Table 8. Oral immunotherapy with omalizumab.
| Design & reference | Sample: size & age | Protocol: duration & daily maintenance dose | Outcome (by ITT) and other significant findings | Notable adverse events |
|---|---|---|---|---|
| Milk OIT with omalizumab | 11 subjects | 6 months, first 4 months with omalizumab | With concomitant administration of milk OIT and omalizumab, 82% achieve DS to 2 g 8 weeks post-omalizumab; and subsequently ingested >8 g milk protein at home. | Just 1.6% of doses elicited any reaction; After omalizumab cessation, 2 had moderate AE for which EAI given |
| Nadeau et al. 2011 | 7–17 years | 2 g | ||
| Milk OIT with or without omalizumab, RCT | 27 omalizumab 18 placebo |
28 months, all with omalizumab | While efficacy in achieving DS to 10 g and 8-wk SU were not different with and without omalizumab, AEs were significantly reduced in active group. | Omalizumab group had reduced reactions (2% vs 16%) and reduced drop-out (2 vs 5) EoE reported in placebo |
| Wood et al. 2016 | 7–32 years | 520 mg | ||
| Milk or egg OIT with omalizumab | 14 subjects, 5 cow milk allergic, 9 egg allergic |
14 months, first 2 months with omalizumab | In a group of 14 subjects unable to tolerate conventional OIT, all were able to achieve maintenance dose while on omalizumab, though some relapsed after omalizumab cessation | 60% of cow milk allergic and 33% of egg allergic developed anaphylaxis between 2.5 and 4 months after cessation of omalizumab |
| Martorell-Calatayud et al. 2016 | 3–11 years | 200 mL milk 1.8 g egg |
||
| Peanut OIT with omalizumab | 13 subjects, highly sensitized |
8 months, with omalizumab for first 2 | Even among highly sensitized, omalizumab allows for safe and effective DS, with 92% completing protocol and achieving DS to 8 g | 2 grade 3 reactions during maintenance |
| Schneider et al. 2013 | 7–15 years | 4 g | ||
| Peanut OIT, with or without omalizumab, RCT | 29 omalizumab 8 placebo |
4 months, 1st month with omalizumab | Omalizumab-treated subjects tolerated OIT at higher doses, with 79% of active achieving DS (to 2 g), vs 1 of 8 placebo. These 79% went on to demonstrate DS to 4 g 12 weeks post-omalizumab | Reactions after 7.8% active vs 16.8% placebo (P=0.15) EAI admin: Active 4, placebo 3 EoE: active 1, placebo 1 |
| MacGinnitie et al. 2017 | 6–19 years | 2 g | ||
| Multi-food OIT with omalizumab | 25 subjects | 6 months, first 4 months with omalizumab | OIT with omalizumab enabled all participants on OIT with up to 5 foods to achieve doses 10-fold higher than eliciting dose at enrollment | All moderate (at least 0.06% of doses) and severe (1 EAI admin) reactions, occurred during maintenance |
| Begin et al. 2014 | 4–15 years | 4 g per protein |
AE, adverse event; DS, desensitization; EAI, epinephrine auto-injector; EoE, eosinophilic esophagitis; ITT, intention to treat; OFC, oral food challenge; OIT, oral immunotherapy; RCT, randomized controlled trial; SU, sustained unresponsiveness.