Clinicians Hesitant to Offer New Oral Immunotherapies

Ingrid Hein

November 18, 2019

"Oral immunotherapy is really an emerging therapy, quite unknown to many practitioners," said Joel Hartman, MD, from Allergy Partners of the Piedmont in Winston-Salem, North Carolina.

"It's still very early in the game with regard to FDA-approved food-allergy therapy," he said. "As with any emerging therapy, more data are needed. I would like to see a larger study with more patients that looks specifically at the logistics of implementing this therapy."

If an educational model could be developed, validated, and standardized, the process could be more streamlined, said Hartman, who has been a speaker for Aimmune Therapeutics.

The FDA Allergenic Products Advisory Committee recently voted to support approval of a standardized oral peanut allergen powder (Palforzia, Aimmune Therapeutics), as reported by Medscape Medical News. It is currently undergoing Risk Evaluation and Mitigation Strategy (REMS) review.

And an epicutaneous immunotherapy (EPIT, DBV Technologies) for peanut allergy is currently undergoing FDA review.

Practitioners are not sure whether oral immunotherapy requires more exam rooms, additional staff, or extra time for education than subcutaneous immunotherapy. "They want to know what's involved, and it makes sense to compare the logistics of oral immunotherapy and allergy shots," Hartman told Medscape Medical News.

To that end, he and his colleagues surveyed 80 board-certified allergists and immunologists who had treated at least five patients with oral immunotherapy for food allergy in the previous 2 years.

Getting Ready

Respondents were overwhelmingly from single-specialty practices — 28.8% with two to five physicians, 10.0% with six to 10 physicians, and 5.0% with more than 10 physicians — but 23.7% were part of a multispecialty group, 20.0% worked in a solo practice, and 12.5% worked in an academic practice.

Of the respondents, 50% had treated five to 25 patients with oral immunotherapy for food allergy — most commonly peanut — in the previous 2 years, 63.8% treated 101 to 1000 patients with subcutaneous immunotherapy for environmental allergy in the previous year, 41.3% had been in practice for at least 15 years, and 85.0% spent 81% to 100% of their time in patient care.

Overall, the survey showed similar staffing and space requirements for subcutaneous and oral immunotherapy.

"We think our data should reassure people that the practicalities of offering oral immunotherapy are comparable to allergy shots," Hartman explained at the American College of Allergy, Asthma & Immunology 2019 Annual Scientific Meeting in Houston.

"The survey answers mirrored my personal experience offering therapy for air allergens and food therapy," he said.

Table 1. Respondents Report the Number of Clinical Staff Needed to Support the Allergy Treatments
Number of Staff Members Subcutaneous Immunotherapy, % Oral Immunotherapy, %
1 26.3 38.8
2 40.0 36.3
3 17.5 17.5

Dedicated staff for subcutaneous immunotherapy was reported by 68.8% of respondents, and dedicated staff for oral immunotherapy was reported by 22.5%.

"Staffing is comparable to what is needed for air allergies," Hartman said.

The informed consent process, however, was reported to take longer for oral than for subcutaneous immunotherapy by 91.5% of respondents.

Table 2. Duration of Discussion for Each Therapy
Duration Subcutaneous Immunotherapy, % Oral Immunotherapy, %
Less than 30 minutes 72.5 45.0
61 to 90 minutes 2.5 16.3

That makes sense, said Hartman. Allergy shots involve weekly visits to the clinic at the beginning, but subsequent visits become less frequent, often monthly.

The regimen for oral immunotherapy is more rigorous, and involves the daily intake of foods for several months and multiple visits to the allergist to increase the dose over time. "This requires a commitment from the family and the patient to follow a very strict protocol outlined prior to therapy," he explained. "It's not only a commitment of time for the patient, but also of lifestyle."

"It makes sense that it would take more time to explain than a weekly visit to the office for allergy shots," he added.

Ratio of Clinical Staff to Providers

The ratio of clinical staff (nurses, medical assistants) to providers (physicians, nurse practitioners, physician assistants) required for treatment was generally 2:1 for subcutaneous and oral immunotherapy (28.8% vs 30.0%) or 3:1 (38.8% vs 38.8%). However, a 1:1 ratio was less common for subcutaneous than for oral immunotherapy (11.3% vs 21.3%).

"Staffing requirements for allergy shots were reported at somewhat greater numbers," Hartman said, but it varied with demand. "As you grow your practice, demand increases, and then staffing requirements also increase."

Lower-volume clinics were less likely to have an exam room dedicated to food dosing for oral immunotherapy than higher-volume clinics.

"As demand increases, so does the need for exam rooms," Hartman explained.

Table 3. Dedicated Exam Room for Food Dosing by Clinic Volume
Number of Patients Dedicated Exam Room, %
5 to 15 3.4
16 to 75 22.6
>76 38.1

"A lot of folks are concerned about what may be involved in terms of additional overload in staffing," said Stanley Fineman, MD, from Atlanta Allergy.

"The purpose of this study was to allay fears," he told Medscape Medical News. "This shows that staffing is about the same, so the bottom line is similar. That's helpful for allergists who want to start offering oral immunotherapy."

Patients need to be watched after treatment with oral and with subcutaneous immunotherapy, he pointed out. However, the risk for anaphylaxis is higher with oral immunotherapy, as reported by Medscape Medical News.

In the PALISADE study of highly allergic patients treated with oral peanut immunotherapy, 10% required epinephrine, as reported by Medscape Medical News.

But "as allergists, we're trained to treat anaphylaxis," said Fineman, who is a PALISADE investigator. "We can handle that."

American College of Allergy, Asthma & Immunology (ACAAI) 2019 Annual Scientific Meeting: Poster 305.

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