ABSTRACT
Background: Chronic urticaria (CU) is a common chronic inflammatory disease. Vaccination against viral infections including COVID-19 can induce increased CU disease activity. As of now, it is unclear how often CU exacerbations occur after COVID-19 vaccination. Method(s): COVAC-CU is an international, multicenter, observational, cross-sectional study of the global network of urticaria centers of reference and excellence (UCAREs). COVAC-CU evaluates the effects of COVID-19 vaccination in patients with CU including rates and risk factors of CU exacerbation. Here, we analyzed 1857 patients with CU who had received at least one COVID-19 vaccination. Data were collected via a questionnaire and retrieved from patient charts. Result(s): Of 1857 patients with CU (median age: 42 years;range: 18-91 years), 72.1% were female and 71.2%, 14.4% and 14.4% had chronic spontaneous urticaria, chronic inducible urticaria, or both, respectively. Most patients had received two doses of COVID-19 vaccine (79.1%), compared to one (9.7%), three (11%), or four (0.3%). Vaccine type included: BTN162b2 (58.4%;BioNTech/Pfizer), ChAdOx1 nCOV-19 (13.8%;AstraZeneca), BBIBP-CorV (8.2%;Sinopharm), Gam-COVID- Vac (8%;Sputnik), mRNA-1273 (5.3%;Moderna), and Ad26.COV 2.5 (4.7%;Janssen/J&J). Less than 10% of patients used premedication, and less than half of patients (44.4%) reported one or more adverse reactions after vaccination. The most common adverse reactions were local injection site reactions (29.6%), fatigue (19.7%), fever (19%), muscle pain (17.9%), headache (14%), and exacerbation of CU (15%). Severe allergic reactions/anaphylaxis were reported by 0.4% of CU patients. In almost all patients who experienced exacerbation of their CU, this occurred within one week after receiving the vaccine, i.e. after 1 to 12 hours (25.8 %), after 12 hours to 48 hours (31.1%) or after 2-7 days (37.9%). Conclusion(s): Most CU patients tolerate COVID-19 vaccination well;severe allergic reaction (anaphylaxis) rates were similar or lower than the self-reported rates reported in the general population. Exacerbation of urticaria was reported in one in five patients, mostly in a week after receiving the vaccine.
ABSTRACT
Mit den Biologika stehen zunehmend mehr Therapeutika zur Verfügung, die zielgerichtet bestimmte Schaltstellen im Pathomechanismus immunologisch dominierter Erkrankungen adressieren. Damit steht mehr die individuelle Krankheitsausprägung des einzelnen Patienten im Fokus der Diagnostik und Therapie (Präzisionsmedizin). Bezüglich der unterschiedlichen Phänotypen atopischer Erkrankungen war das schwere Asthma die erste Entität, für die Biologika zugelassen wurde, gefolgt von Urtikaria, und schließlich der atopischen Dermatitis und der chronischen Rhinosinusitis mit nasalen Polypen. Die Erfahrungen in der Therapie des schweren Asthma bronchiale machten deutlich, dass die Intensität des Ansprechens auf eine Biologikatherapie entscheidend von der Qualität der klinischen und immunologischen Phänotypisierung der Patienten abhängt, wobei diese Unterscheidung z. T. schwierig sein kann und sich verschiedene Phänotypen durchaus überlagern können. Das gilt auch für unterschiedliche Erkrankungen des atopischen Formenkreises, da Patienten in jeweils entsprechend unterschiedlicher Ausprägung unter mehreren atopischen Krankheiten gleichzeitig leiden können. Es bilden sich bereits Biologika heraus, die eine geeignete Therapie für das allergische Asthma bronchiale, das häufig gemeinsam mit einer schweren Neurodermitis auftritt, sowie die chronische Rhinosinusitis mit nasalen Polypen darstellen können. In der Praxis stellt sich dennoch zunehmend die Frage nach möglichen Biologika-Kombinationen zur Therapie komplexer Krankheitsbilder einzelner Patienten. Dabei gilt es, das Nebenwirkungsprofil zu beachten, zu denen auch Hypersensitivitätsreaktionen gehören, deren diagnostisches und logistisches Management eine sichere und effiziente Therapie der Grunderkrankung zum Ziel haben muss. Erhöhte Aufmerksamkeit gilt auch für eine Biologikatherapie bei Schwangerschaften und geplanten (planbaren) Impfungen sowie bestehenden Infektionen, wie zum Beispiel die SARS-CoV-2-Infektion. Vor dem Start einer Biologikatherapie sollten der Immunstatus in Bezug auf chronische Virusund bakterielle Infektionen geprüft und gegebenenfalls vor Therapieeinleitung der Impfstatus aufgefrischt bzw. fehlende Impfungen nachgeholt werden. Derzeit liegen verlässliche Daten zum Effekt von Biologika auf die immunologische Situation der SARS-CoV-2-Infektion und COVID-19 nicht vor. Daher ist die Erforschung und Entwicklung geeigneter Diagnostikverfahren zur Erfassung immunologisch bedingter Nebenwirkungen sowie der Erfassung potenzieller Therapie-Responder und -Non-Responder von großer BedeutungAlternate abstract:With the advent of biologicals, more and more therapeutics are available that specifically address specific switch points in the pathomechanism of immunologically dominated diseases. Thus, the focus of diagnostics and therapy (precision medicine) is more on the individual disease characteristics of the individual patient. Regarding the different phenotypes of atopic diseases, severe asthma was the first entity for which biologicals were approved, followed by urticaria, and finally atopic dermatitis and chronic rhinosinusitis with nasal polyps. Experience in the treatment of severe bronchial asthma has shown that the intensity of the response to biological therapy depends on the quality of clinical and immunological phenotyping of the patients. This also applies to different diseases of the atopic form, as patients can suffer from several atopic diseases at the same time, each with different characteristics. Biologics are already emerging that may represent a suitable therapy for allergic bronchial asthma, which often occurs together with severe neurodermatitis, and chronic rhinosinusitis with nasal polyps. In practice, however, the question of possible combinations of biologicals for the therapy of complex clinical pictures of individual patients is increasingly arising. In doing so, the side effect profile must be taken into account, including hypersensitivity reactions, whose diagnostic and logistical management must aim at a safe and e ficient therapy of the underlying disease. Increased attention must also be paid to biological therapy in pregnancy and planned (predictable) vaccinations as well as existing infections, such as SARS-CoV-2 infection. Before starting a biological therapy, the immune status should be checked with regard to chronic viral and bacterial infections and, if necessary, the vaccination status should be refreshed or missing vaccinations should be made up for before starting therapy. Currently, reliable data on the effect of biologicals on the immunological situation of SARS-CoV-2 infection and COVID-19 are not available. Therefore, research and development of suitable diagnostic methods for detection of immunologically caused side effects as well as detection of potential therapy responders and non-responders is of great importance.