Sub-Lingual Immunotherapy

• DOI: 10.1097/wox.0b013e3181c6c379
• Publication Date: 2009-11-18T10:27:03Z
• Authors: G. Walter Canonica; Jean Bousquet; Thomas Casale; Richard F. Lockey; Carlos E. Baena-C...; Ruby Pawankar; Paul C. Potter; Philippe J. Bousquet; Linda S. Cox; Stephen R. Durham; Harold S. Nelson; Giovanni Passalacqua; Dermot P. Ryan; Jan L. Brozek; Enrico Compalati; Ronald Dahl; Luis Delgado; Roy Gerth van Wijk; Richard G. Gower; Dennis K. Ledford; Nelson Rosario Filho; Erkka J. Valovirta; Osman M. Yusuf; Torsten Zuberbier; Wahiduzzaman Akhanda; Raul Castro Almar...; Ignacio Ansotegui; Floriano Bonifazi; Jan Ceuppens; Tomás Chivato; Darina Dimova; Diana Dumitrascu; Luigi Fontana; Constance H. Kate...; Ranbir Kaulsay; Piotr Kuna; Désirée Larenas-L...; Manolis Manoussakis; Kristof Nekam; Carlos Nunes; Robyn O'Hehir; José M. Olaguibel; Nerin Bahceciler ...; Jung Won Park; Alfred Priftanji; Robert Puy; Luis Sarmiento; Glenis Scadding; Peter Schmid-Gren...; Ester Seberova; Revaz Sepiashvili; Dírceu Solé; Alkis Togias; Carlo Tomino; Elina Toskala; Hugo Van Beever; Stefan Vieths
• Keywords: Clinical immunology

This article was originally published online on 19 November 2009 Asia Pacific Association of Allergology and Clinical Immunology. Commonwealth Independent States (CIS). European Academy Allergy Immunology (EAACI). Latin American Society Interasma (International Asthmology). Albanian South Africa. Allergy, Asthma College Argentine Australasian Allergy. Bangladesh Belgian Brazilian Immunopathology. British for Bulgarian National Allergology. China Chinese Allergists. Cuban Czech Finnish French German Hellenic Hungarian Italian Territorial Hospital Japanese Korean Malaysian Mexican (CMICA). Pediatricians Specialized in Portuguese Romanian Singapore Immunology, & Rheumatology. Spanish Swiss Turkish Venezuelan Southern Society. Allergic Rhinitis Its Impact (ARIA). Federation Airway Diseases Patients (EFA). International Primary Care Respiratory Group (IPCRG). Global Network (GA2LEN). Institutes Health (NIH). Colombian Asthma, Association. Egyptian Pediatric Icelandic Indian Applied Mongolian Norwegian Peruvian Russian Thailand. Sublingual immunotherapy (SLIT) has gained wide acceptance many countries raised the level interest among practicing allergists primary care physicians. Large pivotal double-blind, placebocontrolled, randomized clinical trials have confirmed efficacy safety SLIT, although some negative also been published. In 2008, World Organization (WAO) Board Directors decided that it important timely to advise our global constituents current State Art offer consensus its use based currently available evidence expert opinion, develop practice parameters. Unmet needs would be identified by analysis recent ongoing SLIT trials, then recommendations further studies needed, suggestions appropriate methodology conduct them, offered. To ensure a truly meeting held 22–23 January Paris, France. WAO invited Regional, National, Affiliate Member Societies participate actively sending representatives meeting. Non-Governmental Organizations working field allergy were attend (ARIA), (EFA), (IPCRG), Asthmology (Interasma), (GA2LEN), et al represented. The outcomes remain totally independent from interest/influence/funding pharmaceutical or allergen extract/vaccine industry.Tabled 1Abbreviations:AAAAI:American ImmunologyACAAI:American ImmunologyADR:Adverse Drug ReactionAE:Adverse EventAMP:Adenosine MonophosphateARIA:Allergic AsthmaAUC:Area under CurveBHR:Bronchial HyperresponsivenessCHMP:Committee Human Medicinal ProductsCIS:Commonwealth StatesCMD:Cumulative Monthly DoseCONSORT:Consolidated Standards Reporting TrialsDBPCFC:Double-blind placebo-controlled food challengeDBPCRCT:Double-blind, placebo-controlled–randomised trialEAACI:European ImmunologyEBM:Evidence-based MedicineECP:Eosinophil Cationic ProteinEFA:European AssociationEMEA:European Medicines AgencyEU:European UnionFDA:(US) Food AdministrationFeNO:Fraction exhaled Nitric OxideFEV1:Forced Expiratory Volume One SecondFVC:Forced Vital CapacityGA2.Guideline Allergen Products. Production quality issues. EMEA, CHMP/BWP/304831/2007 adopted CHMP 20, 2008.Google ScholarLEN:Global NetworkGP:General PractitionerGRADE:Grading Recommendations, Assessment, Development EvidenceHCP:Health ProfessionalHDM:House Dust MiteICAM-1:Intercellular Adhesion Molecule-1ICER:Incremental Cost-Effectiveness RatioIDO:Indoleamine 2,3-dioxygenaseIg:ImmunoglobulinIL:InterleukinInterasma:International AsthmologyIPCRG:International GroupIT:ImmunotherapyLLR:Large Local ReactionsMedDRA:Medical Dictionary Regulatory ActivitiesMHC:Major Histocompatibility ComplexmRNA:Messenger Ribonucleic AcidNIH:National HealthPAT:Preventive Treatment (study)PEF:Peak FlowQoL:Quality LifeRCT:Randomized Controlled TrialRQLQ:Rhinoconjunctivitis Quality Life QuestionnaireSAE:Serious Adverse EventSCIT:Subcutaneous ImmunotherapySCORAD:Score Atopic DermatitisSCUAD:Severe Chronic Upper DiseasesECP:Serum Eosinophil ProteinSIT:(allergen-) Specific ImmunotherapySLIT:Sublingual ImmunotherapySMD:Standardized Mean DifferencesSPT:Skin Prick TestSR:Systemic ReactionT regs:Regulatory T CellsTGF:Transforming Growth FactorTh:T Helper CellsVAS:Visual Analogue ScaleWAO:World OrganizationWHO:World Open table new tab Before 1980s there no standardization; this resulted marked variations allergenic strength vaccine batches produced different phases. Until 1991 vaccines considered "Galenic" drugs, because they prepared upon request physician specific patient. administered through injective route only, preparations used both diagnosis therapy. Most firms ready-to-prepare extracts final phase production consisted matching name patient with pre-prepared vaccine. Leading up l991, companies active manufacturing sector noticed physicians had changed their prescribing patterns, now requesting single allergens immunotherapy, rather than mixtures previously supplied. 1990s, when sublingual first appeared market, only preparations, as required guideline field. It immediately became evident regulatory authorities documents pertaining standardization method needed; is not prepare are always equivalent between batches, but an initial reference extract (the standard extract) allergenically/biologically active, provide comparison subsequent batches. According Guideline 2001/83/EC, immunologic medicinal products therefore, general, require marketing authorization. However, several national regulations implemented still allow "named preparations" (NPPs) without For example, Germany estimated approximately 50% market NPPs. segment includes majority SLIT. From point view, difference SCIT. By contrast clear exists requirements natural versus recombinant allergens, particular regarding criteria product quality.1.Lorenz A.R. Lüttkopf D. Seitz R. Vieths S. system Europe special emphasis products.Int Arch Immunol. 2008; 147: 263-275Crossref PubMed Scopus (21) Google Scholar, 2.Guideline Scholar–3.European Pharmacopoeia 6.6. products, 01/2010/1063.Google Scholar Germany, 4 authorized mid-2009, whereas more 200 SCIT Of one grass pollen tablet successfully passed mutual recognition procedure Union (EU) countries. Recent Phase III performed 2 tablets involved hundreds patients each trial according adequate placebo-controlled-randomized (DBPC-RCT) design. These others showed particularly parameters such determination pretreatment period seasonal rhinoconjunctivitis exploratory dose resulting most favorable risk:benefit ratio, major importance. A statement4.Canonica G.W. Baena-Cagnani C.E. Bousquet J. P.J. Lockey R.F. al.Recommendations Immunotherapy respiratory allergy. statement taskforce.Allergy. 2007; 62: 317-324Crossref (303) Agency (EMEA) Guideline5.Guideline Products Diseases. CHMP/EWP/ 18504/2006, define time SIT, will lead improved harmonization assessments agencies data obtained trials. Increased availability proven quality, benefit allergic may improve general SIT established treatment agencies. seem heralded era desensitization; safety, eligible submission registration authorities. New registered allergopathologies approach pathology etiologic way; act real biologic modifiers, long-lasting effects. interesting clinically, terms pharmacoeconomic profile. •The prescription nonauthorized weakens role specialist, contributed paucity specialists treat figure 20% world population suffers allergies.•The sold pharmacies creates difficulties management (from ordering, receipt storage). distributed credibility itself; precludes any interaction pharmacist (a traditional counselor patients) image product, which years.•An offers guarantees, consequently increasing compliance (at present 30% vaccinated complete at least 3 years accordance recommended guidelines duration therapy). •A nonregulated makes possible "low quality" fails give ethical manufacturers who scientific research employ good practices. regulated attracts qualified investors. •Marketing correct pharmacovigilance and, consequence, all activities connected open transparent dialogue stakeholders, eg, pre- postregistration professional training, congress activities. Chapter 1: Introduction Historical Background Immunotherapy, p. 236. 2: 239. 3: Mechanisms 242. 4: Efficacy p 245. 5: Safety 258. 6: history allergy, 261. 7: Children, 263. 8: Guidelines Recommendations 265. 9: Definition selection, 269. 10: Future Community Setting, 271. 11: Methodology Trials 274.