1. Fadhel Saleh 1, Rabab A. Hussain 2, Fadheela A. Saleh 2
USEFULNESS of SUBLINGUAL IMMUNOTHERAPY in HOUSE DUST MITE-SENSITIZED PATIENTS with ATOPIC DERMATITIS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
Fadhel Saleh 1, Rabab A. Hussain 2, Fadheela A. Saleh 2
1 The Allergy & Immunology Clinic
Salmaniya Medical Complex
PO Box 12
Manama – Kingdom of Bahrain
2 Ibn Sinna Health Centre
Ministry of Health

2. AD Background IgE Sensitization T cell reactions
1. Werfel T., Kapp A. Allergy 1998;53:
2. Sager N, et al. J Allergy Clin Immunol 1992;89:

3. Study Design
A single-centre, randomized, double-blind, placebo-controlled study
Children (≥5 yrs) & adults with chronic AD sensitized to HDM (SPT > 3 mm & ImmunoCAP ≥ 0.7 kAU/L)
No food or aeroallergens
Randomization: SLIT (Staloral D.pt/D.f 50/50 extract, Stallergenes) or placebo for 24 months. Rescure therapy given when needed
Assessment: SCORAD, Total IgE & HDM-specific IgE measured at 0, 3, 6, 9, 12, 15, 18, 21 & 24 months.
Consumption of drug scoring:
1 point for each dose of oral anti-histamines
1 point for each dose of topical steroids
2 points for each dose of oral antibiotics
Study approved by Research Committee SMC Hospital, Bahrain
Parents/patients signed consent.

4. Discontinued SLIT (n=1) Lost to follow-up (n=3)
Enrolment
Patients enrolled
(n=93)
Randomized
(n=93)
Allocation
Allocated to SLIT
(n=47)
Allocated to placebo
(n=46)
Lost to follow-up (n=2)
Discontinued SLIT (n=1)
Lost to follow-up (n=3)
Discontinued placebo (n=4)
Follow-up
Analysis
Efficacy analysis (n=44)
Efficacy analysis (n=39)

5. 300 IR 300 IR/ml vial 10 IR/ml vial Treatment Protocol
INDUCTION MAINTENANE
300 IR/ml vial
300 IR
10 IR/ml vial
4 drops daily for 24 months
DAYS

6. Characteristics of enrolled patients at baseline
Placebo
SLIT 46 47
Number
27/19
25/22
Sex (M/F)
14.1/5-42
15/5-43
Age (y) (mean/range)
Arabs
Ethnicity 10
10.5
Disease Duration, mean (y)
42.2
44.7
SCORAD, mean
532
489
Total IgE, mean (kU/L)
23.6
24.4
HDM specific IgE, mean ± SD (kU/L)

7. Change from baseline (∆ SCORAD) in the SLIT and placebo groups* * * * * *
* Significant difference between groups (P=0.001)

8. Mean Total IgE in the SLIT & placebo group at the different time points of study
Mean HDM-specific IgE in the SLIT & placebo groups at the different time points of study.

9. Total drug consumption (means, SEMs) in the 2 study groups

10. Conclusion
This study was designed to assess the efficacy of SLIT in HDM-sensitized AD patients.
SLIT proved effective in reducing AD as shown by the significant reduction in SCOARD, HDM-specific IgE and medication intake.
Therefore, SLIT may represent an additional therapeutic modality in properly selected patients with AD