Palforzia & Palisades Certification

Question 1

Tell me about PALFORZIA (storage, use, dosing, etc)

Answer 1

• Storage: - Refrigerate at 2ºC to 8ºC (36ºF-46ºF)
  - Do not freeze
  - Store in the original packaging until use to protect from moisture.
• Use: Patient aged 4-17 years who has been diagnosed with a peanut allergy
• Dosing: Patients will participate in 3 Treatment Phase Protocol
  - Initial dosing escalation (.5mg, 1.5mg, 3mg,6mg dosing)
  - Up dosing (3mg, 6mg, 12mg, 20mg, 40mg, 80mg, 120mg, 180mg, 200mg, 240mg)
  - Therapeutic Maintenance(300 mg ongoing)

Question 2

What is Palforzia indicated for?

Answer 2

Palforzia is indicated to reduce the incidence and severity of allergic reactions, including anaphylaxis after accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy.

Question 3

Palisades Trial: Where was it published?

Answer 3

Palisades trial was published in The New England Journal of Medicine in 2018 by Vickery.

Question 4

Palisades Trial: How many patients were enrolled?

Answer 4

There were 550 patients enrolled however the ITT patients consisted of 496 ranging in the age of 4-17 years.

Question 5

Palisades Trial: What were the results?

Answer 5

Primary Endpoint:
-Proportion of patients aged 4-17 years was able to ingest >600mg of peanut protein with
no dose limiting symptoms during the exit DBPCFC

Secondary Endpoint:
-Proportion of patients aged 4-17 years was able to ingest 300mg and 1000mg of peanut protein
with no dose limiting symptoms at the exit DBPCFC
-Epinephrine utilization comparison between the entry and exit DBPCFC
-Changes in IgE and Ig4 levels
-Changes in the mean wheal diameters on skin prick test for peanut

Question 6

Palisades Trial: Conclusion

Answer 6

• 67.2% of participants were induced in a state of desensitization to 600 mg of peanut protein as compared to 4% of placebo
• Significantly reduced the the max severity of of symptoms at any dose level up to 1000mg of peanut protein
• Safety profile was consistent with prior AR101 studies
• Induced serious or severe adverse reactions in <6% of participants with no life threatening or fatal events

Question 7

Palisades Trial: How is Palforzia administered?

Answer 7

Palforzia is administered via capsule for the IDE and Up dosing stages and via satchel for the maintenance phase.

Initial Dose Escalations(IDE): .5mg, 1.0mg,1.5mg, 2mg, 3mg and 6mg(4-5 hour process)
Up Dosing Phase:3mg-300mg(11 doses over 6 months w/ a 60 min evaluation period after each dose)
Maintenance Phase: 300mg

Question 8

Palisades Trial: What should we be aware of regarding side effects?

Answer 8

• Systemic allergic reactions occurred in 14.2% of participants receiving Palforzia
• 98.1% of systemic allergic reactions in the Palforzia group were mild or moderate.

Question 9

Palisades Trial: Who is the best patient for Palforzia?

Answer 9

Palforzia is indicated for:

• Kids 4-17 years of age
• Confirmed diagnosis of peanut allergy

Other things to consider:

• Motivated patients and caregivers who are determined to complete the program
• Tight family unit: hypervigilant in protecting against accidental exposure
• Anxious and concerned: accidental exposure to peanut is always on their mind.