Retrospective study of tolerance to short initiation schedules in subcutaneous immunotherapy.

With the aim of evaluating tolerance to new shorter initiation schedules in subcutaneous immunotherapy everyday clinical practice, a study was carried out using Pangramin Plus with initiation periods between 3 (Cluster) and 6 (Plus) weeks. All the information was processed retrospectively and both systemic (SR) and local (LR) adverse reactions occurring between September 2002 and February 2003 were recorded. A total of 353 patients (261 Plus and 91 Cluster) were included and 2,886 doses were administered (2,166 in initiation and 720 in maintenance). Of these, 800 were with Grass mix extract, 1,141 Grass mix + Olea, 273 Olea, 73 Dermatophagoides mix and 599 Dermatophagoides pteronyssinus. As regards adverse reactions (AR), 2.8% of patients showed SR and 4.8% LR, 1.2% of doses caused some type of reaction (SR and LR in 0.3% and 0.9%, respectively). The initiation schedule, first dose or allergens resulted in no significant differences in the frequency of adverse reactions. The Grass mix extract showed the highest frequency of AR. Sixty-seven percent of SR and 68% of LR were delayed. 64% of these reactions resolved spontaneously while the rest responded favourably to treatment. Adrenaline was administered on one occasion for immediate asthma. There were no cases of anaphylactic shock, hospitalisation or life-threatening situations. Pangramin Plus tolerance, therefore, can be classified as good, similar to conventional schedules, but with the benefits of shorter initiation schedules.

Double-blind, placebo-controlled study of immunotherapy with Parietaria judaica: clinical efficacy and tolerance.

Allergy to Parietaria causes significant morbidity in most Mediterranean areas. The aim of this study is to investigate the efficacy and tolerance of Parietaria depot extract at 25 BU/mL (1.5 microg/mL Par j 1). We performed a multicenter double-blind, placebo-controlled study in rhinitic patients with/without asthma, sensitized to Parietaria. 42 patients followed 20-month immunotherapy. Clinical efficacy was based on symptom and medication scores and the percentage of healthy days (days without symptoms or medication). Severity of asthma/rhinitis scales, visual analogue scale, evaluation of the treatment by doctors and patients, immediate and delayed cutaneous response and quality of life questionnaires were also studied. The active group showed a sustained decrease in symptoms (p = 0.008), medication (p = 0.009) and both (p = 0.001), and an increase in healthy days (p = 0.001) throughout the study, with a threefold increase of healthy days and almost a three time reduction in medication only after one year of treatment. Asthma and rhinitis severity scales also decreased after immunotherapy, and blinded clinical evaluation by physicians confirmed efficacy in 85% and 77% of the active patients. Patient's self-evaluation returned similar results. None of these changes were observed with placebo. Immediate cutaneous response was significantly reduced at the maintenance phase in the active group and remained reduced throughout the study. Late-phase response after intradermal testing also showed a statistical decrease in actively treated patients. Immunotherapy was well tolerated and every systemic reaction reported was mild. In conclusion, immunotherapy with Parietaria 25 BU/mL is an effective and safe treatment for patients with respiratory allergies.

Tolerance and effects on skin reactivity to latex of sublingual rush immunotherapy with a latex extract.

BACKGROUND: Specific immunotherapy could be a therapeutic tool for the increasing problem of sensitisation to Natural Rubber Latex (NRL). OBJECTIVE: To investigate the tolerability of SLIT for Latex and its effects on skin reactivity. METHODS: Twenty-six patients (mean age 35.5 years) with an average history of 7.5 years of cutaneous symptoms plus respiratory symptoms (23/26) due to NRL were studied. All underwent rush sublingual therapy (4 days) with a standardized NRL extract followed by a 9-week maintenance treatment. Local and systemic adverse reactions were monitored throughout the treatment. Skin reactivity to NRL extract was evaluated before, during and at the end of the treatment by latex glove-use test, rubbing test and skin prick test. RESULTS: All patients reached the maintenance dose. Out of 1044 administered doses, 257 (24.6%) produced adverse reactions from which 21.4% were local. Only 10.1% of cases required treatment, mainly with antihistamines alone (5.8%), with 2-agonists alone (0.8%) or associated to antihistamines and/or corticosteroids (2.7%). One patient was precautionary treated twice with adrenaline but completed the treatment without further problems. The glove-use test improved significantly after 5 days and 10 weeks of treatment (p = 0.003, p = 0.0004 respectively), whereas the rubbing test improved significantly only after 10 weeks of treatment. Doctor's assessments confirmed the results obtained with the glove-use test (p = 0.003 after 5 days, and p = 0.004 after 10 weeks) but not those obtained with the rubbing test. No change was detected for SPTs. CONCLUSION: SLIT for NRL allergy is able to modify skin reactivity to NRL in days as assessed with methods reproducing HCWs normal exposure to the allergen. Tolerance of SLIT is better than tolerance reported for injective therapy with NRL, but the build up phase should be administered under medical surveillance until sufficient experience has been accumulated. The long-term effect of the treatment deserves further investigation.