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1. Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks

Author

Riedl, Marc A, Maurer, Marcus, Bernstein, Jonathan A, Banerji, Aleena, Longhurst, Hilary J, Li, H Henry, Lu, Peng, Hao, James, Juethner, Salomé, Lumry, William R, Hébert, J, Ritchie, B, Sussman, G, Yang, WH, Ettingshausen, C Escuriola, Magerl, M, Martinez‐Saguer, I, Maurer, M, Staubach, P, Zimmer, S, Cicardi, M, Perego, F, Wu, MA, Zanichelli, A, Al‐Ghazawi, A, Shennak, M, Zaragoza‐Urdaz, RH, Ghurye, R, Longhurst, HJ, Zinser, E, Anderson, J, Banerji, A, Baptist, AP, Bernstein, JA, Boggs, PB, Busse, PJ, Christiansen, S, Craig, T, Davis‐Lorton, M, Gierer, S, Gower, RG, Harris, D, Hong, DI, Jacobs, J, Johnston, DT, Levitch, ES, Li, HH, Lockey, RF, Lugar, P, Lumry, WR, Manning, ME, McNeil, DL, Melamed, I, Mostofi, T, Nickel, T, Otto, WR, Petrov, AA, Poarch, K, Radojicic, C, Rehman, SM, Riedl, MA, Schwartz, LB, Shapiro, R, Sher, E, Smith, AM, Smith, TD, Soteres, D, Tachdjian, R, Wedner, HJ, Weinstein, ME, Zafra, H, and Zuraw, BL

Subjects
Neurosciences, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Angioedemas, Hereditary, Antibodies, Monoclonal, Humanized, Complement C1 Inhibitor Protein, Humans, Treatment Outcome, durable efficacy, hereditary angioedema, long-term prophylaxis, onset of action, HELP Investigators
Abstract

BackgroundLanadelumab demonstrated efficacy in preventing hereditary angioedema (HAE) attacks in the phase 3 HELP Study.ObjectiveTo assess time to onset of effect and long-term efficacy of lanadelumab, based on exploratory findings from the HELP Study.MethodsEligible patients with HAE type I/II received lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo. Ad hoc analyses evaluated day 0-69 findings using a Poisson regression model accounting for overdispersion. Least-squares mean monthly HAE attack rate for lanadelumab was compared with placebo. Intrapatient comparisons for days 0-69 versus steady state (days 70-182) used a paired t test for continuous endpoints or Kappa statistics for categorical endpoints.ResultsOne hundred twenty-five patients were randomized and treated. During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) vs placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs 1.66) and moderate/severe attacks (0.31-0.48 vs 1.33, all P ≤ .001). More patients receiving lanadelumab vs placebo were attack free (37.9%-48.1% vs 7.3%) and responders (85.7%-100% vs 26.8%). During steady state, the efficacy of lanadelumab vs placebo was similar or improved vs days 0-69. Intrapatient differences were significant with lanadelumab 300 mg q4wks for select outcomes. Lanadelumab efficacy was durable-HAE attack rate was consistently lower vs placebo, from the first 2 weeks of treatment through study end. Treatment emergent adverse events were comparable during days 0-69 and 70-182.ConclusionProtection with lanadelumab started from the first dose and continued throughout the entire study period.

Published
2020

2. The Chronic Angioedema Registry (CARE): Rationale, Methods and Implementation.

Author

Buttgereit, T., Aulenbacher, F., Gutsche, A., Kolkhir, P., Weller, K., Vera Ayala, C., Magerl, M., Farkas, H., Grumach, A. S., Aygören‐Pürsün, E., Bara, N., Ben‐Shoshan, M., Bernstein, J., Betschel, S., Bouillet, L., Caballero, T., Cancian, M., Castaldo, A. J., Cimbollek, S., and Cohn, D. M.

Subjects
SCIENTIFIC knowledge, RESEARCH personnel, MEDICAL research personnel, ADVISORY boards, RESEARCH grants
Abstract

The Chronic Angioedema Registry (CARE) is an international disease registry that aims to improve patient care for recurrent angioedema. It collects data through questionnaires completed by physicians and patients to assess disease control, quality of life, and treatment responses. However, the outcomes may not apply to less severe cases typically seen in primary care or community settings, and the findings may not be generalizable to patients from diverse ethnic backgrounds. The document also lists conflicts of interest for authors involved in the CARE study, who have disclosed financial relationships with pharmaceutical companies and other organizations. The study received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin. [Extracted from the article]

Published
2024
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3. Phase II study results of a replacement therapy for hereditary angioedema with subcutaneous C1‐inhibitor concentrate

Author

Zuraw, BL, Cicardi, M, Longhurst, HJ, Bernstein, JA, Li, HH, Magerl, M, Martinez-Saguer, I, Rehman, SMM, Staubach, P, Feuersenger, H, Parasrampuria, R, Sidhu, J, Edelman, J, and Craig, T

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Angioedemas, Hereditary, Complement C1 Inhibitor Protein, Drug Administration Schedule, Female, Humans, Injections, Subcutaneous, Male, Treatment Outcome, Young Adult, Berinert, C1-esterase inhibitor, hereditary angioedema, long-term prophylaxis, subcutaneous treatment, Immunology, Allergy
Abstract

BackgroundHereditary angioedema (HAE) due to C1 inhibitor deficiency manifests as recurrent swelling attacks that can be disabling and sometimes fatal. Long-term prophylaxis with twice-weekly intravenous injections of plasma-derived C1-inhibitor (pdC1-INH) has been established as an effective treatment. Subcutaneous (SC) administration of pdC1-INH has not been studied in patients with HAE.MethodsThis open-label, dose-ranging, crossover study (COMPACT Phase II) was conducted in 18 patients with type I or II HAE who received two of twice-weekly 1500, 3000, or 6000 IU SC doses of highly concentrated volume-reduced CSL830 for 4 weeks each. The mean trough plasma levels of C1-INH functional activity, C1-INH and C4 antigen levels during Week 4, and overall safety and tolerability were evaluated. The primary outcome was model-derived steady-state trough C1-INH functional activity.ResultsAfter SC CSL830 administration, a dose-dependent increase in trough functional C1-INH activity was observed. C1-INH and C4 levels both increased. The two highest dose groups (3000 and 6000 IU) achieved constant C1-INH activity levels above 40% values, a threshold that was assumed to provide clinical protection against angioedema attacks. Compared with intravenous injection, pdC1-INH SC injection with CSL830 showed a lower peak-to-trough ratio and more consistent exposures. All doses were well tolerated. Mild-to-moderate local site reactions were noted with pain and swelling being the most common adverse event.ConclusionsSubcutaneous volume-reduced CSL830 was well tolerated and led to a dose-dependent increase in physiologically relevant functional C1-INH plasma levels. A clinical outcome study of SC CSL830 in patients with HAE warrants further investigation.

Published
2015

8. Urtikaria und Angioödem

Author

Weller, K., Magerl, M., Zuberbier, T., Maurer, M., Biedermann, Tilo, editor, Heppt, Werner, editor, Renz, Harald, editor, and Röcken, Martin, editor

Published
2016
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9. Chronische Urtikaria

Author

Weller, K., Altrichter, S., Ardelean, E., Krause, K., Magerl, M., Metz, M., Siebenhaar, F., and Maurer, M.

Abstract

Zusammenfassung: Die chronische Urtikaria (CU) gehört zu den häufigsten Krankheitsbildern in der Dermatologie. Aktuelle Studien zeigen eine Punktprävalenz zwischen 0,5 und 1% in der Gesamtbevölkerung mit einem Übergewicht an Frauen. Prinzipiell können alle Altersgruppen und Bevölkerungsschichten betroffen sein. Allerdings gibt es eine Häufung in der 3. und 4. Lebensdekade. Nach Definition der aktuellen Leitlinien besteht eine chronische Urtikaria dann, wenn Quaddelbildung und/oderAngioödeme spontan und für länger als 6 Wochen auftreten. Epidemiologische Studien belegen, dass die Mehrheit der Betroffenen über Monate, oft Jahre, unter den Beschwerden leidet. Negativ auf die Dauer der Erkrankung scheinen sich das Vorkommen von Angioödemen, das zeitgleiche Bestehen einer physikalischen Urtikaria, Positivität im autologen Serumtest und eine hohe Krankheitsschwere auszuwirken. Studien zur Lebensqualität zeigen, dass CU-Patienten ähnlich stark unter der Erkrankung leiden wie Menschen mit einer ausgeprägten koronaren Herzkrankheit. Neben den rein körperlichen Symptomen erleben die Patienten auch Einschränkungen bei alltäglichen Tätigkeiten und im Sozialleben. Zudem ist der Schlaf oft stark beeinträchtigt, und die Patienten leiden überdurchschnittlich häufig an psychiatrischen Begleiterkrankungen. Um Missverständnisse und Frustration bei der Betreuung zu vermeiden, ist es wichtig, die Patienten mit ihrer Erkrankung in all ihren Dimensionen wahr- und ernst zu nehmen. Das Ziel der Therapie von CU-Patienten sollte es sein, komplette Beschwerdefreiheit zu erreichen.

Published
2024
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17. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria

Author

Zuberbier, T. Abdul Latiff, A.H. Abuzakouk, M. Aquilina, S. Asero, R. Baker, D. Ballmer-Weber, B. Bangert, C. Ben-Shoshan, M. Bernstein, J.A. Bindslev-Jensen, C. Brockow, K. Brzoza, Z. Chong Neto, H.J. Church, M.K. Criado, P.R. Danilycheva, I.V. Dressler, C. Ensina, L.F. Fonacier, L. Gaskins, M. Gáspár, K. Gelincik, A. Giménez-Arnau, A. Godse, K. Gonçalo, M. Grattan, C. Grosber, M. Hamelmann, E. Hébert, J. Hide, M. Kaplan, A. Kapp, A. Kessel, A. Kocatürk, E. Kulthanan, K. Larenas-Linnemann, D. Lauerma, A. Leslie, T.A. Magerl, M. Makris, M. Meshkova, R.Y. Metz, M. Micallef, D. Mortz, C.G. Nast, A. Oude-Elberink, H. Pawankar, R. Pigatto, P.D. Ratti Sisa, H. Rojo Gutiérrez, M.I. Saini, S.S. Schmid-Grendelmeier, P. Sekerel, B.E. Siebenhaar, F. Siiskonen, H. Soria, A. Staubach-Renz, P. Stingeni, L. Sussman, G. Szegedi, A. Thomsen, S.F. Vadasz, Z. Vestergaard, C. Wedi, B. Zhao, Z. Maurer, M.

Subjects
immune system diseases, parasitic diseases, education, skin and connective tissue diseases
Abstract

This update and revision of the international guideline for urticaria was developed following the methods recommended by Cochrane and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group. It is a joint initiative of the Dermatology Section of the European Academy of Allergology and Clinical Immunology (EAACI), the Global Allergy and Asthma European Network (GA²LEN) and its Urticaria and Angioedema Centers of Reference and Excellence (UCAREs and ACAREs), the European Dermatology Forum (EDF; EuroGuiDerm), and the Asia Pacific Association of Allergy, Asthma and Clinical Immunology with the participation of 64 delegates of 50 national and international societies and from 31 countries. The consensus conference was held on 3 December 2020. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS). Urticaria is a frequent, mast cell–driven disease that presents with wheals, angioedema, or both. The lifetime prevalence for acute urticaria is approximately 20%. Chronic spontaneous or inducible urticaria is disabling, impairs quality of life, and affects performance at work and school. This updated version of the international guideline for urticaria covers the definition and classification of urticaria and outlines expert-guided and evidence-based diagnostic and therapeutic approaches for the different subtypes of urticaria. © 2021 GA²LEN. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

Published
2022

21. WAO/EAACI.

Author

Maurer, M., Magerl, M., Ansotegui, I., Aygören-Pürsün, E., Betschel, S., Bork, K., Bowen, T., Balle Boysen, H., Farkas, H., Grumach, A. S., Hide, M., Katelaris, C., Lockey, R., Longhurst, H., Lumry, W. R., Martinez-Saguer, I., Moldovan, D., Nast, A., Pawankar, R., and Potter, P.

Published
2023

27. How are patients with chronic urticaria interested in using information and communication technologies to guide their healthcare? a UCARE study

Author

Göncü, Özgür Emek Kocatürk (ORCID 0000-0003-2801-0959 & YÖK ID 217219), Cherrez-Ojeda, I.; Vanegas, E.; Cherrez, A.; Felix, M.; Weller, K.; Magerl, M.; Maurer, R. R.; Mata, V. L.; Kasperska-Zajac, A.; Sikora, A.; Fomina, D.; Kovalkova, E.; Godse, K.; Rao, N. D.; Khoshkhui, M.; Rastgoo, S.; Criado, R. F.; Abuzakouk, M.; Grandon, D.; Van Doorn, M. B. A.; Oliveira Rodrigues Valle, S.; De Souza Lima, E. M.; Thomsen, S. F.; Ramón, G. D.; Matos Benavides, E. E.; Bauer, A.; Giménez-Arnau, A. M.; Guillet, C.; Larco, J. I.; Zhao, Z.- T.; Makris, M.; Ritchie, C.; Xepapadaki, P.; Ensina, L. F.; Cherrez, S.; Maurer, M., Göncü, Özgür Emek Kocatürk (ORCID 0000-0003-2801-0959 & YÖK ID 217219), and Cherrez-Ojeda, I.; Vanegas, E.; Cherrez, A.; Felix, M.; Weller, K.; Magerl, M.; Maurer, R. R.; Mata, V. L.; Kasperska-Zajac, A.; Sikora, A.; Fomina, D.; Kovalkova, E.; Godse, K.; Rao, N. D.; Khoshkhui, M.; Rastgoo, S.; Criado, R. F.; Abuzakouk, M.; Grandon, D.; Van Doorn, M. B. A.; Oliveira Rodrigues Valle, S.; De Souza Lima, E. M.; Thomsen, S. F.; Ramón, G. D.; Matos Benavides, E. E.; Bauer, A.; Giménez-Arnau, A. M.; Guillet, C.; Larco, J. I.; Zhao, Z.- T.; Makris, M.; Ritchie, C.; Xepapadaki, P.; Ensina, L. F.; Cherrez, S.; Maurer, M.

Abstract

Background: patients with chronic urticaria (CU) are increasingly using information and communication technologies (ICTs) to manage their health. What CU patients expect from ICTs and which ICTs they prefer remains unknown. We assessed why CU patients use ICTs, which ones they prefer, and what drives their expectations and choices. Methods: in this cross-sectional study, 1841 patients across 17 countries were recruited at UCAREs (Urticaria Centers of Reference and Excellence). Patients with CU who were >12 years old completed a 23-item questionnaire. Results: most patients were interested in receiving disease information (87.3%), asking physicians about CU (84.1%), and communicating with other patients through ICTs (65.6%). For receiving disease information, patients preferred one-to-one and one-to-many ICTs, especially web browsers. One-to-one ICTs were also the ICTs of choice for asking physicians about urticaria and for communicating with other patients, and e-mail and WhatsApp were the preferred ICTs, respectively. Many-to-many ICTs such as Facebook, Instagram, LinkedIn, and Twitter were least preferred for all 3 purposes. Living in rural areas and higher education were linked to higher odds of being interested in receiving disease information, asking physicians, and communicating with patients through ICTs. Conclusions: most patients and especially patients with higher education who live in rural areas are interested in using ICTs for their healthcare, but prefer different ICTs for different purposes, ie, web browsers for obtaining information, e-mail for asking physicians, and WhatsApp for communicating with other patients. Our findings may help to improve ICTs for CU.

Published
2021

35. Long-term safety of icatibant treatment of patients with angioedema in real-world clinical practice

Author

Zanichelli, A., Maurer, M., Aberer, W., Caballero, T., Longhurst, H. J., Bouillet, L., Fabien, V., Andresen, I., Grumach, A., Bygum, A., Blanchard Delaunay, C., Boccon-Gibod, I., Coppere, B., Du Thanh, A., Dzviga, C., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Sobel, A., Aygören-Pürsün, E., Bas, M., Bauer, A., Bork, K., Greve, J., Magerl, M., Martinez Saguer, I., Strassen, U., Papadopoulou-Alataki, E., Psarros, F., Graif, Y., Kivity, S., Reshef, A., Toubi, E., Arcoleo, F., Bova, M., Cicardi, M., Manconi, P., Marone, G., Montinaro, V., Triggiani, M., Baeza, L., Cabañas, R., Gala Ortiz, G., Guilarte, M., Hernandez, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Marques, L., Saenz de San Pedro, B., Björkander, J., Bethune, C., Garcez, T., Zanichelli, A., Maurer, M., Aberer, W., Caballero, T., Longhurst, H. J., Bouillet, L., Fabien, V., Andresen, I., Grumach, A., Bygum, A., Blanchard Delaunay, C., Boccon-Gibod, I., Coppere, B., Du Thanh, A., Dzviga, C., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Sobel, A., Aygören-Pürsün, E., Bas, M., Bauer, A., Bork, K., Greve, J., Magerl, M., Martinez Saguer, I., Strassen, U., Papadopoulou-Alataki, E., Psarros, F., Graif, Y., Kivity, S., Reshef, A., Toubi, E., Arcoleo, F., Bova, M., Cicardi, M., Manconi, P., Marone, G., Montinaro, V., Triggiani, M., Baeza, L., Cabañas, R., Gala Ortiz, G., Guilarte, M., Hernandez, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Marques, L., Saenz de San Pedro, B., Björkander, J., Bethune, C., and Garcez, T.

Subjects
safety, 0301 basic medicine, real-world, medicine.medical_specialty, Immunology, Brief Communication, Off-label use, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Icatibant, Internal medicine, angioedema, icatibant, Immunology and Allergy, Medicine, Reflux esophagitis, Adverse effect, Pregnancy, Angioedema, business.industry, real‐world, medicine.disease, 030104 developmental biology, 030228 respiratory system, chemistry, Anesthesia, Observational study, Long term safety, medicine.symptom, business
Abstract

The Icatibant Outcome Survey (IOS) is an observational study monitoring safety and effectiveness of icatibant in the real‐world setting. We analyzed safety data from 3025 icatibant‐treated attacks in 557 patients (enrolled between July 2009 and February 2015). Icatibant was generally well tolerated. Excluding off‐label use and pregnancy, 438 patients (78.6%) did not report adverse events (AEs). The remaining 119 (21.4%) patients reported 341 AEs, primarily gastrointestinal disorders (19.6%). Of these, 43 AEs in 17 patients (3.1%) were related to icatibant. Serious AEs (SAEs) occurred infrequently. A total of 143 SAEs occurred in 59 (10.6%) patients; only three events (drug inefficacy, gastritis, and reflux esophagitis) in two patients were considered related to icatibant. Notably, no SAEs related to icatibant occurred in patients with cardiovascular disease, nor in those using icatibant at a frequency above label guidelines. Additionally, no major differences were noted in AEs occurring in on‐label vs off‐label icatibant users.

Published
2017

38. EAACI/GA(2)LEN/EDF/WAO guidelines for the definition, classification, diagnosis and treatment of urticaria

Author

Zuberbier, T., Aberer, W., Asero, R., Latiff, A. H. Abdul, Baker, D., Ballmer-Weber, B., Bernstein, J. A., Bindslev-Jensen, C., Brzoza, Z., Bedrikow, R. Buense, Canonica, G. W., Church, M. K., Craig, T., Danilycheva V, I., Dressler, C., Ensina, L. F., Gimenez-Arnau, A., Godse, K., Goncalo, M., Grattan, C., Hebert, J., Hide, M., Kaplan, A., Kapp, A., Katelaris, C. H., Kocaturk, E., Kulthanan, K., Larenas-Linnemann, D., Leslie, T. A., Magerl, M., Mathelier-Fusade, P., Meshkova, R. Y., Metz, M., Nast, A., Nettis, E., Oude-Elberink, H., Rosumeck, S., Saini, S. S., Sanchez-Borges, M., Schmid-Grendelmeier, P., Staubach, P., Sussman, G., Toubi, E., Vena, G. A., Vestergaard, C., Wedi, B., Werner, R. N., Zhao, Z., and Maurer, M.

Published
2020

39. The usage, quality and relevance of information and communications technologies in patients with chronic urticaria: A UCARE study

Author

Maurer, M. Weller, K. Magerl, M. Maurer, R.R. Vanegas, E. Felix, M. Cherrez, A. Mata, V.L. Kasperska-Zajac, A. Sikora, A. Fomina, D. Kovalkova, E. Godse, K. Rao, N.D. Khoshkhui, M. Rastgoo, S. Criado, R.F.J. Abuzakouk, M. Grandon, D. van Doorn, M. Valle, S.O.R. de Souza Lima, E.M. Thomsen, S.F. Ramón, G.D. Matos Benavides, E.E. Bauer, A. Giménez-Arnau, A.M. Kocatürk, E. Guillet, C. Ignacio Larco, J. Zhao, Z.-T. Makris, M. Ritchie, C. Xepapadaki, P. Ensina, L.F. Cherrez, S. Cherrez-Ojeda, I.

Abstract

Background: Chronic urticaria (CU) is characterized by itchy recurrent wheals, angioedema, or both for 6 weeks or longer. CU can greatly impact patients' physical and emotional quality of life. Patients with chronic conditions are increasingly seeking information from information and communications technologies (ICTs) to manage their health. The objective of this study was to assess the frequency of usage and preference of ICTs from the perspective of patients with CU. Methods: In this cross-sectional study, 1800 patients were recruited from primary healthcare centers, university hospitals or specialized clinics that form part of the UCARE (Urticaria Centers of Reference and Excellence) network throughout 16 countries. Patients were >12 years old and had physician-diagnosed chronic spontaneous urticaria (CSU) or chronic inducible urticaria (CIndU). Patients completed a 23-item questionnaire containing questions about ICT usage, including the type, frequency, preference, and quality, answers to which were recorded in a standardized database at each center. For analysis, ICTs were categorized into 3 groups as follows: one-to-one: SMS, WhatsApp, Skype, and email; one-to-many: YouTube, web browsers, and blogs or forums; many-to-many: Instagram, Twitter, Facebook, and LinkedIn. Results: Overall, 99.6% of CU patients had access to ICT platforms and 96.7% had internet access. Daily, 85.4% patients used one-to-one ICT platforms most often, followed by one-to-many ICTs (75.5%) and many-to-many ICTs (59.2%). The daily ICT usage was highest for web browsers (72.7%) and WhatsApp (70.0%). The general usage of ICT platforms increased in patients with higher levels of education. One-to-many was the preferred ICT category for obtaining general health information (78.3%) and for CU-related information (75.4%). A web browser (77.6%) was by far the most commonly used ICT to obtain general health information, followed by YouTube (25.8%) and Facebook (16.3%). Similarly, for CU-specific information, 3 out of 4 patients (74.6%) used a web browser, 20.9% used YouTube, and 13.6% used Facebook. One in 5 (21.6%) patients did not use any form of ICT for obtaining information on CU. The quality of the information obtained from one-to-many ICTs was rated much more often as very interesting and of good quality for general health information (53.5%) and CU-related information (51.5%) as compared to the other categories. Conclusions: Usage of ICTs for health and CU-specific information is extremely high in all countries analyzed, with web browsers being the preferred ICT platform. © 2020

Published
2020

40. The usage, quality and relevance of information and communications technologies in patients with chronic urticaria: A UCARE study

Author

Maurer, M., Weller, K., Magerl, M., Maurer, R.R., Vanegas, E., Felix, M., Cherrez, A., Mata, V.L., Kasperska-Zajac, A., Sikora, A., Fomina, D., Kovalkova, E., Godse, K., Rao, N.D., Khoshkhui, M., Rastgoo, S., Criado, R.F.J., Abuzakouk, M., Grandon, D., van Doorn, M., Valle, S.O.R., de Souza Lima, E.M., Thomsen, S.F., Ramón, G.D., Matos Benavides, E.E., Bauer, A., Giménez-Arnau, A.M., Kocatürk, E., Guillet, C., Ignacio Larco, J., Zhao, Z.T., Makris, M. (M.), Ritchie, C, Xepapadaki, P., Ensina, L.F., Cherrez, S., Cherrez-Ojeda, I., Maurer, M., Weller, K., Magerl, M., Maurer, R.R., Vanegas, E., Felix, M., Cherrez, A., Mata, V.L., Kasperska-Zajac, A., Sikora, A., Fomina, D., Kovalkova, E., Godse, K., Rao, N.D., Khoshkhui, M., Rastgoo, S., Criado, R.F.J., Abuzakouk, M., Grandon, D., van Doorn, M., Valle, S.O.R., de Souza Lima, E.M., Thomsen, S.F., Ramón, G.D., Matos Benavides, E.E., Bauer, A., Giménez-Arnau, A.M., Kocatürk, E., Guillet, C., Ignacio Larco, J., Zhao, Z.T., Makris, M. (M.), Ritchie, C, Xepapadaki, P., Ensina, L.F., Cherrez, S., and Cherrez-Ojeda, I.

Abstract

Background: Chronic urticaria (CU) is characterized by itchy recurrent wheals, angioedema, or both for 6 weeks or longer. CU can greatly impact patients' physical and emotional quality of life. Patients with chronic conditions are increasingly seeking information from information and communications technologies (ICTs) to manage their health. The objective of this study was to assess the frequency of usage and preference of ICTs from the perspective of patients with CU. Methods: In this cross-sectional study, 1800 patients were recruited from primary healthcare centers, university hospitals or specialized clinics that form part of the UCARE (Urticaria Centers of Reference and Excellence) network throughout 16 countries. Patients were >12 years old and had physician-diagnosed chronic spontaneous urticaria (CSU) or chronic inducible urticaria (CIndU). Patients completed a 23-item questionnaire containing questions about ICT usage, including the type, frequency, preference, and quality, answers to which were recorded in a standardized database at each center. For analysis, ICTs were categorized into 3 groups as follows: one-to-one: SMS, WhatsApp, Skype, and email; one-to-many: YouTube, web browsers, and blogs or forums; many-to-many: Instagram, Twitter, Facebook, and LinkedIn. Results: Overall, 99.6% of CU patients had access to ICT platforms and 96.7% had internet access. Daily, 85.4% patients used one-to-one ICT platforms most often, followed by one-to-many ICTs (75.5%) and many-to-many ICTs (59.2%). The daily ICT usage was highest for web browsers (72.7%) and WhatsApp (70.0%). The general usage of ICT platforms increased in patients with higher levels of education. One-to-many was the preferred ICT category for obtaining general health information (7

Published
2020
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41. Definition, aims, and implementation of GA2LEN/HAEi Angioedema Centers of Reference and Excellence

Author

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

Published
2020
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42. The usage, quality and relevance of information and communications technologies in patients with chronic urticaria: A UCARE study

Author

Maurer, M, Weller, K, Magerl, M, Maurer, RR, Vanegas, E, Felix, M, Cherrez, A, Mata, VL, Kasperska-Zajac, A, Sikora, A, Fomina, D, Kovalkova, E, Godse, K, Rao, ND, Khoshkhui, M, Rastgoo, S, Criado, RFJ, Abuzakouk, M, Grandon, D, van Doorn, Martijn, Valle, SOR, de Souza Lima, EM, Thomsen, SF, Ramón, GD, Matos Benavides, EE, Bauer, A, Giménez-Arnau, AM, Kocatürk, E, Guillet, C, Ignacio Larco, J, Zhao, ZT, Makris, M, Ritchie, C, Xepapadaki, P, Ensina, LF, Cherrez, S, Cherrez-Ojeda, I, Maurer, M, Weller, K, Magerl, M, Maurer, RR, Vanegas, E, Felix, M, Cherrez, A, Mata, VL, Kasperska-Zajac, A, Sikora, A, Fomina, D, Kovalkova, E, Godse, K, Rao, ND, Khoshkhui, M, Rastgoo, S, Criado, RFJ, Abuzakouk, M, Grandon, D, van Doorn, Martijn, Valle, SOR, de Souza Lima, EM, Thomsen, SF, Ramón, GD, Matos Benavides, EE, Bauer, A, Giménez-Arnau, AM, Kocatürk, E, Guillet, C, Ignacio Larco, J, Zhao, ZT, Makris, M, Ritchie, C, Xepapadaki, P, Ensina, LF, Cherrez, S, and Cherrez-Ojeda, I

Published
2020

50. Long‐term prevention of hereditary angioedema attacks with lanadelumab: The HELP OLE Study.

Author

Banerji, Aleena, Bernstein, Jonathan A., Johnston, Douglas T., Lumry, William R., Magerl, Markus, Maurer, Marcus, Martinez‐Saguer, Inmaculada, Zanichelli, Andrea, Hao, James, Inhaber, Neil, Yu, Ming, Riedl, Marc A., Hébert, J., Ritchie, B., Sussman, G., Yang, W.H., Aygören‐Pürsün, E., Magerl, M., Martinez‐Saguer, I., and Staubach, P.

Subjects
RESPIRATORY infections, ANGIONEUROTIC edema
Abstract

Background: The aim was to evaluate long‐term effectiveness and safety of lanadelumab in patients ≥12 y old with hereditary angioedema (HAE) 1/2 (NCT02741596). Methods: Rollover patients completing the HELP Study and continuing into HELP OLE received one lanadelumab 300 mg dose until first attack (dose‐and‐wait period), then 300 mg q2wks (regular dosing stage). Nonrollovers (newly enrolled) received lanadelumab 300 mg q2wks from day 0. Baseline attack rate for rollovers: ≥1 attack/4 weeks (based on run‐in period attack rate during HELP Study); for nonrollovers: historical attack rate ≥1 attack/12 weeks. The planned treatment period was 33 months. Results: 212 patients participated (109 rollovers, 103 nonrollovers); 81.6% completed ≥30 months on study (mean [SD], 29.6 [8.2] months). Lanadelumab markedly reduced mean HAE attack rate (reduction vs baseline: 87.4% overall). Patients were attack free for a mean of 97.7% of days during treatment; 81.8% and 68.9% of patients were attack free for ≥6 and ≥12 months, respectively. Angioedema Quality‐of‐Life total and domain scores improved from day 0 to end of study. Treatment‐emergent adverse events (TEAEs) (excluding HAE attacks) were reported by 97.2% of patients; most commonly injection site pain (47.2%) and viral upper respiratory tract infection (42.0%). Treatment‐related TEAEs were reported by 54.7% of patients. Most injection site reactions resolved within 1 hour (70.2%) or 1 day (92.6%). Six (2.8%) patients discontinued due to TEAEs. No treatment‐related serious TEAEs or deaths were reported. Eleven treatment‐related TEAEs of special interest were reported by seven (3.3%) patients. Conclusion: Lanadelumab demonstrated sustained efficacy and acceptable tolerability with long‐term use in HAE patients. [ABSTRACT FROM AUTHOR]

Published
2022
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