Oral immunotherapy combined with omalizumab for high–risk cow’s milk allergy: a randomized controlled trial

Takahashi, Masaya; Soejima, Kazutaka; Taniuchi, Shoichiro; Hatano, Yasuko; Yamanouchi, Sohsaku; Ishikawa, Hideki; Irahara, Makoto; Sasaki, Youhei; Kido, Hiroshi; Kaneko, Kazunari

doi:10.1038/s41598-017-16730-6

Cited by 70 publications

(87 citation statements)

References 39 publications

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“…The use of omalizumab as adjunct therapy to OIT has been reviewed previously [25][26][27][28]. There are 6 uncontrolled trials to date currently indexed in MEDLINE conducted for milk (n = 26) [29][30][31], peanut (n = 39) [32,33], egg (n = 12) [30,34] and multiple food allergens (n = 25) [19]. All conclude to the safety of using omalizumab to achieve rapid desensitization with success rates of reaching maintenance greater than 93%.…”

Section: Use Of Omalizumab In Oral Immunotherapymentioning

confidence: 99%

Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy

Langlois

Lavergne

Leroux

et al. 2020

Allergy Asthma Clin Immunol

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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-toevent 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 costeffective dosage for this indication. Trial registration ClinicalTrials.gov, NCT04045301, Registered 5 August 2019, https ://clini caltr ials.gov/ct2/show/NCT04 04530 1

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Section: Use Of Omalizumab In Oral Immunotherapymentioning

confidence: 99%

Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy

Langlois

Lavergne

Leroux

et al. 2020

Allergy Asthma Clin Immunol

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“…Biologic drugs are indicated or under investigation for chronic rhinosinusitis, 96,97 allergic fungal rhinosinusitis, 98 nasal polyposis, 97,[99][100][101][102][103][104][105][106][107][108][109][110] food allergy [111][112][113][114][115][116][117][118][119][120][121] and eosinophilic oesophagitis. 122 Cost-utility analyses have yet to be conducted for these indications.…”

Section: Other Atopic Disease Without Economic Analysismentioning

confidence: 99%

Economic considerations on the usage of biologics in the allergy clinic

Azzano

Dufresne

Poder

et al. 2020

Allergy

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The introduction of biologic drugs and their expanding use over the last years have transformed the management of patients suffering from severe atopic diseases. Unfortunately, their very high cost also creates new challenges in terms of access and sustainability. This is a problem shared among all medical disciplines. In Europe, the 10 most prescribed biologics accounted for a combined cost of 16.5 billion Euros (14.8 billion USD). 1 In the USA in 2013, they were found to account for 40% of medication costs while representing only 2% of prescription. 2 To evaluate the value and justify coverage of new medications, industry and health technology agencies perform cost-utility analyses, which are the cornerstone of health economic assessment. 3-6 When used within their limits, they can be powerful tools to allow fair comparison of seemingly incomparable health states. Many clinicians feel they have insufficient training to properly interpret health economics studies. 7,8 This is paradoxical since clinicians are often in the best position to judge the credibility of baseline hypotheses, the appropriateness of treatment goals and the applicability to specific patient context and should in fact play a central role in the critical appraisal of such analyses. The objective of this review is to provide key notions to help allergists assess literature on health economics, review and compare available cost-utility studies on the use of biologic drugs in the field of allergy, and reflect on unmet needs and future directions in this area.

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“…Die Kombination einer oralen Immuntherapie mit Omalizumab hat bei Kindern mit schwerer Kuhmilchallergie signifikant weniger Nebenwirkungen, einen geringeren Schwergrad der Reaktion und ein schnelleres Erreichen der Erhaltungsdosis gezeigt [13,14]. Hinsichtlich der Effektivität ergab sich in einer Untersuchung eine deutlich höhere Rate an erfolgreichen Desensibilisierungen (10 vs. 0) [14], in einer anderen Studie jedoch kein Vorteil im Vergleich zu Placebo [13].…”

Section: Bisher Ist Jedoch Kein Biologikum Zur Prävention Schwerer Reunclassified

Schwere Nahrungsmittelallergie: Können Biologika helfen?

Hove¹,

Prenzel²

2020

Kinder- und Jugendmedizin

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ZUSAMMENFASSUNGOmalizumab ist das bisher am meisten untersuchte Biologikum bei Nahrungsmittelallergie. Bisherige Studien und Fallberichte sprechen für eine protektive Wirkung von Omalizumab bei schwerer Nahrungsmittelallergie mit rezidivierenden Anaphylaxien nach akzidenteller Ingestion der Allergene. Eine Hinzunahme von Omalizumab zur oralen Toleranzinduktion kann die Nebenwirkungen vermindern, die vertragene Allergenmenge erhöhen und die Zeit bis zum Erreichen der Erhaltungsdosis reduzieren. Ob dieser Effekt auch ohne eine kontinuierliche Gabe von langfristiger Dauer ist, müssen weitere Untersuchungen zeigen.

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Oral immunotherapy combined with omalizumab for high–risk cow’s milk allergy: a randomized controlled trial

Cited by 70 publications

References 39 publications

Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy

Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy

Economic considerations on the usage of biologics in the allergy clinic

Schwere Nahrungsmittelallergie: Können Biologika helfen?

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