New data suggests the anti-immunoglobulin E monoclonal antibody is more effective than oral immunotherapy at treating multifood allergy – but there’s an important caveat to consider.
An American study has found that treating multifood allergy patients with omalizumab is more successful that using multiallergen oral immunotherapy.
The research was published in JAMA Pediatrics.
One hundred and seventeen people aged one to 55 years with food allergies (allergic to peanuts and at least two of milk, eggs, wheat, cashews, hazelnuts, or walnuts) were recruited. There were slightly more men than women (55% versus 45%), and the median age of participants was 7 years. Individuals with poorly controlled/severe asthma, a history of life-threatening anaphylaxis, eosinophilic gastrointestinal disease, or recent food or other immunomodulatory therapy were excluded.
All participants received 16 weeks of open label omalizumab in the first instance, with MOIT or placebo MOIT being introduced at week 8. After the 16 weeks of open label omalizumab, participants then received blinded injections of either omalizumab or placebo for a further 44 weeks.
A total of 58 participants received omalizumab and placebo MOIT, while 59 received omalizumab-facilitated MOIT between weeks 9 and 16. After the 16-week mark, all 58 of the participants who received open-label omalizumab and blinded placebo MOIT continued to receive omalizumab and placebo MOIT (both double-blinded). In the other treatment arm, 53 of the patients who received open-label omalizumab and blinded MOIT received placebo instead of omalizumab and real MOIT (again, both double-blinded).
The primary outcome for the current study was whether the cumulative tolerated dose for each of the three foods was ≥ 4044mg during food challenges conducted after completing 52 weeks of treatment (the eight weeks of MOIT and the 44 weeks of omalizumab/placebo injections).
A greater proportion of patients who initially received omalizumab and placebo MOIT achieved the primary outcome in the intention-to-treat analysis (21 of 58, 36%) compared to patients who received omalizumab and MOIT (11 of 59, 19%). In other words, patients receiving omalizumab and placebo MOIT had 2.6-fold greater odds (odds ratio and 95% confidence interval 2.6, 1.1-6.3) of passing the required CTD limit during the food challenges compared to patients in the omalizumab/MOIT group.
“After adjustments for multiplicity, superiority of omalizumab over MOIT for a CTD of 4044 mg or greater was also demonstrated in the ITT population for two or more foods (OR, 3.3; 95%CI, 1.5-7.3) and for several individual foods (peanuts, OR, 4.3; 95% CI, 1.9-9.7; milk, OR, 6.2; 95% CI, 1.4-27.6; [and] eggs, OR, 11.7; 95% CI, 1.9-70.2,” the researchers noted.
Adverse events occurred in the same proportion of participants across the omalizumab-facilitated MOIT group and the omalizumab and placebo MOIT group (97% versus 98%), although the raw number of events in the former was more than double that of the latter (762 versus 363).
Related
A greater proportion of participants in the MOIT arm experienced serious adverse events (grade 3 or higher; 31% versus 0%), and a greater proportion of participants in this group experienced an adverse event that resulted in them withdrawing from the study (22% versus 0%). On top of this, there was also a greater proportion of participants who experienced an adverse event that required treatment with epinephrine in the active MOIT group compared to the placebo MOIT group (22% versus 0%).
“Although the overall results of this trial are clear, it is important to note that the superiority of omalizumab over MOIT was largely driven by the high rate of study discontinuations in the participants receiving MOIT, the majority of which were due to AEs related to treatment,” the researchers wrote.
“Both omalizumab and omalizumab-facilitated MOIT represent viable treatment options, each with distinct risk-benefit profiles that must be weighed in the context of individual patient needs and preferences.”
