1052: Short-term Safety of COVID-19 Vaccination in Systemic Sclerosis Patients: Report from a Global Patient-Reported E-survey

Darpan Thakare¹, Naveen R¹, John Pauling², Sakir Ahmed³, Chris Wincup⁴, Nicolletta Del Papa⁵, Gianluca Sambataro⁶, Fabiola Atzeni⁷, Marcello Govoni⁸, SIMONE PARISI⁹, Elena Bartoloni Bocci¹⁰, Gian Domenico Sebastiani¹¹, Enrico Fusaro¹², Marco Sebastiani¹³, Luca Quartuccio¹⁴, Franco Franceschini¹⁵, Pier Paolo Sainaghi¹⁶, Giovanni Orsolini¹⁷, Rossella De Angelis¹⁸, Maria Giovanna Danielli¹⁹, Vincenzo Venerito²⁰, Parikshit Sen²¹, Minchul Kim²², Abraham Edgar Gracia-Ramos²³, Akira Yoshida²⁴, James B. Lilleker²⁵, Vishwesh Agarwal²⁶, Sinan Kardes²⁷, Jessica Day²⁸, Marcin Milchert²⁹, Mrudula Joshi³⁰, Tamer A Gheita³¹, Babur Salim³², Ioannis Parodis³³, Albert Selva O’Callaghan³⁴, Elena Nikiphorou³⁵, Tulika Chatterjee²², Ai Lyn Tan³⁶, Arvind Nune³⁷, Lorenzo Cavagna³⁸, Samuel Shinjo³⁹, Nelly Ziade⁴⁰, Johannes Knitza⁴¹, Hector Chinoy⁴², Oliver Distler⁴³, Masataka Kuwana⁴⁴, Rohit Aggarwal⁴⁵, Latika Gupta⁴⁶, Vikas Agarwal¹ and Ashima Makol⁴⁷, ¹Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, ²North Bristol NHS Trust, Bristol, United Kingdom, ³Kalinga Institute of Medical Sciences, Bhubaneswar, India, ⁴Rayne Institute, University College London, London, United Kingdom, ⁵Unità operativa complessa (UOC) Day Hospital Reumatologia via Gaetano Pini 9, Centro Specialistico Ortopedico Traumatologico, Gaetano Pini-CTO,, Milano, ⁶Medico Immunologia e reumatologia presso, Artoreuma S.R.L., Cors S, Mascalucia, ⁷Rheumatology Unit, University of Messina, Messina, Italy, ⁸S. Anna Hospital and University of Ferrara, Ferrara, Italy, ⁹Italian Society for Rheumatology, Turin, Italy, ¹⁰Rheumatology Unit. Department of Medicine, Perugia, Perugia, Italy, ¹¹U.O.C. Reumatologia, Ospedale San Camillo-Forlanini,, Roma, ¹²Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy, ¹³Azienda Policlinico di Modena, Modena, Italy, ¹⁴Department of Medicine (DAME), ASUFC, University of Udine, Udine, ¹⁵Department of Clinical and Experimental Sciences, ASST Spedali Civili and University of Brescia, Brescia, Italy, ¹⁶IRCAD, Interdisciplinary Research Center of Autoimmune Diseases, Novara, Italy, ¹⁷Department of Medicine, Rheumatology Unit, University of Verona, Verona, Verona, ¹⁸Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Marche, Italy, ¹⁹Dipartimento di Scienze Cliniche e Molecolari, Università Politecnica delle, Marche, Italy, ²⁰Department of Emergency and Organ Transplantations-Rheumatology Unit, University of Bari "Aldo Moro", Bari, Italy, ²¹Maulana Azad Medical College, New Delhi, India, ²²University of Illinois College of Medicine Peoria, Peoria, IL, ²³Instituto Mexicano del Seguro Social, Ciudad de México, Mexico, ²⁴Nippon Medical School Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan, ²⁵The University of Manchester, Manchester, United Kingdom, ²⁶Mahatma Gandhi Missions Medical College, Lucknow, India, ²⁷Istanbul University, Istanbul, Turkey, ²⁸Walter and Eliza Hall Institute, Melbourne, Australia, ²⁹Pomeranian Medical University in Szczecin, Szczecin, Poland, ³⁰Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India, ³¹Rheumatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt, ³²Fauji foundation hospital Rawalpindi, Rawalpindi, Pakistan, ³³Karolinska Institutet, Stockholm, Sweden, ³⁴Hospital Universitari Vall d'Hebron, Barcelona, Spain, ³⁵Leiden University Medical Center & King's College London, London, United Kingdom, ³⁶University of Leeds, Leeds, United Kingdom, ³⁷Southport and Ormskirk Hospital NHS Trust, Southport, United Kingdom, ³⁸Università di Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, Pavia, Italy, ³⁹Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, Brazil, ⁴⁰Saint-Joseph University, Beirut, Lebanon, ⁴¹Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054 Erlangen, Germany; Deutsches Zentrum Immuntherapie, Friedrich-Alexander-UniversityErlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany, ⁴²The University of Manchester, Sale, United Kingdom, ⁴³Department of Rheumatology, University Hospital Zurich, University of Zurich, Zürich, Switzerland, ⁴⁴Nippon Medical School Graduate School of Medicine, Tokyo, Japan, ⁴⁵Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, ⁴⁶Royal Wolverhampton Trust, Wolverhampton/University of Manchester, United Kingdom, ⁴⁷Mayo Clinic, Rochester, MN, Rochester, MN

Background/Purpose: Dedicated data on COVID-19 vaccine-related adverse events (ADEs) in patients with systemic sclerosis (SSc) is limited. Therefore, we aimed to compare all patient-reported ADEs post-COVID-19 vaccination in patients with SSc with those in healthy controls (HCs) or non-SSc autoimmune rheumatic diseases (NS-AIRDs).

Methods: Data from the international patient-reported online survey on COVID-19 Vaccination in Autoimmune Diseases (COVAD) study conducted in 2021 by more than 110 collaborators across 94 countries was analyzed. Major and minor ADEs following receipt of COVID-19 vaccine were compared between patients with SSc, those with NS-AIRDs, or with other autoimmune diseases (AIDs) and HCs. Multivariable regression analysis adjusting for age, gender, ethnicity, vaccine type, and immunosuppressants received were performed.

Results: Of the 10,679 respondents (Table 1), there were 478 SSc patients (4.4%) with a mean (SD) age 53.8 (13.3) years, comprising 88% females. At the time of vaccination, 65% were on immunosuppressants and 24% on glucocorticoids. The most common immunosuppressant was mycophenolate mofetil (25.7%).

Among the SSc patients, 83% had completed two vaccine doses. Pfizer-BioNTech (BNT162b2) (51%) and Oxford/AstraZeneca (ChAdOx1 nCoV-19) (23%) were the most common vaccines received. Vaccination related ADEs (Table 2) were reported in 81.2% of SSc patients (81.2%-minor and 3.3% -major ADEs). Patients on hydroxychloroquine reported lower fatigue [OR 0.4 (0.2-0.8)].

Major ADEs were no different across different vaccine types (Table 3). Pfizer-BioNTech (BNT162b2) recipients reported lower body ache, fever, chills, nausea, and vomiting [OR ranging 0.2-0.4]. Oxford/AstraZeneca (ChAdOx1 nCoV-19) recipients reported higher body ache, fever, chills, nausea vomiting, headache, and fatigue [OR ranging 2.0-5.1]. Moderna (mRNA-1273) recipients reported higher fever, chills, chest pain [OR ranging 2.6-8.9]. Covishield (Serum Institute India) (ChAdOx1 nCoV-19) recipients reported higher body ache, fever, and hospitalization [OR ranging 3.4-13.5]. Sinopharm (BBIBP-CorV) recipients reported lower injection site pain [OR 0.2 (0.06-0.7)].

When compared to HCs and other AIDs, SSc patients reported similar ADEs. When compared to other AIRDs, SSc patients reported higher chills [OR 1.3 (1.0-1.7)] and fatigue [OR 1.3 (1.0-1.6)]. There was no difference in reported hospitalization rates among SSc versus. other AIRDs, other AIDs, and HCs following vaccination.

Conclusion: Despite different vaccines administered worldwide, COVID-19 vaccines were overall largely safe in SSc patients, and vaccine-induced ADEs in SSc were similar to HCs. Pfizer-BioNTech (BNT162b2) recipients reported lower ADE compared to other vaccines.





Disclosures: D. Thakare, None; N. R, None; J. Pauling, None; S. Ahmed, DrReddy, Novartis, Pfizer, Janssen, Cipla; C. Wincup, None; N. Del Papa, None; G. Sambataro, None; F. Atzeni, None; M. Govoni, None; S. PARISI, None; E. Bartoloni Bocci, None; G. Sebastiani, None; E. Fusaro, None; M. Sebastiani, None; L. Quartuccio, None; F. Franceschini, None; P. Paolo Sainaghi, None; G. Orsolini, None; R. De Angelis, None; M. Giovanna Danielli, None; V. Venerito, None; P. Sen, None; M. Kim, None; A. Gracia-Ramos, None; A. Yoshida, None; J. Lilleker, None; V. Agarwal, None; S. Kardes, None; J. Day, CSL; M. Milchert, None; M. Joshi, None; T. Gheita, None; B. Salim, None; I. Parodis, GlaxoSmithKlein(GSK), Amgen, AstraZeneca, Aurinia Pharmaceuticals, Eli Lilly, Gilead, Janssen, Novartis, Roche; A. O’Callaghan, None; E. Nikiphorou, Pfizer, Celltrion, Sanofi, Gilead, Galapagos, AbbVie, Lilly, Fresenius; T. Chatterjee, None; A. Tan, None; A. Nune, None; L. Cavagna, None; S. Shinjo, None; N. Ziade, Pfizer, Roche, AbbVie/Abbott, Eli Lilly, Boehringer-Ingelheim, Janssen; J. Knitza, AbbVie, Novartis, ThermoFisher, UCB, ABATON, Sanofi, Medac, Lilly, BMS, Gilead, GSK, Werfen, Vila Health, Böhringer Ingelheim, Janssen, Galapagos, Chugai; H. Chinoy, Eli Lilly, UCB; O. Distler, AbbVie/Abbott, Amgen, GlaxoSmithKlein(GSK), Novartis, Roche, UCB, Kymera, Mitsubishi Tanabe, Boehringer Ingelheim, 4P-Pharma, Acceleron, Alcimed, Altavant Sciences, AnaMar, Arxx, AstraZeneca, Blade Therapeutics, Bayer, Corbus Pharmaceuticals, CSL Behring, Galapagos, Glenmark, Horizon, Inventiva, Lupin, Miltenyi Biotec, Merck/MSD, Prometheus Biosciences, Redx Pharma, Roivant, Sanofi, Topadur, Pfizer, Janssen, Medscape, Patent issued “mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143), FOREUM Foundation, ERS/EULAR Guidelines, EUSTAR, SCQM (Swiss Clinical Quality Management in Rheumatic Diseases), Swiss Academy of Medical Sciences (SAMW), Hartmann Müller Foundation; M. Kuwana, Boehringer-Ingelheim, Ono pharmaceuticals, Mochida, AbbVie/Abbott, Astellas, Janssen, Bayer, Corbus, Horizon; R. Aggarwal, Mallinckrodt, Bristol Myers Squibb, EMD Serono, Pfizer, Octapharma, CSL Behring, Q32, Kezar, AstraZeneca, Alexion, Argenx, Boehringer Ingelheim, Corbus, Janssen, Kyverna, Roivant, AbbVie, Jubilant, Orphazyme, Genentech; L. Gupta, None; V. Agarwal, None; A. Makol, Boehringer-Ingelheim.