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Urticaria exacerbations and adverse reactions in patients with chronic urticaria receiving COVID-19 vaccination: Results of the UCARE COVAC-CU study - 03/11/23

Doi : 10.1016/j.jaci.2023.07.019 
Emek Kocatürk, MD a, b, c, , Pascale Salameh, PharmD, MPH, PhD, HDR b, c, d, e, f, g, Esra Sarac, MD a, Carolina E. Vera Ayala, MD b, c, Simon Francis Thomsen, MD, PhD h, Torsten Zuberbier, MD, PhD b, c, Luis Felipe Ensina, MD i, Todor A. Popov, MD, PhD j, Martijn B.A. van Doorn, MD, PhD k, l, Ana Maria Giménez-Arnau, MD, PhD m, Riccardo Asero, MD n, Paulo Ricardo Criado, MD, MSc, PhD o, Fernando M. Aarestrup, MD, PhD p, Zainab AbdulHameed Ansari, MD, MRCP q, Salma Al Abri, MD q, Mona Al-Ahmad, MD, FRCPC r, Bushra Al Hinai, SSN q, Anastasiia Allenova, MD, PhD s, t, Maryam Al-Nesf, MD, MScR, ABHS u, Sabine Altrichter, MD b, c, v, Rand Arnaout, MD w, Joanna Bartosińska, MD, PhD x, Andrea Bauer, MD, MPH y, Jonathan A. Bernstein, MD z, Mojca Bizjak, MD, PhD aa, Hanna Bonnekoh, MD b, c, Laurence Bouillet, MD, PhD bb, Zenon Brzoza, MD, PhD cc, Ana Caroline Calvalcanti Dela Bianca Melo, MD, PhD dd, Fernanda L. Campinhos, MD ee, Emily Carne, MD ff, Saleema Cherichi Purayil, MD, ABHS u, Ivan Cherrez-Ojeda, MD, MsC gg, hh, Herberto Jose Chong-Neto, MD, PhD ii, George Christoff, MD, PhD, MPH jj, Niall Conlon, PhD, FRCPath kk, Roberta Fachini Jardim Criado, MD, PhD o, Klara Cvenkel, MD ll, Ebru Damadoglu, MD mm, Inna Danilycheva, MD nn, Cascia Day, MD oo, Laurence de Montjoye, MD, PhD pp, Semra Demir, MD qq, Silvia Mariel Ferucci, MD rr, Daria Fomina, MD, PhD ss, tt, uu, Atsushi Fukunaga, MD, PhD vv, Elizabeth Garcia, MD ww, Asli Gelincik, MD qq, Joe Hannah Göbel, PhD b, c, Kiran Godse, MD, PhD, FRCP xx, Margarida Gonçalo, MD, PhD yy, Maia Gotua, MD, PhD zz, Clive Grattan, MD aaa, Agata Gugala, MD bbb, Carole Guillet, MD ccc, Ali Fuat Kalyoncu, MD mm, Gul Karakaya, MD mm, Alicja Kasperska-Zając, MD, PhD ddd, Constance H. Katelaris, MD, PhD eee, Maryam Khoshkhui, MD fff, Andreas Kleinheinz, MD ggg, Marta Kolacinska-Flont, MD, PhD hhh, Pavel Kolkhir, MD b, c, Mitja Košnik, MD, PhD aa, Dorota Krasowska, MD, PhD x, Muthu Sendhil Kumaran, MD iii, Izabela Kuprys-Lipinska, MD, PhD hhh, Marcin Kurowski, MD, PhD bbb, Elizaveta V. Kuznetsova, MD tt, Désirée Larenas-Linnemann, MD jjj, Marina S. Lebedkina, MD ss, Youngsoo Lee, MD, PhD kkk, Michael Makris, MD, PhD lll, René Maximiliano Gómez, MD mmm, Iman Nasr, MD, MRCP, FRCP, FAAAI q, Sophia Neisinger, MD b, c, Yoshiko Oda, MD nnn, Rabia Öztaş Kara, MD ooo, Esther Bastos Palitot, MD ppp, qqq, Niki Papapostolou, MD lll, Claudio Alberto Salvador Parisi, MD dddd, David Pesque, MD m, Jonathan Peter, MD, PhD oo, Elena Petkova, MD xxx, Katie Ridge, MD kk, Michael Rudenko, MD, PhD, FAAAAI bbbb, Krzysztof Rutkowski, MD, PhD rrr, Sarbjit S. Saini, MD sss, Andac Salman, MD ttt, uuu, Jorge Sanchez, MD, PhD vvv, Bülent Şekerel, MD www, Sofia A. Serdotetskova, MD ss, Faradiba S. Serpa, PhD ee, Bahar Sevimli Dikicier, MD ooo, Nikitas Sidiropoulos, MD lll, Agnieszka Sikora, MD, PhD ddd, Jennifer Astrup Sørensen, MD h, Angele Soria, MD, PhD yyy, Ozlem Su Kucuk, MD zzz, Sherin Rahim Thalappil, MD, ABHS u, Katarzyna Tomaszewska, MD, PhD aaaa, Gulseren Tuncay, MD mm, Derya Unal, MD qq, Solange Valle, MD, PhD cccc, Esmee van Lindonk, MD k, Christian Vestergaard, MD, PhD, DMSc eeee, Raisa Y. Meshkova, MD hhhh, Aleksandr Vitchuk, MD ffff, Paraskevi Xepapadaki, PhD gggg, Young-Min Ye, MD kkk, Anna Zalewska-Janowska, MD, PhD aaaa, Mateusz Zamlynski, MD, PhD ddd, Marcus Maurer, MD b, c,
a Department of Dermatology, Koc University School of Medicine, Istanbul, Turkey 
b Institute of Allergology, Charité–Universitätsmedizin Berlin, Berlin, Germany 
c Department of Immunology and Allergology, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Berlin, Germany 
d Department of Clinical Epidemiology, Institut National de Santé Publique, Epidémiologie Clinique et Toxicologie–Liban (INSPECT-LB), Beirut, Lebanon 
e Department of Primary Care and Population Health, University of Nicosia Medical School, Nicosia, Cyprus 
f School of Medicine, Lebanese American University, Beirut, Germany 
g Faculty of Pharmacy, Lebanese University, Hadat, Lebanon 
h Department of Dermatology, Department of Biomedical Sciences, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark 
i Department of Dermatology, Federal University of São Paulo, São Paulo, Brazil 
j Department of Allergology, University Hospital Sv Ivan Rilski, Sofia, Bulgaria 
k Department of Dermatology, Erasmus MC Rotterdam, Rotterdam, The Netherlands 
l Centre for Human Drug Research, Leiden, The Netherlands 
m Department of Dermatology, Hospital del Mar Research Institute, Universitat Pompeu Fabra, Barcelona, Spain 
n Ambulatorio di Allergologia, Clinica San Carlo, Paderno Dugnano, Italy 
o Alergoskin Alergia e Dermatologia, Centro Universitário Faculdade de Medicina do ABC, Santo André, Brazil 
p Department of Allergy and Immunology, Faculdade de Ciências, Médicas e da Saúde de Juiz de Fora (SUPREMA), Hospital Maternidade Therezinha de Jesus, Minas Gerais, Brazil 
q Clinical Immunology and Allergy Unit, Royal Hospital, Muscat, Oman 
r Microbiology Department, College of Medicine, Kuwait University, Kuwait City, Kuwait 
s Laboratory of Immune-Mediated Skin Diseases, Institute for Regenerative Medicine, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia 
t Medical Research and Education Center, M. V. Lomonosov Moscow State University, Moscow, Russia 
u Department of Medicine, Allergy and Immunology Division, Hamad Medical Corporation, Doha, Qatar 
v Department of Dermatology and Venereology, Kepler University Hospital, Linz, Austria 
w Department of Dermatology, King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia 
x Department of Dermatology, Venereology, and Pediatric Dermatology, Medical University of Lublin, Lublin, Poland 
y Department of Dermatology, Technical University Dresden, University Hospital Carl Gustav Carus, Dresden, Germany 
z Department of Internal Medicine, Division of Rheumatology, Allergy, and Immunology, University of Cincinnati College of Medicine, Cincinnati, Ohio 
aa Division of Allergy, University Clinic of Respiratory and Allergic Diseases Golnik, Golnik, Slovenia 
bb National Reference Center for Angioedema, Grenoble University Hospital, Grenoble, France 
cc Department of Internal Diseases with the Division of Allergology, Institute of Medical Sciences, University of Opole, Opole, Poland 
dd Centro de Pesquisa em Alergia e Imunologia, Hospital das Clinicas, Universidade Federal de Pernambuco, Recife, Brazil 
ee Asthma Reference Center, UCARE Hospital Santa Casa de Misericórdia de Vitória, Esperito Santo, Brazil 
ff Department of Dermatology, University Hospital of Wales, Cardiff, United Kingdom 
gg Research Department, Universidad Espiritu Santo, Samborondon, Ecuador 
hh Department Allergy and Pulmonology, Respiralab Research Group, Guayaquil, Ecuador 
ii Departamento de Pediatria, Serviço de Alergia e Imunologia, Complexo Hospital de Clínicas, Universidade Federal do Paraná, Curitiba, Brazil 
jj Faculty of Public Health, Medical University Sofia, Sofia, Bulgaria 
kk School of Medicine, Trinity College Dublin, St James’s Hospital Dublin, Dublin, Ireland 
ll Department of Dermatovenereology, University Medical Centre Ljubljana, Ljubljana, Slovenia 
mm Department of Chest Diseases, Division of Allergy and Immunology, Hacettepe University School of Medicine, Ankara, Turkey 
nn Department of Allergology, NRC Institute of Immunology FMBA of Russia, Moscow, Russia 
oo Department of Medicine, University of Cape Town, Cape Town, South Africa 
pp Department of Dermatology, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, Brussels, Belgium 
qq Department of Internal Medicine, Division of Immunology and Allergy Diseases, Faculty of Medicine, Istanbul University, Istanbul, Turkey 
rr Department of Dermatology, Fondazione IRCCS Ca’Granda Ospedale Maggiore Policlinico Milan, Milan, Italy 
ss Moscow Healthcare Department, Moscow City Research and Practical Center of Allergoloy and Immunology, Moscow, Russia 
tt Department of Clinical Immunology and Allergy, Sechenow First Moscow State Medical University, Moscow, Russia 
uu Department of Pulmonology, Astana Medical University, Kazakhstan, Russia 
vv Department of Dermatology, Osaka Medical and Pharmaceutical University, Osaka, Japan 
ww Faculty of Medicine, Universidad de los Andes–UNIMEQ ORL, Bogota, Colombia 
xx Department of Dermatology, Dr D. Y. Patil Medical College & Hospital, Navi Mumbai, India 
yy Department of Dermatology, University Hospital and Faculty of Medicine, University of Coimbra, Coimbra, Portugal 
zz Center of Allergy and Immunology, David Tvildiani Medical University, Tbilisi, Georgia 
aaa Department of Dermatology, St Thomas Hospital London, London, United Kingdom 
bbb Department of Immunology and Allergy, Medical University of Lodz, Lodz, Poland 
ccc Department of Dermatology, University Hospital Zurich, Zurich, Switzerland 
ddd Department of Clinical Allergology and Urticaria, Medical University of Silesia, Silesia, Poland 
eee Campbelltown Hospital and Western Sydney University, Sydney, Australia 
fff Allergy Research Center, Mashhad University of Medical Sciences, Mashhad, Iran 
ggg Department of Dermatology, Elbe Klinikum Buxtehude, Buxtehude, Germany 
hhh Department of Internal Medicine, Asthma, and Allergy, Barlicki Memorial Hospital, Medical University of Lodz, Lodz, Poland 
iii Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, India 
jjj Centro de excelencia en asma y alergia, Hospital Médica Sur, Mexico City, Mexico 
kkk Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea 
lll Allergy Unit, 2nd Department of Dermatology and Venereology, University Hospital “Attikon”, National and Kapodistrian University of Athens, Athens, Greece 
mmm Faculty of Health Sciences, Catholic University of Salta, Salta, Argentina 
nnn Department of Dermatology, Graduate School of Medicine, Kobe University, Kobe, Japan 
ooo Department of Dermatology, University of Sakarya School of Medicine, Sakarya, Turkey 
ppp Federal University of Paraiba, Department of Infectious, Parasitic and Inflammatory Diseases, João Pessoa, Paraiba, Brazil 
qqq Lauro Wanderley University Hospital - Ebserh Network, João Pessoa, Brazil 
rrr Urticaria Clinic, St John’s Institute of Dermatology, London, United Kingdom 
sss Department of Medicine, Division of Allergy and Clinical Immunology, Johns Hopkins Asthma and Allergy Center, Baltimore, Md 
ttt Department of Dermatology, Marmara University School of Medicine, Istanbul, Turkey 
uuu Department of Dermatology, School of Medicine, Acıbadem Mehmet Ali Aydınlar University, Istanbul, Turkey 
vvv Group of Clinical and Experimental Allergy, Hospital “Alma Mater de Antioquia”, University of Antioquia, Antioquia, Colombia 
www Pediatric Allergy Asthma Division, Hacettepe University, Ankara, Turkey 
xxx University Hospital “Alexandrovska”, Clinic of Allergology, Sofia, Bulgaria 
yyy Department of Dermatology and Allergy, Tenon Hospital APHP, Sorbonne Université Paris, Paris, France 
zzz Department of Dermatology, Bezmialem Vakif University School of Medicine, Istanbul, Turkey 
aaaa Psychodermatology Department, Medical University of Lodz, Lodz, Poland 
bbbb London Allergy & Immunology Centre, Department of Allergy and Immunology, London, United Kingdom 
cccc Medicine Department, Immunology Service, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil 
dddd Adult and Pediatric Allergy Sections of the Italian Hospital of Buenos Aires, Buenos Aires 
eeee Department of Dermatology, Aarhus University Hospital, Arhus, Denmark 
ffff Department of Dermatology, Smolensk State Medical University, Smolensk, Russia 
gggg Allergy Department, 2nd Pediatric Clinic, National and Kapodistrian University of Athens, Athens, Greece 
hhhh Department of Clinical Immunology and Allergology, Smolensk State Medical University, Smolensk 

Corresponding author: Marcus Maurer, MD, and Emek Kocatürk, MD, Charité–Universitätsmedizin Berlin, Campus Benjamin Franklin, Institute of Allergology, Paul-Ehrlich-Haus, Institut für Hygiene und Umweltmedizin, Hindenburgdamm 27, 12203 Berlin, Germany.Charité–Universitätsmedizin BerlinCampus Benjamin FranklinInstitute of AllergologyInstitut für Hygiene und UmweltmedizinPaul-Ehrlich-HausHindenburgdamm 27Berlin12203Germany

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Graphical abstract




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Abstract

Background

Concern about disease exacerbations and fear of reactions after coronavirus disease 2019 (COVID-19) vaccinations are common in chronic urticaria (CU) patients and may lead to vaccine hesitancy.

Objective

We assessed the frequency and risk factors of CU exacerbation and adverse reactions in CU patients after COVID-19 vaccination.

Methods

COVAC-CU is an international multicenter study of Urticaria Centers of Reference and Excellence (UCAREs) that retrospectively evaluated the effects of COVID-19 vaccination in CU patients aged ≥18 years and vaccinated with ≥1 dose of any COVID-19 vaccine. We evaluated CU exacerbations and severe allergic reactions as well as other adverse events associated with COVID-19 vaccinations and their association with various CU parameters.

Results

Across 2769 COVID-19–vaccinated CU patients, most (90%) received at least 2 COVID-19 vaccine doses, and most patients received CU treatment and had well-controlled disease. The rate of COVID-19 vaccination–induced CU exacerbation was 9%. Of 223 patients with CU exacerbation after the first dose, 53.4% experienced recurrence of CU exacerbation after the second dose. CU exacerbation most often started <48 hours after vaccination (59.2%), lasted for a few weeks or less (70%), and was treated mainly with antihistamines (70.3%). Factors that increased the risk for COVID-19 vaccination–induced CU exacerbation included female sex, disease duration shorter than 24 months, having chronic spontaneous versus inducible urticaria, receipt of adenovirus viral vector vaccine, having nonsteroidal anti-inflammatory drug/aspirin intolerance, and having concerns about getting vaccinated; receiving omalizumab treatment and Latino/Hispanic ethnicity lowered the risk. First-dose vaccine–related adverse effects, most commonly local reactions, fever, fatigue, and muscle pain, were reported by 43.5% of CU patients. Seven patients reported severe allergic reactions.

Conclusions

COVID-19 vaccination leads to disease exacerbation in only a small number of CU patients and is generally well tolerated.

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Key words : Adverse effects, COVID-19, exacerbation, omalizumab, real life, treatment, urticaria, vaccination, vaccine, worsening

Abbreviations used : AE, aOR, ASST, AVV, CI, CIndU, COVID-19, CsA, CSU, CU, GCS, IVV, mRNA, NSAID, SARS-CoV-2, UCARE


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