CHAMGAP
APPROVEDReviewed and approved by the Chamgap Editorial Team (2026-08-08). The draft was written by AI, the existence of all 5 cited sources was verified at the original page, and the verdict passed blind grading and adversarial audit. Methodology v0.7.
Verdict No. 2464 · Search date 2026-08-08 · Methodology v0.7

House-dust-mite SLIT tablet,
does it really help with Reduced combined allergic-rhinitis symptoms and rescue-medication use?

30-Second Summary
C
Evidence Grade C · 46 · Safety caution
The symptom-plus-medication contrast was small and withdrawal was higher with active treatment
Oral itching, lip or mouth swelling, and throat irritation are common; systemic allergic reactions and anaphylaxis can occur rarely. The first dose requires medical supervision, and uncontrolled asthma or acute oral wounds require label-directed precautions.
What the
research shows
The grade is C. In 992-participant European MT-06, the final eight-week symptom-plus-medication score was 5.71 with 12 SQ-HDM versus 6.81 with placebo: difference -1.09 (95% CI -1.84 to -0.35). Approximate standardization from the interval and sample sizes gives Cohen d near 0.22, below the 0.5 medium-effect convention. Overall withdrawal was 20.7% and differential, 24.2% active versus 17.2% placebo, giving C with 46 points.
What the
ads claim
ACARIZAX 12 SQ-HDM is a prescription product in Korea and should be initiated after confirming mite allergy and clinical suitability. It is not an over-the-counter wellness tablet; first dosing requires supervision capable of managing a severe allergic reaction.
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Useful facts when choosing a product

  • 12 SQ-HDM contains allergen extracts from D. pteronyssinus and D. farinae in a rapidly dissolving sublingual tablet.
  • TCRS combines rhinitis symptom and rescue-medication scores.
  • Pivotal MT-06 and P001 evidence came from the ALK-Merck development ecosystem.
Gap Measurement · Verdict 2464 · C 46
What advertising claims
What independent, higher-quality research supports
△ GAP
01

What the research actually shows

MT-06 randomized 992 European adults to placebo (338), 6 SQ-HDM (336), or 12 SQ-HDM (318) for about 52 weeks. Overall withdrawal was 205/992 (20.7%), with differential loss of 77/318 (24.2%) on 12 SQ-HDM versus 58/338 (17.2%) on placebo. This differential withdrawal is the avoidable defect. Participants, investigators, and sponsor staff were blinded. P001 was directionally consistent but remained in the ALK-Merck development network. Manufacturer relationships were used only for independence and were not counted again as a withdrawal defect. MT-06 states 'Supported by ALK, Hørsholm, Denmark.'

02

Why this is classified as C (46)

The one-year placebo contrast was approximately d=0.22, below Cohen's medium-effect convention, and overall 20.7% differential withdrawal gives C with 46 points.

Counterpoint. A modest average effect may still matter to selected patients with medication-resistant symptoms, but it does not establish that a validated clinical threshold was exceeded.

Rejudgment record. Cross-check applied — Approximate Cohen d 0.22 for TCRS and differential withdrawal of 20.7% overall, 24.2% active versus 17.2% placebo; regulatory gates excluded as grade grounds

Scoring profile behind this grade
EndpointPPatient-reported treatment goal - the symptom is the goal
ReplicationR1Single confirmatory trial
IndependenceI0Evidence comes only from manufacturer studies
Effect sizeE~Statistically positive but below the threshold

The scoring table and the verdict agree (C).

Sub-claim grades by effect

This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.

Effect (sub-claim)GradeBasis
Reduced combined symptom-plus-medication scoreCThe difference was -1.09 points, a 16.1% reduction and approximate d of 0.22.
Reduced rhinitis symptom scoreCObserved-data relative reduction was 16.2%.
Reduced rescue-medication scoreCObserved-data relative reduction was 21.4%, with a wide 3.2% to 36.6% interval.

Cross-check — Codex and Claude

This verdict was drafted by Codex through literature review and source-existence checks, cross-checked through blind grading and adversarial audit, and settled by reapplying the methodology boundary rules. Cases with split grades were resolved through rejudgment.
03

Evidence Table

StudyDesignSampleFundingEndpointResultWeight
Study 1Double-blind three-arm placebo-controlled phase 3 trial in 12 European countries318Paper wording: 'Supported by ALK, Hørsholm, Denmark.'Primary: average TCRS during the final eight weeks of one-year treatment12 SQ-HDM 5.71 versus placebo 6.81; difference -1.09 (95% CI -1.84 to -0.35), relative reduction 16.1% (5.7% to 25.8%)Pivotal manufacturer trial; the regulatory 20% gate was not used for grading
Study 2North American double-blind placebo-controlled phase 3 trial620Merck & Co./ALK-Abelló development programPrimary: average TCRS during the final eight weeks4.10 versus 4.95; difference -0.80, relative reduction 17.2% (95% CI 9.7% to 25.0%)Directionally consistent trial from the same manufacturer ecosystem
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Receipt — 5 References

All 5 cited sources were verified for existence at the original page (as of 2026-08-08).

Demoly P, Emminger W, Rehm D, Backer V, Tommerup L, Kleine-Tebbe J. Effective treatment of house dust mite-induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet. J Allergy Clin Immunol. 2016;137(2):444-451.e8. PMID: 26292778. DOI: 10.1016/j.jaci.2015.06.036. NCT01454544.
checked
Nolte H, Bernstein DI, Nelson HS, et al. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults. J Allergy Clin Immunol. 2016;138(6):1631-1638. PMID: 27521719. DOI: 10.1016/j.jaci.2016.06.044. NCT01700192.
checked
US FDA. Clinical Review Memorandum: ODACTRA. February 24, 2017.
checked
Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.
checked
Reference 5
checked
Draft and rewrite: Codex (AI) · Verification: Codex blind grading and adversarial audit · Final adjudication: Claude
Reviewed and approved: Chamgap Editorial Team · Approval date: 2026-08-08 · Corrections: none

Cite this verdict

House-dust-mite SLIT tablet x reduced rhinitis symptoms and rescue medication Evidence Grade C card
[Chamgap] House-dust-mite SLIT tablet x reduced rhinitis symptoms and rescue medication — Evidence Grade C·46. 5 cited sources checked. Source: https://chamgap.com/en/verdicts/immunity/house-dust-mite-slit-tablet-allergic-rhinitis-score/ · CC BY 4.0

CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.

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