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Background: Allergen immunotherapy (AIT) is the only treatment that has modified the natural history of allergic diseases. However, since its overall effect on the immune system has not been elucidated, AIT is either absolutely or relatively contraindicated in patients with rheumatic autoimmune diseases (RADs). Therefore, there have been no long-term observations of patients with RADs receiving AIT; thus, the effectiveness and safety of AIT in these patients remain unclear. Methods: This was a single-center retrospective observational study. RAD patients receiving AIT for allergic rhinitis at our institution were selected. Changes in the activity of RAD patients were investigated for 2 years from baseline, including those who discontinued AIT. The effectiveness of AIT was also investigated using the Japan Allergic Rhinitis Standard Quality of Life Questionnaire. Results: Thirteen patients with RADs were enrolled in the study. All patients received sublingual immunotherapy, of which four discontinued AIT owing to adverse events. Among all patients, the symptoms of RADs in three patients worsened during the observation period; however, none of them were causally related to AIT. Most of the adverse events associated with AIT were mild, in which only one patient required drug intervention due to worsening rhinitis symptoms. In the nine patients who were able to continue AIT, their eye and nasal symptom scores showed a significant improvement from 1.67 (1.5–2.0) at baseline to 0.67 (0–1.17) in the 2nd year of treatment (p = 0.0141). Conclusions: AIT is a safe and effective treatment modality for patients with allergic rhinitis complicated by RADs. [ABSTRACT FROM AUTHOR]

Background: Previous proof-of-concept studies have shown that a short course of omalizumab can safely accelerate the oral immunotherapy schedule for multiple allergens simultaneously. Considering the high cost of medication, the dose-related efficacy of omalizumab at decreasing the duration of oral immunotherapy up-dosing phase must be objectively quantified before cost–benefit analyses can be performed. The primary objective of this trial will be to compare the efficacy of 2 omalizumab dosages to placebo at decreasing time-to-maintenance dose during a symptom-driven multi-food OIT protocol. Methods: A total of 90 participants aged 6 to 25 with multiple food allergies (3 or more) will be enrolled at four sites in Canada. Participants will be randomized to: (A) Omalizumab 8 mg/kg per month (n = 36); (B) Omalizumab 16 mg/kg per month (n = 36); or (C) Placebo (n = 18). Study drug will be administered at full dosage for 12 weeks, then progressively tapered at 50% dosage (8 mg/kg vs 4 mg/kg vs placebo) for 4 weeks and at 25% dosage (4 mg/kg vs 2 mg/kg vs placebo) for another 4 weeks. After a pre-treatment period of 8 weeks, participants will undergo an initial food escalation (IFE) to an OIT mix containing 3 allergens and start daily home dosing with biweekly increases until a target daily maintenance of 1500 mg protein is achieved. The amount escalated at each visit will vary based on treatment tolerance according to a standardized up-dosing algorithm. Participants will be followed for at least 12 months following the initial food escalation. The primary endpoint will be time from IFE to the target maintenance dose of 1500 mg protein. Time-to-event analytic methods, including the log-rank test, will be used to compare the 3 arms. Discussion: This trial uses a novel pragmatic approach to compare OIT with omalizumab to OIT without omalizumab in a blinded manner, which allows to single out the effect of this anti-IgE medication on treatment effectiveness speed without the recourse to predetermined schedules. The innovative patient-centered up-dosing algorithm allows to maximise treatment effectiveness speed without compromising patient safety, regardless of whether the patient is on omalizumab or not. This study will also provide novel prospective data to inform on the optimal and most cost-effective dosage for this indication. Trial registration ClinicalTrials.gov, NCT04045301, Registered 5 August 2019, https://clinicaltrials.gov/ct2/show/NCT04045301 [ABSTRACT FROM AUTHOR]

Background Allergic rhinitis is estimated to affect 20-25% of Canadians and has a significant impact on quality of life, with many patients reporting inadequate control of their symptoms [1]. Mainstays of treatment for allergic rhinitis include avoidance, intranasal steroids, oral antihistamines and leukotriene receptor antagonists [2]. Specific immunotherapy offers disease-modifying treatment for those uncontrolled by, intolerant to, or averse to pharmacotherapy [3]. Currently two types of aeroallergen immunotherapy are used in clinical practice: subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT). SLIT was first accepted as an alternative to SCIT by the WHO in 1998, and was then introduced into the ARIA guidelines [4, 5]. While SLIT has been available in Europe for some time, Canada first approved a sublingual grass immunotherapy tablet in 2012. At present, there are three sublingual tablet immunotherapy products on the market in Canada (Table 1). There will be other allergens for SLIT available soon. The sublingual route of immunotherapy offers multiple potential benefits over the subcutaneous route including the comfort of avoiding injections, convenience of home administration and a favourable safety profile. In addition, SLIT tablets appear to be economically favourable to standard drug therapy, and possibly also to SCIT [6, 7]. This position statement discusses SLIT tablets only, as SLIT drops are not approved by Health Canada. [ABSTRACT FROM AUTHOR]

Introduction: To assess the safety and efficacy of an oral immunotherapy regimen in patients with allergy to lipid transfer proteins (LTPs). Materials and methods: Prospective study of 24 patients allergic to LTP with positive skin test and a history of anaphylaxis. All patients underwent a desensitization protocol with commercial peach juice. Rising doses of peach juice were administered, starting with an initial dose of seven drops of a 1/1000 dilution and finishing with a dose of 5 ml at visit 17. At visit 18, all patients performed an open challenge with whole juice at a cumulative dose of 200 ml. All adverse reactions occurring during the administration of the different doses were recorded. Levels of rPru p 3 in the juice were quantified. Results: There were no severe reactions during the desensitization process in the 24 patients. Seven patients (29%) reported mild oral symptoms, and two patients (8%) had urticaria associated with co-factors (one due to exercise and another due to non-steroidal anti-inflammatory drugs). Nineteen patients were able to swallow 5 ml of juice and five withdrew from the study. In two pregnant patients the final challenge was not performed. In all, 17/24 patients were able to consume 200 ml peach juice without developing symptoms. Conclusions: Oral immunotherapy with the regimen used in this study is an effective and safe short-term therapeutic option for patients with allergy to LTPs. Commercial peach juice appears to be suitable for this treatment. [ABSTRACT FROM AUTHOR]

Background: Allergic rhinitis affects around one quarter of the Western European population. Prophylactic allergen immunotherapy may be useful to reduce the risk of acute symptomatic attacks (hayfever). A five-grass pollen extract sublingual immunotherapy (5GPE-SLIT) has been developed for the treatment of allergic rhinitis to grass pollen. The objective of this study was to describe real-world treatment patterns with 5GPE-SLIT in France with respect to the prescribing information. Methods: This prospective cohort study was conducted by 90 community and hospital allergists. Adults and children (> 5 years old) starting a first treatment with 5GPE-SLIT prior to the 2015 pollen season were eligible. Data was collected at the inclusion visit and at the end of the pollen season. The primary outcome variable was compatibility of 5GPE-SLIT prescription with the prescribing information. This was determined with respect to four variables: (1) interval between 5GPE-SLIT initiation and onset of the pollen season ≥ 3 months, (2) age of patient ≥ 5 years, (3) intermittent symptoms or mild symptom severity (4) confirmatory diagnostic test. At study end, symptoms reported during the pollen season and any modifications to treatment or adverse events were documented. Results: 280 adults and 203 children were enrolled. The prescribing information was respected for 82.5% of adults and 86.7% of children. A skin test was performed for all patients. 5GPE-SLIT was started 3–5 months before the pollen season for 85.3%. Treatment was discontinued before the start of the pollen season in 11.0% of patients overall, generally because of an adverse event (78.8% of discontinuations). The mean duration of treatment was 5.2 months in adults and 5.6 months in children. At the end of follow-up, symptoms during the pollen season were intermittent for 75.0% of adults and 85.7% of children, and severity was mild for 61.8 and 66.0% respectively. During 5GPE-SLIT, the following symptoms reported during the previous year were not reported again in > 50% of patients: nasal congestion, rhinorrhoea, repeated sneezing, conjunctivitis and nasal pruritus. Conclusions: 5GPE-SLIT use was generally consistent with prescribing recommendations and was associated with an improvement of AR severity, with resolution of the principal AR symptoms in around half the patients treated. Trial registration EUPAS9358. Registered 13 May 2015. Not prospectively registered. http://www.encepp.eu/encepp/viewResource.htm?id=16229 [ABSTRACT FROM AUTHOR]