M A Calderón1, C Vidal2, P Rodríguez Del Río3, J Just4, O Pfaar5,6, A I Tabar7, I Sánchez-Machín8, P Bubel9, J Borja10, P Eberle11, R Reiber12, M Bouvier13, A Lepelliez14, L Klimek5, P Demoly15. 1. Section of Allergy and Clinical Immunology, Imperial College London, National Heart and Lung Institute, Royal Brompton Hospital, London, UK. 2. Allergy Department, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain. 3. Allergy Section, Hospital Infantil Universitario Niño Jesús, Madrid, Spain. 4. Service d'Allergologie, Centre de l'Asthme et des Allergies, Hôpital d'Enfants Armand-Trousseau (APHP)-Sorbonne Universités, UPMC Univ Paris 06, UMR-S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe EPAR, Paris, France. 5. Center for Rhinology and Allergology, Wiesbaden, Germany. 6. Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. 7. Allergy Department, Complejo Hospitalario de Navarra, Pamplona, Spain. 8. Allergy Management Unit, Hospital del Tórax, Complejo Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain. 9. Ear, Nose and Throat Practice, Lutherstadt, Eisleben, Germany. 10. Allergy Section, Hospital General Universitario, Ciudad Real, Spain. 11. Allergy Center, Kassel, Germany. 12. Otorhinolaryngology and Allergology Center Schorndorf-Nord, Schorndorf, Germany. 13. Allergology and Immunology Clinique, University Claude Bernard, Lyon, France. 14. Medical Practitioner, Compiègne, France. 15. Département de Pneumologie et Addictologie, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, Sorbonne Universités, UPMC Paris 06, UMR-S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe EPAR, Paris, France.
Abstract
BACKGROUND: Outside clinical trials, data on systemic reactions (SRs) due to allergen immunotherapy (AIT) are scarce. METHODS: A prospective, longitudinal, web-based survey of 'real-life' respiratory allergen immunotherapy (AIT) clinical practice was conducted in France, Germany and Spain. SRs were recorded and coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and risk factors associated with SRs were identified. RESULTS: A total of 4316 patients (corresponding to 4363 ongoing courses of AIT) were included. A total of 109 SRs were recorded, and 90 patients (2.1%) presented at least one SR. Most of the SRs occurred in subcutaneous allergen immunotherapy (SCIT) (89%, n = 97). The most frequently reported symptoms were urticaria, rhinitis, dyspnoea and cough. Respiratory symptoms appeared before skin symptoms. Most SRs occurred during the up-dosing phase (75.8%) and were mild in severity (71.6%). Intramuscular adrenaline was administered in 17 SRs, but only 65% of these were subsequently classified as anaphylaxis. Independent risk factors for SRs during SCIT were as follows: the use of natural extracts (odds ratio, OR) [95% confidence interval (CI)] = 2.74 [1.61-4.87], P = 0.001), the absence of symptomatic allergy medications (1.707 [1.008-2.892], P = 0.047), asthma diagnosis (1.74 [1.05-2.88], P = 0.03), sensitization to animal dander (1.93 [1.21-3.09], P = 0.006) or pollen (1.16 [1.03-1.30], P = 0.012) and cluster regimens (vs rush) (4.18 [1.21-14.37], P = 0.023). A previous episode of anaphylaxis increased the risk for anaphylaxis in SCIT (OR [95% CI] = 17.35 [1.91-157.28], P = 0.01). CONCLUSION: AIT for respiratory allergy is safe, with a low number of SRs observed in real-life clinical practice. A personalized analysis of risk factors could be used to minimize SRs.
BACKGROUND: Outside clinical trials, data on systemic reactions (SRs) due to allergen immunotherapy (AIT) are scarce. METHODS: A prospective, longitudinal, web-based survey of 'real-life' respiratory allergen immunotherapy (AIT) clinical practice was conducted in France, Germany and Spain. SRs were recorded and coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and risk factors associated with SRs were identified. RESULTS: A total of 4316 patients (corresponding to 4363 ongoing courses of AIT) were included. A total of 109 SRs were recorded, and 90 patients (2.1%) presented at least one SR. Most of the SRs occurred in subcutaneous allergen immunotherapy (SCIT) (89%, n = 97). The most frequently reported symptoms were urticaria, rhinitis, dyspnoea and cough. Respiratory symptoms appeared before skin symptoms. Most SRs occurred during the up-dosing phase (75.8%) and were mild in severity (71.6%). Intramuscular adrenaline was administered in 17 SRs, but only 65% of these were subsequently classified as anaphylaxis. Independent risk factors for SRs during SCIT were as follows: the use of natural extracts (odds ratio, OR) [95% confidence interval (CI)] = 2.74 [1.61-4.87], P = 0.001), the absence of symptomatic allergy medications (1.707 [1.008-2.892], P = 0.047), asthma diagnosis (1.74 [1.05-2.88], P = 0.03), sensitization to animal dander (1.93 [1.21-3.09], P = 0.006) or pollen (1.16 [1.03-1.30], P = 0.012) and cluster regimens (vs rush) (4.18 [1.21-14.37], P = 0.023). A previous episode of anaphylaxis increased the risk for anaphylaxis in SCIT (OR [95% CI] = 17.35 [1.91-157.28], P = 0.01). CONCLUSION: AIT for respiratory allergy is safe, with a low number of SRs observed in real-life clinical practice. A personalized analysis of risk factors could be used to minimize SRs.
Authors: Oliver Pfaar; Tobias Ankermann; Matthias Augustin; Petra Bubel; Sebastian Böing; Randolf Brehler; Peter A Eng; Peter J Fischer; Michael Gerstlauer; Eckard Hamelmann; Thilo Jakob; Jörg Kleine-Tebbe; Matthias Volkmar Kopp; Susanne Lau; Norbert Mülleneisen; Christoph Müller; Katja Nemat; Wolfgang Pfützner; Joachim Saloga; Klaus Strömer; Peter Schmid-Grendelmeier; Antje Schuster; Gunter Johannes Sturm; Christian Taube; Zsolt Szépfalusi; Christian Vogelberg; Martin Wagenmann; Wolfgang Wehrmann; Thomas Werfel; Stefan Wöhrl; Margitta Worm; Bettina Wedi; Susanne Kaul; Vera Mahler; Anja Schwalfenberg Journal: Allergol Select Date: 2022-09-06
Authors: Clara Padró; Diego Gutiérrez; Francisco Moreno; Antonio Parra; Manuel J Rial; Ramón Lleonart; Carla Torán-Barona; José L Justicia; Albert Roger Journal: Immun Inflamm Dis Date: 2022-05
Authors: J Bousquet; C A Akdis; C Grattan; P A Eigenmann; K Hoffmann-Sommergruber; P W Hellings; I Agache Journal: Clin Transl Allergy Date: 2018-11-27 Impact factor: 5.871
Authors: Ralph Mösges; Nils Y Breitrück; Silke Allekotte; Kija Shah-Hosseini; Van-Anh Dao; Petra Zieglmayer; Katrin Birkholz; Mark Hess; Maximilian Bastl; Katharina Bastl; Uwe Berger; Matthias F Kramer; Sonja Guethoff Journal: World Allergy Organ J Date: 2019-03-08 Impact factor: 4.084
Authors: O Pfaar; S Lang; U Pieper-Fürst; A Astvatsatourov; F Gerich; L Klimek; M F Kramer; Y Reydelet; K Shah-Hosseini; R Mösges Journal: Allergy Date: 2017-09-05 Impact factor: 13.146