Palforzia: Peanut immunotherapy for children

Palforzia is a peanut immunotherapy drug to help reduce the severity of children’s allergic reactions that may occur with accidental exposure to peanuts. Evelina London Children’s Hospital was one of the centres involved in the clinical trials for Palforzia, which has been licensed for use in children aged 4 to 17 years old with a confirmed peanut allergy.

Peanut allergies in children

Peanut allergies affect 2% of children in the UK, which is around 1 in 50 children. Symptoms of a peanut allergy can vary according to the severity of the allergy, with minor symptoms including skin reactions, oral discomfort like itching or tingling, and a runny nose.

More serious symptoms of peanut allergy are described by the term anaphylaxis. Anaphylaxis is a spectrum and its symptoms can range in severity, at times requiring emergency medical treatment. Symptoms of anaphylaxis include:

swelling in the throat
narrowing of airways
difficulty breathing
high heart rate
loss of consciousness.

Although Palforzia is not a cure for peanut allergies, it can help to reduce the severity of allergic reactions if your child is accidentally exposed to peanuts. Palforzia is not suitable for everyone with a peanut allergy, so it’s important to speak to one of our specialists at Evelina London about whether Palforzia is right for your child.

How does Palforzia work?

Palforzia is the first treatment licensed for peanut desensitisation in children. It’s manufactured to include each of the different components which can trigger allergic reactions, and it’s the only NICE-approved immunotherapy for a food allergy.

Palforzia works by gradually increasing the body’s tolerance to peanuts through a method called oral immunotherapy (OIT). OIT is a process of exposing people with food allergies to small amounts of the food they are allergic to over time. This helps the body to build up a tolerance to the food and to reduce the risk of an allergic reaction to an accidental exposure.

The Palforzia treatment programme consists of three stages: an initial dose escalation on the first day, then an up-dosing stage (which lasts around 4.5 months), and a maintenance stage. The up-dosing stage involves increasing the amount of peanut protein every two weeks. The dose is taken every day at home until the maximum dose of 300mg is reached. The patient must continue to take 300mg of Palforzia daily during the maintenance stage, which ensures the body remains exposed to peanut protein.

Following the end of the maintenance stage – which typically lasts up to 18 months – the patient will need to eat a small amount of peanut every day. This ensures that the body’s tolerance of peanuts continues. It’s possible that the patient’s immunity will fade if exposure to peanuts is stopped, even after they have completed the Palforzia treatment course.

Palforzia treatment prices

Before starting Palforzia treatment, it is important to talk to the clinical team about your child’s medical history and inform them about any medications (prescription or over the counter) your child is taking. Their current condition including medications and activities need to be considered when taking Palforzia in order to reduce the risk of of an allergic reaction.

Initial assessment (face to face appointment)	£750	Includes consultation and assessment, blood and skin prick tests.
	12 month treatment plan	Description
	£15,900
Palforzia starter dose	✓	Includes 5 hour day admission at Evelina London.
Bi-weekly up-dosing	✓	Includes 11 assessments at two weekly intervals at Evelina London.
Follow-up appointment	✓	End of treatment follow-up with allergy consultant.
Palforzia medication	✓	6 months up-dosing and 6 months maintenance treatment plans.
Dietician support	✓	If required.
'Transition' food challenge	✓	During end of treatment period if required.
Access to nurse led telephone helpline	✓	5 days a week, 9am-5pm.
Baseline food allergy challenge	Not included	If required, charged separately.
Lung function and asthma assessment	Not included	If clinically indicated, charged separately.
Medications beyond 12 month treatment plan	Not included	If required, approximately £400 - £500 per month.
Additional consultations with allergy consultant	Not included	If required, charged separately.
Private consultations with non-allergy specialists	Not included	If required, charged separately.
Hospital admission fees	Not included	If required, charged separately.

Refund and cancellations

Cancellation admin fee (applicable at any point of treatment plan) – £190.
If you change your mind before the initial escalation visit you will receive a full refund with exception of admin fee.
70% refund if patient does not tolerate treatment after initial escalation dose.
50% refund if patient stops treatment between doses 2-6 of treatment plan.
25% refund if patient stops treatment between doses 6-10 of treatment plan.
No refund if patients stops treatment after the 10^th dose of treatment plan.

Payment plans are available, please get in touch with our private patients customer service team for more information 020 7188 5197 or email privatepatientenquiries@gstt.nhs.uk.

What are the benefits of Palforzia treatment at Evelina?

Palforzia has been shown to reduce the severity of allergic reactions and increase the amount of peanut children can tolerate. Clinical studies showed that after approximately one year of treatment, when looking at the whole group who started Palforzia (including any participants who stopped Palforzia), 50% tolerated 1000mg (approximately three peanuts), 67% tolerated 600mg (approximately two peanuts), and 76% tolerated 300mg (approximately one peanut).

In those who continued treatment with Palforzia for 12 months, 96% of children could consume more than one peanut with no more than mild symptoms. 84% could tolerate two peanuts, while 63% could tolerate at least 3 peanuts.

Studies have shown that Palforzia improves the quality of life in patients with a peanut allergy, as well as for their families. If you and your child are less worried about the risk of an allergic reaction, then you may be able to participate in more activities such as eating out or travelling.

This treatment helps to remove the daily fear of dealing with a severe allergic reaction. The majority of patients only experience mild or no symptoms in response to peanut exposure by the end of the programme.

At Evelina London, the largest paediatric allergy service in Europe, we offer clinical nurse specialist support with a dedicated phone number and email address for the clinical team to answer any questions or concerns you may have once the treatment has been started.

Our Palforzia treatment package also includes dietician support. We can also refer patients to psychological support services, but if your child needs any sessions with a psychologist, this will incur an extra fee.

Our multidisciplinary team approach will provide a comprehensive patient experience during your child’s Palforzia journey.

What are the risks of Palforzia?

The most common side effects of Palforzia are abdominal pain, throat irritation, itching, nausea, vomiting and hives. These side effects are usually mild and temporary but, in some cases, may lead to the patient wishing to discontinue treatment.

Serious side effects of Palforzia are less common but, if they do occur, it’s usually within the first two hours after taking the dose. It’s important to be aware of the risks before starting on the Palforzia treatment programme.

Severe reactions to Palforzia can include anaphylaxis. If your child experiences any symptoms of anaphylaxis after taking Palforzia, you should seek urgent medical attention. You must then inform the clinical team who can adjust the treatment dose. You and your child will be trained in recognising and treating allergic reactions at every up-dosing appointment.

Each time your child’s Palforzia dose is increased, they will take the first dose in hospital. This allows the allergy team to observe any reaction to it and to act quickly in the event of allergic symptoms. If your child does not tolerate the increase in dose, they may need extra time at the previous dose level before increasing again. If there are no reactions, you will then give the same dose to your child at home until the next up-dosing appointment, which is usually two weeks later.

How is Palforzia taken?

Palforzia is a powder that is mixed with semi-solid foods like yoghurt or rice pudding to be eaten after a meal and should be taken daily at roughly the same time. Foods which are not recommended for mixing with Palforzia include soups and smoothies, as the powder must be fully coated by the food, with no chance of any product being left over at the end. Thoroughly coating Palforzia in the food also reduces the chance of any oral allergic symptoms occurring.

Palforzia comes in either capsules or sachets containing 0.5mg, 1mg, 10mg, 20mg, 100mg and 300mg. Your child will take the required amount of the capsules to make up their prescribed dose each day. There are 11 different up-dosing levels which are taken every day for two weeks over several months until the maintenance dose of 300mg is reached.

It is important to take Palforzia every day as directed by the clinical team. Your child should not routinely miss any doses. However, if they do, speak to your team for advice. There are some situations in which Palforzia shouldn’t be taken as it may affect the body’s immune response to the treatment. This will all be discussed with you before your child starts their treatment.

Additionally, Palforzia should not be taken within two hours of bedtime so that, should a reaction occur, your child is awake and you can treat the reaction and seek medical help if needed.

What could prevent my child from taking Palforzia?

It’s important to tell your doctor if your child has any of the following conditions:

asthma
eczema
hay fever
gastrointestinal issues
other allergies.

If your child has any of these conditions, the Palforzia treatment plan may need to be adjusted. It is important that these conditions are well controlled whilst on Palforzia. If there is a flare up of other allergic conditions such as asthma, then your child is more likely to react to their Palforzia dose. If they are unwell, for example with a virus or a fever, doses need to be temporarily stopped. You will then need to contact the team to discuss when to restart the treatment.

Certain medications and activities need to be considered when taking Palforzia in order to reduce the risk of reacting. Non-steroidal anti-inflammatory medicines like ibuprofen can also change the way the body reacts to Palforzia. You should take extra care when giving these to your child and speak to the Palforzia specialist team if your child needs to take ibuprofen.

Palforzia shouldn’t be taken immediately before or after a hot shower or bath, or after exercising. Your child should avoid exercising for three hours after taking Palforzia, or doing anything that may raise their heart rate. Activities which cause their heart rate to rise can affect the way the immune system reacts to the Palforzia medication.

Menstruation is another factor which can influence how the body reacts to the medication. If your child has allergic symptoms whilst on their period, inform the clinical team as they may need to adjust the Palforzia doses.

What should I know before my child starts Palforzia treatment?

The most important point to note is that Palforzia is not a cure for peanut allergy. It changes the threshold at which children react to peanuts, reducing the chance of a severe reaction and instead making mild symptoms more likely. While your child may experience some allergic symptoms while taking Palforzia, the reactions are more predictable and can be managed more easily than an accidental exposure to an unknown amount of peanut.

Palforzia treatment involves time commitment from both the patient and their family. Your child will be admitted for a full day case for the initial dose escalation, and then for two hours every two weeks in order to up-dose, which may involve time off school and travelling time.

Once the Palforzia treatment is complete, your child will need to continue eating approximately 1.5 peanuts every day for the rest of their life, in order to maintain their tolerance to peanuts. They will also need to continue to avoid peanuts and carry their autoinjector device with them at all times.

The success of Palforzia depends on a lifelong commitment to eating the specified small amount of peanut each day after treatment has finished, but otherwise avoiding all food containing peanuts.

Further information on Palforzia

There are a number of patient resources available on Palforzia which can provide information including how to take it, what to expect during treatment, and how to manage any side effects.

Contact us to receive further information and to learn more about what our treatment programme involves. You can do this via email or by calling us on 020 7188 5197.

This content has been verified by Dr Elizabeth Powell, consultant in paediatric allergy and joint lead for peanut oral immunotherapy at Evelina London.

Frequently asked questions

What is peanut oral immunotherapy (POIT)?

Peanut oral immunotherapy in practice means eating a very small amount of peanut (in hospital under supervision) which is continued daily. This dose is increased at two-week intervals (every increase is in hospital and then taken daily) until a maintenance dose is tolerated and is continued daily. This process of gradually increasing the amount of peanut the body is exposed to reduces the reactivity of the body to peanut. This means that if there is an accidental exposure to peanut, the person is less likely to react or will have a less severe reaction.

Will taking POIT mean I am/my child is cured of my/their peanut allergy?

No, POIT is not a cure, and you/your child will still need to avoid peanut and carry emergency medication at all times. POIT reduces the risk that you/your child will react to peanut if accidentally exposed.

Can I/my child eat peanuts when on POIT and after this?

No, avoidance of peanut is still needed throughout POIT and for life afterwards.

Can I/my child stop POIT and restart it after a pause?

No, the effect of POIT is usually lost if you stop/your child stops treatment and you/your child would need to start again at the lowest dose.

Are there risks of taking this treatment?

There are side effects of POIT including allergic reactions, so you will be regularly trained in recognition and treatment of allergic reactions. Reactions are usually mild but it is important to have access to adrenaline at all times. There is a small risk (approximately 1%) of inflammation affecting the oesophagus (food pipe) called eosinophilic oesophagitis which would mean immunotherapy would need to be stopped.

What happens after the maintenance dose?

After a time on maintenance dose (usually up to 6-18 months modified depending on the patient), you/your child will be switched onto real-world peanut, unless there is a reason or you prefer to carry on using the Palforzia product. You/your child will need to continue taking real-world peanut indefinitely to maintain the effect of POIT.

Are there times when POIT has to be discontinued?

As mentioned above, eosinophilic oesophagitis would be an indication to stop. Recurrent anaphylaxis after taking a dose, or poorly controlled asthma would also mean POIT should be stopped.

Are there instances when somebody shouldn’t have POIT?

Health conditions need to be considered, for example, poorly controlled asthma would make it unsafe to start POIT.

What is the schedule for how POIT is delivered?

Initiation of POIT begins over two days (initial dose escalation phase and first up-dosing) which involves an initial day admission (around five hours) followed by the first up-dose on the second day. You/your child will continue to take this daily but come to hospital every two weeks to start the next dose of peanut (these visits are shorter, around two hours). The same dose is taken every day at home for two weeks following the up-dose in hospital. (The dose is not taken if coming into hospital for the next up-dose that day.) After 11 dose levels the maintenance dose of 300mg is reached and taken every day for up to 18 months before transition to real-world peanut.

Does POIT affect what I/my child can do?

There are certain precautions around the dose to reduce the likelihood of a reaction. This includes no exercise immediately before or for three hours after. Exercise includes anything that raises the heart rate such as walking to/from school or playing an exciting video game. Hot baths or showers can also reduce the threshold to react, so again should be avoided after taking the dose. These and other ‘co-factors’ will be discussed with you/your child at the assessment and subsequent appointments.

Are there medications which interact with POIT?

It is important to tell the team regarding any medication you/your child is taking. Non-steroidal anti-inflammatory drugs such as ibuprofen can lower the threshold for you or your child to react to their peanut dose so it is important to discuss this with the team. Vaccines which make you feel unwell, such as having a fever may also do this, so it is important to discuss this too.

What else should we be aware of?

There are certain situations where a dose needs to be missed such as illness or asthma exacerbation. It is important to miss the dose if your child is unwell and contact the team. If there are three or more missed doses, the next dose usually needs to be taken in hospital.

What support is available?

We have a specialist nurse-led phone number and email address for patients whom are on Palforzia, so that we can answer queries promptly, which is available from 9am-5pm, Monday to Friday.

Is POIT for everybody with a peanut allergy?

POIT versus standard avoidance advice is a very individual decision and is not for everyone. We can give you information particularly at the assessment appointment to help you make that decision.

Does it work?

POIT increases the threshold at which peanut allergic patients react to peanut, and in those that have reactions these tend to be less severe. In the largest clinical trial of Palforzia, 67% of participants on the active Palforzia treatment tolerated 600mg (approximately 2 peanuts) versus 4% on the inactive drug (placebo); 50% on Palforzia tolerated 1000mg versus 2.4% on placebo. In a follow-up clinical trial, in those that have been followed up for 18 months or two years and continued taking POIT, between 79% and 96% respectively can tolerate 1000mg of peanut (approximately 3 peanuts (size of peanuts is variable)). The quality of life of those taking POIT also improved with less fear of a serious allergic reaction.

Can I choose when my appointments are?

Unfortunately, due to the nature of the treatment and planning for admissions needed, the appointment days are fixed. Of course, we can adapt this if there is a medical need, for example, if a patient is unwell and has to miss several doses at home, and therefore needs to take their dose again in hospital.

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Peanut allergy treatment with Palforzia

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