakar Yerima: Department of Medicine, University of Maiduguri Teaching Hospital, Maiduguri, Borno State, Nigeria. Dr Hakeem Olaosebikan: Rheumatology, Lagos State University Teaching Hospital/ Lagos State University College of Medicine,Ikeja, Lagos, Nigeria. Dr Okwara Celestine Chibuzo: Rheumatology, University of Nigeria Teaching Hospital, Enugu, Nigeria. Ethiopia: Dr Becky A: Rheumatology Unit, Internal Medicine Department, Addis Ababa University, Addis Ababa, Ethiopia. Mauritius: Dr Ouma Devi Koussougbo: Rheumatology, Victoria hospital, Mauritius. Mozambique: Dr Elisa Palalane: Rheumatology and Internal Medicine, Hospital Central de Maputo, Maputo, Mozambique. Australia: Dr Daman Langguth: Department of Immunology, Sullivan Nicolaides Pathology, Brisbane, Queensland, Australia. Dr Vidya Limaye: Rheumatology, Royal Adelaide Hospital and Discipline of Medicine, University of Adelaide, Australia. Dr Merrilee Needham: 1. Neurology Department, Fiona Stanley Hospital, Murdoch, Australia; 2. Institute for Immunology and Infectious Diseases, Murdoch University, Murdoch, Australia; 3. Perron Institute for Neurological and Translational Science, Nedlands, Australia; 4. University of Notre Dame, Fremantle, Australia. Dr Nilesh Srivastav: Alfred Health, The Alfred, Caulfield Hospital, Sandringham Hospital, Melbourne, Victoria, Australia. Canada: Dr Marie Hudson: Department of Medicine, McGill University, Montreal, Quebec; Division of Rheumatology, Jewish General Hospital, Montreal, Quebec, and Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada. Dr Océane Landon-Cardinal: 1. Department of Medicine, University of Montreal, Montreal, Canada. 2. Department of Medicine, CHUM Research Centre, Montreal, Canada. Colombia: Dr Wilmer Gerardo Rojas Zuleta: Department of Rheumatology, Universidad de Antioquia, Cl. 67 #53—108, Medellín, Colombia. Dr. Álvaro Arbeláez: Médico especialista en Reumatología y Medicina Interna. Universidad Libre. Clínica Imbanaco. Clínica de Artritis Temprana. Cali, Valle, Colombia. Dr. Javier Cajas: Institute of Rheumatology Ferdinand Chalem, Bogota, Colombia. Portugal: Dr José António Pereira Silva: Rheumatology Department, Centro Hospitalar e Universitário de Coimbra EPE, and Coimbra Institute of Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Portugal. Dr João Eurico Fonseca: Hospital de Santa Maria, Centro Hospitalar Lisboa Norte Centro Académico de Medicina de Lisboa, Lisboa, Portugal; Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal. Ukraine: Dr Olena Zimba: Department of Internal Medicine #2, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine. Dr Doskaliuk Bohdana: Department of Pathophysiology, Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine. Hong Kong: Dr Ho So: Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong. Peru: Dr Manuel Francisco Ugarte-Gil: Servicio de Reumatología, Hospital Nacional Guillermo Almenara Irigoyen, EsSalud, Lima, Peru. School of Medicine, Universidad Científica del Sur, Lima, Peru. Dr. Lyn Chinchay: Seguro Social de Salud del Peru (ESSALUD), Lima, Peru. Dr. José Proaño Bernaola: 1. Cayetano Heredia National Hospital, Lima, Peru. 2. Anglo-American Clinic. San Isidro, Lima, Peru. 3. Peruvian University Cayetano Heredia, Lima, Peru. 4. Rheumatologist, San Judas Tadeo Clinic—Research Center (ENDOMED), Lima. 5. Environmental and Food Health—DIRIS – Lima, Peru. Dr. Victorio Pimentel: Rheumatology Department, Hospital Guillermo Almenara Irigoyen, EsSalud, Av. Grau 800, La Victoria, Lima 13, Lima, Peru. Bangladesh: Dr A.T.M. Tanveer Hasan: Department of Rheumatology, Enam Medical College and Hospital, 9/3 Parboti Nagar, Thana Rd, Savar Union 1340, Bangladesh. Sreoshy Saha: Mymensingh Medical College, Mymensingh, Bangladesh. Nepal: Dr Binit Vaidya: Department of Rheumatology, National Centre for Rheumatic Diseases, Ratopul, Kathmandu, Nepal. Egypt: Dr Hanan Mohamed Fathi: Rheumatology and Autoimmune Diseases, Faculty of Medicine, Fayoum University, Faiyum, Egypt. Dr Reem Hamdy A Mohammed: Department of Rheumatology and Clinical Immunology, Kasr Alainy School of Medicine- Cairo University, Cairo, Egypt. Taiwan: Dr Yi-Ming Chen: Division of Allergy, Immunology and Rheumatology, Department of Medical Research, Taichung Veterans General Hospital, Taiwan. blacklark@gmail.com. United Arab Emirates: Dr Ghita Harifi: Department of Rheumatology, Mediclinic Parkview Hospital, 3 Umm Suqeim St—Al Barsha Al Barsha South, Dubai, United Arab Emirates. Saudi Arabia: Dr Lina El Kibbi: Department of Rheumatology, Specialised Medical Center Hospital, Alfaisal University, Riyadh, Saudi Arabia. Dr Hussein Mohammed Halabi: Department of Medicine, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia. Thailand: Dr P Akawatcharangura: Department of Medicine, Queen Savang Vadhana Memorial Hospital, Chonburi, Thailand. Dr. Wanruchada Katchamart: 1. Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand 2. Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand. Venezuela: Dr. Yurilís Fuentes-Silva: 1. Health Sciences School, University of Oriente– Bolivar Nucleus, Ciudad Bolivar, Venezuela. 2. Centro Clínico Universitario de Oriente, Ciudad Bolivar, Venezuela. Paraguay: Dr. Karoll Cabriza: Kinesiologa, Hospital de clinicas asuncion, Paraguay. Dr. Jonathan Losanto: Hospital de Clínicas, San Lorenzo, Paraguay. Dr. Nelly Colaman: Hospital de Clínicas, San Lorenzo, Paraguay. Panama: Dr. Antonio Cachafeiro-Vilar: Pacífica Salud-Hospital Punta Pacífica, Ciudad de Panamá, Panamá. Dr. Generoso Guerra Bautista: Centro de Investigación Marbella, Paitilla Panamá, Panamá. Dr. Enrique Julio Giraldo Ho: Rheumatology, Universidad de Panamá, República de Panamá, Panamá. Dr. Raúl Agustín González: Caja de Seguro Social de Panamá, Panamá. Chile: Dr. Lilith Stange Nunez: Rheumatology, University of Valparaiso, Pontifical Catholic University of Chile, Chile. Dr. Cristian Vergara M: Departamento de Medicina Interna, Escuela de Medicina Dirección de PostGrado y Post Título, Facultad de Medicina, Universidad de Valparaíso, Santiago, Chile. Dominican Republic: Dr. Jossiell Then Báez: Hospital Metropolitano de Santiago (HOMS), Santiago, Dominican Republic. Honduras: Dr. Hugo Alonzo: Jefe del Departamento de Medicina Interna en Hospital de Especialidades del Seguro Social en Tegucigalpa, Honduras. Dr. Carlos Benito Santiago Pastelin: Médico especialista, Instituto Hondureño del Seguro Social, Honduras. Argentina: Dr. Rodrigo García Salinas: Rheumatology Unit, La Plata Italian Hospital, Buenos Aires, Argentina. Guatemala: Dr. Alejandro Quiñónez Obiols: Universidad Mariano Gálvez de Guatemala, Guatemala City, Guatemala. Dr. Nilmo Chávez: Instituto Guatemalteco de Seguridad Social—Universidad San Carlos de Guatemala, Ciudad de Guatemala, Guatemala. Dr. Andrea Bran Ordóñez: Hospital Universitario Esperanza, Guatemala City, Guatemala. Dr. Sandra Argueta: Rheumatology and Immunology, Universidad de San Carlos de Guatemala, Ciudad de Guatemala, Guatemala. Dr. Daniel Quijivix: Medicina Interna, Hidro Clinic, Quezaltenangro, Guatemala. Cuba: Dr. Gil Alberto Reyes Llerena: Surgical Medical Research Center (CIMEQ), Rheumatology Service, 216th Street and 11B, Siboney. Beach. Havana, Cuba. Puerto Rico: Dr. Radames Sierra-Zorita: University of Puerto Rico, School of Medicine, San Juan, Puerto Rico. Costa Rica: Dr. Dina Arrieta: Hospital México, Caja Costarricense del Seguro Social, San José de Costa Rica, Costa Rica. Dr. Eduardo Romero Hidalgo: Jackson's Memorial Medical Center, San Ramon, Alajuela, Costa Rica. Dr. Ricardo Saenz: Jefe Servicio Reumatología Hospital Dr. Calderón Guardia C.C.S.S, Costa Rica. Nicaragua: Dr. Idania Escalante M.: 1. Internal Medicine, Oscar Danilo Rosales School Hospital, Leon-Nicaragua. 2. Internal Medicine, National Autonomous University of Nicaragua, Managua, Nicaragua. Dr. Roberto Morales. Equador: Dr. Wendy Calapaqui: Instituto Ecuatoriano de Seguridad Social, Centro de atención ambulatoria “El Batán”, Quito, Ecuador. Dr. Ivonne Quezada: Hospital de Especialidades Eugenio Espejo, Quito, Ecuador. Bolivia: Dr. Gabriela Arredondo: Reumatóloga, Caja, Bancaria Estatal de Salud, Le Paz, Bolivia.
Author contributions
Conceptualisation: ZZF, PS, MJ, LG, VA, RA. Data curation: all authors. Formal analysis: ZZF, PS, NR, LG, VA, RA Funding acquisition: N/A. Investigation: ZZF, PS, MJ, LG, VA, RA. Methodology: LG, VA, JBL, HC, RA. Software: LG. Validation: LG, VA, RA, JBL, HC. Visualisation: RA, VA, LG. Writing-original draft: ZZF, PS, MJ, LG, VA. Writing-review and editing: all authors.
Funding
HC is supported by the National Institution for Health Research Manchester Biomedical Research Centre Funding Scheme. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.
Declarations
Conflict of interest
ALT has received honoraria for advisory boards and speaking for Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB. EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Lilly and holds research grants from Pfizer and Lilly. HC has received grant support from Eli Lilly and UCB; consulting fees from Novartis, Eli Lilly, Orphazyme, Astra Zeneca; speaker for UCB, Biogen. IP has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis and F. Hoffmann-La Roche AG. JD has received research funding from CSL Limited. NZ has received speaker fees, advisory board fees and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, Pierre Fabre; none is related to this manuscript. OD has/had consultancy relationship with and/or has received research funding from or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three years: Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, Baecon, Blade, Bayer, Boehringer Ingelheim, ChemomAb, Corbus, CSL Behring, Galapagos, Glenmark, GSK, Horizon (Curzion), Inventiva, iQvia, Kymera, Lupin, Medac, Medscape, Mitsubishi Tanabe, Novartis, Roche, Roivant, Sanofi, Serodapharm, Topadur and UCB. Patent issued “mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143). RA has/had a consultancy relationship with and/or has received research funding from the following companies-Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, and Abbvie, Janssen, Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant. Rest of the authors have no conflict of interest relevant to this manuscript.
Ethical approval
Ethical approval was obtained from the Institutional Ethics Committee of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road, Lucknow, 226014 (IEC Code: 2021-143-IP-EXP-39).
Footnotes
The complete list of authors part of the COVAD Study Group as well as their affiliations are provided in Supplementary File 1 and in Acknowledgements section.
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rohit Aggarwal and Latika Gupta have contributed equally.
Contributor Information
Latika Gupta, Email: drlatikagupta@gmail.com.
COVAD Study Group:
Bhupen Barman, Yogesh Preet Singh, Rajiv Ranjan, Avinash Jain, Sapan C Pandya, Rakesh Kumar Pilania, Aman Sharma, Manesh Manoj M, Vikas Gupta, Chengappa G Kavadichanda, Pradeepta Sekhar Patro, Sajal Ajmani, Sanat Phatak, Rudra Prosad Goswami, Abhra Chandra Chowdhury, Ashish Jacob Mathew, Padnamabha Shenoy, Ajay Asranna, Keerthi Talari Bommakanti, Anuj Shukla, Arun Kumar R Pandey, Prithvi Sanjeevkumar Gaur, Mahabaleshwar Mamadapur, Akanksha Ghodke, Kunal Chandwar, Kshitij Jagtap, Zoha Zahid Fazal, Döndü Üsküdar Cansu, Reşit Yıldırım, Aarat Patel, John D Pauling, Chris Wincup, Margherita Giannini, François Maurier, Julien Campagne, Alain Meyer, Nicoletta Del Papa, Gianluca Sambataro, Atzeni Fabiola, Marcello Govoni, Simone Parisi, Elena Bartoloni Bocci, Gian Domenico Sebastiani, Enrico Fusaro, Marco Sebastiani, Luca Quartuccio, Franco Franceschini, Pier Paolo Sainaghi, Giovanni Orsolini, Rossella De Angelis, Maria Giovanna Danielli, Vincenzo Venerito, Silvia Grignaschi, Alessandro Giollo, Lisa S Traboco, Syahrul Sazliyana Shaharir, Suryo Anggoro Kusumo Wibowo, Erick Adrian Zamora Tehozol, Jorge Rojas Serrano, Ignacio García-De La Torre, Iris J. Colunga‑Pedraza, Iris J. Colunga‑Pedraza, Javier Merayo-Chalico, Jesús Loarce-Martos, Sergio Prieto-González, Albert Gil-Vila, Raquel Aranega, Leonardo Santos Hoff, Ran Nakashima, Shinji Sato, Naoki Kimura, Yuko Kaneko, Stylianos Tomaras, Fabian Nikolai Proft, Marie-Therese Holzer, Margarita Aleksandrovna Gromova, Or Aharonov, Melinda Nagy-Vincze, Zoltán Griger, Ihsane Hmamouchi, Pr Imane El bouchti, Zineb Baba, Uyi Ima-Edomwonyi, Ibukunoluwa Dedeke, Emorinken Airenakho, Nwankwo Henry Madu, Abubakar Yerima, Hakeem Olaosebikan, Okwara Celestine Chibuzo, Becky A, Ouma Devi Koussougbo, Elisa Palalane, Daman Langguth, Vidya Limaye, Merrilee Needham, Nilesh Srivastav, Marie Hudson, Océane Landon-Cardinal, Wilmer Gerardo Rojas Zuleta, Álvaro Arbeláez, Javier Cajas, José António Pereira Silva, João Eurico Fonseca, Olena Zimba, Doskaliuk Bohdana, Ho So, Manuel Francisco Ugarte-Gil, Lyn Chinchay, José Proaño Bernaola, Victorio Pimentel, A. T. M. Tanveer Hasan, Sreoshy Saha, Binit Vaidya, Hanan Mohamed Fathi, Reem Hamdy A Mohammed, Yi-Ming Chen, Ghita Harifi, Lina El Kibbi, Hussein Mohammed Halabi, P Akawatcharangura, Wanruchada Katchamart, Yurilís Fuentes-Silva, Karoll Cabriza, Jonathan Losanto, Nelly Colaman, Antonio Cachafeiro-Vilar, Generoso Guerra Bautista, Enrique Julio Giraldo Ho, Raúl Agustín González, Lilith Stange Nunez, Cristian Vergara M, Jossiell Then Báez, Hugo Alonzo, Carlos Benito Santiago Pastelin, Rodrigo García Salinas, Alejandro Quiñónez Obiols, Nilmo Chávez, Andrea Bran Ordóñez, Sandra Argueta, Daniel Quijivix, Gil Alberto Reyes Llerena, Radames Sierra-Zorita, Dina Arrieta, Eduardo Romero Hidalgo, Ricardo Saenz, Idania Escalante M., Roberto Morales, Wendy Calapaqui, Ivonne Quezada, and Gabriela Arredondo
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