New immunotherapy for food allergies?

The use of adrenaline pens has been the only treatment option for food allergies in the event of accidental exposure. Will this change soon?

No safe and effective treatments for food allergies so far

Over the past decade, various forms of immunotherapy have been investigated for treating food allergies.2,3 However, adverse reactions, including anaphylaxis, have been reported very frequently in patients receiving oral immunotherapy for food allergies. Therefore, there is a significant need for effective and safe treatments for patients with severe food allergies, especially those who are allergic to multiple foods.

The ‘Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Participants’ (OUtMATCH, NCT03881696) study was designed as a multi-stage clinical trial to evaluate the safety and efficacy of omalizumab in people with multiple food allergies.4

Omalizumab monotherapy: 67% achieve primary endpoint 

Wood et al. reported the study's first-stage results in the New England Journal of Medicine. The first stage was designed to evaluate the efficacy of omalizumab monotherapy in patients with peanut allergy and allergies to at least two other foods from the predefined list (cashew nut, milk, egg, walnut, wheat and hazelnut). Participants had to avoid their food allergens during the study. The primary endpoint was the consumption of a single dose of at least 600 mg of peanut protein without dose-limiting symptoms at the end of the first stage of the study.

Among the 177 participants who were children or adolescents, a significantly greater percentage in the treatment group than in the placebo group (67% vs. 7%) met the primary endpoint criterion. Although an increase in response threshold was shown for each of the other foods, only 47% of participants in the treatment group were able to successfully consume three of the foods at a cumulative dose of 1044 mg.

Concerns about the durability of response to treatment

With longer treatment (40 to 44 weeks) assessed in the open-label extension, the response threshold for peanut remained the same as at the end of the 16- to 20-week period (in 45% of participants) or increased (in 34%). However, the reaction threshold decreased in 21% of participants at the end of the extension period. These findings raise concerns about the durability of the treatment response. Patients should be informed that protection may be cancelled as soon as treatment is stopped.

Will the use of omalizumab, either as monotherapy or as an adjunct to immunotherapy, really outperform other treatment options for patients with multiple food allergies? The next two stages of the OUtMATCH trial may provide answers to some of the remaining questions.

References
  1. In German only: https://de.statista.com/statistik/daten/studie/1267347/umfrage/umfrage-zu-lebensmittelunvertraeglichkeiten-in-deutschland/
  2. Chu DK, Wood RA, French S, et al. Oral immunotherapy for peanut allergy (PACE): a systematic review and meta-analysis of efficacy and safety. Lancet 2019; 393:2222-32
  3. Leung DY, Sampson HA, Yunginger JW, et al. Effect of anti-IgE therapy in patients with peanut allergy. N Engl J Med. 2003; 348:986-93.
  4. Wood RA, Togias A, Sicherer SH, et al. Omalizumab for the treatment of multiple food allergies. N Engl J Med 2024; 390:889-99.