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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. Short-Term Subcutaneous Allergy Immunotherapy and Dupilumab are Well Tolerated in Allergic Rhinitis: A Randomized Trial

Author

Corren J, Saini SS, Gagnon R, Moss MH, Sussman G, Jacobs J, Laws E, Chung ES, Constant T, Sun Y, Maloney J, Hamilton JD, Ruddy M, Wang CQ, and O’Brien MP

Subjects
dupilumab, seasonal allergic rhinitis, subcutaneous immunotherapy, nasal allergen responses, Immunologic diseases. Allergy, RC581-607
Abstract

Jonathan Corren,1 Sarbjit S Saini,2 Remi Gagnon,3 Mark H Moss,4 Gordon Sussman,5 Joshua Jacobs,6 Elizabeth Laws,7 Elinore S Chung,8 Tatiana Constant,8 Yiping Sun,8 Jennifer Maloney,8 Jennifer D Hamilton,8 Marcella Ruddy,8 Claire Q Wang,8 Meagan P O’Brien8 1Departments of Medicine and Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, CA, USA; 2Department of Internal Medicine, Division of Allergy and Clinical Immunology, Johns Hopkins Asthma and Allergy Center, Baltimore, MD, USA; 3Clinique Spécialisée en Allergie de la Capitale, Québec, QC, Canada; 4Departments of Medicine and Pediatrics, Division of Allergy, Pulmonary and Critical Care, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA; 5Department of Medicine, University of Toronto, Toronto, ON, Canada; 6Allergy and Asthma Clinical Research, Inc, Walnut Creek, CA, USA; 7Sanofi, Bridgewater, NJ, USA; 8Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USACorrespondence: Meagan P O’BrienRegeneron Pharmaceuticals, Inc, 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USATel +1 914 826-5271Email meagan.obrien@regeneron.comJonathan CorrenDepartments of Medicine and Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, 10833 Le Conte Ave, Los Angeles, CA, 90095, USATel +1 310 312-5050, ext 250Email jcorren@ucla.eduBackground: Subcutaneous immunotherapy (SCIT) has been proven as an effective therapy against some allergens for seasonal allergic rhinitis (SAR) patients unresponsive to intranasal corticosteroids and/or antihistamines but carries risk of systemic allergic reactions. Dupilumab blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation in multiple diseases.Objective: To evaluate the efficacy and safety of SCIT+dupilumab vs SCIT alone.Methods: This phase 2a, multicenter, double-blind, placebo-controlled parallel-group study conducted in 103 adults with grass pollen-induced SAR (NCT03558997) randomized patients 1:1:1:1 to SCIT, dupilumab (300 mg every 2 weeks), SCIT+dupilumab, or placebo. SCIT was administered using an 8-week cluster protocol followed by 8 weeks of maintenance injections. Primary endpoint was change from pre-treatment baseline in area under the curve (AUC) in total nasal symptom score (TNSS) 0– 1 h following nasal allergen challenge (NAC) with timothy grass extract at Week 17.Results: Although 16 weeks of treatment with SCIT+dupilumab did not significantly improve TNSS AUC (0– 1 h) following NAC at Week 17 vs SCIT (least squares mean − 56.76% vs − 52.03%), a higher proportion of SCIT+dupilumab-treated patients (61.5%) achieved SCIT maintenance dose vs SCIT (46.2%). A lower proportion of SCIT+dupilumab-treated patients (7.7%) required epinephrine rescue treatment vs SCIT (19.2%). There were significantly fewer withdrawals in the SCIT+dupilumab group than in the SCIT group (n = 2 [7.7%] vs n = 8 [30.8%]; P = 0.0216); the majority of SCIT group withdrawals were due to SCIT-related intolerability, compared with no discontinuations from the SCIT+dupilumab group.Conclusion: In SAR patients, 16 weeks of SCIT+dupilumab may improve SCIT tolerability but did not incrementally reduce post-allergen challenge nasal symptoms compared with SCIT alone.Clinical Study Number: NCT03558997.Keywords: dupilumab, seasonal allergic rhinitis, subcutaneous immunotherapy, nasal allergen responses

Published
2021

4. Nurses' experiences of hospital‐acquired pressure injury prevention in acute healthcare services in Victoria, Australia: A qualitative study using the Theoretical Domains Framework

Author

Team, V, Bouguettaya, A, Qiu, Y, Turnour, L, Banaszak‐Holl, JC, Weller, CD, Sussman, G, Jones, A, Teede, H, Team, V, Bouguettaya, A, Qiu, Y, Turnour, L, Banaszak‐Holl, JC, Weller, CD, Sussman, G, Jones, A, and Teede, H

Abstract

AbstractWe investigated nurses' experiences of hospital‐acquired pressure injury (PI) prevention in acute care services to better understand how PI prevention may be optimised. We used the Theoretical Domains Framework to systematically identify barriers and enablers to evidence‐based preventive practices as required by the International Guideline. This study was one element of a complex capacity building project on PI surveillance and prevention within the acute health service partners of Monash Partners Academic Health Science Centre, an accredited academic health partnership located in Melbourne, Australia. We adopted a qualitative descriptive design. We interviewed 32 nurses that provided care in intensive care units, general wards and COVID wards of four acute care services. Nurses were recruited from four large acute care services (three public, one private) located in Melbourne. Most of them worked with patients who were at high risk of hospital‐acquired PI on a daily basis. Interview transcripts were coded and analysed using thematic analysis guided by the Theoretical Domains Framework. The domains referred to most frequently by all participants included: Knowledge, Skills, Social/Professional Role and Identity, Beliefs about Capabilities, and Environmental Context and Resources. The key barriers discussed by nurses included gaps in nurses' knowledge and skills related to identification and staging of PI, heavy nursing workload and inadequate staffing levels, stigma and self‐blame related to PI identification, and exacerbating impacts of the COVID‐19 pandemic. Main facilitators discussed were training programmes, nursing audits and feedback, and teamwork. Participants suggested improvements including accessible and tailored training, visual reminders, and addressing heavy workloads and emotional barriers nurses face. Investing in tailored training initiatives to improve nurses' knowledge and organisational changes to address

Published
2024

6. Solutions to the chronic wounds problem in Australia: A call to action

Author

Pacella, RE, Tulleners, R, Cheng, Q, Burkett, E, Edwards, H, Yelland, S, Brain, D, Bingley, J, Lazzarini, P, Warnock, J, Barnsbee, L, Pacella, T, Clark, K, Smith, M, Griffiths, I, Sussman, G, van Netten, J, Gibb, M, Gordon, J, Harvey, G, Hickling, D, Lee, X, Ploderer, B, Vallejo, A, Whalley, S, and Graves, N

Published
2018

13. Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study

Author

Menzies-Gow, A., Gurnell, M., Heaney, L. G., Corren, J., Bel, E. H., Maspero, J., Harrison, T., Jackson, D. J., Price, D., Lugogo, N., Kreindler, J., Burden, A., de Giorgio-Miller, A., Faison, S., Padilla, K., Martin, U. J., Gil, E. G., Ardusso, L., Bazerque, R. F., Doreski, P. A. C., Elias, P. C., Gattolin, G., Medina, A. C., Ruiz, X. B., Salvado, A., Del Olmo Sansone, R. A., Wehbe, L., Verra, F. J. B., Brusselle, G., Pilette, C., Martinot, J. -B., Antila, M. A., Blanco, D. C., Cerci, A., Cunha, T. M., Fiss, E., Franza, L., Machado, A. S., De Mattos, W. L. L. D., Grava, S., Minamoto, S. E. T., De Oliveira, C. A., Cheema, A. S., Dorscheid, D., Fera, T. A. E., Gagnon, R., Philteos, G., Sussman, G., Yang, W. H. -C., Aguilar, C. D., Jaller, R., Jazime, M. L., Serrano, F. O., Vanegas, A. C., Vargas, L. K., Villegas, M. F., Hilberg, O., Nielsen, H. B., Nielsen, J., Weinreich, U. M., Ulrik, C. S., Adam, S. M., Deslee, G., Pegliasco, H., Pradelli, J., Roux, P. -M., Russier, M., Deckelmann, R., Eich, A., Forster, A., Herth, F., Kirschner, J., Kirsten, A. -M., Schuhmann, M., Schultz, T. K., Ludwig-Sengpiel, A., Teber, I., Zimmermann, G. S., Almerigogna, F., Celi, A., Paggiaro, P., D'Amato, M., Palange, P., Pirina, P., Spanevello, A., Colin, D. D. H., Hernandez, A. R., Garcia, E. A. R., Gonzalez, E. M., Terrones, R. A. R., Javier, R. C., Suarez, J. F. R., Cheimihska, M., Cudzik, K., Olech-Cudzik, A., Filipek, K., Golinski, L., Kwasniewski, A., Madra-Rogacka, D., Mroz, R., Nittner-Marszalska, M., Pawlukiewicz, M., Lekarska, P. P., Pioszczuk, A., Springer, E., Swiderska, A., Zurowska-Gebala, M., Emelyanov, A. V., Kurbacheva, O., Odegova, A., Peskov, A., Petrov, D. V., Rubanik, T. V., Vasilev, M., Vershinina, M., Barcala, F. J. G., Blanco, V. R., Fernandez, A. M. P., Fernandez, C. G., Garcia, J. M. I., Munoz, A. V. A., Ramos, C. C., Sanz, C. C., Bjermer, L., Chen, C. -Y., Fang, W. -F., Hang, L. -W., Hsu, J. -Y., Kuo, H. -P., Lee, K. -Y., Shen, S. -Y., Sheu, C. -C., Gore, R., Saralaya, D., Alpizar, S. A., Bansal, S., Ismail, H., Kaelin, T. D., Koura, F., Lee, M. D., Maddipati, V., Malur, A., Mcevoy, C. E., Mehta, H., Mohan, A., Moore, W. C., Krings, J., Pippins, A., Deaton, I., Hmieleski, B., Field, P., Reibman, J., Siri, D. D., Sumino, K., Swenson, C., Tilley, S. L., Villareal, M., Pulmonology, and Pulmonary medicine

Subjects
Pulmonary and Respiratory Medicine, Adrenal Cortex Hormones, Humans, Anti-Asthmatic Agents, Recovery of Function, Asthma, Adrenal Insufficiency
Abstract

BackgroundOral corticosteroid (OCS) dependence among patients with severe eosinophilic asthma can cause adverse outcomes, including adrenal insufficiency. PONENTE's OCS reduction phase showed that, following benralizumab initiation, 91.5% of patients eliminated corticosteroids or achieved a final dosage ≤5 mg·day−1(median (range) 0.0 (0.0–40.0) mg).MethodsThe maintenance phase assessed the durability of corticosteroid reduction and further adrenal function recovery. For ∼6 months, patients continued benralizumab 30 mg every 8 weeks without corticosteroids or with the final dosage achieved during the reduction phase. Investigators could prescribe corticosteroids for asthma exacerbations or increase daily dosages for asthma control deteriorations. Outcomes included changes in daily OCS dosage, Asthma Control Questionnaire (ACQ)-6 and St George's Respiratory Questionnaire (SGRQ), as well as adrenal status, asthma exacerbations and adverse events.Results598 patients entered PONENTE; 563 (94.1%) completed the reduction phase and entered the maintenance phase. From the end of reduction to the end of maintenance, the median (range) OCS dosage was unchanged (0.0 (0.0–40.0) mg), 3.2% (n=18/563) of patients experienced daily dosage increases, the mean ACQ-6 score decreased from 1.26 to 1.18 and 84.5% (n=476/563) of patients were exacerbation free. The mean SGRQ improvement (–19.65 points) from baseline to the end of maintenance indicated substantial quality-of-life improvements. Of patients entering the maintenance phase with adrenal insufficiency, 32.4% (n=104/321) demonstrated an improvement in adrenal function. Adverse events were consistent with previous reports.ConclusionsMost patients successfully maintained maximal OCS reduction while achieving improved asthma control with few exacerbations and maintaining or recovering adrenal function.

Published
2022
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17. Efficacité du remibrutinib chez les patients atteints d’urticaire chronique spontanée avec ou sans exposition préalable aux biothérapies dans les études de phase 3 REMIX-1 et REMIX-2

Author

Bérard, F., Mosnaim, G., Giménez-Arnau, A.M., Hide, M., Lebwohl, M., Maurer, M., Metz, M., Saini, S.S., Sussman, G., Haemmerle, S., Lheritier, K., Martzloff, E.D., Seko, N., Wang, P., and Gogate, S.

Abstract

Le remibrutinib, un inhibiteur de la tyrosine kinase de Bruton (BTK) hautement sélectif administré par voie orale, a démontré sa supériorité par rapport au placebo en termes de changement par rapport aux valeurs initiales du score hebdomadaire d’activité de l’urticaire (UAS7) à la semaine 12 dans les études REMIX de phase 3 menées chez des patients souffrant d’urticaire chronique spontanée (UCS) insuffisamment contrôlée par les antihistaminiques H1. Nous évaluons ici le remibrutinib chez des patients ayant ou non reçu un traitement biologique anti-immunoglobulines E (anti-IgE) dans le cadre d’analyses poolées des études REMIX.

Published
2024
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18. Tolérance du remibrutinib chez les patients atteints d’urticaire chronique spontanée : résultats des études de phase 3 REMIX-1 et REMIX-2

Author

Bérard, F., Staubach, P., Saini, S.S., Giménez-Arnau, A.M., Hide, M., Lebwohl, M., Sussman, G., Haemmerle, S., Lheritier, K., Martzloff, E.D., Zharkov, A., and Maurer, M.

Abstract

Les données poolées de tolérance du remibrutinib issues des deux études de phase 3 chez des patients atteints d’urticaire chronique spontanée (UCS) sont présentées. Ces données complètent les preuves actuelles de la sécurité et de la bonne tolérance du remibrutinib dans l’UCS.

Published
2024
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19. Efficacité et sécurité à long terme du remibrutinib chez les patients atteints d’urticaire chronique spontanée dans les études de phase 3 REMIX-1 et REMIX-2

Author

Metz, M., Giménez-Arnau, A.M., Hide, M., Jain, V., Khemis, A., Lebwohl, M., Palumbo, M., Saini, S.S., Savk, E., Sussman, G., Szalewski, R., Walecka Herniczek, I., Windom, H., Haemmerle, S., Lheritier, K., Machado, P.G.P., Martzloff, E.D., Seko, N., Wang, P., Zharkov, A., and Maurer, M.

Abstract

Le remibrutinib, un inhibiteur de la tyrosine kinase de Bruton (BTK) hautement sélectif administré par voie orale, a déjà démontré une efficacité supérieure à celle du placebo à la semaine 12 et un profil de tolérance favorable au cours des études de phase 3 REMIX-1 et -2 chez des patients souffrant d’urticaire chronique spontanée (UCS). Nous rapportons ici les données à long terme de ces études.

Published
2024
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22. 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

34. Methods report on the development of the 2013 revision and update of the EAACI/GA2LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of urticaria

Author

Zuberbier, T., Aberer, W., Asero, R., Bindslev-Jensen, C., Brzoza, Z., Canonica, G. W., Church, M. K., Ensina, L. F., Giménez-Arnau, A., Godse, K., Gonçalo, M., Grattan, C., Hebert, J., Hide, M., Kaplan, A., Kapp, A., Latiff, Abdul A. H., Mathelier-Fusade, P., Metz, M., Saini, S. S., Sánchez-Borges, M., Schmid-Grendelmeier, P., Simons, F. E. R., Staubach, P., Sussman, G., Toubi, E., Vena, G. A., Wedi, B., Zhu, X. J., Nast, A., and Maurer, M.

Published
2014
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35. The EAACI/GA2LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update

Author

Zuberbier, T., Aberer, W., Asero, R., Bindslev-Jensen, C., Brzoza, Z., Canonica, G. W., Church, M. K., Ensina, L. F., Giménez-Arnau, A., Godse, K., Gonçalo, M., Grattan, C., Hebert, J., Hide, M., Kaplan, A., Kapp, A., Latiff, Abdul A. H., Mathelier-Fusade, P., Metz, M., Nast, A., Saini, S. S., Sánchez-Borges, M., Schmid-Grendelmeier, P., Simons, F. E. R., Staubach, P., Sussman, G., Toubi, E., Vena, G. A., Wedi, B., Zhu, X. J., and Maurer, M.

Published
2014
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36. Autoimmune diseases are linked to type IIb autoimmune chronic spontaneous urticaria

Author

Kolkhir, P. Altrichter, S. Asero, R. Daschner, A. Ferrer, M. Giménez-Arnau, A. Hawro, T. Jakob, T. Kinaciyan, T. Kromminga, A. Konstantinou, G.N. Makris, M. Metz, M. Skov, P.S. Staubach, P. Sussman, G. Zhang, K. Maurer, M.

Abstract

Purpose: Patients with chronic spontaneous urticaria (CSU) have an increased risk for comorbid autoimmune diseases. In this retrospective multicenter study of CSU patients, we evaluated clinical and laboratory features of CSU associated with a higher risk of comorbid autoimmune diseases. Methods: We analyzed records of CSU patients (n = 1,199) for a history or presence of autoimmune diseases. Patients were diagnosed with type IIb autoimmune CSU (aiCSU) if all 3 tests were positive: autologous serum skin test (ASST), basophil histamine release assay (BHRA) and/or basophil activation test (BAT), and IgG autoantibodies against FcεRIα/IgE detected by immunoassay. Results: Twenty-eight percent of CSU patients had at least 1 autoimmune disease. The most prevalent autoimmune diseases were Hashimoto's thyroiditis (HT) (≥ 21%) and vitiligo (2%). Two percent of CSU patients had ≥ 2 autoimmune diseases, most frequently HT plus vitiligo. Comorbid autoimmune diseases, in patients with CSU, were associated with female sex, a family history of autoimmune diseases, and higher rates of hypothyroidism and hyperthyroidism (P < 0.001). Presence of autoimmune diseases was linked to aiCSU (P = 0.02). The risks of having autoimmune diseases were 1.7, 2.9 and 3.3 times higher for CSU patients with a positive ASST, BHRA and BAT, respectively. In CSU patients, markers for autoimmune diseases, antinuclear antibodies and/or IgG anti-thyroid antibodies were associated with non-response to omalizumab treatment (P = 0.013). Conclusions: In CSU, autoimmune diseases are common and linked to type IIb autoimmune CSU. Our results suggest that physicians assess and monitor all adult patients with CSU for signs and symptoms of common autoimmune diseases, especially HT and vitiligo. Copyright © 2021 The Korean Academy of Asthma, Allergy and Clinical Immunology.

Published
2021

37. Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one-year extension study

Author

Maurer, M. Giménez-Arnau, A. Bernstein, J.A. Chu, C.-Y. Danilycheva, I. Hide, M. Makris, M. Metz, M. Savic, S. Sitz, K. Soong, W. Staubach, P. Sussman, G. Barve, A. Burciu, A. Hua, E. Janocha, R. Severin, T.

Abstract

Background: Ligelizumab, a next-generation, humanized anti-immunoglobulin E (IgE) monoclonal antibody is in development as a treatment for patients with chronic spontaneous urticaria, whose symptoms are inadequately controlled with standard-of-care therapy. Objective: To evaluate the long-term safety and re-treatment efficacy of ligelizumab 240 mg in patients who completed the core study and extension study. Methods: This open-label, single-arm, long-term Phase 2b extension study was designed to assess patients who were previously administered various doses of ligelizumab, omalizumab or placebo in the Phase 2b, dose-finding core study and who presented with active disease after Week 32. In the extension study, patients received ligelizumab 240 mg subcutaneously every 4 weeks, for 52 weeks and were monitored post-treatment for 48 weeks. Results: Overall, ligelizumab was well-tolerated with no newly identified safety signals. A total of 95.4% (226/237) screened patients received ligelizumab 240 mg in the extension study; 84.1% (190/226) of patients experienced at least one treatment-emergent adverse event. Most reported events were mild (41.6%) or moderate (35.8%) and mostly unrelated to the study treatment. At Week 12, 46.5% of patients had a complete response increasing to 53.1% after 52 weeks. Following 52 weeks of extension study treatment, 75.8% (95% confidence interval, 69.9, 81.3) of patients had cumulative complete responses. The median time to relapse in complete responders was 38 weeks. Conclusion: The long-term safety profile of ligelizumab 240 mg in patients with chronic spontaneous urticaria was consistent with the core study and re-treatment efficacy was shown. Trial Registration: ClinicalTrials.gov Identifier: NCT02477332 and NCT02649218. © 2021 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

Published
2021

43. Le traitement à long terme par le ligélizumab permet un contrôle prolongé des symptômes chez les patients atteints d’urticaire chronique spontanée pendant le suivi post-traitement

Author

Soong, W., primary, Bernstein, J.A., additional, Sussman, G., additional, Lanier, B., additional, Sitz, K., additional, Maurer, M., additional, Gimenez Arnau, A.M., additional, Hua, E., additional, Barve, A., additional, Severin, T., additional, and Janocha, R., additional

Published
2020
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49. 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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50. 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
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