Search

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: The Allergy Patient Identification for Immunotherapy (AsPIRe) program was a parallel physician and patient survey. The objectives were to examine physician and patient perceptions of seasonal allergy symptoms and their impact on patients, and to examine patient and physician attitudes to allergen immunotherapy (AIT) for seasonal allergies. AsPIRe was led by a steering committee and received research ethics board clearance from Queen's University. Methods: Allergists (17) from across Canada enrolled in the AsPIRe program and completed an on-line survey to collect demographic information and baseline perceptions. Allergists then recruited patients and completed paper-based parallel physician and patient questionnaires. Patients received an AIT informational booklet with their questionnaire. Patients who were AIT-naïve with no contraindication to AIT and 12 years of age and older met the inclusion criteria. Results: The survey was in field from February 2018 to June 2018. A total of 141 allergist surveys and 136 patient surveys were completed. Mean age of patients was 30 years old (range 12–70). Fifty-seven percent of patients reported prior knowledge of AIT. Seventy-two percent of patients reported seasonal allergies of longer than 5 years duration and in this subset of patients, 46% were at their first allergist visit. Seventy-three percent of all patients indicated they would be likely or very likely to try sublingual immunotherapy (SLIT), if recommended by their allergist compared to 36% for subcutaneous immunotherapy (SCIT). Conversely, 10% of patients reported they would be unlikely or very unlikely to try SLIT compared to 46% of patients who would be unlikely or very unlikely to try SCIT if recommended by their allergist. Conclusions: In this particular study cohort, there was a gap in perception between allergists and their patients as to the impact of allergy symptoms on daily life. Patients reported being more frequently impacted vs. their physician's assessment. When asked about preference for AIT options, Canadian patients reported they were more likely to follow their allergists' recommendation for initiation of SLIT compared to SCIT. [ABSTRACT FROM AUTHOR]

Background: A cost-minimization analysis (CMA) was performed to estimate the economic impact of introducing the SQ house dust mite sublingual immunotherapy (SQ HDM SLIT)-tablet marketed as ACARIZAX™ (regulatory approval May 2017) for the treatment of HDM-induced allergic rhinitis in Canada (Ontario and Quebec), where house dust mite subcutaneous immunotherapy (HDM SCIT) is already an available treatment option. Methods: A CMA was deemed appropriate and was based on the assumption that the SQ HDM SLIT-tablet has comparable efficacy to HDM SCIT. A societal perspective was adopted in the model, including relevant costs of medications, health care services and productivity loss. A 3 year time horizon was used corresponding to a recommended treatment course of allergy immunotherapy. Resource use and costs were based on published sources, where possible, and validated and complemented by a Canadian specialist clinician (allergist) in active practice in Ontario and in Quebec, respectively, where applicable. A discount rate of 1.5% was applied in accordance with the Canadian Agency for Drugs and Technologies in Health (CADTH) guidelines. To assess the robustness of the results, sensitivity analyses were performed by testing alternative assumptions for selected parameters, to understand their impact on the results of the analysis. Results: The direct treatment costs for a 3-year treatment with SQ HDM SLIT-tablets were higher than for HDM SCIT for both provinces, Ontario and Quebec ($4732.12 and $4829.03 vs. $3434.51 and $2987.74). However, when adding the indirect costs to the model, total savings for the treatment with SQ HDM SLIT-tablets of $1833.00 for Ontario and $769.03 for Quebec were observed. Sensitivity analyses with varying HDM SCIT resource use, discount rates, titration and maintenance injections, nurse time, and number of injections per vial resulted in savings of SQ HDM SLIT-tablets over HDM SCIT in all scenarios analysed. Conclusions: The CMA indicates that SQ HDM SLIT-tablets are a cost-minimizing alternative to HDM SCIT when considered from a societal perspective in Ontario and Quebec. [ABSTRACT FROM AUTHOR]