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Aim: To evaluate tolerability of subcutaneous immunotherapy, in a polymerized mixture ( Olea europaea/ Phleum pratense) depot presentation. Patients & methods: A total of 47 poly-allergic patients received: an abbreviated schedule with three injections at weekly intervals or a cluster schedule with two administrations in 1 day. Both treatments continued with 3 monthly maintenance administrations. Results: Two systemic reactions, (4.3%). One grade 0 and one grade I. No local reactions. Immunoglobulin levels, increased significantly at final visit versus baseline in sIgG and sIgG4; in both schedules and allergens, no significant changes in specific immunoglobulin E levels were detected. Cutaneous reactivity at final visit decreased significantly. Conclusion: Both administration schedules with polymerized mixture of O. europaea/ P. pratense, presented an excellent tolerability profile and induced preliminary efficacy changes.

Aim: Sublingual immunotherapy (SLIT) is significantly less concerned by systemic reactions than subcutaneous immunotherapy. Allergoids were introduced to reduce systemic reaction to subcutaneous immunotherapy, but may also be used for SLIT. Methods: This pharmacovigilance study evaluated the post-marketing reports collected in a safety database, including the number and the type (serious or not serious) of adverse drug reactions (ADRs) in Italy by SLIT with the carbamylated monomeric allergoid (CMA). Results: More than 15,000,000 CMA tablets were administered, with 25 spontaneous reports of ADRs, only two being serious. Conclusion: The rate of ADRs to CMA we found in this pharmacovigilance survey, corresponding to 0.0004% of all administered doses, is far lower than the rates commonly reported for allergen SLIT products.

Aim: Assessment of safety, tolerability and changes in global clinical impression with an multiallergen immunotherapy treatment without dilutional effect in polyallergic patients. Patients & methods: This observational prospective study included patients with allergic rhinitis-rhinoconjunctivitis with or without asthma between 5 and 60 years old receiving immunotherapy treatment with a mixture of two allergenic sources. All adverse events were recorded. Global clinical impression, tolerability subjective assessment and satisfaction were also assessed. Results: 130 patients were analyzed. Nine clinically relevant local adverse reactions were reported in six patients (4.6%). Six systemic reactions (grades 0–I) occurred in four patients (3.1%). Patients improved significantly in their global clinical impression. Good tolerability subjective assessment and satisfaction values were also observed. Conclusion: This multiallergen immunotherapy treatment without dilutional effect can be considered as a potential therapeutic alternative for polyallergic patients suffering from allergic rhinitis.

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.

Aim: We assessed the safety of allergoid adjuvanted by monophosphoryl lipid A (uSCIT-MPL-4) in a real-life setting. Materials & methods: Patients treated with uSCIT-MPL-4 were followed-up for 1 year. Systemic reactions (SRs) were registered and the association with potential risk factors was evaluated. Results: 2929 patients were included. Grade 0, 1, 2, 3 and 4 SR reactions were observed respectively in 3.3, 1.5, 0.31, 0.07 and 0.07% of patients. A significant association was detected between Grade ≥1 SRs and: female gender, number of administrations, previous local reactions. Conclusion: uSCIT-MPL-4 is safe. Local reactions should be accurately assessed as they may represent a risk factor for Grade ≥1 SRs, together with gender and number of doses/year.

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.

Subcutaneous venom immunotherapy is the only effective treatment for patients who experience severe hymenoptera sting-induced allergic reactions, and the treatment also improves health-related quality of life. This article examines advances in various areas of this treatment, which include the immunological mechanisms of early and long-term efficacy, indications and contraindications, selection of venom, treatment protocols, duration, risk factors for systemic reactions in untreated and treated patients as well as for relapse following cessation of treatment. Current and future strategies for improving safety and efficacy are also examined. However, although progress in the past few years has been fruitful, much remains to be accomplished.

Local reactions from subcutaneous allergen immunotherapy are very common during the course of immunotherapy. These local reactions are not bothersome to patients. Local reactions from immunotherapy also do not predict future local or systemic reactions. This review discusses the studies that show that local reactions are not predictive of future reactions and that dose adjustments for local reactions from allergen immunotherapy are unnecessary. The article also focuses on factors that lead to patient noncompliance with immunotherapy and evaluates methods to prevent local reactions from subcutaneous allergen immunotherapy.