OMALIZUMAB IS RECOMMENDED FOR THE TREATMENT OF CHRONIC IDIOPATHIC URTICA RESISTANT TO H1-HISTAMINE RECEPTOR BLOCKERS IN PATIENTS 12 YEARS OF AGE AND OLDER.

The determination of the specific role of omalizumab in tolerance development was first investigated in a double-blind placebo-controlled trial comparing omalizumab with a placebo as an adjunctive therapy for cow’s milk OIT in 57 subjects (7–32 years) with severe cow’s milk allergy. During a washout period, participants received 4 months of omalizumab and were subsequently continued on treatment until a maintenance dose of OIT was achieved (at 28 months). Although no differences were detected in the rates of desensitization, significantly fewer reactions requiring epinephrine occurred in the omalizumab-treated group as compared to the placebo-treated group (2 vs. 18 doses) [22]. These findings were confirmed in a subsequent case series on 14 egg-allergic and cow’s milk–allergic children (age, 4 months to 11 years). All patients were able to tolerate OIT only when omalizumab was administered as a pretreatment and in conjunction with OIT [42]. Lastly, in a post-hoc analysis, Bedoret et al. postulated that an anergy of the milk-specific CD4-T cells could be implicated in omalizumab-mediated allergen desensitization [43]. Taken together, these data suggest the possibility of using omalizumab as a therapeutic weapon to increase threshold tolerance levels, providing more protection in cases of accidental ingestion in patients with FA [39,40,41,42,43,44]. However, to date, omalizumab is still an off-label treatment with no established dosages. Recently, an individualized anti-IgE treatment, both in terms of dose and length, has been proposed through monitoring of basophil allergen threshold sensitivity [45]. To fill the gap in the evidence supporting omalizumab as a monotherapy or in combination with OIT for food allergy treatment, a clinical development plan is currently ongoing (Table 2).

A second generation noncompetitive H1 antihistamine and mast cell stabilizer used to treat allergic conjunctivitis*1 pointAcetazolamidePilocarpineKetotifenZafirlukastZileuton

A second generation noncompetitive H1 antihistamine and mast cell stabilizer used to treat allergic conjunctivitis

The first investigation of anti-IgE therapy for the management of FA was performed in a double-blind, randomized, dose-ranging (150, 300, or 450 mg of anti-IgE antibodies (TNX-901)) trial in 84 patients, 12 to 60 years of age, with a positive history of peanut allergy. Although the highest TNX-901 dose significantly improved clinical symptoms and increased the threshold dose for peanuts, 25% failed to develop a tolerance to peanuts, suggesting a wide treatment response variability [36]. A subsequent double-blinded, placebo-controlled study was started in children 6 years of age, but discontinued because of safety issues related to pre-omalizumab challenges [37]. An open-label study in 14 adults between 18 and 50 years of age showed a significant increase in the mean tolerated dose of peanut protein (from 80 mg to 5080 mg) after 6 months of omalizumab; however, the administration of antihistamines and epinephrine was required in 10 of the 14 enrolled subjects [38]. To increase the safety of immunotherapy and possibly enhance tolerance development, a combination of anti-IgE therapy and FA-AIT was investigated. Two small double-blind, placebo-controlled food challenge trials in patients (age, 7–25 years) with a peanut [39] or cow’s milk [40] allergy were conducted by using omalizumab in combination with rapid oral food desensitization. During a washout period, participants were generally treated with omalizumab for 2 to 5 months and subsequently continued on treatment until a maintenance dose of OIT was achieved. In the first study, 92% of patients tolerated the challenge, but 46% of children experienced moderate to severe adverse events [39]. In the second trial, 9 out of 11 patients were able to complete dose escalation and only 1.8% of subjects still showed reactions requiring epinephrine [40]. Subsequently, a phase one clinical trial was designed in 25 participants (median age 7 years) with multiple FA. Participants were receiving OIT for up to 5 allergens simultaneously with omalizumab. Anti-IgE therapy was administered for 8 weeks prior to and 8 weeks following the initiation of the OIT protocol. Adverse reactions were reported in 5.3% of subjects. Additionally, 94% of reactions were mild and only one subject experienced a severe reaction requiring epinephrine [23]. Following this, a phase one double-blind, placebo-controlled food challenges study, enrolling patients aged 4–15 years with multiple FA, confirmed that adjunctive omalizumab with OIT provided a safe and rapid desensitization with a lower median rate of adverse events (27% vs. 68%). Interestingly, no serious or severe adverse events were recorded [41].

Given the following diagnosis, which is the most accurate treatment plan?UrticariaGroup of answer choicesAvoid causative agentsMedicationSurgeryTherapy