PMID- 37068915 OWN - NLM STAT- MEDLINE DCOM- 20230419 LR - 20230421 IS - 2056-5933 (Electronic) IS - 2056-5933 (Linking) VI - 9 IP - 2 DP - 2023 Apr TI - Characteristics and outcomes of SARS-CoV-2 breakthrough infections among double-vaccinated and triple-vaccinated patients with inflammatory rheumatic diseases. LID - 10.1136/rmdopen-2023-002998 [doi] LID - e002998 AB - OBJECTIVE: To analyse the clinical profile of SARS-CoV-2 breakthrough infections in at least double-vaccinated patients with inflammatory rheumatic diseases (IRDs). METHODS: Data from the physician-reported German COVID-19-IRD registry collected between February 2021 and July 2022 were analysed. SARS-CoV-2 cases were stratified according to patients' vaccination status as being not vaccinated, double-vaccinated or triple-vaccinated prior to SARS-CoV-2 infection and descriptively compared. Independent associations between demographic and disease features and outcome of breakthrough infections were estimated by multivariable logistic regression. RESULTS: In total, 2314 cases were included in the analysis (unvaccinated n=923, double-vaccinated n=551, triple-vaccinated n=803, quadruple-vaccinated n=37). SARS-CoV-2 infections occurred after a median of 151 (range 14-347) days in patients being double-vaccinated, and after 88 (range 14-270) days in those with a third vaccination. Hospitalisation was required in 15% of unvaccinated, 8% of double-vaccinated and 3% of triple-vaccinated/quadruple-vaccinated patients (p<0.001). Mortality was 2% in unvaccinated, 1.8% in the double-vaccinated and 0.6% in triple-vaccinated patients. Compared with unvaccinated patients, double-vaccinated (OR 0.43, 95% CI 0.29 to 0.62) and triple-vaccinated (OR 0.13, 95% CI 0.08 to 0.21) patients showed a significant lower risk of COVID-19-related hospitalisation. Using multivariable analysis, the third vaccination was significantly associated with a lower risk for COVID-19-related death (OR 0.26; 95% CI 0.01 to 0.73). CONCLUSIONS: Our cross-sectional data of COVID-19 infections in patients with IRD showed a significant reduction of hospitalisation due to infection in double-vaccinated or triple-vaccinated patients compared with those without vaccination and even a significant reduction of COVID-19-related deaths in triple-vaccinated patients. These data strongly support the beneficial effect of COVID-19 vaccination in patients with IRD. TRIAL REGISTRATION NUMBER: EuDRACT 2020-001958-21. CI - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Hasseli, Rebecca AU - Hasseli R AUID- ORCID: 0000-0002-2982-8253 AD - Department of Internal Medicine D, Section of Rheumatology and Clinical Immunology, University Hospital Munster, Munster, Germany hasseli@rheumathek.de. AD - Department of Rheumatology and Clinical Immunology, Campus Kerckhoff, Justus Liebig University Giessen, Giessen, Germany. FAU - Richter, Jutta G AU - Richter JG AD - Clinic for Rheumatology, University Hospital Duesseldorf, Medical Faculty of Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany. AD - Hiller Research Center, University Hospital Duesseldorf, Medical Faculty of Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany. FAU - Hoyer, Bimba Franziska AU - Hoyer BF AUID- ORCID: 0000-0002-5252-1719 AD - Clinic for Internal Medicine I, Rheumatology and Clinical Immunology, University Medical Center Schleswig-Holstein Campus, Kiel, Germany. FAU - Lorenz, Hanns-Martin AU - Lorenz HM AD - Division of Rheumatology, Department of Medicine V, University Hospital Heidelberg, Heidelberg, Germany. FAU - Pfeil, Alexander AU - Pfeil A AUID- ORCID: 0000-0002-2709-6685 AD - Department of Internal Medicine III, University Hospital Jena, Jena, Germany. FAU - Regierer, Anne Constanze AU - Regierer AC AUID- ORCID: 0000-0003-2456-4049 AD - Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany. FAU - Schmeiser, Tim AU - Schmeiser T AUID- ORCID: 0000-0001-7342-0020 AD - Rheumatology, Private Practice "Rheumatologie im Veedel" Cologne, Cologne, Germany. FAU - Strangfeld, Anja AU - Strangfeld A AUID- ORCID: 0000-0002-6233-022X AD - Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany. AD - Department of Rheumatology and Clinical Immunology, Charite Universitatsmedizin, Berlin, Germany. FAU - Voll, Reinhard E AU - Voll RE AD - Department of Rheumatology and Clinical Immunology, Medical Center - University of Freiburg, Faculty of Medicine, Freiburg, Germany. AD - Centre of Chronic Immunodeficiency, Medical Center - University of Freiburg, Faculty of Medicine, Freiburg, Germany. FAU - Krause, Andreas AU - Krause A AD - Department of Rheumatology, Clinical Immunology and Osteology, Immanuel Hospital, Berlin, Germany. FAU - Reckert, Sabine AU - Reckert S AD - Rheumatology, Private Practice, Potsdam, Germany. FAU - Grassler, Anett AU - Grassler A AD - Rheumatology, Private Practice, Pirna, Germany. FAU - Saar, Petra AU - Saar P AD - Rheumatology, Private Practice Endokrinologikum, Frankfurt, Germany. FAU - Kapelle, Andreas AU - Kapelle A AD - Rheumatology, Private Practice, Hoyerswerda, Germany. FAU - Backhaus, Marina AU - Backhaus M AD - Department of Internal Medicine, Rheumatology and Clinical Immunology, Park-Klinik Weissensee, Academic Hospital of the Charite Berlin, Berlin, Germany. FAU - Blank, Norbert AU - Blank N AD - Division of Rheumatology, Department of Medicine V, University Hospital Heidelberg, Heidelberg, Germany. FAU - Henes, Joerg AU - Henes J AD - Centre for Interdisciplinary Clinical Immunology, Rheumatology and Autoinflammatory Diseases (INDIRA) and Department of Internal Medicine II (Oncology, Haematology, Rheumatology and Clinical Immunology), University Hospital Tuebingen, Tuebingen, Germany. FAU - Osiek, Silke AU - Osiek S AD - Rheumatology, Private Practice Dialysezentrum, Schweinfurt, Germany. FAU - Knothe, Anna AU - Knothe A AD - Department of Rheumatology and Clinical Immunology, Campus Kerckhoff, Justus Liebig University Giessen, Giessen, Germany. FAU - Hoese, Guido AU - Hoese G AD - Rheumatology, Private Practice, Stadthagen, Germany. FAU - Brandt-Jurgens, Jan AU - Brandt-Jurgens J AD - Rheumatology, Private Practice, Berlin, Germany. FAU - Maltzahn, Anja AU - Maltzahn A AD - Rheumatology, Private Practice, Gottingen, Germany. FAU - Specker, Christof AU - Specker C AUID- ORCID: 0000-0003-2504-3229 AD - Department of Rheumatology and Clinical Immunology, KEM Kliniken Essen-Mitte, Essen, Germany. FAU - Muller-Ladner, Ulf AU - Muller-Ladner U AD - Department of Rheumatology and Clinical Immunology, Campus Kerckhoff, Justus Liebig University Giessen, Giessen, Germany. FAU - Schulze-Koops, Hendrik AU - Schulze-Koops H AUID- ORCID: 0000-0002-1681-491X AD - Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians-University, Munich, Germany. CN - COVID-19 task force of the German Society of Rheumatology collaborators CN - COVID19-Rheuma.de collaborators LA - eng SI - EudraCT/2020-001958-21 PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - RMD Open JT - RMD open JID - 101662038 RN - 0 (COVID-19 Vaccines) RN - COVID-19 breakthrough infections SB - IM MH - Humans MH - COVID-19 Vaccines/therapeutic use MH - *COVID-19/epidemiology/prevention & control MH - SARS-CoV-2 MH - Breakthrough Infections MH - Cross-Sectional Studies MH - *Rheumatic Diseases/complications/epidemiology PMC - PMC10111193 OTO - NOTNLM OT - COVID-19 OT - antirheumatic agents OT - inflammation OT - vaccination COIS- Competing interests: None declared. FIR - Albach, Fredrik IR - Albach F FIR - Alberding, Annette IR - Alberding A FIR - Alexander, Tobias IR - Alexander T FIR - Alten, Rieke IR - Alten R FIR - Aman, Susanne IR - Aman S FIR - Amberger, Christopher IR - Amberger C FIR - Amberger, Michaela IR - Amberger M FIR - Andermann, Bianka IR - Andermann B FIR - Anders, Nils IR - Anders N FIR - Andreica, Ioana IR - Andreica I FIR - Andresen, Jan IR - Andresen J FIR - Andriopoulos, Nikolaos IR - Andriopoulos N FIR - Arauj, Elizabeth IR - Arauj E FIR - Aries, Peer IR - Aries P FIR - Aringer, Martin IR - Aringer M FIR - Arndt, Uta IR - Arndt U FIR - Avemarg, Sarah IR - Avemarg S FIR - Baerwald, Christoph IR - Baerwald C FIR - Barlin, Erich IR - Barlin E FIR - Bartholoma, Nora IR - Bartholoma N FIR - Bastian, Hans IR - Bastian H FIR - Bauerle, Michael IR - Bauerle M FIR - Bauhammer, Jutta IR - Bauhammer J FIR - Baumann, Christine IR - Baumann C FIR - Becker, Klaus IR - Becker K FIR - Becker, Heidemarie IR - Becker H FIR - Bellm, Michaela IR - Bellm M FIR - Berger, Sylvia IR - Berger S FIR - Berghofen, Andrea IR - Berghofen A FIR - Birkner, Gerhard IR - Birkner G FIR - Blendea, Daniel IR - Blendea D FIR - Bloching, Hans IR - Bloching H FIR - Blotz, Sebastian IR - Blotz S FIR - Blum, Christian IR - Blum C FIR - Boeddeker, Stephanie IR - Boeddeker S FIR - Bogner, Susanne IR - Bogner S FIR - Bohl-Buhler, Martin IR - Bohl-Buhler M FIR - Bohnen, Lara IR - Bohnen L FIR - Bosenberg, Ilka IR - Bosenberg I FIR - Bottcher, Nicole IR - Bottcher N FIR - Braun, Matthias IR - Braun M FIR - Braun, Diana IR - Braun D FIR - Braunisch, Matthias IR - Braunisch M FIR - Bremer, Jan Philipp IR - Bremer JP FIR - Broll, Matthias IR - Broll M FIR - Bruckner, Andreas IR - Bruckner A FIR - Brumberger, Veronika IR - Brumberger V FIR - Brzank, Martin IR - Brzank M FIR - Bullesfeld, Sahra IR - Bullesfeld S FIR - Burger, Sandra IR - Burger S FIR - Chehab, Gamal IR - Chehab G FIR - Christenn, Michaela IR - Christenn M FIR - Claussnitzer, Anne IR - Claussnitzer A FIR - Groot, Kirsten de IR - Groot K FIR - Decker, Elvira IR - Decker E FIR - Demtroder, Frank IR - Demtroder F FIR - Detert, Jacqueline IR - Detert J FIR - Dorfler, Rainer IR - Dorfler R FIR - Drexler, Elke IR - Drexler E FIR - Dudics, Valeria IR - Dudics V FIR - Edelmann, Edmund IR - Edelmann E FIR - Eder, Roman IR - Eder R FIR - Eisterhues, Christina IR - Eisterhues C FIR - Engel, Joachim Michael IR - Engel JM FIR - Erbsloh-Moller, Brigitte IR - Erbsloh-Moller B FIR - Feine, Miriam IR - Feine M FIR - Ferdinan, Samantha IR - Ferdinan S FIR - Feuchtenberger, Martin IR - Feuchtenberger M FIR - Fiehn, Christoph IR - Fiehn C FIR - Finzel, Stephanie IR - Finzel S FIR - Fischer-Betz, Rebecca IR - Fischer-Betz R FIR - Fleck, Martin IR - Fleck M FIR - Franke, Claudia IR - Franke C FIR - Freudenberg, Stefanie IR - Freudenberg S FIR - Frabel, Christian IR - Frabel C FIR - Fuchs, Petra IR - Fuchs P FIR - Gaissmaier, Regina IR - Gaissmaier R FIR - Gao, Ino IR - Gao I FIR - Gardt, Oliver IR - Gardt O FIR - Gauler, Georg IR - Gauler G FIR - Geissler, Katrin IR - Geissler K FIR - Gente, Karolina IR - Gente K FIR - Georgi, Joachim IR - Georgi J FIR - Gilly, Jasmin IR - Gilly J FIR - Gkanatsas, Yannik IR - Gkanatsas Y FIR - Glaser, Cornelia IR - Glaser C FIR - Schwister, Agnes Gniezinski- IR - Schwister AG FIR - Gold, Rahel IR - Gold R FIR - Gorl, Norman IR - Gorl N FIR - Gorlitz, Ralf IR - Gorlitz R FIR - Gottl, Karl-Heinz IR - Gottl KH FIR - Gottle, Beate IR - Gottle B FIR - Bouyer, Ricardo Grieshaber IR - Bouyer RG FIR - Grothues, Gisela IR - Grothues G FIR - Grunke, Mathias IR - Grunke M FIR - Gunther, Janine IR - Gunther J FIR - Gunther, Florian IR - Gunther F FIR - Haag, Mirjam IR - Haag M FIR - Haas, Linda IR - Haas L FIR - Haas-Wohrle, Anna IR - Haas-Wohrle A FIR - Hadjiski, Denitsa IR - Hadjiski D FIR - Haibel, Hildrun IR - Haibel H FIR - Hallmann-Bohm, Till IR - Hallmann-Bohm T FIR - Harle, Peter IR - Harle P FIR - Hartmann, Urs IR - Hartmann U FIR - Hasenkamp, Charlotte IR - Hasenkamp C FIR - Hauf, Maura-Maria IR - Hauf MM FIR - Hauser, Matthias IR - Hauser M EDAT- 2023/04/18 06:00 MHDA- 2023/04/19 06:42 PMCR- 2023/04/17 CRDT- 2023/04/17 21:03 PHST- 2023/01/11 00:00 [received] PHST- 2023/03/22 00:00 [accepted] PHST- 2023/04/19 06:42 [medline] PHST- 2023/04/17 21:03 [entrez] PHST- 2023/04/18 06:00 [pubmed] PHST- 2023/04/17 00:00 [pmc-release] AID - rmdopen-2023-002998 [pii] AID - 10.1136/rmdopen-2023-002998 [doi] PST - ppublish SO - RMD Open. 2023 Apr;9(2):e002998. doi: 10.1136/rmdopen-2023-002998.