Month: October 2025

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Systematic Review of Omalizumab and OIT

Italian review of 11 studies of the use of the Anti-IgE medicine Omalizumab in oral immunotherapy (OIT) – Pharmaceuticals 2025 Mar 20;18(3):437.

3 studies looked at peanut allergy. Schneider’s study looked at 13 children aged 8-16. On the first day of OIT, all passed a 500mg dose of peanut flour! Within 8 weeks, all but 1 could manage a 4000mg dose. Hardly any side effects or adverse reactions were reported.

Brandstrom’s study looked at 23 young people aged 12-19. All reached a 2800mg dose within 10 weeks. Curiously, IgE did not change significantly whereas skin prick test results decreased.

There has only been 1 randomized controlled study, using a placebo, similar results were found, with most subjects managing 4000mg within 8 weeks of starting OIT.

Studies that looked at treating multiple food allergies simultaneously are also reviewed (up to 5 different foods!). Protocols were individualised, of course. Omalizumab was given in Begin’s study for 8 weeks before and 8 weeks after starting OIT, again using a “rush protocol”. 1 severe reaction was seen. Median time to reach 4000mg maintenance was 18 weeks.

So many obvious potential benefits. The optimal dose and duration (prior to, and after starting OIT) of omalizumab has yet to be determined, unfortunately. Some people adjust for body weight, others for total IgE level. Cost is a major issue, of course.

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Omalizumab and early life OIT

Helen Brough et al review the use of the Anti-IgE antibody to improve outcomes in oral immunotherapy (OIT). [J Allergy Clin Immunol Pract 2025 Apr;13(4):731-739]

To begin with though, they review data on early life (pre-school) OIT. They suggest adherence is better, which I’m not convinced about, but point out that if you start early, you can avoid the common problems of anxiety and social isolation in later life.

In practice, young children get more infections and illnesses, so delays are common and it may take longer to complete protocol. But there is evidence that adverse reactions are less likely, and that treatment is more effective (with more potential for sustained unresponsiveness, or “cure”).

Pros and cons of early life OIT

Omalizumab is a drug used for asthma and chronic urticaria, given as a monthly injection. It costs £250-500 a month. It works by suppressing the allergy side of the immune system, which means you would expect less side effects with OIT. It has been studied for more than 20 years so is far from new!

In the US it has been approved by the Federal Drug Administration (FDA) for use in food allergy, based on a trial of peanut allergic children and young people, where 67% of the subjects were able to pass a challenge of at least 600mg (3-5 peanuts) after treatment (and without OIT).

That sounds great but a third still couldn’t manage the target dose, plus you have to challenge everyone to work out whether they are in the successful group or not.

So other trials have looked at starting omalizumab first, then doing OIT (around 16 weeks later). In one study, 83% of patients passed a 2000mg challenge to not just 1 food, but 2 or more (compared with 33% of placebo treated subjects). Adverse events were also significantly less.

Unfortunately, sustained unresponsiveness was not often seen, with half of those stopping maintenance treatment failing their next challenge.

The final part of the review looks at the Shared Decision Making (SDM) process, and ways of making this more comprehensive with printed or online decision aids.