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PALISADE study: Phase 3 clinical trial studied PALFORZIA1,2

Duration of trial was 12 months with food challenges at entry and exit1,3

Entry DBPCFC*
Entry DBPCFC*

In-office visit with gradual increasing peanut protein dose levels ranging from 1 mg to 100 mg

Initial Dose Escalation(1 day)
Initial Dose Escalation(1 day)

In-office visit with dose gradually increasing from 0.5 mg to 6 mg

Up-Dosing(~6 months)
Up-Dosing(~6 months)

Daily home dosing with in-office dose escalation every ~2 weeks (11 levels) until 300 mg is achieved

Maintenance Dosing(6 months)
Maintenance Dosing(6 months)

Daily 300-mg dose taken at home

Exit DBPCFC
Exit DBPCFC

Primary endpoint and other study endpoints assessed; in-office visit to assess desensitization; peanut protein levels ranging from 3 mg to 1000 mg

*Entry food challenge was required only in the PALISADE study for screening. It also provided a baseline comparator for results at treatment end.

PALFORZIA was studied in highly peanut-allergic participants1,3

All study participants had an allergic reaction at 100 mg or less of peanut protein at the entry food challenge.

Key inclusion criteria:
Clinical history of peanut allergy
pslgE of ≥0.35 kUA/L and/or mean peanut skin-prick test wheal diameter ≥3 mm larger than the negative control

Key exclusion criteria: Uncontrolled asthma, history of eosinophilic esophagitis, other eosinophilic gastrointestinal disease, or severe anaphylaxis within 60 days of screening

72% of participants reported a history of peanut-related anaphylaxis prior to enrolling in the study.

PALISADE is the largest randomized, double-blind, placebo-controlled clinical trial for peanut allergy1,2

Primary analysis population graphic

Primary efficacy analysis was in patients aged 4 through 17 years

Intent-to-treat population graphic

*Three participants were randomized in error; a total of 496 participants were exposed to ≥1 dose of study product. For placebo, 125 participants should have received placebo, but 1 did not due to withdrawal of consent. For PALFORZIA, 374 should have received treatment, but 2 did not (1 withdrawal of consent and 1 randomization error).

Reasons for participant discontinuation graphic
Completer population graphic

Primary analysis population

496 participants aged 4 through 17 years

Primary efficacy analysis was in patients aged 4 through 17 years

Intent-to-treat population

3:1 randomization ratio *

372 participants received PALFORZIA

124 participants received placebo

*Three participants were randomized in error; a total of 496 participants were exposed to ≥1 dose of study product. For placebo, 125 participants should have received placebo, but 1 did not due to withdrawal of consent. For PALFORZIA, 374 should have received treatment, but 2 did not (1 withdrawal of consent and 1 randomization error).

Reasons for participant discontinuation

Adverse event: 43 with PALFORZIA vs 3 with placebo

Withdrew consent: 30 with PALFORZIA vs 5 with placebo

Removed by investigator: 1 with PALFORZIA vs 0 with placebo

Other: 2 with PALFORZIA vs 0 with placebo

Completer population

296 participants treated with PALFORZIA were assessed for levels of desensitization

116 participants treated with placebo were assessed for levels of desensitization

    Proven to reduce sensitivity to peanut1

    Intent-to-treat Population*

    PALFORZIA met its primary endpoint in PALISADE1,2

    Primary efficacy endpoint: The percentage of participants receiving at least 1 study dose who tolerated a challenge of 600 mg of peanut protein as a single dose with no more than mild allergic symptoms in the exit DBPCFC. The DBPCFC at the end of the Maintenance Phase was used to approximate an accidental exposure to peanut.

    Palforzia vs Placebo

    Desensitization response rate, single dose
    67%(n=250/372)
    4%(n=5/124; p<0.0001)

    1000 mg dose is 8x the median amount of peanut protein that triggered an allergic reaction (125 mg) in the observational MIRABEL study. This median accidental exposure amount was studied outside of the PALFORZIA clinical trials4

    The maintenance dose during the study was 300 mg daily. Many participants who received PALFORZIA were able to tolerate more than 300 mg of peanut protein in the exit DBPCFC.
    1. *All study participants who received at least 1 dose of treatment, including those who discontinued the study.

    Intent-to-treat Population*

    Ready for less-severe symptoms1

    Comparison of the maximum severity of symptoms at any challenge dose of peanut protein during the exit DBPCFC

    5% of patients treated with PALFORZIA experienced severe symptoms compared with 11% on placebo during the exit DBPCFC.

    Maximum severity of symptoms

    Maximum severity of symptoms comparison chart
    1. *All study participants who received at least 1 dose of treatment, including those who discontinued the study.
    2. Subjects without an exit DBPCFC were assigned the maximum severity during the screening DBPCFC, which equates to no change from screening. P-value < 0.0001. Symptom severity was assigned with equally spaced scores (e.g. 0, 1, 2, and 3 for none, mild, moderate, and severe, respectively), and the difference of mean scores between the two treatment arms was tested using the Cochran-Mantel-Haenszel statistic stratified by geographic region (North America, Europe).
    3. Includes severe symptoms and life-threatening or fatal reactions. No subjects had symptoms considered life threatening or fatal.

    Completer Population

    The completer population consisted of subjects aged 4 through 17 years in the ITT population who stayed on treatment and had an evaluable exit DBPCFC (296 PALFORZIA, 116 placebo)

    During the exit dbpcfc after 12 months in the clinical study

    96.3% of patient who received PALFORZIA were able to tolerate 300 mg of peanut protein with no more than mild symptoms (vs 8.6% for placebo)
    84.5% of patients who received PALFORZIA were able to tolerate 600 mg of peanut protein with no more than mild symptoms (vs 4.3% for placebo)
    63.2% of patients who received PALFORZIA were able to tolerate 1000 mg of peanut protein with no more than mild symptoms (vs 2.6% for placebo)

    PALFORZIA had consistent safety results across both studies.

    See Results
    Important Safety Information
    Warning: Anaphylaxis
    PALFORZIA can cause anaphylaxis, which may be life threatening and can occur at any time during PALFORZIA therapy.
    Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.
    Do not administer PALFORZIA to patients with uncontrolled asthma.
    Dose modifications may be necessary following an anaphylactic reaction.
    Observe patients during and after administration of the Initial Dose Escalation and the first dose of each Up-Dosing level, for at least 60 minutes.
    PALFORZIA is available only through a restricted program called the PALFORZIA REMS.
    Indication

    PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older.  

    PALFORZIA is to be used in conjunction with a peanut-avoidant diet.  

    Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

    Contraindications

    PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease.

    Warnings and Precautions

    ANAPHYLAXIS

    PALFORZIA can cause anaphylaxis, which may be life threatening. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA.

    Anaphylaxis has been reported during all phases of PALFORZIA dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures.

    Do not initiate PALFORZIA treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. PALFORZIA may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including but not limited to markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, PALFORZIA may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine.

    All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered under observation in a certified health care setting.

    Patients may be more likely to experience allergic reactions following PALFORZIA administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (e.g., viral infection), or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding PALFORZIA temporarily.

    ASTHMA

    Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of PALFORZIA.

    PALFORZIA should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of PALFORZIA should be undertaken cautiously. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of PALFORZIA.

    EOSINOPHILIC GASTROINTESTINAL DISEASE

    Discontinue PALFORZIA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain.

    GASTROINTESTINAL ADVERSE REACTIONS

    Gastrointestinal adverse reactions were commonly reported in PALFORZIA-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms consider a diagnosis of eosinophilic esophagitis.

    Adverse Reactions

    The most common adverse events reported in subjects treated with PALFORZIA (incidence ≥ 5% and at least 5% greater than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus.

    Indication

    PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older.  

    PALFORZIA is to be used in conjunction with a peanut-avoidant diet.  

    Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

    Please see full Prescribing Information, including Boxed WARNING, and Medication Guide.

    References

    1. PALFORZIA [package insert]. Brisbane, CA: Aimmune Therapeutics, Inc.
    2. The PALISADE Group of Clinical Investigators: Vickery BP, Vereda A, Casale TB, et al. N Engl J Med. 2018;379:1991-2001.
    3. The PALISADE Group of Clinical Investigators: Vickery BP, Vereda A, Casale TB, et al. Protocol. N Engl J Med. 2018;379:1991-2001.
    4. Deschildre A, Elegbédé CF, Just J, et al. Clin Exp Allergy. 2016;46:610-620.
    5. The PALISADE Group of Clinical Investigators: Vickery BP, Vereda A, Casale TB, et al. Supplementary Appendix. N Engl J Med. 2018;379(suppl):1991-2001.