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The patient images are AI generated and are not real patients treated with PALFORZIA.
Individual results will vary with each patient.
PALISADE
PALISADE
PALISADE & POOLED
Occurred at 66 sites in 10 countries in North America and Europe2
Study duration: approximately 12 months with food challenges at entry and exit2
496 participants
aged 4–17 years2*
372 participants received PALFORZIA2*
124 participants received placebo2*
*555 participants were identified as eligible, of which 499 were 4 to 17 years of age. 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).2
In-office visit with gradually increasing peanut protein dose levels ranging from 1 mg to 100 mg.3
In-office visit with dose escalation increase ranging from 0.5 mg to 6 mg of PALFORZIA or placebo with confirmation of tolerability of the 3 mg dose on day 2.3
Participants continued onto Up-Dosing for 20–40 weeks, starting when 3 mg dose was reached. Up-Dosing was executed with an in-office dose toleration confirmed and continued with daily home dosing for ~2 weeks at each Up-Dose level. Duration of the Up-Dosing period varied for each participant depending on doses tolerated.3
Daily 300 mg dose of PALFORZIA or placebo taken at home.3
Primary endpoint and other study endpoints assessed; in-office visit to assess desensitization; peanut protein levels ranging from 3 mg to 1,000 mg.3
†Entry food challenge was required only in the PALISADE study for screening. It also provided a baseline comparator for results at treatment end.2,3
The proportion of participants aged 4 through 17 years receiving at least one study dose who tolerated at least 600 mg of peanut protein as a single dose during the DBPCFC, without dosing limited (no more than mild allergic symptoms) at the exit. The DBPCFC at the end of the Maintenance phase was used to approximate an accidental exposure to peanut.1,2
The proportion of participants who could tolerate single doses of 300 mg and 1,000 mg at the exit food challenge and the maximum severity of symptoms that occurred at any dose level of peanut protein during the exit food challenge.2
72% of participants reported a history of peanut-related
anaphylaxis prior to enrolling in the study.2
Primary and secondary endpoints: Percentage of subjects tolerating peanut protein in the exit DBPCFC with no more than mild allergic symptoms.2*
At 1 year, more than
7 in 10 (76.6%)
increased tolerability to
vs ~1 in 12 (8.1%)
receiving placebo.2
1,000 mg dose is eight times the median amount of peanut protein that
triggered an accidental allergic reaction (125 mg) in the observational
MIRABEL study.4 This median amount was studied outside of the
PALFORZIA clinical trials.
The Maintenance dose during the study
was 300 mg daily.2 Many participants (67.2%
and 50.3%) who received PALFORZIA were
able to tolerate 600 mg and 1,000 mg of peanut protein, respectively, in the exit
DBPCFC.1,2
*The suspected allergen is eaten in an allergy clinic under medical surveillance, in small doses that increase in size over time until dose-limiting symptoms occur.1
†The key secondary endpoints included the proportion of participants who could tolerate single doses of 300 mg and 1,000 mg at the exit food challenge.2
‡The primary endpoint was the proportion of participants 4 to 17 years of age who had a response to the trial regimen, which was defined as the ability to tolerate a single dose of at least 600 mg of peanut protein (cumulative dose, ≥1,043 mg) during the exit food challenge, with no dose-limiting symptoms.2
§One peanut kernel is equivalent to 300 mg.2
Peanut shown is for illustrative purposes only.
Exit DBPCFC protocol
The exit food challenge measured the ability to tolerate increasing amounts of peanut protein, with no more than mild allergic symptoms.1
§One peanut kernel is equivalent to 300 mg.2
¶Due to the natural variability of peanuts, this amount will vary. It is critical to always maintain a peanut-free diet and have self-injectable adrenaline (epinephrine) available while taking PALFORZIA.1
Peanuts shown are for illustrative purposes only.
In an open-label, follow-on study, daily continued treatment with PALFORZIA for up to 2 years demonstrated a sustained decrease in sensitivity to peanut protein in the population from PALISADE that completed the study and then continued treatment.5
Endpoints: Percentage of subjects tolerating peanut protein in the exit DBPCFC with no more than mild allergic symptoms.5*
At 2 years, more than
8 in 10 (80.8%)
taking PALFORZIA
increased tolerability to
vs. ~1 in 5 (19%)
receiving placebo.5#
*The suspected allergen is eaten in an allergy clinic under medical surveillance, in small doses that increase in size over time until dose-limiting symptoms occur.1
§One peanut kernel is equivalent to 300 mg.2
#Data are descriptive only and are not included in the FDA-approved labelling for PALFORZIA.
Peanuts shown are for illustrative purposes only.
Comparison of the maximum severity of symptoms at any challenge dose of peanut protein during the exit DBPCFC.1
5% of participants treated with PALFORZIA experienced severe symptoms compared with 10.5% of those given placebo, during the exit DBPCFC.1
*Participants 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).1
†Includes severe symptoms and life-threatening or fatal reactions. No participants had symptoms considered life threatening or fatal.1
In PALFORZIA safety data, anaphylactic reaction includes systemic allergic reactions of any severity:1
Severe anaphylaxis was reported in 0.6% of participants (4/709) during Up-Dosing and in 0.3% of participants (1/310) during Maintenance dosing across studies.1
‡Data was pooled across two phase 3 clinical trials of participants ages 4 through 17 years. (Study 1-PALISADE), (Study 2-RAMSES).
The majority of adverse reactions were mild to moderate and were more frequently reported during the Up-Dosing and decreased during Maintenance dosing.1,6
Symptoms during in-office PALFORZIA dosing had a median time to onset of 4 minutes for 71% of participants. Median time to resolution was 37 minutes.1
At each level of summarization (any event, system organ class, or preferred term), participants with more than one adverse reaction were counted only once within each study period.1
§TEAEs reported in ≥5% of participants treated with PALFORZIA and ≥5% percentage points were greater than reported in participants treated with placebo in any dosing phase (aged 4 through 17 years).
¶AEs were coded to system organ class and preferred term using the MedDRA, version 19.1. In RAMSES, no adverse events ≥5% were reported in participants following treatment with 300 mg PALFORZIA (n=265).1
#Study 1 (PALISADE) was a randomized, double-blind, placebo-controlled efficacy and safety study conducted in the United States, Canada, and Europe evaluating PALFORZIA vs placebo in 496 participants aged 4-17 years with peanut allergy. Participants were Up-Dosed for 20 to 40 weeks followed by Maintenance dosing for 24 to 28 weeks.1,3
ΔStudy 2 (RAMSES) was a randomized, double-blind, placebo-controlled safety study conducted in the United Staes and Canada evaluating PALFORZIA vs placebo in 506 participants aged 4 through 17 with peanut allergy. Participants were Up-Dosed for 20 to 40 weeks up to 300 mg daily dose with no extended Maintenance dosing.1
**Includes preferred terms of abdominal pain, abdominal pain upper, and abdominal discomfort.1
††Includes preferred terms of oral pruritus, tongue pruritus, and lip pruritus.1
‡‡The anaphylactic reaction preferred term includes systemic allergic reactions of any severity, or which severe anaphylaxis was reported in four PALFORZIA-treated participants (0.6%) during Up-Dosing and one PALFORZIA-treated participant (0.3%) during Maintenance dosing.1
PALFORZIA safety continued to improve over time (Pooled safety analysis of patients aged 4–17 years from 6 PALFORZIA clinical trials)6
Adapted from: Bird JA, et al. 2023.6
From a pooled safety analysis from six PALFORZIA clinical trials and three open-label extension studies to describe additional long-term pooled safety data from baseline through approximately 5 years of treatment.6
In children and adolescents, continued daily treatment with PALFORZIA beyond 1 year has demonstrated an acceptable safety profile with continued and improved efficacy.5
Overall summary of treatment-emergent adverse events (integrated safety population; N=351)7
§§Participants in cohorts 3B and 3C underwent initial daily dosing for 28 weeks.6
¶¶Participants with >1 AE were counted only once using the highest severity and closest relationship to study product.6
##Exposure-adjusted event rates were defined as the total number of events divided by the total number of participant-years at risk during the period.6
Models for illustrative purposes only.
Models for illustrative purposes only.
AE, adverse event; DBPCFC, double-blind, placebo-controlled food challenge; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.
References:
WARNING: ANAPHYLAXIS
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 1 through 17 years. Up-Dosing and Maintenance may be continued in patients 1 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 reactions reported in subjects ages 1 through 3 years treated with PALFORZIA (incidence ≥5%) are cough, sneezing, rhinitis, nasal congestion, throat irritation, wheezing, abdominal pain, vomiting, diarrhea, oral pruritus, oropharyngeal pain, urticaria, rash, pruritus, and perioral dermatitis.
The most common adverse events reported in subjects ages 4 through 17 years 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.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide.