Use of omalizumab as adjuvant therapy in AIT in FA
| Reference | Study type | Allergen | Patients | Main results/aims |
|---|---|---|---|---|
| Nadeau et al. [43], 2011 | RCT, DBPC | Milk | 11 | Omalizumab helped to shorten the escalation phase of milk OIT, which decreased the number of dose-related reactions requiring intervention, including those needing epinephrine injections |
| Bégin [44], 2014 | Phase 1, SC, DBPC | Multiple foods | 25 | Phase 1 rush OIT protocol with omalizumab pre-treatment was conducted in an open-label manner to evaluate its dose tolerability and safety. Results indicated that the treatment was generally well-tolerated |
| Martorell-Calatayud et al. [45], 2016 | Case series | Milk | 14 | Omalizumab as an add-on therapy to cow’s milk OIT resulted to be effective in enhancing the safety of milk desensitization protocols. |
| Wood [46], 2016 | RCT, DBPC | Milk | 57 | In the omalizumab arm, the increase in dose was shorter in length. Regarding the success of the oral challenge, no significant differences were found. Omalizumab had a higher percentage of doses without symptoms, compared to placebo |
| MacGinnitie et al. [47], 2017 | Phase 2, RCT, DBPC | Peanuts | 37 | Addition of omalizumab increased the speed of the desensitization process. Fewer adverse reactions were recorded during the desensitization process |
| Takahashi et al. [48], 2017 | Phase 2, RCT, DBPC | Cow’s milk | 16 | Throughout the escalation phase, each patient in the omalizumab group was able to consume 200 mL of milk without experiencing any severe adverse reactions. All patients treated with omalizumab passed the DBPCFC at week 32, while none of the untreated patients did |
| Andorf [49], 2018 | Phase 2, RCT, MC, DBPC | Multiallergen | 48 | Significant improvement in tolerance of various food allergens. Treatment also led to a decrease in the frequency and severity of allergic reactions, as well as an increase in the participants’ QoL |
| Andorf [50], 2019 | Phase 2, RCT, DBPC | Multiallergen | 60 | Percentage of patients who passed the DPBCFC while consuming two or more of their prohibited food at the end of the 16-week period. The study found that omalizumab-facilitated OIT was safe and well-tolerated and that a high proportion of participants remained desensitized to all foods at the end of the 16-week period. However, a significantly higher proportion of participants in the continued omalizumab group remained desensitized compared to the discontinued omalizumab group |
| Sindher [51], 2022 | Phase 2, RCT, DBPC | Multiallergen | 60 | Data suggest that changes in IgG4/IgE ratio are induced early when OIT is combined with fixed-dose omalizumab |
| NCT03881696 [52] | Phase 3, RCT, MC, DBPC | Multiallergen | 225 | Number of patients who are able to consume a single dose of > 600 mg of peanut protein approximately 16 to 20 weeks after the initiation of stage 1 treatment |
| NCT04984876 [53] | Phase 3, RCT, MC, DBPC | Peanuts | 486 | Number of patients who tolerate a single dose of > 600 mg of peanut protein at week 12 |
| NCT01781637 [54] | Phase 2, RCT, MC, DBPC | Peanuts | 36 | Number of patients who tolerate 2,000 mg 6 weeks after their last dose of either omalizumab or placebo |
DBPCFC: DBPC food challenge; MC: multicentre; SC: single centre