Safety aspects of Cluster immunotherapy with semi-depot allergen extracts in seasonal allergic rhinoconjunctivitis. 2010

Oliver Pfaar, and Ralph Mösges, and Karl Hörmann, and Ludger Klimek
Department of Otorhinolaryngology, Head and Neck Surgery,University Hospital Mannheim, Mannheim, Germany.

In addition to allergen avoidance and pharmaceutical medication, specific immunotherapy (SIT) stands for the third most important mainstay offered to allergic patients. SIT has been widely used in pollen-allergic rhinitis,and clinical efficacy has been validated in several controlled clinical trials. Classic SIT protocols begin with an initial dose-increase period (subcutaneous injections of gradually ascending dosages of the allergen extract in weekly intervals) followed by the dose-maintenance period.However, dosage schedules are not commonly standardized yet. Cluster-SIT is an accelerated procedure to achieve the maintenance dose after a shorter time interval by the application of 2-3 injections per treatment day.A total of 395 pollen-allergic patients (173 females,222 males) aging from 18 to 61 years (mean age 32.6 +/- 5.9 years) have been investigated using a Cluster schedule for Alutard SQ that allows up dosing up to 100,000 SQ-U in six treatment days (within 5 weeks). The schedule was investigated with regard to the side effects during dosage increase. The total number of systemic reactions was n = 148 or 2.05% of all injections. Of these,119 (80%) were classified as immediate reactions, 27(18%) were late-phase reactions and 2 (2%) were both immediate- and late-phase reactions. Of all systemic reactions, 124 (84%) were classified as grade 1 reactions,and 24 (16%) as grade 2. No reactions of grades 3 and 4 occurred. Age, gender and the type of the allergen used had no influence on the frequency or severity of local or systemic reactions. The appearance and amount of adverse side effects in Cluster-SCIT is comparable to those in conventional schedules. With respect to safety aspects, this accelerated dosage schedule could turn into an interesting alternative for dosage increase during subcutaneous immunotherapy (SCIT).

UI MeSH Term Description Entries
D007167 Immunotherapy Manipulation of the host's immune system in treatment of disease. It includes both active and passive immunization as well as immunosuppressive therapy to prevent graft rejection. Immunotherapies
D007279 Injections, Subcutaneous Forceful administration under the skin of liquid medication, nutrient, or other fluid through a hollow needle piercing the skin. Subcutaneous Injections,Injection, Subcutaneous,Subcutaneous Injection
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011058 Pollen The fertilizing element of plants that contains the male GAMETOPHYTES. Male Gametes, Plant,Male Gametophytes,Microspores, Plant,Plant Microspores,Pollen Grains,Gamete, Plant Male,Gametes, Plant Male,Gametophyte, Male,Gametophytes, Male,Grain, Pollen,Grains, Pollen,Male Gamete, Plant,Male Gametophyte,Microspore, Plant,Plant Male Gamete,Plant Male Gametes,Plant Microspore,Pollen Grain
D003233 Conjunctivitis, Allergic Conjunctivitis due to hypersensitivity to various allergens. Allergic Conjunctivitis,Conjunctivitis, Atopic,Conjunctivitis, Giant Papillary,Conjunctivitis, Vernal,Keratoconjunctivitis, Vernal,Allergic Conjunctivitides,Atopic Conjunctivitides,Atopic Conjunctivitis,Conjunctivitides, Allergic,Conjunctivitides, Atopic,Conjunctivitides, Giant Papillary,Conjunctivitides, Vernal,Giant Papillary Conjunctivitides,Giant Papillary Conjunctivitis,Keratoconjunctivitides, Vernal,Papillary Conjunctivitides, Giant,Papillary Conjunctivitis, Giant,Vernal Conjunctivitides,Vernal Conjunctivitis,Vernal Keratoconjunctivitides,Vernal Keratoconjunctivitis
D004305 Dose-Response Relationship, Drug The relationship between the dose of an administered drug and the response of the organism to the drug. Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D004334 Drug Administration Schedule Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience. Administration Schedule, Drug,Administration Schedules, Drug,Drug Administration Schedules,Schedule, Drug Administration,Schedules, Drug Administration
D005260 Female Females
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup

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