Fadhel Saleh 1, Rabab A. Hussain 2, Fadheela A. Saleh 2

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Presentation transcript:

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

AD Background IgE Sensitization T cell reactions 1. Werfel T., Kapp A. Allergy 1998;53:731-739 2. Sager N, et al. J Allergy Clin Immunol 1992;89:801-810

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.

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)

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

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)

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

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.

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

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