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

Meeting: ACR Convergence 2022

Keywords: COVID-19, Scleroderma

Session Information

Date: Sunday, November 13, 2022

Title: Systemic Sclerosis and Related Disorders – Clinical Poster I

Session Type: Poster Session B

Session Time: 9:00AM-10:30AM

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.

To cite this abstract in AMA style:

Thakare D, R N, Pauling J, Ahmed S, Wincup C, Del Papa N, Sambataro G, Atzeni F, Govoni M, PARISI S, Bartoloni Bocci E, Sebastiani G, Fusaro E, Sebastiani M, Quartuccio L, Franceschini F, Paolo Sainaghi P, Orsolini G, De Angelis R, Giovanna Danielli M, Venerito V, Sen P, Kim M, Gracia-Ramos A, Yoshida A, Lilleker J, Agarwal V, Kardes S, Day J, Milchert M, Joshi M, Gheita T, Salim B, Parodis I, O’Callaghan A, Nikiphorou E, Chatterjee T, Tan A, Nune A, Cavagna L, Shinjo S, Ziade N, Knitza J, Chinoy H, Distler O, Kuwana M, Aggarwal R, Gupta L, Agarwal V, Makol A. Short-term Safety of COVID-19 Vaccination in Systemic Sclerosis Patients: Report from a Global Patient-Reported E-survey [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/short-term-safety-of-covid-19-vaccination-in-systemic-sclerosis-patients-report-from-a-global-patient-reported-e-survey/. Accessed .

« Back to ACR Convergence 2022

ACR Meeting Abstracts - https://acrabstracts.org/abstract/short-term-safety-of-covid-19-vaccination-in-systemic-sclerosis-patients-report-from-a-global-patient-reported-e-survey/