Few children discontinue peanut oral immunotherapy in real-world setting
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Real-world patterns of peanut oral immunotherapy treatment showed high persistence and rare modification among a demographically diverse group of children, according to a study published in Annals of Allergy, Asthma & Immunology.
To better understand the real-world experiences of using peanut (Arachis hypogaea) allergen powder-dnfp (PTAH; Palforzia, Aimmune Therapeutics) in clinical practice,
Jay M. Portnoy, MD, pediatric allergist and immunologist at Children’s Mercy Kansas City, and colleagues conducted a retrospective chart review of data from 43 physicians equally distributed across the U.S. and 118 of their pediatric patients (50% girls; 58.5% white; median age at PTAH initiation, 9 years; range, 4-17) with peanut allergy.
All the patients had one or more diagnostic tests before initiating PTAH, including skin prick test (23.7%), peanut-specific IgE test (16.9%), both SPT and peanut sIgE (58.5%), peanut component test (49.2%) and oral food challenge (6.8%).
Researchers noted these test results were heterogenous across the population, with 76.4% showing low to moderate sensitivity to peanut on peanut sIgE.
Treatment patterns
Of 98 patients who underwent initial dose escalation (IDE), three (3.1%) stopped treatment after IDE and 95 (96.9%) proceeded with the up-dosing stage.
At the time of analysis, 21 (21.4%) patients were actively in the up-dosing stage, seven (7.1%) stopped treatment during up-dosing, and 67 (68.4%) had reached maintenance.
Four (4.1%) patients repeated IDE, including two who did so due to personal or family preference and one due to treatment-related gastrointestinal symptoms.
Eight (8.2%) patients repeated a dose level during up-dosing, four of whom who did so due to treatment-related symptoms.
Also, five (5.1%) patients down-dosed during the up-dosing phase, with two doing so because of intercurrent flaring of comorbid conditions.
Three (3.1%) patients had a temporary interruption during maintenance due to intercurrent flaring of comorbid conditions, scheduling conflicts or time commitment and economic reasons (n = 1 for each).
Percentages of patients who completed the planned dose duration for each up-dosing level, from 3 mg to 300 mg, ranged from 88% to 98.6%. The median time to reach 300 mg was 21.3 weeks.
Estimated PTAH treatment persistence rates included 93.4% at 24 weeks after initiation and 85.8% at 36 weeks after initiation.
Discontinuing treatment
Reasons that four patients (4.2%) stopped PTAH during the first 12 weeks included treatment-related symptoms (gastrointestinal symptoms, n = 3; systemic allergic reaction, n = 1), taste aversion (n = 2) and scheduling conflicts or issues with time commitment (n = 1).
Reasons that two (2.2%) patients stopped treatment during the second 12 weeks included treatment-related symptoms (skin symptoms, n = 1; other, n = 1) and personal or family preference (n = 1).
None of the five (5.3%) patients who stopped treatment during weeks 36 to 48 did so because of treatment-related symptoms. Instead, they mainly stopped due to scheduling conflicts or time commitment (n = 3).
Only one patient discontinued treatment due to treatment-related systemic allergic symptoms after PTAH initiation, occurring within the first 30 days of up-dosing.
Once up-dosing began, the most common reason for stopping treatment other than treatment-related symptoms was personal or family preference (n = 7; 7.4%).
Also, 33.9% of patients used prophylactic oral antihistamines to prevent PTAH side effects, and 33.1% used rescue oral antihistamines to treat PTAH side effects.
Once they reached the maintenance phase, three (3.1%) patients switched to unapproved OIT.
Conclusions, next steps
Overall, these results showed geographically diverse children with peanut allergy had high treatment persistence with few modifying their treatment, according to the researchers. When patients did not complete PTAH, the researchers continued, treatment-related systemic allergic symptoms usually were not the cause.
The researchers called for further study to provide additional characterization of these treatment patterns in larger populations, including demographics, antihistamine use, shared decision-making, adverse events and treatment discontinuation.
Perspective
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These findings are not surprising. Uptake of Palforzia was low, but for those who started, it was well tolerated, and the vast majority stayed on therapy. This is similar to our clinical experience as well, with uptake ranging from 5% to 10% of eligible children aged 4 to 17 years with peanut allergy.
Given the low uptake, the medical community needs to think about the pros and cons, along with the value proposition, for Palforzia. Among individuals with peanut allergy aged 4 to 17 years, it is very unlikely to facilitate remission of peanut allergy.
Emerging literature shows that if peanut OIT is started at a younger age, the likelihood of remission is much greater. This has a significant upside and warrants further investigation and likely incorporation into clinical practice. More robust studies of peanut OIT in younger individuals and of subsequent long-term remission of peanut allergy with this therapy also are needed.
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