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
AIMS: To establish the optimal dose of Phleum pratense subcutaneous immunotherapy (SCIT) in patients with allergic rhinoconjunctivitis with/without asthma. MATERIALS & METHODS: One hundred and fifty-one patients were randomized to receive SCIT 0.25, 0.5, 1.0, 2.0 or 4.0 skin-prick test units (SPT) or placebo. The primary end point was the variation in the concentration of Phleum pratense extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). RESULTS: After 17 weeks, a dose-dependent trend was apparent in the concentration of P. pratense extract needed to produce a positive nasal provocation response. Systemic adverse reactions occurred with 3.2% of administered doses. Grade III (n = 2) and IV (n = 2) events were observed only at the two highest doses. CONCLUSION: P. pratense depot SCIT showed signs of clinical and immunological efficacy by dose-dependently decreasing the allergen sensitization rate. Risk-benefit favored doses below 1.0 SPT units for confirmatory trials.
Subject(s)
Allergens/administration & dosage , Antigens, Plant/administration & dosage , Asthma/therapy , Conjunctivitis, Allergic/therapy , Desensitization, Immunologic , Phleum/immunology , Rhinitis, Allergic, Seasonal/therapy , Rhinitis, Allergic/therapy , Adult , Allergens/adverse effects , Antigens, Plant/adverse effects , Asthma/complications , Asthma/immunology , Conjunctivitis, Allergic/complications , Conjunctivitis, Allergic/immunology , Dose-Response Relationship, Immunologic , Female , Follow-Up Studies , Humans , Injections, Subcutaneous , Male , Middle Aged , Nasal Provocation Tests , Pollen/immunology , Portugal , Rhinitis, Allergic/complications , Rhinitis, Allergic/immunology , Rhinitis, Allergic, Seasonal/complications , Rhinitis, Allergic, Seasonal/immunology , Risk Assessment , Spain , 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 up-dosing regimens of Phleum pratense subcutaneous immunotherapy. MATERIALS & METHODS: Forty-two patients were randomized to groups: A (6 weekly doses), B (8 weekly doses) or C (eight doses, two clustered increasing doses over 3 weeks). RESULTS: The most frequent adverse events were local reactions. No serious adverse events were found. Higher number and more severe systemic reactions were reported in group C. A decrease in cutaneous responses and an increase of specific antibodies was shown in all active groups even at very short-term. CONCLUSION: Phleum pratense subcutaneous immunotherapy in depot presentation exhibited good safety and tolerability. Group A seemed to show the best profile.
