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Background: Hymenoptera venom immunotherapy (VIT) is a safe and effective treatment for Hymenoptera venom allergy (HVA). Unexpected events, such as venom extracts shortage or COVID-19 pandemic, can impact HVA management, and a change in VIT supplier may became necessary. We aimed to evaluate the safety of switching VIT manufacturer without any dose adjustments. Method(s): A retrospective study of patients treated with VIT between 2013 and 2021, in the maintenance phase and without any previous systemic reactions was performed. All the patients switched to another manufacturer while keeping the same venom without any dose modification. All venom extracts were aqueous preparations. Demographic and clinical data were also analyzed. Result(s): A total of 40 patients were included (31 male, median age 44 years old);76% lived in a rural environment, 58% had apiaries <3km from home or work, and 18% were medicated with beta-blockers and/or angiotensin converting enzyme inhibitors. Most patients (68%) were treated with bee venom and the remaining wasp venom. The median time between the beginning of the maintenance phase and the switch to a different VIT supplier was 18 months [1-52 months]. A total of 42 changes between 4 suppliers were performed without any dose adjustments (39 Roxall to Leti;2 Stallergenes to Roxall;1 Inmunotek -> Roxall), with only local reaction reported. This healthy 50-year- old female patient treated with wasp VIT for 3-months in the maintenance phase, switched from Inmunotek to Roxall and presented a local reaction, similar to previous reactions with the former manufacturer. Two years later, she did not react when VIT was changed from Roxall to Leti. No systemic reactions occurred, and no one discontinued VIT. Conclusion(s): International recommendations regarding changing VIT supplier are scarce. Our results suggest that is safe to switch venom extracts from different manufacturers without the need for dose adjustment in patients on maintenance VIT without any previous systemic reactions.
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Background: Mastocytosis is a disorder characterized by an accumulation of mast cells in one or more organ systems and increased risk for severe anaphylaxis. Coronavirus disease 2019 (COVID-19) is associated with a relatively high rate of severe lung disease and mortality. During 2020, vaccines against COVID-19 were developed. The reported frequency of severe side effects appears to be low even in patients with severe allergies and mastocytosis. The aim of this study was to evaluate the safety of vaccines against COVID-19 in patients with mastocytosis. Method(s): Retrospective analysis of patients with a diagnosis of mastocytosis who have been vaccinated against COVID-19 in our department, from January to December 2021. Demographic data, history of anaphylactic reactions, COVID-19 vaccines used, premedication with antihistamines and hypersensitivity reactions were reviewed. Result(s): This study included 14 patients (64% (n = 9) were female, median age 51 +/- 18 years). Twelve (86%) patients had indolent systemic mastocytosis and two (14%) had cutaneous mastocytosis. Four (29%) patients had a history of idiopathic anaphylaxis, three (21%) reported anaphylaxis to hymenoptera venoms and one (7%) anaphylaxis to NSAID. The median basal serum tryptase level was 38.9 ng/ml, with a range from 12.7 to 91 ng/ml. Thirteen (93%) patients received an mRNA vaccine, and one adenoviral vector vaccine (7%), 2 doses each (28 administrations in total). None of the patients received premedication with antihistamines before the vaccination. None of the patients presented hypersensitivity reactions after the vaccine against COVID-19. Conclusion(s): As reported in recent studies, vaccination against COVID-19 in adult patients with mastocytosis is safe. Some authors recommend premedication in patients with mastocytosis at high risk for anaphylaxis. In our study, none of the patients received premedication and no hypersensitivity reactions were observed. More studies are needed, but in our sample, as observed for other vaccines, the vaccine against COVID-19 in patients with mastocytosis was safe.
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Background: SARS-Cov- 2 is a new respiratory virus that causes COVID-19 disease. It is a new infectious agent and knowledge is still very limited, particularly its interaction with allergic disease. The aim of this study was to assess the effect of allergic disease on the risk of hospitalization for COVID-19. Method(s): A total of 7542 SARS-CoV- 2 infections were diagnosed from 1 March to 31 December 2020 at the Centro Hospitalar Universitario de Sao Joao. A total of 1727 (22.9%) patients were hospitalized (31% in intensive care) and 5815 were followed up by an outpatient clinic. Of this group, 3479 (65%) answered a telephone questionnaire, 3 to 6 months after acute infection, about sociodemographic, clinical, behavioral and psychological characteristics. They were also asked about a previous diagnosis of allergic disease. Individuals aged < 18 years and those with asymptomatic infection were excluded. Result(s): A sample of 2702 participants was analyzed, 33.5% reported allergic disease prior to the diagnosis of COVID-19: 215 (8%) asthma, 517 (19.2%) rhinitis, 138 (5.1%) drug allergy, 36 (1.3%) food allergy, 22 (0.8%) atopic dermatitis and 2 (0.1%) hymenoptera venom allergy. The proportion of participants with asthma is not statistically different across age groups, but when grouping other allergic diseases other than asthma, a reduction was observed with age (21.5% of 18-29 years old vs. 4.9 % with >=80 years, p > 0.001). Allergic disease was significantly more prevalent in women (asthma 9.8% vs. 5.2%;other allergies: 17.9% vs. 12.7%, p < 0.001). In a univariate analysis, the risk of hospitalization of patient with COVID-19 was significantly lower in those with allergic disease (OR = 0.7;95% CI: 0.55-0.92), but for asthma the effect was not significant. Gender was an interaction factor in this association, so in a separate multivariate model for women and men and adjusted for the other significant risk factors -age, obesity and comorbidities -the effect on risk reduction remained only in the men (adjusted OR = 0.6;95% CI:0.33-1.07). Conclusion(s): In this study, allergic disease, excluding asthma, was associated with a decrease in the severity of COVID-19, especially in men. However, further studies, namely prospective studies, are needed to better characterize this effect and the underlying mechanisms.
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Background: The development of vaccines against coronavirus disease 2019 (COVID-19) and the report of associated allergic reactions has led to growing concern about their safety, especially in populations at risk for anaphylaxis such as patients with systemic mastocytosis. Method(s): We conducted a retrospective descriptive analysis of patients with systemic mastocytosis referred to our Allergy and Clinical Immunology Department, between June 2021 and February 2022, for COVID-19 vaccination. Patients were divided into two groups according to their risk of allergic reaction: low/moderate-risk (no history of severe allergic reaction, with or without a history of allergic disease) and high-risk (history of any severe allergic reaction). All patients were premedicated with 60 mg of oral prednisolone 24 hours and 1 hour prior inoculation, and with an oral antihistamine 1 hour before vaccine administration. Low/moderate-risk patients were monitored for 30 minutes after vaccine inoculation. High-risk patients got a peripheral venous access and remained under medical surveillance for 60 minutes. Result(s): A total of 45 patients were included in the analysis: 62.2% females, with a mean age of 48.8 years (range: 22-85). All patients had indolent systemic mastocytosis subtype, with a median tryptase level of 15.6 ng/mL (range: 4.3-185 ng/mL);11 (24.4%) were in the high-risk group (8 with history of anaphylaxis to hymenoptera venom and 3 with prior drug anaphylaxis). Low/moderate-risk and high-risk groups had similar median levels of serum tryptase (15.5 vs. 16.6 ng/ mL, p = 0.932). All patients received BNT162b2 mRNA COVID-19 vaccine and a total of 118 doses were administered (24.6% in the high risk group). No adverse events, including allergic reactions, after vaccine inoculation were recorded during the surveillance period. Conclusion(s): To our knowledge, this is the largest series reporting safety of a mRNA COVID-19 vaccine in patients with systemic mastocytosis. Our data reinforce the fact that even patients with increased risk for allergic reactions can be safely vaccinated against COVID-19, and that earlier concerns should be abandoned so a widespread immunization can be achieved.
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The care of patients suffering from allergological disorders is a clinical priority of the Karlsruhe Dermatology Clinic. Previously, the diagnostic focus was on detection of type-IV-sensitisation. However, due to increasing demand, the diagnosis of hymenoptera venom allergies has become a much more prominent issue. The direct impact of recent events on the allergological activity in the Karlsruhe Dermatology Clinic, was, with regard to the clarification on a potential allergy to a Covid 19 vaccine, recently becoming even more noticeable. Copyright © 2022 Georg Thieme Verlag. All rights reserved.
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The basophil activation test (BAT) is a flow cytometric assay that evaluates the percentage of activation or degranulation of peripheral blood basophils, after “in vitro” exposure to specific allergens. In sensitized patients, the stimulation of peripheral blood basophils with a specific allergen induces or up-regulates the expression of molecules, such as CD63 and CD203c, which represent, markers of degranulation and activation of basophils, respectively. The validity of the BAT requires a negative control (sterile saline) and a positive control (anti-IgE molecules). Several studies have demonstrated the role of the BAT in supporting the diagnosis of drug, food and hymenoptera venom allergy. The BAT has shown a low sensitivity but good specificity in diagnosing allergy to drugs such as NSAIDs, beta-lactam antibiotics, quinolones and muscle relaxants. In food allergy, the sensitivity and specificity of the BAT depends on the food;in the case of peanut allergy the sensitivity reaches 96% while the specificity the 100%. In addition, the BAT is an useful tool to monitor the natural resolution of allergies and the clinical effects induced by either immunotherapy or anti-IgE treatment. Finally, the BAT has been utilized to study the pathogenetic mechanisms underlying several IgE-mediated diseases. For example, in patients affected by severe bronchial asthma, the BAT has demonstrated the ability of Staphylococcus aureus enterotoxins to induce the activation of basophils supporting the role of these enterotoxins as “triggers” of the inflammatory cascade in bronchial asthma. In patients with cystic fibrosis the BAT can be used to dis-criminate allergic bronchopulmonary aspergillosis from Aspergillus colonization. More recently, the BAT has been demonstrated as a potential diagnostic tool to evaluate allergy to the polyethylene glycol (PEG) present in the anti-SARS-CoV-2 BNT162b2 mRNA vaccine.
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Background: COVID-19 vaccines are being administered all over the world, but information is lacking about the frequency and type of allergic reactions associated to these new vaccines. Method: Retrospective study of health care professionals (HCP) from our hospital who received COVID 19 vaccine Comirnaty, between 29/12/2020 and 20/2/2021. We reviewed clinical data, particularly the immediate reactions after the administration (<6h), skin tests (ST) and graded vaccine administration. Following national guidelines, all HCP with previous history of food, drug or hymenoptera venom allergy or idiopathic anaphylaxis (IA) were first evaluated by an allergist. Vaccination was postponed if HCP had previous history of IA and/or recurrent anaphylaxis (RA), severe allergic reactions to vaccines and mast cell activation syndromes. ST to the vaccine (prick and intradermal) were performed in HCP with IA and/ or RA, severe allergic reactions to vaccines and HCP with immediate reactions to the 1st dose. Graded administration of the vaccine (0.1+0.2cc after 30') was performed in the postponed HCP and the ones with immediate reactions to the 1st dose. Results: From 3073 HCP who received the vaccine, 74.2% were female, mean age 40.2 years-old ± 13.4, 316 (10.3%) were evaluated by an allergist and 4 (1.3%) postponed the administration and performed allergy investigation. 2955 HCP (97%) were able to receive the 2 doses of the vaccine. 118 employees received only one dose: 98 had COVID-19 meanwhile, 7 got pregnant, 13 due to other conditions. Adverse reactions to the vaccine with possible hypersensitivity mechanisms, occurred in 17 (0.6%) HCP, 12 on the 1st dose and 5 on the 2nd dose. Observed reactions were 6 (0.2%) urticaria, 5 (0.16%) pruritus with or without flushing, 2 (0.07%) anaphylaxis (mild), 2 (0.07%) flushing and hoarseness, 1 (0.03%) flushing and nausea and 1 (0.03%) asthma exacerbation. ST with the vaccine were performed in 4 HCP, all negative in the immediate reading and 1 positive in non-immediate reading. 7 HCP undertook the graded administration with the vaccine: 6 tolerated, but one reproduced the immediate urticaria with 0.1cc of the vaccine (0.03% vaccine allergy). Conclusion: In the evaluated sample, suspicious allergic reactions to COVID19 vaccine Commirnaty were rare and allergy was only confirmed in one HCP. The allergist initial evaluation was essential for a safe risk stratification and permitted the non-exclusion of a considerable number of HCP from the vaccination program.
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Background: During the ongoing pandemic of Coronavirus Disease 2019 (COVID-19) allergic patients need to continue their constant and proper treatment, including allergen-specific immunotherapy. These patients are expected to be at a higher risk for exacerbation of lung inflammation during viral infection. We investigated the putative interplay existing between allergen-specific immunotherapy and COVID-19 infection in Hymenoptera venom-allergic population. Method: We evaluated the frequency and severity of COVID-19 infection in a cohort of 211 Hymenoptera venom-allergic patients referring to our Center from the end of February till May 20th 2020 for the regular administration of venom immunotherapy (VIT). Each patient completed a form with information regarding symptoms (fever, cough, dyspnoea, sore throat, anosmia and/or ageusia) and eventual close COVID-19 contacts in the previous 14 days. Results: Our result showed that the median age of our cohort is similar to the one that in our region has been associated with a high incidence of COVID-19 infection, increased hospitalization and mortality rates. We reported only an isolated positivity of COVID-19 in the overall group, whereas none suffered from upper airway symptoms associated with COVID-19 (fever, cough, dyspnoea, sore throat, anosmia and/or ageusia). In our cohort 24 patients were in monotherapy with ACE-i, but none of these patients developed COVID-19 disease. In our cohort the median serum tryptase level at baseline was 8.13 ± 11.49: no correlations were found between tryptase levels and COVID-19 infection. Conclusion: Even though the demographic characteristics pose a substantial risk for such a population, we suggest that a regular administration of VIT may help to the development of an immunological milieu able to down modulate the Th1/Th17 environment that has been linked to inflammatory manifestations of COVID-19. To the best of our knowledge, this is the first description of the incidence of COVID-19 infection in Hymenoptera venom allergic patients treated with VIT, suggesting indirectly that venom immune tolerance-inducing treatment may be capable of reducing the aberrant inflammatory response induced by the virus in this specific population. (Table Presented).
ABSTRACT
Allergen immunotherapy (AIT) is a standard treatment for venom allergy. Our purpose was to determine if the administration of both allergen and protective vaccines during one visit is safe and if such a procedure does not deteriorate the tolerance of both vaccines. As current guidelines are based on theoretical assumptions, our aim was to establish the safety and tolerance of shortening the recommended interval between vaccinations. During two influenza seasons, 44 adult patients, with a history of systemic allergic reactions after a Hymenoptera sting, underwent 58 simultaneous allergen and seasonal influenza vaccinations (study group) while in the maintenance phase of venom immunotherapy (VIT). The control group consisted of 57 healthy adults who were vaccinated against influenza only. The conditions of the patients were monitored during hospital visits, and via telecommunication methods to evaluate the safety and tolerance of the procedure. Within the study group, there were no immediate or delayed allergic reactions after vaccinations. The presence of common, adverse influenza vaccine reactions among study group patients (29%) and control group patients (32%) did not differ significantly (p = 0.841). We did not observe a difference in the frequency of various adverse reactions in either group or a dependence of previous vaccinations against influenza on the occurrence of adverse reactions. The most frequent occurrences were local adverse reactions. All adverse reactions were resolved without treatment. These findings demonstrate the safety and tolerance of an influenza vaccination and Hymenoptera venom immunotherapy administration during one visit.
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BACKGROUND: According to expert consensus, the time interval between Hymenoptera venom immunotherapy (VIT) injections can be extended up to 12 weeks, without significant impact on efficacy and safety. However, the coronavirus disease 2019 pandemic caused longer delays, and no recommendations are available to manage this huge extension. OBJECTIVES: To provide advice on how to resume VIT safely after a long delay from the last injection considering the potential risk factors for side effects, without starting again with the induction phase. METHODS: All the patients who delayed VIT because of the pandemic were consecutively enrolled in this single-center study. The time extension was decided according to their risk profile (eg, long prepandemic time interval, severe pre-VIT reaction, older age, multitreatments), and correlation analyses were performed to find potential risk factors of side effects. RESULTS: The mean delay from the pre- (7 weeks) to the postpandemic VIT interval (15.5 weeks) was 8.5 weeks. The total amount of the prepandemic VIT maintenance dose was safely administered in 1 day in 78% of patients, whereas only 3, of 87, experienced side effects, and their potential risk factors were identified in bee venom allergy and recent VIT initiation. CONCLUSIONS: In a real-world setting, long VIT delays may be safe and well tolerated, but more caution should be paid in resuming VIT in patients with long prepandemic maintenance interval, severe pre-VIT reaction, recent VIT initiation, older age, multidrug treatments, and bee venom allergy. This is useful in any case of long, unplanned, and unavoidable VIT delay.