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Abstract Number: 0100

Safety of COVID-19 Vaccines After First Vaccination in Patients with Rheumatic Diseases in a Patient Reported Survey

Rebecca Hasseli1, Bimba Franziska Hoyer2, Hanns-Martin Lorenz3, Alexander Pfeil4, Jutta Richter5, Anne Regierer6, Tim Schmeiser7, Anja Strangfeld8, Reinhard Voll9, Andreas Krause10, Hendrik Schulze-Koops11, Ulf Müller-Ladner12 and Christof Specker13, 1Justus-Liebig-University Giessen, Bad Nauheim, Germany, 2Universittsklinikum Schleswig-Holstein, Kiel, Germany, 3University Hospital Heidelberg Germany, Heidelberg, Germany, 4Friedrich Schiller University Jena, Jena, Germany, 5Rheumatology and Hiller Research Unit, Heinrich-Heine-University Duesseldorf, Medical Faculty, Duesseldorf, Germany, 6German Rheumatism Research Center, Berlin, Germany, 7Private Practice, Cologne, Germany, 8Deutsches Rheuma-Forschungszentrum Berlin, Berlin, Germany, 9Department of Rheumatology and Clinical Immunology, University Medical Center, Faculty of Medicine, Albert-Ludwigs-University of Freiburg, Freiburg, Germany, 10Immanuel Hospital, Berlin, Germany, 11Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany, 12JLU Giessen, Campus Kerckhoff, Dept. Rheum & Clin Immunol, Bad Nauheim, Germany, 13Evangelisches Krankenhaus, Kliniken Essen-Mitte, Essen, Germany

Meeting: ACR Convergence 2021

Keywords: autoimmune diseases, COVID-19, Disease-Modifying Antirheumatic Drugs (Dmards), Epidemiology, prevention

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Session Information

Date: Saturday, November 6, 2021

Title: Epidemiology & Public Health Poster I: COVID-19 & Vaccination (0084–0117)

Session Type: Poster Session A

Session Time: 8:30AM-10:30AM

Background/Purpose: Among patients with rheumatic and musculoskeletal diseases (RMDs) and their treating physicians, concerns prevail about the effectiveness and safety of vaccination against COVID-19, especially with respect to triggering RMD flares. The aim of our study was to collect safety data among RMD patients receiving COVID-19 vaccines.

Methods: The German COVID-19 vaccination registry is an observational longitudinal study launched February 8th, 2021. Data are entered voluntarily by RMD patients who have received at least 1 vaccination against SARS-CoV-2. The characteristics of all patients registered until May 29th, 2021 is presented here.

Results: So far, 866 patients reported their experience after the first COVID-19 vaccination. Median age was 54 years (range 18-86) and 81% of the participants were female (table 1). Most of the patients (50%) were diagnosed with rheumatoid arthritis, followed by spondyloarthritides (31%). At the time of vaccination, 33% were treated with glucocorticoids, 59% with conventional synthetic DMARDs, 23% with TNF-inhibitors, 9% with JAK-inhibitors, and 5% with IL17-inhibitors. No immunomodulatory therapy was reported from 9% of the patients. Within the last 12 months, 42% of the patients reported no disease activity and 40% did not state further comorbidities. The most common comorbidity was arterial hypertension (33%). Prior to COVID-19 vaccination, 77% of the patients had received ever influenza and 57% pneumococcal vaccinations. The majority of the patients were vaccinated with Pfizer-BioNTech vaccine (67%), followed by AstraZeneca vaccine (28%). Most of the participants reported no or low concerns regarding COVID-19 vaccination (80%) and 70% did not change their immunomodulation around the vaccination period. The most common side effect was pain at the injection site (71%), followed by fatigue (41%), headache (33%), and arthralgia (24%). Only 1% of the patients reported allergic reactions. Side effects lasted in median for two days (range 0-99 days) and 15% reported no relevant side effects. Disease flares after first COVID-19 vaccination as reported by patients on a 1-10 scale was indicated in 13% of the patients. In these patients, 6% needed a change of their immunomodulation treatment. In 41% of the cases with disease flares, increasing the GC dose was sufficient to cope with the flares.

Conclusion: The first COVID-19 vaccination was well tolerated by the majority of RMD patients. Adverse events were similar to those observed in the general population. Only in 13% of the patients, self-reported disease flare was indicated and in these patients, only 6% needed changes in their immunomodulatory therapy. These preliminary results support the recommendation for COVID-19 vaccination in RMD patients.

Table 1: Characteristics of COVID_19 vaccinated RMD patients.


Disclosures: R. Hasseli, Pfizer, Novartis, Medac, Abbvie, Galapagos, BMS, Biogen, Takeda, Roche/Chugai, Janssen, Amgen, 1, 2, 6, Pfizer, 5; B. Hoyer, Pfizer, 1, 6, Abbvie, 6, UCB, 6; H. Lorenz, None; A. Pfeil, None; J. Richter, Abbvie, 2, Lilly, 2, 6, Pfizer, 6, Sanofi, 2, 6; A. Regierer, None; T. Schmeiser, None; A. Strangfeld, Pfizer, 6, Roche, 6, MSD, 6, BMS, 6, Abbvie, 6, Celltrion, 6; R. Voll, None; A. Krause, None; H. Schulze-Koops, Roche/Chugai, 2, 5, 6, Sobi, 6, Novartis, 2, 5, 6, AbbVie, 2, 5, 6, Amgen, 2, 6, Bristol-Myers Squibb, 2, 6, Celgene, 2, 6, Celltrion, 2, 6, Chugai, 2, 6, Gilead Sciences, 2, 6, Janssen, 2, 6, Eli Lilly, 2, 6, MSD, 2, 6, Pfizer Inc, 2, 6, Sanofi, 2, 6, Galapagos, 1, 2, UCB, 1, 2; U. Müller-Ladner, Biogen, 6; C. Specker, AbbVie, 1, 6, Boehringer, 1, 6, Chugai, 2, 6, GSK, 1, 6, Lilly, 6, MSD, 6, Novartis, 1, 6, Pfizer, 6, Roche, 6, Sanofi, 6, Sobi, 1, 6.

To cite this abstract in AMA style:

Hasseli R, Hoyer B, Lorenz H, Pfeil A, Richter J, Regierer A, Schmeiser T, Strangfeld A, Voll R, Krause A, Schulze-Koops H, Müller-Ladner U, Specker C. Safety of COVID-19 Vaccines After First Vaccination in Patients with Rheumatic Diseases in a Patient Reported Survey [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/safety-of-covid-19-vaccines-after-first-vaccination-in-patients-with-rheumatic-diseases-in-a-patient-reported-survey/. Accessed .
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