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1. Safety of mRNA-based COVID-19 vaccination in paediatric patients with a PEG-asparaginase allergy

Author

Nancy Broos, Leiah J. Brigitha, Annemieke Schuurhof, Heike Röckmann-Helmbach, Wim J.E. Tissing, Rob Pieters, Inge M. van der Sluis, and Marike B. Stadermann

Subjects
PEG-Asparaginase, Polyethylene glycol, COVID-19 vaccine, Allergy, Paediatric, Antibodies, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background: Children treated for a malignancy are at risk to develop serious illness from a COVID-19 infection. Pegylated E. coli asparaginase (PEG-asparaginase) is used in the treatment of acute lymphoblastic leukemia. Allergy to this drug is common and both asparaginase and polyethylene glycol (PEG) are identified as possible antigens. The mRNA-based vaccines against COVID-19 contain PEG as a stabilizing component. Methods: We developed a protocol to be able to safely vaccinate children with a PEG-asparaginase allergy. All patients with a history of allergy to PEG-asparaginase have been included and skin prick testing for various PEGs was performed before vaccination with the mRNA Pfizer-BioNTech COVID-19 vaccine. Results: Twelve children between six and 16 years old were vaccinated, without allergic reaction. None of them got a positive skin prick test for PEG. Ten patients had pre-existing IgG or IgM antibodies against PEG. Conclusion: Children with a PEG-asparaginase allergy can be safely vaccinated against COVID-19 with mRNA vaccines containing PEG irrespective of IgG/IgM antibodies to PEG-asparaginase. Routine skin prick testing in patients with PEG-asparaginase allergy does not seem to be of added value.

Published
2023
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2. Causes of perioperative hypersensitivity reactions in the Netherlands from 2002 to 2014

Author

Maurits S. van Maaren, Ron Tupker, Vera Nederhoed, Heike Röckmann-Helmbach, Joanne N G Oude Elberink, Annick A J M van de Ven, Internal Medicine, and Groningen Research Institute for Asthma and COPD (GRIAC)

Subjects
medicine.medical_specialty, drug hypersensitivity reaction, medicine.drug_class, Immunology, Antibiotics, Drug allergy, Immunoglobulin E, Drug Hypersensitivity, Internal medicine, Allergy test, medicine, Immunology and Allergy, Humans, General anaesthesia, general anaesthesia, perioperative, Perioperative Period, Netherlands, ANESTHESIA, biology, ANAPHYLAXIS, business.industry, Incidence (epidemiology), Perioperative, medicine.disease, ALLERGY, biology.protein, business, Anaphylaxis, drug allergy
Abstract

Although relatively rare, immediate perioperative hypersensitivity reactions (POH) are important complications of drug administration prior to, during and after surgical and other interventional procedures. Both the incidence of immediate POH as well as their major culprits are difficult to establish and vary considerably between reports; the incidence may be as high as 1:1250 or almost a tenfold lower.(1) Most studies have a yield of positive allergy test results of 50 to 60%, suggestive of an immunoglobulin E (IgE)-mediated reaction. Neuromuscular blocking agents (NMBA) were shown to be the most common cause of immediate POH in various countries including France and Australia,(2) while other countries (U.S.A., U.K., Spain, Denmark) identify antibiotics to be the primary culprit.(1, 3, 4).

Published
2022

3. Definition, aims, and implementation of GA [sup] 2 LEN/HAEi Angioedema Centers of Reference and Excellence

Author

Kemal Özyurt, Teresa Caballero, Aharon Kessel, Andrew J. MacGinnitie, Solange Oliveira Rodrigues Valle, Anthony J. Castaldo, Markus Magerl, Regis A. Campos, Adam Reich, Heike Röckmann-Helmbach, R. Y. Meshkova, Mario Sánchez-Borges, Richard G. Gower, Anna Zalewska-Janowska, Daria Fomina, Célia Costa, Allen P. Kaplan, Marc A. Riedl, Naoko Inomata, Avner Reshef, Alejandro Malbrán, Aurélie Du-Thanh, N. Prior, Hilary Longhurst, Margarida Gonçalo, Kiran Godse, Rosana Câmara Agondi, Andreas Kleinheinz, Inmaculada Martinez-Saguer, Mona Al-Ahmad, Thilo Jakob, Luis Felipe Ensina, José Ignacio Larco Sousa, Anna Tagka, Chikako Nishigori, Nicola Wagner, Hye Ryun Kang, Michael Makris, Nicholas Brodszki, Ricardo Dario Zwiener, Jan Nicolay, Alicja Kasperska-Zając, Iris V Medina, Ignacio J. Ansotegui, Marcin Stobiecki, Alejandro Berardi, Danny M. Cohn, Claudio A S Parisi, Angèle Soria, Torsten Zuberbier, Dario O. Josviack, E Serra-Baldrich, Jonathan A. Bernstein, Anette Bygum, Isao Ohsawa, Henriette Farkas, Iman Nasr, Thomas Buttgereit, Jonathan Peter, Carsten Bindslev-Jensen, Paulo Ricardo Criado, Wolfgang Pfützner, Natalia Fili, Silvia Mariel Ferrucci, Petra Staubach, Peter Schmid-Grendelmeier, M. Gotua, Marcus Maurer, Jose Fabiani, Gordon Sussman, A. Marsland, Konrad Bork, Andrea Zanichelli, Simon Francis Thomsen, Isabelle Boccon-Gibod, Mauro Cancian, German D. Ramon, Zuotao Zhao, Nikolaos G. Papadopoulos, Martijn B. A. van Doorn, Andrea Bauer, Kanokvalai Kulthanan, Claudio Fantini, Henrik Balle Boysen, Lilian Varga, Dorota Krasowska, Ana Giménez-Arnau, Werner Aberer, Ivan Cherrez-Ojeda, Roberta F. Criado, Constance H. Katelaris, Martin Metz, Riccardo Asero, Mitja Košnik, Stephen Betschel, M Sendhil Kumaran, Sigurd Broesby-Olsen, Moshe Ben-Shoshan, Rand Arnaout, Regina Treudler, Laurence Bouillet, Natalia Ilina, Maryam Ali Al-Nesf, Emek Kocatürk, Emel Aygören-Pürsün, William R. Lumry, Guillermo Guidos-Fogelbach, Yuxiang Zhi, Mark Gompels, Andac Salman, Christina Weber-Chrysochoou, Michihiro Hide, Young Min Ye, Aslı Gelincik, William B Smith, Timothy J. Craig, Bruce Ritchie, Daniel O. Vázquez, Mojca Bizjak, Atsushi Fukunaga, Ragıp Ertaş, Urs C. Steiner, Faradiba Sarquis Serpa, Farrukh R. Sheikh, Michael Rudenko, Paula J. Busse, Luisa Karla de Paula Arruda, Liangchun Wang, Todor A. Popov, Anete Sevciovic Grumach, Joachim Dissemond, Dorottya Csuka, Ignasi Figueras-Nart, Aleena Banerji, Tıp Fakültesi, Kemal Özyurt / 0000-0002-6913-8310, Vascular Medicine, ACS - Atherosclerosis & ischemic syndromes, Dermatology, Göncü, Özgür Emek Kocatürk (ORCID 0000-0003-2801-0959 & YÖK ID 217219), Maurer, Marcus, Werner, Aberer, Agondi, Rosana, Al-Ahmad, Mona, Al-Nesf, Maryam Ali, Ansotegui, Ignacio, Arnaout, Rand, Arruda, Luisa Karla, Asero, Riccardo, Aygoeren-Puersue, Emel, Banerji, Aleena, Bauer, Andrea, Ben-Shoshan, Moshe, Berardi, Alejandro, Bernstein, Jonathan A, Betschel, Stephen, Bindslev-Jensen, Carsten, Bizjak, Mojca, Boccon-Gibod, Isabelle, Bork, Konrad, Bouillet, Laurence, Boysen, Henrik Balle, Brodszki, Nicholas, Broesby-Olsen, Sigurd, Busse, Paula, Buttgereit, Thomas, Bygum, Anette, Caballero, Teresa, Campos, Regis A., Cancian, Mauro, Cherrez-Ojeda, Ivan, Cohn, Danny M., Costa, Celia, Craig, Timothy, Criado, Paulo Ricardo, Criado, Roberta F., Csuka, Dorottya, Dissemond, Joachim, Du-Thanh, Aurelie, Ensina, Luis Felipe, Ertaş, Ragıp, Fabiani, Jose E., Fantini, Claudio, Farkas, Henriette, Ferrucci, Silvia Mariel, Figueras-Nart, Ignasi, Fili, Natalia L., Fomina, Daria, Fukunaga, Atsushi, Gelincik, Aslı, Gimenez-Arnau, Ana, Godse, Kiran, Gompels, Mark, Goncalo, Margarida, Gotua, Maia, Gower, Richard, Grumach, Anete S, Guidos-Fogelbach, Guillermo, Hide, Michihiro, Ilina, Natalia, Inomata, Naoko, Jakob, Thilo, Josviack, Dario O., Kang, Hye-Ryun, Kaplan, Allen, Kasperska-Zajac, Alicja, Katelaris, Constance, Kessel, Aharon, Kleinheinz, Andreas, Kosnik, Mitja, Krasowska, Dorota, Kulthanan, Kanokvalai, Kumaran, M. Sendhil, Larco Sousa, Jose Ignacio, Longhurst, Hilary J., Lumry, William, MacGinnitie, Andrew, Magerl, Markus, Makris, Michael P., Malbran, Alejandro, Marsland, Alexander, Martinez-Saguer, Inmaculada, Medina, Iris V., Meshkova, Raisa, Metz, Martin, Nasr, Iman, Nicolay, Jan, Nishigori, Chikako V., Nishigori, Chikako, Ohsawa, Isao, Özyurt, Kemal, Papadopoulos, Nikolaos G., Parisi, Claudio A. S., Peter, Jonathan Grant, Pfuetzner, Wolfgang, Popov, Todor, Prior, Nieves, Ramon, German D., Reich, Adam, Reshef, Avner, Riedl, Marc A., Ritchie, Bruce, Rockmann-Helmbach, Heike, Rudenko, Michael, Salman, Andaç, Sanchez-Borges, Mario, Schmid-Grendelmeier, Peter, Serpa, Faradiba S., Serra-Baldrich, Esther, Sheikh, Farrukh R., Smith, William, Soria, Angele, Staubach, Petra, Steiner, Urs C., Stobiecki, Marcin, Sussman, Gordon, Tagka, Anna, Thomsen, Simon Francis, Treudler, Regina, Valle, Solange, van Doorn, Martijn, Varga, Lilian, Vazquez, Daniel O., Wagner, Nicola, Wang, Liangchun, Weber-Chrysochoou, Christina, Ye, Young-Min, Zalewska-Janowska, Anna, Zanichelli, Andrea, Zhao, Zuotao, Zhi, Yuxiang, Zuberbier, Torsten, Zwiener, Ricardo D., Castaldo, Anthony, and School of Medicine

Subjects
medicine.medical_specialty, Edema angioneuròtic, Urticaria, media_common.quotation_subject, Immunology, education, GA2LEN, Angioedema, Center, Excellence, Management, urticaria, centres of reference and excelence, immune system diseases, center, medicine, Immunology and Allergy, Center (algebra and category theory), Angioneurotic edema, skin and connective tissue diseases, media_common, udc:616.1, business.industry, angioedema, humanities, referenčni centri odličnosti, Medicine, Allergy, Family medicine, excellence, medicine.symptom, business, Global Allergy and Asthma European Network, Urticària, management
Abstract

This document summarizes the aims of GA2 LEN/HAEi Angioedema Centers of Reference and Excellence (ACAREs) and elaborates the requirements that ACAREs must fulfill to become certified. It also provides (see Appendix S1) background information on GA2LEN and HAEi, including HAEi member organizations and regional patient advocates, on why we need an Angioedema Center of Reference and Excellence (ACARE) program and network, and on the accreditation and certification process, governance and funding, and on the interaction with other GA2LEN networks of centers of reference and excellence. The protocols, aims, requirements, and provisions related to becoming a certified CARE are based on (a) the experience of the GA2LEN UCARE network and (b) input from angioedema patients, general practitioners, and angioedema specialists.

Published
2020
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4. Definition, aims, and implementation of GA

Author

Marcus, Maurer, Werner, Aberer, Rosana, Agondi, Mona, Al-Ahmad, Maryam Ali, Al-Nesf, Ignacio, Ansotegui, Rand, Arnaout, Luisa Karla, Arruda, Riccardo, Asero, Emel, Aygören-Pürsün, Aleena, Banerji, Andrea, Bauer, Moshe, Ben-Shoshan, Alejandro, Berardi, Jonathan A, Bernstein, Stephen, Betschel, Carsten, Bindslev-Jensen, Mojca, Bizjak, Isabelle, Boccon-Gibod, Konrad, Bork, Laurence, Bouillet, Henrik Balle, Boysen, Nicholas, Brodszki, Sigurd, Broesby-Olsen, Paula, Busse, Thomas, Buttgereit, Anette, Bygum, Teresa, Caballero, Régis A, Campos, Mauro, Cancian, Ivan, Cherrez-Ojeda, Danny M, Cohn, Célia, Costa, Timothy, Craig, Paulo Ricardo, Criado, Roberta F, Criado, Dorottya, Csuka, Joachim, Dissemond, Aurélie, Du-Thanh, Luis Felipe, Ensina, Ragıp, Ertaş, José E, Fabiani, Claudio, Fantini, Henriette, Farkas, Silvia Mariel, Ferrucci, Ignasi, Figueras-Nart, Natalia L, Fili, Daria, Fomina, Atsushi, Fukunaga, Asli, Gelincik, Ana, Giménez-Arnau, Kiran, Godse, Mark, Gompels, Margarida, Gonçalo, Maia, Gotua, Richard, Gower, Anete S, Grumach, Guillermo, Guidos-Fogelbach, Michihiro, Hide, Natalia, Ilina, Naoko, Inomata, Thilo, Jakob, Dario O, Josviack, Hye-Ryun, Kang, Allen, Kaplan, Alicja, Kasperska-Zając, Constance, Katelaris, Aharon, Kessel, Andreas, Kleinheinz, Emek, Kocatürk, Mitja, Košnik, Dorota, Krasowska, Kanokvalai, Kulthanan, M Sendhil, Kumaran, José Ignacio, Larco Sousa, Hilary J, Longhurst, William, Lumry, Andrew, MacGinnitie, Markus, Magerl, Michael P, Makris, Alejandro, Malbrán, Alexander, Marsland, Inmaculada, Martinez-Saguer, Iris V, Medina, Raisa, Meshkova, Martin, Metz, Iman, Nasr, Jan, Nicolay, Chikako, Nishigori, Isao, Ohsawa, Kemal, Özyurt, Nikolaos G, Papadopoulos, Claudio A S, Parisi, Jonathan Grant, Peter, Wolfgang, Pfützner, Todor, Popov, Nieves, Prior, German D, Ramon, Adam, Reich, Avner, Reshef, Marc A, Riedl, Bruce, Ritchie, Heike, Röckmann-Helmbach, Michael, Rudenko, Andaç, Salman, Mario, Sanchez-Borges, Peter, Schmid-Grendelmeier, Faradiba S, Serpa, Esther, Serra-Baldrich, Farrukh R, Sheikh, William, Smith, Angèle, Soria, Petra, Staubach, Urs C, Steiner, Marcin, Stobiecki, Gordon, Sussman, Anna, Tagka, Simon Francis, Thomsen, Regina, Treudler, Solange, Valle, Martijn, van Doorn, Lilian, Varga, Daniel O, Vázquez, Nicola, Wagner, Liangchun, Wang, Christina, Weber-Chrysochoou, Young-Min, Ye, Anna, Zalewska-Janowska, Andrea, Zanichelli, Zuotao, Zhao, Yuxiang, Zhi, Torsten, Zuberbier, Ricardo D, Zwiener, and Anthony, Castaldo

Subjects
Urticaria, Humans, Angioedema
Published
2020

5. Allergenicity and safety of recombinant human C1 esterase inhibitor in patients with allergy to rabbit or cow's milk

Author

Heike Röckmann-Helmbach, Anurag Relan, Mignon T. van den Elzen, Helma van Doorn, Ans F.M. Lebens, C. Erik Hack, Carla A.F.M. Bruijnzeel-Koomen, Els van Hoffen, Leonard Kaufman, André C. Knulst, Rob J.B. Klemans, and Harmieke van Os-Medendorp

Subjects
Male, Allergy, Immunoglobulin E, Gastroenterology, Severity of Illness Index, law.invention, 030207 dermatology & venereal diseases, 0302 clinical medicine, law, Immunology and Allergy, Young adult, skin and connective tissue diseases, subcutaneous administration, Hereditary angioedema, biology, food and beverages, Middle Aged, cow's milk allergy, Recombinant Proteins, Milk, Phenotype, allergenicity, Recombinant DNA, Female, Rabbits, Complement C1 Inhibitor Protein, intracutaneous test, Adult, medicine.medical_specialty, Immunology, 03 medical and health sciences, Young Adult, Internal medicine, parasitic diseases, Severity of illness, Journal Article, medicine, Animals, Humans, In patient, recombinant human C1 esterase inhibitor, Adverse effect, Skin Tests, subcutaneous challenge, business.industry, Angioedemas, Hereditary, medicine.disease, intradermal testing, skin prick test, 030228 respiratory system, biology.protein, Cattle, rabbit allergy, Milk Hypersensitivity, business
Abstract

Recombinant human C1 inhibitor (rhC1INH) for on-demand treatment of hereditary angioedema is purified from milk of transgenic rabbits. It contains low amounts (0.002%) of host-related impurities, which could trigger hypersensitivity reactions in patients with rabbit allergy (RA) and/or cow's milk allergy (CMA).This study is an assessment of allergenicity and safety of rhC1INH in patients with RA and/or CMA.Patients with CMA and/or RA underwent skin prick test (SPT), intracutaneous test (ICT), and, when results for both were negative, subcutaneous (SC) challenge with up to 2100U (14 mL) rhC1INH. The negative predictive value of the skin test protocol was calculated, defined as the ratio of patients without systemic symptoms of hypersensitivity following SC challenge, over the number of patients having tested negative for both the SPT and the ICT. Adverse events after exposure to rhC1INH were recorded.Twenty-six patients with RA and/or CMA were enrolled. Twenty-four had negative SPT and ICT results for rhC1INH, whereas 2 had negative SPT result but positive ICT result to rhC1INH (only the highest concentration). Twenty-two patients with negative SPT and ICT results underwent SC challenge. None developed allergic symptoms. Local treatment-emergent adverse events occurred in 7 patients (32%) after SC challenge. In 5 these were considered drug related. All were mild.None of the patients with negative SPT and ICT results for rhC1INH had allergic symptoms during rhC1INH challenge. The negative predictive value of the combination of SPT and ICT for the outcome of the SC challenge was 100% (95% CI, 84.6%-100%). SC administration of rhC1INH was well tolerated.

Published
2016

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