Interested in a treatment that can manage her allergy symptoms without requiring regular office visits
EXPERT’S OPINION
Tested positive for house dust mites (HDM) (Dermatophagoides farinae and Dermatophagoides pteronyssinus) and environmental allergens (grasses, trees, weeds).
SCIT
"My days are busy with work and my children’s activities. I would like a medication that provides symptom relief and doesn’t require frequent visits to a medical professional’s office."
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Fewer than 10%
Fewer than 30%
Fewer than 50%
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Majority of the patients refuse to initiate SCIT
Even with provider-recommended AIT discussion, approximately
Of those adults who initiate SCIT,
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Patient lifestyle/ability to adhere to therapy
Allergen profile
Patient treatment goals
Existence of perennial or seasonal allergy symptoms
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Only 1 out of 3 potential candidates receives AIT*
*The numbers represented are approximate.
SLIT-tablets can extend the benefits of AIT to patients and are an ideal opportunity that offers flexibility for
"I am fed up with my year-round allergy symptoms and I am looking for further relief."
Upon reviewing Susan's skin prick test results, HDMs were noted and her symptoms pointed to a perennial and an indoor element.
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42%
Stop SCIT
27%
Start sublingual immunotherapy tablet
14%
Modify symptomatic medications
17%
Continue SCIT
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An estimated 84% of homes in the United States have detectable HDM allergens.8
"I prefer a treatment that I can take at home. Is there an oral treatment option available for me to treat my HDM-mediated allergic rhinitis?"
IgE=immunoglobulin E.
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Reduction in symptoms and allergy rescue medication use when added to traditional pharmacotherapy
Requires in-office administration of first dose to observe for systemic adverse reactions
Onset of action in 8 to 14 weeks
Proven efficacy in mono- and polysensitized patients throughout the year
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Epinephrine use: As with all allergy immunotherapies, auto-injectable epinephrine is used to manage any serious adverse reactions that may occur, such as anaphylaxis, which can include trouble breathing,
dizziness, nausea, vomiting, and diarrhea. In the clinical trials, use of epinephrine occurred at a rate
AE=adverse event.
Percentage of solicited adverse reactions within 28 days after initiation of treatment
| Adverse Reaction | Adverse Reactions of Any Intensity | Adverse Reaction That Were Severe | ||
| ODACTRA® (n=640) | Placebo (n=631) | ODACTRA® (n=640) | Placebo (n=631) | |
| Throat irritation/tickle | 67.0% | 20.8% | 0.3% | — |
| Itching in the mouth | 61.3% | 14.1% | 0.2% | — |
| Itching in the ear | 51.7% | 11.7% | 0.3% | — |
| Swelling of the uvula/back of | 19.8% | 2.4% | — | — |
| Swelling of the lips | 18.0% | 2.7% | — | — |
| Swelling of the tongue | 15.8% | 2.1% | — | — |
| Nausea | 14.2% | 7.1% | — | — |
| Tongue pain | 14.2% | 3.0% | — | — |
| Throat swelling | 13.6% | 2.4% | 0.2% | — |
| Tongue ulcer/sore on the tongue | 11.6% | 2.1% | — | — |
| Stomach pain | 11.3% | 5.2% | 0.2% | — |
| Mouth ulcer/sore int mouth | 10.3% | 2.9% | — | — |
| Taste alteration/food tasted different | 10.0% | 3.6% | — | — |
| Diarrhea | 6.9% | 3.6% | — | — |
| Vomiting | 2.5% | 1.4% | — | — |
| Adverse Reaction | Adverse Reactions of Any Intensity | Adverse Reaction That Were Severe | ||
| ODACTRA® (n=640) | Placebo (n=631) | ODACTRA® (n=640) | Placebo (n=631) | |
| Throat irritation/tickle | 67.0% | 20.8% | 0.3% | — |
| Itching in the mouth | 61.3% | 14.1% | 0.2% | — |
| Itching in the ear | 51.7% | 11.7% | 0.3% | — |
| Swelling of the uvula/back of | 19.8% | 2.4% | — | — |
| Swelling of the lips | 18.0% | 2.7% | — | — |
| Swelling of the tongue | 15.8% | 2.1% | — | — |
| Nausea | 14.2% | 7.1% | — | — |
| Tongue pain | 14.2% | 3.0% | — | — |
| Throat swelling | 13.6% | 2.4% | 0.2% | — |
| Tongue ulcer/sore on the tongue | 11.6% | 2.1% | — | — |
| Stomach pain | 11.3% | 5.2% | 0.2% | — |
| Mouth ulcer/sore int mouth | 10.3% | 2.9% | — | — |
| Taste alteration/food tasted different | 10.0% | 3.6% | — | — |
| Diarrhea | 6.9% | 3.6% | — | — |
| Vomiting | 2.5% | 1.4% | — | — |
*North American Field Efficacy Study.
Reduction in TNSS
WEEK 8
(SECONDARY END POINT)11,12
20.4%
REDUCTION
IN TNSS*
ODACTRA®: 5.34 (n=40)
Placebo: 6.71 (n=39)
95% Cl: –33.3%, –6.8%
(P<.05)
WEEK 24
(PRIMARY END POINT)11,12
48.6%
REDUCTION
IN TNSS
ODACTRA®: 3.83 (n=36)
Placebo: 7.45 (n=34)
95% Cl: –60.2%, –35.3%
(P<.05)
*TNSS is defined as a total score comprising the following: rhinorrhea, nasal congestion, nasal itching, and sneezing.
IgG4 levels increased with ODACTRA® vs placebo at week 8 based on the prespecified analyses (P<.001).11
Reduction in TOSS
WEEK 2411
67.9%
REDUCTION
IN TOSS
ODACTRA®: 0.61 (n=40)
Placebo: 1.87 (n=40)
95% Cl: –87.4%, –41.2%
(P<.001)
Study design
A randomized, single-site, placebo-controlled, double-blind, onset-of-action trial was conducted for 24 weeks in adults aged ≥18 years with
HDM-induced AR/conjunctivitis, with or without asthma (N=83; ODACTRA® =42, placebo=41), using the Vienna Challenge Chamber. Mean age (years/range) was 28 (18-58) for the ODACTRA®
patients and 27 (19-43) for placebo patients. Mean duration of AR/conjunctivitis was 16 years and 17 years for ODACTRA® and placebo patients, respectively. Of
ODACTRA® patients, 88% were polysensitized. Patients received ODACTRA®
or placebo and symptoms were scored every 15 minutes during exposure challenges, which occurred at screening and at weeks 8, 16, and 24.
The primary efficacy end point was the average TNSS at week 24, which was the sum of the 4 nasal symptoms (runny nose, blocked nose, sneezing, and itchy nose), with a maximum score of
12. A key secondary end point was the average TOSS at weeks 8, 16, and 24. The TOSS was the sum of the 2 ocular symptoms (gritty/red/itchy eyes and watery eyes). There were 10 patients
and 9 patients with asthma (ODACTRA® and placebo, respectively).11
TOSS=total ocular symptom score.
Statistically significant reduction in combined nasal symptom and medication usage scores occurred as early as week 14 and continued throughout the year.13
Reduction in TCRS* over 52 weeks
DMS=daily medication score;
*TCRS is defined as the sum of the rhinitis DSS and the rhinitis DMS.
Primary end point: During the last 8 weeks of treatment, ODACTRA® with symptomatic medications produced a
"In addition to HDMs, I have sensitivity to other allergens, including trees and grasses. Will I still be a good candidate for ODACTRA®?"
"How do I start my patients on ODACTRA®?"
Refer patients to Administration Instructions under “Patient Counseling Information” in the ODACTRA® Prescribing Information.
Administer first dose in a health care setting under the supervision of a medical professional12
Observe the patient for at least
If patient tolerates the first dose, subsequent doses may be taken at home12,*
Practice parameters recommend that patients receiving AIT for HDM allergens be treated for 3 to 5 years to obtain maximum benefits15
*Data regarding the safety of restarting treatment after missing a dose of ODACTRA are limited. If a missed dose occurs, it is recommended that the next dose be taken at the normally scheduled time. If more than one dose is missed, patients should contact their physician to discuss re-initiation. In clinical trials, treatment interruptions for up to 7 days were allowed.12
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False
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Not all patients will qualify for the manufacturer’s copay assistance card, please see www.ALKsavings.com for terms and conditions.
"ALK’s support program helped me initiate ODACTRA® and made it affordable for me."
"I’m glad to have a treatment that provided significant allergy relief, and that I was able to take while continuing with my busy days."
Patients should read all of the instructions for use provided under the patient information section in the Full Prescribing Information before using ODACTRA® for the first time.
References
ADDITIONAL INFORMATION 
