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9. Requirements for acquiring a high-quality house dust mite extract for allergen immunotherapy

Author

Frati F, Incorvaia C, David M, Scurati S, Seta S, Padua G, Cattaneo E, Cavaliere C, Di Rienzo A, Dell'Albani I, and Puccinelli P

Subjects
Therapeutics. Pharmacology, RM1-950
Abstract

Franco Frati,1 Cristoforo Incorvaia,2 Marie David,3 Silvia Scurati,3 Simona Seta,4 Guglielmo Padua,4 Eleonora Cattaneo,1 Carlo Cavaliere,5 Alessia Di Rienzo,6 Ilaria Dell'Albani,1 Paola Puccinelli11Medical and Scientific and Regulatory Department, Stallergenes, Milan, Italy; 2Allergy/Pulmonary Rehabilitation, ICP Hospital, Milan, Italy; 3Laboratoire Stallergenes, Antony, France; 4Marketing Department, Stallergenes, Milan, Italy; 5Ear, Nose and Throat Department, University Sapienza, Rome, Italy; 6Azienda Sanitaria Locale, Allergology Service, Frosinone, ItalyAbstract: The house dust mite is a major cause of respiratory allergy worldwide. The management of mite allergy is based on avoidance measures, drug treatment, and allergen immunotherapy, but only allergen immunotherapy is able to modify the natural history of the disease. Injectable subcutaneous immunotherapy was introduced a century ago, while sublingual immunotherapy was proposed in the 1980s and emerged in the ensuing years as an effective and safe option to subcutaneous immunotherapy. However, the quality of the extracts to be used in allergen immunotherapy is crucial for the success of treatment. The mite extract for sublingual immunotherapy known as Staloral 300 was developed to offer optimal characteristics concerning the mite culture medium, standardization, and allergen dose. Double-blind, placebo-controlled trials with Staloral 300 have provided a substantial part of the clinical evidence analyzed in a meta-analysis of the efficacy of allergen immunotherapy in mite-induced rhinitis and asthma. Safety and tolerability are very good, mild local reactions in the mouth being the most common side effect. This makes it feasible to carry out sublingual immunotherapy for the 3–5-year duration needed to achieve long-lasting tolerance to the specific allergen. The performance of Staloral 300 may provide optimal conditions for an effective and safe sublingual immunotherapy in patients with mite-induced respiratory allergy.Keywords: house dust mite, rhinitis, asthma, allergen extracts, sublingual immunotherapy

Published
2012

21. Adherence issues related to sublingual immunotherapy as perceived by allergists

Author

Scurati, S., Frati, F., Passalacqua, G., Puccinelli, P., Hilaire, C., Incorvaia, C., D Avino, G., Comi, R., Lo Schiavo, M., Pezzuto, F., Montera, C., Pio, A., Teresa Ielpo, M., Cellini, F., Vicentini, L., Pecorari, R., Aresu, T., Capra, L., Benedictis, E., Bombi, C., Zauli, D., Vanzi, A., Alberto Paltrinieri, C., Bondioli, A., Paletta, I., Ventura, D., Mei, F., Paolini, F., Colangelo, C., Cavallucci, E., Cucinelli, F., Tinari, R., Ermini, G., Beltrami, V., Novembre, E., Begliomini, C., Marchese, E., Solito, E., Ammannati, V., Molino, G., Galli, E., Baldassini, M., Di Michele, L., Calvani, M., Gidaro, M., Venuti, A., Li Bianchi, E., Benassi, F., Pocobelli, D., Zangari, P., Rocco, M. G., Lo Vecchio, A., Pingitore, G., Grimaldi, O., Schiavino, D., Perrone, N., Antonietta Frieri, M., Di Rienzo, V., Tripodi, S., Scarpa, A., Tomsic, M., Bonaguro, R., Enrico Senna, G., Sirena, A., Turatello, F., Crescioli, S., Favero, E., Billeri, L., Chieco Bianchi, F., Gemignani, C., Zanforlin, M., Angiola Crivellaro, M., Hendrick, B., Maltauro, A., Masieri, S., Elisabetta Conte, M., Fama, M., Pozzan, M., Bonadonna, P., Casanova, S., Vallerani, E., Schiappoli, M., Borghesan, F., Giro, G., Casotto, S., Berardino, L., Zanoni, G., Ariano, R., Aquilina, R., Pellegrino, R., Marsico, P., Del Giudice, A., Narzisi, G., Tomaselli, V., Fornaca, G., Favro, M., Loperfido, B., Gallo, C., Buffoni, S., Gani, F., Raviolo, P., Faggionato, S., Truffelli, T., Vivalda, L., Albano, M., Enzo Rossi, R., Lattuada, G., Bona, F., Quaglio, L., Chiesa, A., Trapani, M., Seminara, R., Cucchi, B., Oderda, S., Borio, G., Galeasso, G., Garbaccio, P., Marco, A., Marengo, F., Cadario, G., Manzoni, S., Vinay, C., Curcio, A., Silvestri, A., Peduto, A., Riario-Sforza, G. G., Maria Forgnone, A., Barocelli, P., Tartaglia, N., Feyles, G., Giacone, A., Ricca, V., Guida, G., Nebiolo, F., Bommarito, L., Heffler, E., Vietti, F., Galimberti, M., Savi, E., Pappacoda, A., Bottero, P., Porcu, S., Felice, G., Berra, D., Francesca Spina, M., Pravettoni, V., Calamari, A. M., Varin, E., Iemoli, E., Lietti, D., Ghiglioni, D., Alessandro Fiocchi, Tosi, A., Poppa, M., Caviglia, A., Restuccia, M., Russello, M., Alciato, P., Manzotti, G., Ranghino, E., Luraschi, G., Rapetti, A., Rivolta, F., Allegri, F., Terracciano, L., Agostinis, F., Paolo Piras, P., Ronchi, G., Gaspardini, G., Caria, V., Tolu, F., Fantasia, D., Carta, P., Moraschini, A., Quilleri, R., Santelli, A., Prandini, P., Del Giudice, G., Apollonio, A., Bonazza, L., Teresa Franzini, M., Branchi, S., Zanca, M., Rinaldi, S., Catelli, L., Zanoletti, T., Cosentino, C., Della Torre, F., Cremonte, L., Musazzi, D., Suli, C., Rivolta, L., Ottolenghi, A., Marino, G., Sterza, G., Sambugaro, R., Orlandini, A., Minale, P., Voltolini, S., Bignardi, D., Omodeo, P., Tiri, A., Milani, S., Ronchi, B., Licardi, G., Bruni, P., Scibilia, J., Schroeder, J., Crosti, F., Maltagliati, A., Alesina, M. R., Mosca, M., Leone, G., Napolitano, G., Di Gruttola, G., Scala, G., Mascio, S., Valente, A., Marchetiello, I., Catello, R., Gazulli, A., Del Prete, A., Varricchio, A. M., Carbone, A., Forestieri, A., Stillitano, M., Leonetti, L., Tirroni, E., Castellano, F., Abbagnara, F., Romano, F., Levanti, C., Cilia, M., Longo, R., Ferrari, A., Merenda, R., Di Ponti, A., Guercio, E., Surace, L., Ammendola, G., Tansella, F., Peccarisi, L., Stragapede, L., Minenna, M., Granato, M., Fuiano, N., Pannofino, A., Ciuffreda, S., Giannotta, A., Morero, G., D Oronzio, L., Taddeo, G., Nettis, E., Cinquepalmi, G., Lamanna, C., Mastrandrea, F., Minelli, M., Salamino, F., Muratore, L., Latorre, F., Quarta, C., Ventura, M., D Ippolito, G., Giannoccaro, F., Dambra, P., Pinto, L., Triggiani, M., Munno, G., Manfredi, G., Lonero, G., Damiano, V., Errico, G., Di Leo, E., Manzari, F., Spagna, V., Arsieni, A., Matarrese, A., Mazzarella, G., Scarcia, G., Scarano, R., Ferrannini, A., Pastore, A., Maionchi, P., Filannino, L., Tria, M., Giuliano, G., Damiani, E., Scichilone, N., Marchese, M., Lucania, A., Marino, M., Strazzeri, L., Tumminello, S., Vitale, G. I., Gulotta, S., Gragotto, G., Zambito, M., Greco, D., Valenti, G., Licitra, G., Cannata, E., Filpi, R., Contraffatto, M., Sichili, S., Randazzo, S., Scarantino, G., Lo Porto, B., Pavone, F., Di Bartolo, C., Paternò, A., Rapisarda, F., Laudani, E., Leonardi, S., Padua, V., Cabibbo, G., Marino Guzzardi, G., Deluca, F., Agozzino, C., Pettinato, R., Ghini, M., Scurati S., Frati F., Passalacqua G., Puccinelli P., Hilaire C., Incorvaia C., D'Avino G., Comi R., Lo Schiavo M., Pezzuto F., Montera C., Pio A., Teresa Ielpo M., Cellini F., Vicentini L., Pecorari R., Aresu T., Capra L., De Benedictis E., Bombi C., Zauli D., Vanzi A., Alberto Paltrinieri C., Bondioli A., Paletta I., Ventura D., Mei F., Paolini F., Colangelo C., Cavallucci E., Cucinelli F., Tinari R., Ermini G., Beltrami V., Novembre E., Begliomini C., Marchese E., Solito E., Ammannati V., Molino G., Galli E., Baldassini M., Di Michele L., Calvani M., Gidaro M., Venuti A., Li Bianchi E., Benassi F., Pocobelli D., Zangari P., De Rocco M.G., Lo Vecchio A., Pingitore G., Grimaldi O., Schiavino D., Perrone N., Antonietta Frieri M., Di Rienzo V., Tripodi S., Scarpa A., Tomsic M., Bonaguro R., Enrico Senna G., Sirena A., Turatello F., Crescioli S., Favero E., Billeri L., Chieco Bianchi F., Gemignani C., Zanforlin M., Angiola Crivellaro M., Hendrick B., Maltauro A., Masieri S., Elisabetta Conte M., Fama M., Pozzan M., Bonadonna P., Casanova S., Vallerani E., Schiappoli M., Borghesan F., Giro G., Casotto S., Berardino L., Zanoni G., Ariano R., Aquilina R., Pellegrino R., Marsico P., Del Giudice A., Narzisi G., Tomaselli V., Fornaca G., Favro M., Loperfido B., Gallo C., Buffoni S., Gani F., Raviolo P., Faggionato S., Truffelli T., Vivalda L., Albano M., Enzo Rossi R., Lattuada G., Bona F., Quaglio L., Chiesa A., Trapani M., Seminara R., Cucchi B., Oderda S., Borio G., Galeasso G., Garbaccio P., De Marco A., Marengo F., Cadario G., Manzoni S., Vinay C., Curcio A., Silvestri A., Peduto A., Riario-Sforza G.G., Maria Forgnone A., Barocelli P., Tartaglia N., Feyles G., Giacone A., Ricca V., Guida G., Nebiolo F., Bommarito L., Heffler E., Vietti F., Galimberti M., Savi E., Pappacoda A., Bottero P., Porcu S., Felice G., Berra D., Francesca Spina M., Pravettoni V., Calamari A.M., Varin E., Iemoli E., Lietti D., Ghiglioni D., Fiocchi A., Tosi A., Poppa M., Caviglia A., Restuccia M., Russello M., Alciato P., Manzotti G., Ranghino E., Luraschi G., Rapetti A., Rivolta F., Allegri F., Terracciano L., Agostinis F., Paolo Piras P., Ronchi G., Gaspardini G., Caria V., Tolu F., Fantasia D., Carta P., Moraschini A., Quilleri R., Santelli A., Prandini P., Del Giudice G., Apollonio A., Bonazza L., Teresa Franzini M., Branchi S., Zanca M., Rinaldi S., Catelli L., Zanoletti T., Cosentino C., Della Torre F., Cremonte L., Musazzi D., Suli C., Rivolta L., Ottolenghi A., Marino G., Sterza G., Sambugaro R., Orlandini A., Minale P., Voltolini S., Bignardi D., Omodeo P., Tiri A., Milani S., Ronchi B., Licardi G., Bruni P., Scibilia J., Schroeder J., Crosti F., Maltagliati A., Alesina M.R., Mosca M., Leone G., Napolitano G., Di Gruttola G., Scala G., Mascio S., Valente A., Marchetiello I., Catello R., Gazulli A., Del Prete A., Varricchio A.M., Carbone A., Forestieri A., Stillitano M., Leonetti L., Tirroni E., Castellano F., Abbagnara F., Romano F., Levanti C., Cilia M., Longo R., Ferrari A., Merenda R., Di Ponti A., Guercio E., Surace L., Ammendola G., Tansella F., Peccarisi L., Stragapede L., Minenna M., Granato M., Fuiano N., Pannofino A., Ciuffreda S., Giannotta A., Morero G., D'Oronzio L., Taddeo G., Nettis E., Cinquepalmi G., Lamanna C., Mastrandrea F., Minelli M., Salamino F., Muratore L., Latorre F., Quarta C., Ventura M., D'Ippolito G., Giannoccaro F., Dambra P., Pinto L., Triggiani M., Munno G., Manfredi G., Lonero G., Damiano V., Errico G., Di Leo E., Manzari F., Spagna V., Arsieni A., Matarrese A., Mazzarella G., Scarcia G., Scarano R., Ferrannini A., Pastore A., Maionchi P., Filannino L., Tria M., Giuliano G., Damiani E., Scichilone N., Marchese M., Lucania A., Marino M., Strazzeri L., Tumminello S., Vitale G.I., Gulotta S., Gragotto G., Zambito M., Greco D., Valenti G., Licitra G., Cannata E., Filpi R., Contraffatto M., Sichili S., Randazzo S., Scarantino G., Lo Porto B., Pavone F., Di Bartolo C., Paterno A., Rapisarda F., Laudani E., Leonardi S., Padua V., Cabibbo G., Marino Guzzardi G., Deluca F., Agozzino C., Pettinato R., Ghini M., Scurati S, Frati F, Passalacqua G, Puccinelli P, Hilaire C, Incorvaia I, D'Avino G, Comi R, Lo Schiavio M, Pezzuto F, Montera C, Pio A, Ielpo MT, Cellini F, Vicentini L, Pecorari R, Aresu T, Capra L, De Benedictis E, Bombi C, Zauli D, and et al

Subjects
medicine.medical_specialty, Pathology, genetic structures, efficacy, Alternative medicine, Medicine (miscellaneous), Adherence, Cost, Efficacy, Side effects, Sublingual immunotherapy, Settore MED/10 - Malattie Dell'Apparato Respiratorio, sublingual immunotherapy, ALLERGEN, cost, medicine, Subcutaneous immunotherapy, Sublingual immunotherapy, adherence, Clinical efficacy, Intensive care medicine, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), sublingual immunoterapy, Original Research, Asthma, AEROALLERGENS, side effects, business.industry, Health Policy, medicine.disease, Slit, eye diseases, Clinical trial, Patient Preference and Adherence, immunotherapy, sense organs, Allergists, ADHERENCE TO TREATMENT, business, Social Sciences (miscellaneous)
Abstract

Silvia Scurati1, Franco Frati1, Gianni Passalacqua2, Paola Puccinelli1, Cecile Hilaire1, Cristoforo Incorvaia3, Italian Study Group on SLIT Compliance 1Scientific and Medical Department, Stallergenes, Milan, Italy; 2Allergy and Respiratory Diseases, Department of Internal Medicine, Genoa; 3Allergy/Pulmonary Rehabilitation, ICP Hospital, Milan, ItalyObjectives: Sublingual immunotherapy (SLIT) is a viable alternative to subcutaneous immunotherapy to treat allergic rhinitis and asthma, and is widely used in clinical practice in many European countries. The clinical efficacy of SLIT has been established in a number of clinical trials and meta-analyses. However, because SLIT is self-administered by patients without medical supervision, the degree of patient adherence with treatment is still a concern. The objective of this study was to evaluate the perception by allergists of issues related to SLIT adherence.Methods: We performed a questionnaire-based survey of 296 Italian allergists, based on the adherence issues known from previous studies. The perception of importance of each item was assessed by a VAS scale ranging from 0 to 10.Results: Patient perception of clinical efficacy was considered the most important factor (ranked 1 by 54% of allergists), followed by the possibility of reimbursement (ranked 1 by 34%), and by the absence of side effects (ranked 1 by 21%). Patient education, regular follow-up, and ease of use of SLIT were ranked first by less than 20% of allergists.Conclusion: These findings indicate that clinical efficacy, cost, and side effects are perceived as the major issues influencing patient adherence to SLIT, and that further improvement of adherence is likely to be achieved by improving the patient information provided by prescribers.Keywords: adherence, sublingual immunotherapy, efficacy, cost, side effects

Published
2010

22. Anticorpi anti-Beta2 Glicoproteina 1: non solo marker diagnostico ma anche mediatore patogenetico della sindrome da anticorpi anti-fosfolipidi

Author

Meroni, P. L., Borghi, M. O., Raschi, E., Scurati, S., Grossi, C., Lavazza, T., Malgaroli, A., Fischetti, Fabio, Tincani, A., Tedesco, F., L. Punzi, Società Ital di Reumatologia, Meroni, P. L., Borghi, M. O., Raschi, E., Scurati, S., Grossi, C., Lavazza, T., Malgaroli, A., Fischetti, Fabio, Tincani, A., and Tedesco, F.

Subjects
"anticorpi anti-Beta2 glicoproteina I, sindrome da anticorpi anti-fosfolipidi, LES, infiammazione, trombosi"
Published
2007

24. Correlation between the clinical form of allergic rhinitis and nasal cytology

Author

Gelardi, M, Petrone, P, Fiorella, M, Quaranta, N, Russo, C, Troiano, L, Ciofalo, A, Caruso, G, Salerni, L, Tomaiuolo, M, Maffezzoni, E, Poletti, D, Bocciolini, C, Dall’Olio, D, Landi, M, Soffia, S, Scurati, S, Puccinelli, P, Boccardo, R, Incorvaia, C, and Frati, F4

Subjects
ALLERGIC RHINITIS, NASAL CYTOLOGY, GRASS POLLEN, ALLERGIC RHINITIS, NASAL CYTOLOGY, GRASS POLLEN
Published
2011

25. Sublingual immunotherapy in polysensitized patients: effect on quality of life

Author

Giorgio Ciprandi, Cadario, G., Valle, C., Ridolo, E., Verini, M., Di Gioacchino, M., Minelli, M., Gangemi, S., Sillano, V., Colangelo, C., Pravettoni, V., Pellegrino, R., Borrelli, P., Fiorina, A., Carosso, A., Gasparini, A., Riario-Sforza, G. G., Incorvaia, C., Puccinelli, P., Scurati, S., and Frati, F.

Subjects
Adult, Male, Rhinitis, Allergic, Perennial, Adolescent, Pyroglyphidae, Administration, Sublingual, Rhinitis, Allergic, Seasonal, Antigens, Plant, Poaceae, Parietaria, Desensitization, Immunologic, Quality of Life, Animals, Humans, Pollen, Female, Immunization, Antigens, Dermatophagoides
Abstract

Quality of life (QOL) is an important issue in allergic rhinitis and has been evaluated in a number of studies that have shown how it is impaired in untreated patients and improved by effective treatment. However, there are no data concerning QOL after sublingual immunotherapy (SLIT) in polysensitized patients.To evaluate the effect, in real-life clinical practice, of SLIT on QOL in a population of polysensitized patients with allergic rhinitis.We prospectively evaluated 167 consecutively enrolled polysensitized patients with allergic rhinitis. QOL was measured in all cases with the Rhinoconjunctivitis Quality of Life Questionnaire at baseline and after 1 year of SLIT (performed in approximately 70% of cases using single allergen extracts provided by the same manufacturer).The most frequent causes of sensitization were grass pollen, Parietaria, and house dust mites. The mean number of sensitizations per patient was 3.65. SLIT was performed with 1 extract in 123 patients (73.6%), with 2 extracts in 31 patients (18.6%), and with more than 2 extracts in 13 patients (7.8%). The mean values of all the QOL items improved significantly (P.01 in all cases), with the following reductions noted: activities, 3.96 to 2.89; sleep, 2.07 to 1.56; general problems, 2.16 to 1.5; practical problems, 3.69 to 2.58; nasal symptoms, 3.57 to 2.50; eye symptoms, 2.92 to 1.83; and emotional aspects, 2.2 to 1.44.This study provides evidence that QOL can be improved in polysensitized patients treated with SLIT, and that the use of just 1 or 2 allergen extracts seems to be sufficient and effective in terms of improving QOL.

Published
2010

28. Identification of novel dual peroxisome proliferator-activated receptor alpha/gamma ligands and characterization of their biochemical properties by 3D structural studies

Author

Scotti, E., Godio, C., Pochetti, G., Mitro, N., Loiodice, F., Lavecchia, A., Novellino, E., Giuseppe FRACCHIOLLA, Tortorella, P., Laghezza, A., Mazza, F., Galmozzi, A., Caruso, D., Scurati, S., Crestani, M., E., Scotti, C., Godio, G., Pochetti, N., Mitro, F., Loiodice, Lavecchia, Antonio, Novellino, Ettore, G., Fracchiolla, P., Tortorella, A., Laghezza, F., Mazza, A., Galmozzi, D., Caruso, S., Scurati, and M., Crestani

Published
2008

30. Testosterone derivatives are neuroprotective agents in experimental diabetic neuropathy

Author

Roglio, I, Bianchi, R, Giatti, S, Cavaletti, G, Caruso, D, Scurati, S, Crippa, D, Garcia Segura, L, Camozzi, F, Lauria, G, Melcangi, R, Garcia Segura, LM, Melcangi, RC, CAVALETTI, GUIDO ANGELO, Roglio, I, Bianchi, R, Giatti, S, Cavaletti, G, Caruso, D, Scurati, S, Crippa, D, Garcia Segura, L, Camozzi, F, Lauria, G, Melcangi, R, Garcia Segura, LM, Melcangi, RC, and CAVALETTI, GUIDO ANGELO

Abstract

In this study we have assessed the effect of testosterone (T), dihydrotestosterone (DHT) and 5alphaandrostan-3alpha, 17beta-diol (3alpha-diol) therapies on diabetic neuropathy. Diabetes was induced in adult male rats by the injection of streptozotocin and resulted in decreased T and increased 3alpha-diol levels in plasma and in decreased levels of pregnenolone and DHT in the sciatic nerve. Moreover, a reduced expression of the enzyme converting Tinto DHT (i.e., the 5alpha-reductase) also occurs at the level of sciatic nerve, suggesting that the decrease of DHT levels could be due to an impairment of this enzyme. Chronic treatment for 1 month with DHT or 3alpha-diol increased tail nerve conduction velocity and partially counteracted the increase of thermal threshold induced by diabetes. Treatment with DHT increased tibial Na(+),K(+)-ATPase activity and the expression of myelin protein P0 in the sciatic nerve.DHT, 3alpha-diol and T reversed the reduction of intra-epidermal nerve fiber density induced by diabetes. These observations indicate that T metabolites can reverse behavioral, neurophysiological, morphological and biochemical alterations induced by peripheral diabetic neuropathy.

Published
2007

35. Inflammation in Respiratory Allergy Treated by Sublingual Immunotherapy

Author

Frati, F., primary, Scurati, S., additional, Puccinelli, P., additional, Morviducci, C., additional, Di Cara, G., additional, Boccardo, R., additional, Piergentili, E., additional, Milioni, M., additional, Bernardini, R., additional, Sambugaro, R., additional, Castellano, F., additional, Varricchio, A., additional, Manfredi, G., additional, Cordero, L., additional, Russello, M., additional, Guercio, E., additional, Mauro, M., additional, and Incorvaia, C., additional

Published
2009
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37. Sublingual immunotherapy: administration, dosages, use

Author

Frati, F., Stefania La Grutta, Bernardini, R., Zampogna, S., Scurati, S., Puccinelli, P., Riario-Sforza, G. G., Incorvaia, C., Frati, F, La Grutta, S, Bernardini, R, Zampogna, S, Scurati, S, Puccinelli, P, Riario-Sforza, G, and Incorvaia, C

Subjects
Randomized Controlled Trials as Topic, Humans, Allergens, Desensitization, Immunologic, Vaccines, Administration, Sublingual, Allergen, Vaccine, Human
Abstract

Allergen extracts for sublingual immunotherapy (SLIT) are currently marketed by several manufacturers, with administration schedules and amount of allergen(s) quite variable in the different products, although almost all are standardized biologically or immunologically. The allergen extracts for SLIT are available in two main pharmaceutical forms: solution to be delivered by drop-counters, pre-dosed actuators (mini-pumps) or disposable single-dose vials; tablets with appropriate composition that allows a slow (1-2 minutes) dissolution in the mouth in contact with saliva. In Europe, SLIT is prescribed in general for one or a few allergens, and mixtures are less used, though there is no immunological contraindication to give multiple allergens. SLIT traditionally involves a build-up phase and a maintenance phase with the top dose. The build-up phase has usually the duration of 4 - 6 weeks. The patient must start with the lowest concentration and gradually increase, using the different dosage preparations, until the maintenance dose is reached. Rush and ultra-rush inductions have been introduced, based on the safety profile of SLIT that is very favorable. For these reasons it has been suggested that an updosing phase maybe even not necessary. The no-updosing approach would result in a treatment that is more patient-friendly and convenient to manage. Indeed, the most recent randomized trials were performed with the no-updosing regimen and their results in term of safety were as favorable as the studies performed with the traditional updosing approach. The currently recommended duration of SLIT is comprised between 3 and 4 years depending on the clinical response in single patients.

38. Evaluation of stability of allergen extracts for sublingual immunotherapy during transport under unfavourable temperature conditions with an innovative thermal insulating packaging

Author

Puccinelli, P., Natoli, V., Albani, I., Scurati, S., Incorvaia, C., Barberi, S., Simonetta MASIERI, and Frati, F.

Subjects
Allergens, Drug Packaging, Drug Stability, Humans, Temperature, Transportation, Vaccines, Sublingual Immunotherapy
Abstract

Many pharmaceutical and biotechnological products are temperature-sensitive and should normally be kept at a controlled temperature, particularly during transport, in order to prevent the loss of their stability and activity. Therefore, stability studies should be performed for temperature-sensitive products, considering product characteristics, typical environmental conditions, and anticipating environmental extremes that may occur during product transport in a specific country. Staloral products for sublingual immunotherapy are temperature sensitive and are labelled for maintenance under refrigerated conditions (2-8°C). Given the peculiar climatic context of Italy and the great temperature fluctuations that may occur during transport, this study was aimed at evaluating the impact of a new engineered thermal insulating packaging for Staloral. In particular, the purpose was to assess whether the new packaging could create a container condition able to preserve the stability and immunological activity of the product during the transport phase throughout Italy. The results showed that the range of temperatures that can affect the product, in the area surrounding the product packaging, may reach a peak of 63°C during transport under the most unfavourable climatic conditions, i.e. in a non-refrigerated van during the summer season, from the site of production in France to the patient's house in Catania, the city with the highest temperatures in Italy. However, the highest temperature reached inside the vaccine did not exceed 45°C over a period of about 2 h. The ELISA inhibition test on samples subjected to the extreme temperature conditions previously defined (45°C) showed an immunological activity higher than 75% of that initially measured and was comparable to those obtained with samples stored at controlled temperature (5°C). This means that, even in the worst case scenario, the structure of the allergen extracts is not influenced and the vaccine potency is preserved.

40. Attitude of allergists in managing polysensitised patients

Author

Ciprandi, G., Alesina, R., Ariano, R., Aurnia, P., Borrelli, P., Cadario, G., Capristo, A., Carosso, A., Casino, G., Castiglioni, G., Cesinaro Di Rocco, P., Colangelo, C., Di Giocchino, M., Di Paola, M., Errico, G., Fiorina, A., Gambuzza, F., Gangemi, S., Gasparini, A., Giugno, R., Iemoli, E., Isola, S., Maniero, G., Marengo, F., Mazzali, P., Minelli, M., Mosca, M., Pellegrino, R., Piconi, S., Pravettoni, V., Quaglio, L., Luisa RICCIARDI, Ridolo, E., Sillano, V., Valle, C., Varin, E., Verini, M., Zambito, M., Puccinelli, P., Incorvvaia, C., Scurati, S., and Frati, F.

41. Factors influencing the prescription of allergen immunotherapy: The Allergen Immunotherapy Decision Analysis (AIDA) study

Author

Frati, F., Incorvaia, C., Cadario, G., Fiocchi, A., Senna, G. E., Rossi, O., Romano, A., Scala, E., Romano, C., Ingrassia, A., Zambito, M., Albani, I., Scurati, S., Passalacqua, G., GIORGIO WALTER CANONICA, Lucrezia, A., Augusto, A., Giorgia, A., Antonino, A., Tiziana, A., Renato, A., Riccardo, A., Ruggiero, B., Lorenzo, B., Valerio, B., Livia, B. M., Daniele, B., Donatella, B., Arrigo, B., Patrizia, B., Lucio, B., Franco, B., Alessandro, B., Silvia, C., Marco, C., Maria, C. D., Paolo, C., Enzo, C., Renato, C., Laura, C., Annamaria, C., Mario, C., Cristiano, C., Stefano, C., Vincenzo, C., Francesco, C., Gloria, C., Luca, C., Maurizia, C., Fulvia, C. B., Giannino, C., Marcello, C., Giorgio, C., Caterina, C., Giselda, C., Giovanni, C., Mariaelisabetta, C., Rosario, C., Antonio, C., Cristina, C., Luigi, C., Nunzio, C., Francesca, C., Salvatore, C., Mariangela, D., Elisabetta, D., Antonino, D. M., Maurizio, D. M., Massimo, D., Enrico, I., Paolo, F., Filippo, F., Elisabetta, F., Annamaria, F., Giulia, F. M., Salvatore, F. A., Ettore, F., Enrico, F., Vittorio, F. B., Ilenia, F., Maurizio, F., Nicola, F., Alessandra, F., Pietro, G., Enrico, G., Federica, G., Domenico, G., Alberto, G., Giuseppina, G., Antonio, G., Maurizio, G., Oriano, G., Giuseppe, G., Loredana, I. M., Stefania, L. G., Luigi, L. R., Massimo, L., Giovanni, L., Erasmo, L., Lionello, M., Gianbruno, L., Mario, L. S., Filomena, L., Carlo, L., Carla, L., Salvatore, M., Guido, M., Cinzia, M. M., Mauro, M., Nicolò, M., Pietro, M., Antonietta, M., Andrea, M., Francesco, M., Manlio, M., Elisabetta, M. S. F., Stefano, M., Paola, M., Enrico, M., Michela, M., Domenico, M. A., Paolo, M., Nunzialfina, M. S., Gilda, N., Rosalba, N., Franco, N., Saverio, N., Eustachio, N., Andrea, N., Rosanna, N., Rosa, O. M., Vincenzo, P., Antonio, P., Maddalena, P., Angela, P., Valentina, P., Alfio, P., Diego, P., Silvia, P., Lejla, P., Elena, P., Lia, P., Sandra, P., Marcella, P. S., Valerio, P., Enrico, P., Salvatore, P., Oliviero, Q., Claudio, R., Vanda, R., Stefania, R., Federico, R., Erminia, R., Sandro, R., Anthi, R., Renato, R., Gabriele, R., Gaetano, S., Sebastiano, S., Eleonora, S., Guglielmo, S., Sergio, S., Michele, S., Domenico, S., Antonietta, S. M., Silvia, S., Paolo, S., Maria, S., Maurizio, S., Stefania, S., Valeria, S., Virgilio, S., Francesca, S., Mario, S., Francesco, T., Rosalia, T., Cinzia, T., Sergio, T., Mirela, T., Maurizio, T., Michele, T., Salvatore, T., Franca, T., Stefano, T., Laura, V., Giuseppe, V., Nicola, V., Licia, V., Claudio, V., Marinella, V., Susanna, V., Andrea, Z., Paola, Z., Giovanna, Z., and Giuliana, Z.

42. Characteristics of patients with allergic polysensitization: The polismail study

Author

Ciprandi, G., Alesina, R., Ariano, R., Aurnia, P., Borrelli, P., Cadario, G., Capristo, A., Carosso, A., Casino, G., Castiglioni, G., Di Rocco, P. C., Colangelo, C., Di Gioacchino, M., Di Paola, M. G., Errico, G., Fiorina, A., Gambuzza, F., sebastiano gangemi, Gasparini, A., Giugno, R., Iemoli, E., Isola, S., Maniero, G., Marengo, F., Mazzali, P., Minelli, M., Mosca, M., Pellegrino, R., Piconi, S., Pravettoni, V., Quaglio, L., Ricciardi, L., Ridolo, E., Sillano, V., Valle, C., Varin, E., Verini, M., Zambito, M., Riario-Sforza, G. G., Incorvaia, C., Puccinelli, P., Scurati, S., and Frati, F.

Subjects
Adult, Male, Rhinitis, Allergic, Perennial, Adolescent, Cohort Studies, Young Adult, Dogs, Anti-Allergic Agents, Animals, Humans, Prospective Studies, Child, Aged, Skin Tests, Pyroglyphidae, Smoking, Age Factors, Fungi, Rhinitis, Allergic, Seasonal, Allergens, Antigens, Plant, Middle Aged, Asthma, Italy, Child, Preschool, Cats, Quality of Life, Pollen, Female, Immunization
Abstract

The natural history of respiratory allergy is commonly characterized by a worsening of symptom severity, frequent comorbidity of rhinitis and asthma, and polysensitization to aeroallergens. The polysensitization phenomenon starts since childhood and is rare to find monosensitized adult patients. However, there are few studies investigating the characteristics of polysensitized patients.This study was performed on a large cohort of patients with allergic rhinitis (assessed by ARIA criteria) and/or mild to moderate asthma (assessed by GINA). The kind and the number of sensitizations, their patterns, and the relation with quality of life (QoL) measured by the Juniper's RQLQ guestionnaire, were evaluated.Globally 418 patients (50.2% males, 49.8% females, mean age 26.4 years, range 3.5-65 years, 64 smokers, 371 non-smokers) were enrolled: 220 had allergic rhinitis alone, and 198 allergic rhinitis and asthma. The mean number ofsensitizations was 2.6. Three hundred-five patients (73%) had persistent rhinitis (PER), 220 of them with moderate-severe form. There was no significant derence in rate of rhinitis and asthma in monosensitized or polysensitized patients. Most patients were sensitized to pollens, whereas only 24.2% of them were sensitized to perennial allergens. Polysensitization was significantly associated with some issues of QoL, confirming previous findings, but not with number ofsensitizations.This study provides data confirming for poly-sensitized patients the relevance of ARIA classification of AR. PER is the most common form of AR in this cohort, symptoms are frequently moderate-severe, and asthma is present in about the half of patients with AR.

43. Lack of sterol regulatory element binding factor-1c imposes glial Fatty Acid utilization leading to peripheral neuropathy

Author

Cinzia Ferri, Samuele Scurati, Enrique Saez, Luis M. Garcia-Segura, Donatella Caruso, Emma De Fabiani, Roberto Cosimo Melcangi, Iñigo Azcoitia, Emanuela Pettinato, Matteo Audano, Silvia Giatti, Maurizio D'Antonio, Nico Mitro, Carla Porretta-Serapiglia, Valentina Alda Carozzi, Maurizio Crestani, Guido Cavaletti, Gaia Cermenati, Harvard University, Fondazione Cariplo, Ministero della Salute, Cermenati, G, Audano, M, Giatti, S, Carozzi, V, Porretta Serapiglia, C, Pettinato, E, Ferri, C, D'Antonio, M, De Fabiani, E, Crestani, M, Scurati, S, Saez, E, Azcoitia, I, Cavaletti, G, Garcia Segura, L, Melcangi, R, Caruso, D, and Mitro, N

Subjects
Physiology, Blotting, Western, Endogeny, Biology, Real-Time Polymerase Chain Reaction, Myelin, Mice, BIO/16 - ANATOMIA UMANA, Microscopy, Electron, Transmission, medicine, Animals, Metabolomics, Glycolysis, PPAR alpha, Receptor, Molecular Biology, Oxazoles, Chromatography, High Pressure Liquid, Myelin Sheath, chemistry.chemical_classification, Mice, Knockout, Analysis of Variance, Catabolism, Fatty Acids, Fatty acid, Peripheral Nervous System Diseases, Cell Biology, Peroxisome, medicine.disease, Microarray Analysis, Cell biology, medicine.anatomical_structure, Peripheral neuropathy, Biochemistry, chemistry, Tyrosine, Sterol Regulatory Element Binding Protein 1, Neuroglia
Abstract

Myelin is a membrane characterized by high lipid content to facilitate impulse propagation. Changes in myelin fatty acid (FA) composition have been associated with peripheral neuropathy, but the specific role of peripheral nerve FA synthesis in myelin formation and function is poorly understood. We have found that mice lacking sterol regulatory element-binding factor-1c (Srebf1c) have blunted peripheral nerve FA synthesis that results in development of peripheral neuropathy. Srebf1c-null mice develop Remak bundle alterations and hypermyelination of small-caliber fibers that impair nerve function. Peripheral nerves lacking Srebf1c show decreased FA synthesis and glycolytic flux, but increased FA catabolism and mitochondrial function. These metabolic alterations are the result of local accumulation of two endogenous peroxisome proliferator-activated receptor-α (Pparα) ligands, 1-palmitoyl-2-oleyl-sn-glycerol-3-phosphatidylcholine and 1-stearoyl-2-oleyl-sn-glycerol-3-phosphatidylcholine. Treatment with a Pparα antagonist rescues the neuropathy of Srebf1c-null mice. These findings reveal the importance of peripheral nerve FA synthesis to sustain myelin structure and function., These studies were supported by funding from Giovanni Armenise-Harvard Foundation Career Development Grant (N.M.), Fondazione CARIPLO 2014-0991 (N.M.), Fondazione CARIPLO 2012-0547 (R.C.M.), Italian Ministry of Health GR-2011-02346791 (M.D. and N.M.) and Research Center for the Characterization and Safe Use of Natural Compounds—“Giovanni Galli” directed by D.C. S.S. is an employee and founder of DASP s.r.l.; all other authors declare no competing financial interests.

Published
2014

44. Testosterone derivatives are neuroprotective agents in experimental diabetic neuropathy

Author

Guido Cavaletti, Roberto Bianchi, Roberto Cosimo Melcangi, Donatella Crippa, Ilaria Roglio, Francesca Camozzi, Donatella Caruso, Luis M. Garcia-Segura, Samuele Scurati, Giuseppe Lauria, Silvia Giatti, Roglio, I, Bianchi, R, Giatti, S, Cavaletti, G, Caruso, D, Scurati, S, Crippa, D, Garcia Segura, L, Camozzi, F, Lauria, G, and Melcangi, R

Subjects
Male, medicine.medical_specialty, endocrine system, Diabetic neuropathy, Neuroprotective Agent, Nerve fiber, Nerve conduction velocity, Diabetes Mellitus, Experimental, Rats, Sprague-Dawley, Cellular and Molecular Neuroscience, Anabolic Agents, Diabetic Neuropathies, Diabetes mellitus, Internal medicine, medicine, polycyclic compounds, Animals, Testosterone, Molecular Biology, Pharmacology, urogenital system, Chemistry, Animal, Dihydrotestosterone, Cell Biology, medicine.disease, Streptozotocin, Androstane-3,17-diol, Rats, Neuroprotective Agents, Endocrinology, medicine.anatomical_structure, Anabolic Agent, Molecular Medicine, Rat, Diabetic Neuropathie, Sciatic nerve, hormones, hormone substitutes, and hormone antagonists, medicine.drug
Abstract

In this study we have assessed the effect of testosterone (T), dihydrotestosterone (DHT) and 5αandrostan-3α, 17β-diol (3α-diol) therapies on diabetic neuropathy. Diabetes was induced in adult male rats by the injection of streptozotocin and resulted in decreased T and increased 3α-diol levels in plasma and in decreased levels of pregnenolone and DHT in the sciatic nerve. Moreover, a reduced expression of the enzyme converting Tinto DHT (i.e., the 5α-reductase) also occurs at the level of sciatic nerve, suggesting that the decrease of DHT levels could be due to an impairment of this enzyme. Chronic treatment for 1 month with DHT or 3α-diol increased tail nerve conduction velocity and partially counteracted the increase of thermal threshold induced by diabetes. Treatment with DHT increased tibial Na+,K+-ATPase activity and the expression of myelin protein P0 in the sciatic nerve.DHT, 3α-diol and T reversed the reduction of intra-epidermal nerve fiber density induced by diabetes. These observations indicate that T metabolites can reverse behavioral, neurophysiological, morphological and biochemical alterations induced by peripheral diabetic neuropathy. © 2007 Birkhäuser Verlag.

Published
2007

45. A 300 IR 5-grass pollen sublingual immunotherapy tablet-specific systematic review and meta-analysis confirms its clinical benefits for patients with allergic rhinoconjunctivitis with or without asthma.

Author

Di Bona D, Paoletti G, Ordak M, Dragonieri S, Cognet-Sice J, Scurati S, and Canonica GW

Abstract

Background: In the realm of allergen immunotherapy (AIT), the quality of evidence varies across different products, making it unjustifiable to extend overall conclusions to all AIT products, as highlighted by WAO and EAACI., Objective: To confirm the efficacy of the 300 IR 5-grass pollen sublingual AIT (SLIT)-tablet through a specific meta-analysis of randomized controlled trials (RCTs) involving patients with allergic rhino-conjunctivitis (ARC) with/without mild/intermittent asthma., Methods: Data from published RCTs on the 300 IR 5-grass SLIT-tablet were gathered from electronic databases (MEDLINE, ISI Web of Science, LILACS, the Cochrane Library and ClinicalTrial.gov) and manual searches up to November 2023. Populations, treatments, and outcome data were combined. Efficacy was assessed based on symptom score (SS) and medication score (MS), measured as standardized mean difference (SMD) or mean difference (MD)., Results: Results from 5 RCTs comprising 1468 patients revealed a significant reduction in SS (SMD, -0.36; 95%confidence interval [CI], -0.52 to -0.19; P  < 0.05) and MS (SMD, -0.29; 95%CI, -0.40 to -0.19; P  < 0.05) compared to placebo. The difference of -0.36 SMD for SS corresponds to a MD of -1.26 SS points, greater than the minimal important difference. Subgroup analysis did not show differences in efficacy according to age, asthma status, and geographic location of the study (USA, Canada, Europe, Russia). No safety issues were reported., Conclusion: This product-specific meta-analysis reinforces the evidence of clinical benefits associated with the 300 IR 5-grass SLIT-tablet, suggesting its appropriateness as a therapeutic choice for patients with ARC, irrespective of concurrent asthma, and exhibiting a favorable safety profile., Competing Interests: DDB reports having received fees from Stallergenes Greer. GP reports having received support for attending meetings and/or travel from Stallergenes Greer and Sanofi Regeneron, and fees for participation on a Data Safety Monitoring Board or Advisory Board from Stallergenes Greer, AstraZeneca and GlaxoSmithKline. MO and SD report no competing interests. JCS and SS are employees of Stallergenes Greer. GWC reports having received consulting fees, and/or payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events (to him or his institution Humanitas Research Hospital, Milan, Italy), and/or support for attending meetings and/or travel, and/or participation on a Data Safety Monitoring Board or Advisory Board, from Stallergenes Greer, Hal Allergy, Menarini, AstraZeneca, GlaxoSmithKline, Chiesi, OmPharma, Sanofi Regeneron, Faes, Sanofi Aventis., (© 2024 The Authors.)

Published
2024
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46. Correction to "Impact of liquid sublingual immunotherapy on asthma onset and progression in patients with allergic rhinitis: a nationwide population-based study (EfficAPSI study)" [The Lancet Regional Health - Europe 41 (2024) 100915].

Author

Demoly P, Molimard M, Bergmann JF, Delaisi B, Gouverneur A, Vadel J, Collin C, Girard L, Scurati S, and Devillier P

Abstract

[This corrects the article DOI: 10.1016/j.lanepe.2024.100915.]., (© 2024 Published by Elsevier Ltd.)

Published
2024
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47. Impact of liquid sublingual immunotherapy on asthma onset and progression in patients with allergic rhinitis: a nationwide population-based study (EfficAPSI study).

Author

Demoly P, Molimard M, Bergmann JF, Delaisi B, Gouverneur A, Vadel J, Collin C, Girard L, Scurati S, and Devillier P

Abstract

Background: The only disease-modifying treatment currently available for allergic rhinitis (AR) is allergen immunotherapy (AIT). The main objective of the EfficAPSI real-world study (RWS) was to evaluate the impact of liquid sublingual immunotherapy (SLIT-liquid) on asthma onset and evolution in AR patients., Methods: An analysis with propensity score weighting was performed using the EfficAPSI cohort, comparing patients dispensed SLIT-liquid with patients dispensed AR symptomatic medication with no history of AIT (controls). Index date corresponded to the first dispensation of either treatment. The sensitive definition of asthma event considered the first asthma drug dispensation, hospitalisation or long-term disease (LTD) for asthma, the specific one omitted drug dispensation and the combined one considered omalizumab or three ICS ± LABA dispensation, hospitalisation or LTD. In patients with pre-existing asthma, the GINA treatment step-up evolution was analysed., Findings: In this cohort including 112,492 SLIT-liquid and 333,082 controls, SLIT-liquid exposure was associated with a significant lower risk of asthma onset vs. control, according to all definitions (combined: HR [95% CI] = 0.62 [0.60-0.63], sensitive: 0.77 [0.76-0.78], and specific: 0.67 [0.61-0.72]). Exposure to SLIT was associated with a one-third reduction in GINA step-up regardless baseline steps., Interpretation: In this national RWS with the largest number of person-years of follow-up to date in the field of AIT, SLIT-liquid was associated with a significant reduction in the risk of asthma onset or worsening. The use of three definitions (sensitive or specific) and GINA step-up reinforced the rigorous methodology, substantiating SLIT-liquid evidence as a causal treatment option for patients with respiratory allergies., Funding: Stallergenes Greer., Competing Interests: Pascal Demoly: fees directed to research and teaching purposes: ALK-Abelló, AstraZeneca, Ménarini, GlaxoSmithKline, Stallergenes Greer, ThermoFisherScientific, Viatris, Zambon; fees for consulting: Chiesi, Puressentiel. Mathieu Molimard: fees for consulting: ALK-Abelló, Novartis, Stallergenes Greer; Jean-François Bergmann: fees for advisory boards and counselling: Amgen, AstraZeneca, Bayer, BMS, Gilead, GlaxoSmithKline, IQVIA, Lilly, Novartis, Pfizer, Roche, Sanofi, Takeda; Silvia Scurati and Laurence Girard: Employees of Stallergenes Greer; Philippe Devillier: fees for advisory boards, lectures, consulting, or support for attending meetings: ALK-Abelló, Astra Zeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, IQVIA, LEN Médical, Menarini, Novartis, Stallergenes-Greer, Viatris., (© 2024 Published by Elsevier Ltd.)

Published
2024
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48. A successful linkage of a named patient products of sublingual immunotherapy-dispensing registry to French healthcare insurance database (SNDS): methodological constitution of the EfficAPSI cohort.

Author

Devillier P, Molimard M, Bergmann JF, Delaisi B, Gouverneur A, Vadel J, Collin C, Girard L, Scurati S, and Demoly P

Subjects
Male, Humans, Female, Adult, Desensitization, Immunologic methods, Registries, Delivery of Health Care, Allergens therapeutic use, Sublingual Immunotherapy methods, Asthma therapy, Rhinitis, Allergic epidemiology, Rhinitis, Allergic therapy
Abstract

Background: The only causal treatment for allergic rhinitis (AR) is allergen immunotherapy (AIT) including personalized liquid sublingual AIT (SLIT). We present the methodology for establishing the EfficAPSI cohort to further evaluate the real-life effectiveness and use of SLIT liquid., Research Design and Methods: The EfficAPSI cohort was constituted by deterministic linkage of Stallergenes Greer dispensing and nationwide French healthcare insurance system (SNDS) databases. Data from 2006 to 2018 were extracted. All patients who initiated Stallergenes Greer SLIT liquid between 2010 and 2013 were considered as exposed and those dispensed with AR symptomatic treatment only as control. To limit the impact of confounding, the models will be weighted using the inverse probability of treatment weighting (IPTW)., Results: A total of 445,574 patients were included; median age was 38 years; 59.1% were female. Exposed patients ( n  = 112,492) were significantly younger, more frequently males, and less likely to have comorbidities than controls ( n  = 333,082). After IPTW, patients' characteristics from both groups were similar., Conclusions: To date, the EfficAPSI cohort has the largest number of person-years of follow-up in the field of AIT. The completeness of the data allows to evaluate SLIT liquid effectiveness with rigorous methodology, leading to important insights on personalized medicine in real-life.

Published
2024
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49. IR (index of reactivity)-house dust mite sublingual immunotherapy liquid formulation for allergic rhinoconjunctivitis: Systematic review and meta-analysis of randomized and nonrandomized studies.

Author

Di Bona D, Carlucci P, Spataro F, Paoletti G, Cognet-Sicé J, Scurati S, and Canonica GW

Abstract

Background: Although randomized controlled trials (RCT) are the reference standard of evidence in allergen immunotherapy (AIT), nonrandomized studies (NRS) are needed to confirm their results in more representative populations, particularly for treatment duration and persistence. However, when discrepancies are observed between RCT and NRS, NRS reliability decreases because these discrepant results are generally attributed to the methodologic flaws of NRS., Objective: We compared the benefit of sublingual AIT (SLIT) for allergic rhinoconjunctivitis in NRS versus RCT focusing on a single product/allergen to reduce heterogeneity., Methods: For meta-analysis, house dust mite (HDM) SLIT liquid formulation studies were sourced from computerized (Medline, Web of Science, and LILACS databases, to January 2023) and manual literature searches. Populations, treatments, and outcome data were combined (DerSimonian-Laird method). Noncomparative NRS were compared to RCT' SLIT arm before and after treatment. Efficacy was determined as the standardized mean difference (SMD) in symptom score (SS) and medication score (MS)., Results: Data from 12 NRS (682 patients) and 8 RCT (176 patients) were analyzed. The benefit with index of reactivity (IR)-HDM SLIT liquid formulation was found significant for, first, SS in both NRS (SMD = -1.27; 95% confidence interval [CI], -1.64, -0.90) and RCT (SMD = -0.56; 95% CI, -0.90, -0.21), and second, MS with SMD equal to -1.35 (95% CI, -1.77, -0.93) and -0.46 (95% CI, -0.67, -0.25), respectively. Metaregression showed that symptom improvement was correlated with treatment duration with consistent results in NRS and RCT with 12-month SS data: -0.87 (interquartile range, -1.02, -0.77) and -0.75 (interquartile range, -0.93, -0.41), respectively., Conclusion: This meta-analysis showed comparable clinical benefit of IR-HDM SLIT liquid formulation increasing over time in both NRS and RCT, suggesting that NRS may reliably integrate RCT results and be considered for guidelines., (© 2024 The Authors.)

Published
2024
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50. Deciphering Differential Behavior of Immune Responses as the Foundation for Precision Dosing in Allergen Immunotherapy.

Author

Magnan A, Nicolas JF, Caimmi D, Vocanson M, Haddad T, Colas L, Scurati S, Mascarell L, and Shamji MH

Abstract

Like in many fields of medicine, the concept of precision dosing has re-emerged in routine practice in allergology. Only one retrospective study on French physicians' practice has addressed this topic so far and generated preliminary data supporting dose adaptation, mainly based on experience, patient profile understanding and response to treatment. Both intrinsic and extrinsic factors shape the individual immune system response to allergen immunotherapy (AIT). Herein, we focus on key immune cells (i.e., dendritic cells, innate lymphoid cells, B and T cells, basophils and mast cells) involved in allergic disease and its resolution to further understand the effect of AIT on the phenotype, frequency or polarization of these cells. We strive to discriminate differences in immune responses between responders and non-responders to AIT, and discuss the eligibility of a non/low-responder subset for dose adaptation. A differential behavior in immune cells is clearly observed in responders, highlighting the importance of conducting clinical trials with large cohorts of well-characterized subjects to decipher the immune mechanism of AIT. We conclude that there is a need for designing new clinical and mechanistic studies to support the scientific rationale of dose adaptation in the interest of patients who do not properly respond to AIT.

Published
2023
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