Allergoid Sublingual Immunotherapy Research Articles

Peripheral effector memory regulatory T cells are incremented and functionally enhanced in successful mite monomeric allergoid sublingual immunotherapy

Peripheral effector memory regulatory T cells are incremented and functionally enhanced in successful mite monomeric allergoid sublingual immunotherapy

Olea sublingual allergoid immunotherapy administered with two different treatment regimens

Sublingual immunotherapy (SLIT) with monomeric carbamylated allergoid administered in accordance with the standard regimen has proven to be effective and safe. Achieving clinical benefit, however, requires a lengthy period of time so it is not very suitable for short-lasting allergies. We thus performed this study to compare an administration protocol starting in the coseasonal period (with a 4-day build-up phase) with a precoseasonal scheme to verify if the former regimen provides the same benefit in a shorter period of time. The prospective, randomized, drug therapy-controlled study was conducted in 33 rhinitic patients monosensitized to Olea with or without asthma. Ten patients were assigned to the coseasonal therapy with 5000 allergic units (AU)/week for 6 weeks, 11 to the precoseasonal therapy with 3000 AU/week for 10 weeks, and 12 to drug therapy. They were treated from April or May to June 2008. A visual analog scale (VAS) was performed at baseline and after treatment to assess the well being of the patients. Drug consumption was evaluated by means of a monthly diary. There was greater VAS improvement in both the SLIT groups versus the controls, but it was statistically significant only in the coseasonal group (p < 0.01). Furthermore, there was a reduction in the rescue medication only in the coseasonal SLIT (p < 0.05 versus drug therapy). One mild adverse event was observed. The allergoid SLIT was shown to be effective and safe in Olea allergy in particular when a coseasonal regimen was used.

Parietaria sublingual allergoid immunotherapy with a co-seasonal treatment schedule

Sublingual immunotherapy (SLIT) with monomeric allergoid, given according to the standard scheme, resulted effective and safe. However, the achievement of a clinical benefit requires a long time. We thus performed this study using an administration protocol starting in the co-seasonal period with a 3-day build-up phase and lasting only 6 months, in order to obtain the above benefit in a shorter time. The study, prospective, randomised and controlled versus drug therapy, was conducted on 65 rhinitic and/or asthmatic patients allergic to Parietaria with or without other sensitisations. Twenty-four were allocated to 1,000 AU/week, 21 to 3,000 AU/week and 21 to drug therapy. They were treated from April to September 2006. At baseline, 3 and 6 months a Visual Analogue Scale (VAS) was performed to assess the patients' well-being. Drug consumption was evaluated by means of monthly diary cards. Bronchial reactivity was investigated at baseline and 6 months by methacholine challenge test. There was a greater VAS improvement in both the SLIT groups than in the controls after 6 months (p<0.05). In patients taking 3,000 AU/week this was already evident after 3 months. There was a significant reduction in rescue medication consumption between 3 and 6 months (p<0.05) in all three groups. The bronchial reactivity was reduced only in the SLIT groups (p<0.001). No adverse events were observed. At 6 months the allergoid SLIT showed itself to be effective and safe. In addition the subjective clinical benefit was obtained in a more rapid period, i.e. 3 instead of 6 months, when a higher maintenance dose was administered.

Clinical efficacy and safety of preseasonal sublingual immunotherapy with grass pollen carbamylated allergoid in rhinitic patients. A double-blind, placebo-controlled study

Background The aim of this study was to confirm the clinical efficacy and safety of a preseasonal sublingual immunotherapy (SLIT) in a group of allergic patients with seasonal rhinoconjunctivitis with or without mild intermittent or mild persistent asthma. The immunotherapy was administered through the oral mucosa with a monomeric carbamylated allergoid (allergoid SLIT) for grass pollens. A secondary endpoint was to evaluate the effect of the allergoid SLIT on nasal reactivity. Methods and results A single-center, randomized, double-blind, placebo-controlled study was performed.Patients were selected and randomly allocatedto two groups: one group received active treatment (allergoid SLIT) for 2 years and the otherreceived placebo. Both groups received the necessary drug treatment throughout the trial. Thirty-three outpatients (20 men and 13 women, mean age: 30 years; range: 19-43) attending our center were enrolled in the study. Symptoms and medications were scored on diary cards during the pollen season. An allergen nasal challenge was performed at baseline and after 2 years of SLIT to evaluate nasal reactivity. Because the clinical scores were non-normally distributed, the Mann-Whitney and the Chi-square tests for intergroup comparisons and the Wilcoxon test for intragroup comparisons were used. The results were evaluated after 1 and 2 years of treatment. Between the first and second years of treatment, no changes in the scores for the placebo group were found, while for the active vaccine group significant decreases were found in rhinorrhea (p < 0.03), sneezing (p < 0.03), and conjunctivitis (p < 0.02). Symptom scores after nasal challenge decreased (p < 0.03) after 2 years’ treatment. Nasal steroid use significantly decreased in the active treatment group during May and June in both the years of treatment (p < 0.02). Only two mild local adverse events were reported in the active group and none was reported in the placebo group. Conclusions The results of this study show thatthe allergoid SLIT is safe and effective in decreasing symptom scores and drug use in rhinitic patients allergic to grass pollen.

Safety and Tolerability of Ultra-Rush (20 minutes) Sublingual Immunotherapy in Patients with Allergic Rhinitis and/or Asthma

Background The safety and good tolerability of sublingual immunotherapy (SLIT) has already been proved in allergic patients, but only one study has investigated the occurrence of immediate adverse reactions in allergic patients after a 2-hour ultra-rush regimen of SLIT performed with a chemically modified extract (sublingual monomeric allergoid, Lais ®, Lofarma S.p.A., Milan). The objective of the present study was to evaluate the occurrence of immediate adverse reactions in allergic patients after a very fast (20 minutes) ultra-rush regimen of sublingual allergoid SLIT. Methods and results We studied 105 patients: 28 children (20 male, mean age 13.3 ± 2.1 yr) and 77 adults (29 male, mean age 34.7 ± 9.9 years) with a history of intermittent/persistent rhinitis or intermittent/ mild persistent asthma due to House Dust Mite (n = 56), Parietaria (n = 34) and Timothy-grass (n = 15) The build-up ultra-rush phase involved the administration, every five minutes, of increasing doses of the sublingual allergoid SLIT. All patients tolerated the treatment very well. Only one patient out of 105 (0.9 %) had a mild local symptoms (gastric pirosis) that occurred 30 minutes after the last initial dose and spontaneously disappeared as the treatment was continued. Conclusions These data show the excellent safety and tolerability profile of an ultra-rush SLIT regimen performed with a chemically modified extract, even when high doses were administered through an extremely short induction phase (20 minutes), thus confirming the previously reported results.

Safety and tolerability of ultra-Rush (20 minutes) sublingual immunotherapy in patients with allergic rhinitis and/or asthma

Background The safety and good tolerability of sublingual immunotherapy (SLIT) has already been proved in allergic patients, but only one study has investigated the occurrence of immediate adverse reactions in allergic patients after a 2-hour ultra-rush regimen of SLIT performed with a chemically modified extract (sublingual monomeric allergoid, Lais ®, Lofarma S.p.A., Milan). The objective of the present study was to evaluate the occurrence of immediate adverse reactions in allergic patients after a very fast (20 minutes) ultra-rush regimen of sublingual allergoid SLIT. Methods and results We studied 105 patients: 28 children (20 male, mean age 13.3 ± 2.1 yr) and 77 adults (29 male, mean age 34.7 ± 9.9 years) with a history of intermittent/persistent rhinitis or intermittent/mild persistent asthma due to House Dust Mite (n = 56), Parietaria (n = 34) and Timothy-grass (n = 15) The build-up ultra-rush phase involved the administration, every five minutes, of increasing doses of the sublingual allergoid SLIT. All patients tolerated the treatment very well. Only one patient out of 105 (0.9 %) had a mild local symptom (gastric pirosis) that occurred 30 minutes after the last initial dose and spontaneously disappeared as the treatment was continued. Conclusions These data show the excellent safety and tolerability profile of an ultra-rush SLIT regimen performed with a chemically modified extract, even when high doses were administered through an extremely short induction phase (20 minutes), thus confirming the previously reported results.

Safety and tolerability of ultra-rush (20 minutes) allergoid sublingual immunotherapy in patients with allergic rhinitis and/or asthma

Rationale The safety of sublingual immunotherapy (SLIT) has already been demonstrated in allergic patients, but only one study evaluated the occurrence of immediate adverse reactions in allergic patients after an ultra-rush regimen of SLIT with a monomeric allergoid (Lais, Lofarma, Milan). Aim of the present study is to confirm these preliminary data and to investigate the tolerability of the allergoid SLIT as well. Methods Twenty patients (10M, 10F, mean age: 33 years) took part in this trials on the allergoid ultra-rush SLIT for the treatment of IgE-mediated rhinitis and/or asthma due to House Dust Mite (n=14) or Parietaria (n=6). The build-up ultra-rush phase was done by administering increasing doses of the monomeric sublingual allergoid every 5 minutes. The cumulative dose administered, after 20 minutes, was about 4000 A.U. Careful checks to evaluate the occurrence of any adverse event were done at the same time intervals. Results All patients tolerated the treatment very well. No adverse events were seen in any patients at any time, neither during the build-up phase nor during the first week of the maintenance treatment, performed with 2000 A.U. of the allergoid SLIT. Conclusions Our data, show the excellent safety and tolerability profile of the ultra-rush allergoid SLIT, even when high doses are administered through an extremely short induction phase, thus confirming the previously reported results.

Efficacy of allergoid sublingual immunotherapy in children with asthma and/or allergic rhinoconjunctivitis: Comparison study with drugs

Rationale Sublingual immunotherapy (SLIT), since the last years has always been used more and more in the treatment of pediatric respiratory allergic diseases, because of its proved safety, efficacy and good compliance of children and their parents. Aim of this study was to evaluate, in a pediatric population, the clinical efficacy and the easy of use of a monomeric allergoid SLIT (Lais, Lofarma, Italy), in comparison with drug treatment (antihistamines plus beta-2 agonists and salbutamol). Methods Thirty three children with asthma and/or allergic rhinitis (mean age: 7.2 years) were enrolled. Eighteen children were treated with the allergoid SLIT while the other 19 with the above mentioned drugs. The allergens more frequently involved were mite and grass. Patients with severe persistent asthma, poliallergies and vernal conjunctivitis were excluded. Results The drug consumption was significantly lower in the group assigned to the allergoid SLIT (p<0.001). Only in 3 patients out of 18 it was necessary to employ antihistamines and in 5 out of 18 salbutamol. Also the symptoms score was statistically lower (p<0.01) in the allergoid SLIT group. In particular, the clinical efficacy was higher in patients allergic to mites with weak/moderate persistent asthma. Conclusions These results show that, in a population of pediatric patients suffering from asthma and/or rhinitis, the allergoid SLIT improves the allergic symptoms to a greater extent than drug treatment. Furthermore, the clinical efficacy of the allergoid SLIT is also confirmed by the favorable judgement expressed by the children' parents after one year of treatment.

Efficacy of allergoid sublingual immunotherapy in patients with allergic bronchial asthma to house dust mite

Rationale Aim of this study was to verify, in subjects with mild/moderate allergic bronchial asthma due to house dust mite (HDM), the efficacy of the sublingual immunotherapy (SLIT) performed with a monomeric allergoid (Lais, Lofarma, Italy). Methods Forty seven patients were enrolled. Twenty four were randomized to the standard therapy according to the international guidelines (group 1) while 23 received, in addition to this therapy, the allergoid SLIT (group 2). At baseline and every six months, for 3 years, all the patients carried out a bronchial provocation test (BPT) specific for HDM and an aspecific BPT with methacholine, to investigate bronchial hyperreactivity (BHR). Before every visit, the patients filled in, for 2 weeks, a diary card to register the symptom score and the morning and evening peak expiratory flow (PEF). The patients with a symptom score less than 12 and/or needing a dose of budesonide greater than 400 μg/day for more than 2 weeks were excluded. Results Nineteen patients out of 24 in group 1 (79%) and 21 out of 23 in group 2 (91%) completed the study (p<0.05). The symptom score, the on demand use of bronchodilator drugs and PEF measurements were statistically better in group 2, already after the first year of therapy. Specific and aspecific BPT improved to a greater extent in the patients treated with the allergoid SLIT too (p<0.05). Conclusions These results show that, in patients with allergic bronchial asthma to HDM, allergoid SLIT, in addition to the standard therapy, significantly improves symptoms control, specific and aspecific BHR.

Tolerability of the allergoid sublingual immunotherapy with a monomeric allergoid in patients with allergic rhinitis and/or asthma

Rationale Purpose of this study was to assess the tolerability of the allergoid sublingual immunotherapy (SLIT) performed with a monomeric allergoid (Lais, Lofarma, Italy). Methods We selected 183 patients (101M/82F, age: 9-47 years, mean age: 27 years), allergic to Mites (88), Grass (82), Parietaria (8), and Corylaceae/Betulaceae (5), suffering either from rhinitis (152) or asthma (5) or asthma and rhinitis (26). All patients or their parents were instructed to keep a diary for the daily evaluation of any local and/or systemic side effect related to the SLIT administration. Patients were authorised to use rescue drugs to control allergy symptoms, if necessary. All patients were treated with the allergoid SLIT in tablets for two years, according to the schedule suggested. Results No adverse reaction were observed in 173 out of 183 patient (94,5%). Ten patients (5,4%) showed side effects, consisting in 1 intense pharyngeal edema and itching, successfully managed by rescue medication, 5 mild local itching of the mouth, 1 mild abdominal pain and 3 intercurrent flu-like episodes, not related to allergoid SLIT. No adverse events occurred when the allergoid SLIT was re-administered, thus reaching the maintenance dose in all patients but one child. Conclusions Allergoid SLIT is generally well tolerated in more than 90% of the treated patients.

Quantitative assessment of the adherence to allergoid sublingual immunotherapy in patients with house dust mite sensitization: The INSIT study

Rationale Sublingual Immunotherapy (SLIT) is a viable alternative to conventional immunotherapy, but some concerns exist about the adherence to SLIT, and few experimental data exist about this topic. We aimed at quantifying the adherence to the SLIT in patients with mite allergy. Methods We performed a multicenter study (INSIT) to assess the adherence, given as allergoid SLIT in tablets (Lais, Lofarma, Italy), in patients with mite allergy. Patients underwent random telephonic interviews, during which they were asked to immediately count the remaining tablets. The adherence was measured by assessing the reported number of remaining tablets versus that expected, based on the administration schedule. Demographic and socio-economic data and clinical scores were also recorded. Results Forty-one patients (16 male: 15-65 yrs, mean age: 36.3), 19 with rhino-conjunctivitis and 22 with concomitant asthma were enrolled in the first year of the study. Allergoid SLIT was given continuously and the compliance was assessed at the end of 1 year of treatment. There were two dropouts: one lack of efficacy, one onset of nasal polyps. In the remaining 39 patients, the adherence was 3.929/4.056 tablets (96.8%). Sporadically omitted doses (less than 1 tablet/month) were reported by 6 patients (14.6%). No systemic or local side-effects were reported. We also observed a statistically significant improvement of rhinoconjunctivitis and asthma symptoms score and medication consumption. The compliance was in general lower in patients frequently travelling for business reasons. Conclusions The preliminary results of this ongoing study show that the adherence to allergoid SLIT is satisfactory, despite it is self-administered.

Tolerability of sublingual immunotherapy with monomeric allergoid in allergic sensitizations to house dust mite, Parietaria and grass

Rationale The tolerability of the sublingual immunotherapy (SLIT) has been shown in allergic patients, but only a few studies evaluated the occurrence of adverse reactions during a SLIT performed with monomeric allergoid (Lais, Lofarma, Milan). Aim of the present study is to confirm these first data in a broader population of allergic patients. Methods We evaluated 1284 patients that assumed the allergoid SLIT for 5 years for the treatment of IgE-mediated allergies to House Dust Mite (n=650) or Parietaria (n=390) or Grass (n=244). Results All patients tolerated the treatment very well, but 6 subjects (0.9%) allergic to Mite that showed, after a time interval ranging from a few minutes to 2-3 hours from the assumption of the therapy, a weak headache and a worsening of the rhinitic symptoms. All the patients regularly completed the whole period of 5 years' treatment. Conclusions These data show that the allergoid SLIT is very well tolerated, even when administered for a long period of time and confirm, in a broader population, the previously reported results.