Allergen Immunotherapy as Add-on to Biologic Agents

Carlo Lombardi; Giorgio W. Canonica; Giovanni Passalacqua


Curr Opin Allergy Clin Immunol. 2018;18(6):502-508. 

In This Article

Abstract and Introduction


Purpose of review: In this review, we sought to outline many of the recent evidences about the available clinical trials in which biologic agents [i.e. omalizumab (OMA)] were associated as add-on to allergen-specific immunotherapy (AIT).

Recent findings: The available literature shows that OMA may be a valuable option as add-on to AIT for respiratory allergy, or food desensitization, especially in the escalation or build-up phases, in which adverse events are more commonly expected. The encouraging data for hymenoptera venom allergy remain limited to case reports, and no structured clinical trial is available.

Summary: Over the past decade, studies of OMA used with AIT have shown promising results. Today, big randomized, double-blind, placebo-controlled trials are needed to better select those patients who would benefit from the addition of OMA (or other biologic agents) to AIT, as well as optimal dosing schedules, optimal duration of treatments and, finally, adequate evaluation about pharmacoeconomic aspects.


It is now well recognized that, in the field of allergy, asthma and rhinitis share the same pathogenic mechanism, in which the IgE–allergen–mast-cell reaction remains the principal trigger.[1] Allergic respiratory diseases (allergic rhinitis and asthma) are indeed the most common immune-mediated disorders, which frequently coexist, and allergic rhinitis is an independent risk factor for asthma development.[2]

Allergen-specific immunotherapy (AIT) is a disease modulator, affecting the specific immune response to allergens themselves at various levels,[3] thus resulting in symptom relief in both allergic rhinitis and asthma.[4,5] In addition, AIT provides a long-lasting, carry-over and/or preventive effects that cannot be seen with the traditional treatments.[6] If it is true that the subcutaneous route of administration remains burdened with the risk of severe reactions, the sublingual route appears to be safer.[7,8,9] So far, severe or uncontrolled asthma remains the main absolute or relative contraindication to the use of AIT.[10] On the other hand, biological treatments are now available for severe asthma such as omalizumab (OMA), mepolizumab, reslizumab, benralizumab and dupilumab, which can decrease the rate of asthma exacerbation and the need for adjunctive care. OMA was commercialized for allergic asthma more than 10 years ago; thus, a vast literature on its clinical use, efficacy and safety is present.[11,12] In this regard, the association of OMA and AIT appeared as a promising approach to both: decrease the onset and severity of adverse events during AIT induction phases; increase the efficacy of AIT itself.[13,14] We are reviewing herein the available clinical trials in which OMA was associated as add-on to AIT, as no clinical study with other mAbs has been published so far.