Author: admin

Categories
Uncategorized

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.

Categories
Uncategorized

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.

Categories
Cure Research

Predicting remission

Article from Australia – remission is defined as being able to discontinue treatment for at least 8 weeks and still not have any reaction to peanut.

This was a group of 162 children treated between the ages of 1 and 10 with peanut flour +/-probiotics, not Palforzia.

The higher your peanut blood IgE level is at baseline, the lower your chance of achieving remission. But there is no clear cut off:

Young children tend to have lower IgEs, which might be why they are more likely to achieve remission according to IMPACT study and others – in this study, the age they started treatment did not predict remission, once you correct for IgE.

Categories
Research Under 4s

Safety of peanut OIT in young children in a clinic setting

Study from Canada – 69 children under the age of 3 reached maintenance dose of peanut over a median of 29 weeks (so slightly more than 6 months, on average).

One patient had a peanut ingestion-related emergency department (ED) visit requiring adrenaline during initial dose escalation (first day).

During the first year of maintenance phase, no patients had peanut ingestion-related ED visits nor required adrenaline.

Categories
Practical

What if we want to go on holiday?

Not a problem.

We can “coast” on the same dose for as long as necessary. We would just continue with updoing when you get back.

You would take the usual precautions around your allergies, with regards to informing your insurer, the airline, your accommodation.

You can still message us if there are any issues.

We wouldn’t recommend you go anywhere remote from medical facilities, of course.

Categories
Treatment

BSACI Palforzia Guidance

BSACI Palforzia guidelines

A Delphi consensus study, by the British Society of Allergy and Clinical Immunology, involving a panel of clinicians but also parents.

The guidelines state that “clinical capacity should not constrain access to this treatment” – this is not one of the consensus statements, however. In supplement, advises on how to approach local commissioners for additional funding, saying that Palforzia may now be considered an “essential part of paediatric allergy service delivery”.

Palforzia treatment should be seen as one aspect of overall allergy management, and that individual needs may justify its use, even when resources are limited.

This fits with the Canadian (CSACI) 2020 guidelines which say “Individuals vary with respect to their level of comfort with risk as well as their perception of the extent of benefit derived from a treatment. Thus, the decision to pursue [treatment] should be left to the well-informed patient as much as clinically possible, rather than based on external criteria.” And the inability of clinicians to reliably predict risk and severity of future reactions means “[Palforzia] should be available to all patients who wish to receive it”.

One of the consensus statements states “Parents of children with peanut allergy who are aged at least 4 years of age should be informed that peanut oral immunotherapy (OIT) is an option for management and be offered a discussion with a HCP who understands the child and their family’s context.”

In other words, it shouldn’t be up to the whim of a doctor/nurse to decide whether to talk about it, or whether to offer it.

It is also clearly stated that families/children with multiple food allergies (not just peanut) were keen to undertake OIT – which highlights that avoidance of peanut is a particular burden on families.

Another consensus statement was around converting to “real world” peanut rather than continuing with the commercial product – all the focus group participants were in favour of real world peanut, as it highlights the sense of progress, and it feels “normal” rather than medical.

With regards to follow up, the guidance recommends that each patient should be reviewed on at least one occasion around 12 months after achieving stability on either real world peanut or Palforzia maintenance before considering discharge – since it takes at least 6 months to achieve stability, this emphasizes that even where tolerance is successfully achieved, further support and review is essential.

Categories
NHS

Parliamentary question

In January 2023, Alexander Burnett, MSP for Aberdeenshire West, Scottish Conservative and Unionist Party, asked about plans for Palforzia to be approved for use by the NHS in Scotland, given it has been approved in England – https://www.parliament.scot/chamber-and-committees/questions-and-answers/question?ref=S6W-13815

The reply from Humza Yousaf was to re-state the decision of the Scottish Medicines Consortium, and to say the manufacturers of Palforzia were intending to resubmit their application for its use in NHS Scotland.

This question appears to have been driven by the family of Carter Ross, as reported here.

Categories
Treatment

Anaphylaxis

Anaphylaxis is an allergic reaction that involves the airways, breathing and/or circulation – it is therefore potentially life threatening if it progresses rapidly.

It may still look like a typical, mild allergic reaction – you can still get hives, itching, lip or eye swelling.

There may just be a persistent cough, or a wheeze, or you may just feel dizzy.

Anaphylaxis can therefore look different in different people, at different times.

It is very difficult to predict if or when it will happen. Most people who have an immediate type allergy to a food are at risk, but anaphylaxis is rare, and severe anaphylaxis requiring hospital treatment even more rare.

A few things seem to increase the risk:

  • Having asthma, especially asthma that is tricky to control with medication
  • Being a teenager or young adult
  • Doing exercise immediately before the reaction
  • Being sleep deprived
  • Peanut and nut allergies, especially cashew

The best treatment for anaphylaxis is an injection of adrenaline, from an Epipen for example, as soon as possible after the reaction starts.