ABSTRACT
AIM: To evaluate tolerability and efficacy of Parietaria judaica subcutaneous immunotherapy on patients with allergic rhinoconjunctivitis. PATIENTS & METHODS: 51 patients were assigned to build-up scheme (six increasing doses) of P. judaica depot native extract, plus three maintenance monthly administrations. RESULTS: Out of 470 administered doses, only 3.8% elicited systemic reactions (1.5% nonspecific and 2.3% grade I). Concerning the exploratory efficacy parameters: cutaneous reactivity at the final visit versus baseline was significantly decreased; specific titers of IgG and IgG4 increased significantly and patients showed a significant decrease in the rhinitis symptoms score. CONCLUSION: P. judaica subcutaneous immunotherapy (Allergovac® depot ROXALL Medicina España S.A., Zamudio, Spain) with an abbreviated up-dosing scheme showed an adequate safety and tolerability profile and induced preliminary efficacy changes.
Subject(s)
Allergens/therapeutic use , Antigens, Plant/therapeutic use , Desensitization, Immunologic/methods , Plant Extracts/therapeutic use , Rhinitis, Allergic, Seasonal/therapy , Rhinitis, Allergic/therapy , Adult , Allergens/immunology , Antigens, Plant/immunology , Female , Humans , Immunoglobulin E/metabolism , Infusions, Subcutaneous , Male , Middle Aged , Parietaria/immunology , Plant Extracts/immunology , Rhinitis, Allergic/immunology , Rhinitis, Allergic, Seasonal/immunology , Skin Tests , Young AdultABSTRACT
AIM: To evaluate the efficacy of Dermatophagoides pteronyssinus (DPT) subcutaneous immunotherapy in allergic rhinoconjunctivitis patients. PATIENTS & METHODS: This 17-week double-blind study randomized 136 patients (95 evaluable) to five dose groups of DPT depot extract (0.0625-0.75 skin prick test [SPT] units) or placebo, administered in a six updosing schedule. RESULTS: A dose-response was observed for clinical efficacy (allergen concentration needed to induce a positive nasal provocation test response from baseline to final visit) and safety (adverse reactions). Local and systemic reactions occurred with 14.8 and 6.4% of administered doses, respectively; a single anaphylactic reaction occurred in each of Groups 3, 4 and 5 (0.3% of doses). CONCLUSION: The risk-benefit profile appeared most favorable with a DPT dose of 0.125 SPT units.
Subject(s)
Antigens, Dermatophagoides/administration & dosage , Cell Extracts/administration & dosage , Conjunctivitis, Allergic/therapy , Dermatophagoides pteronyssinus/immunology , Desensitization, Immunologic , Rhinitis, Allergic/therapy , Adult , Animals , Antigens, Dermatophagoides/adverse effects , Antigens, Dermatophagoides/immunology , Cell Extracts/adverse effects , Conjunctivitis, Allergic/immunology , Dose-Response Relationship, Immunologic , Female , Humans , Injections, Subcutaneous , Male , Rhinitis, Allergic/immunology , Treatment Outcome , Young AdultABSTRACT
AIM: A double-blind placebo-controlled study was conducted according to EMA guidelines, to evaluate safety, tolerability and short-term treatment effects of three updosing regimens of Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy. PATIENTS & METHODS: Forty-eight patients were randomized to groups: A (six weekly doses), B (eight weekly doses) or C (eight doses, two clustered doses over 3 weeks). RESULTS: The most frequent adverse events were local reactions. No serious adverse events were found. Severe systemic reactions were reported more frequently in Group C. Decreased cutaneous responses and increased specific IgGs were shown in all active groups, even within the short-term. CONCLUSION: Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy in depot presentation exhibited good safety and tolerability. Group A seemed to show the best profile for further clinical development.
