L7
Efficacy and Safety of Long-Term Epicutaneous Immunotherapy (EPIT) Treatment of Peanut Allergy with Viaskin® peanut: Results of the Two-Year Extension of the Vipes Phase IIb Clinical Trial
Sunday, March 5, 2017: 2:15 PM
Rooms B207-B208 (Georgia World Congress Center, Building B)
Wayne G. Shreffler, MD PhD FAAAAI, , , ,
Rationale:

A 24-month extension of the VIPES phase IIb randomized controlled trial was conducted to assess the long-term efficacy and safety of Viaskin®Peanut (VP) treatment up to 36-months.

Methods:

In the VIPES trial, VP was administered at 50μg, 100μg, 250μg peanut protein for 12 months. 171 subjects (6-55 years) were rolled over into the open label OLFUS-VIPES extension with VP 250 μg and 116 completed the 24-month treatment.

The main efficacy endpoint was the proportion of subjects reaching an eliciting dose (ED) at the 24-month double-blind placebo controlled food-challenge (DBPCFC) ≥1,000 mg peanut protein or ≥10-fold above the baseline ED in VIPES study. Changes in the cumulative reactive dose (CRD) and in peanut-specific IgE and IgG4 were assessed.

Results:

Treatment with VP 250μg showed enhanced efficacy after 36 months in children 6-11 years, with 83.3% (15/18) of responders compared to 53.6% (15/28) after 12 months. The median CRD was 44 mg at VIPES entry and raised to 1440 mg at month 36. The median peanut-specific IgE decrease from baseline was -36.5% at month 36 and the median peanut-specific IgG4 increase was +473%. The overall compliance was 95%. No serious adverse events (AEs) related to VP occurred during the study and the dropout rate for AEs was 2.3%.

Conclusions:

Long-term treatment with VP 250 μg shows a progressive improvement with time in peanut desensitization threshold of peanut-allergic children and is well tolerated.