A Randomized, Double-Blind, Placebo-Controlled Trial of Omalizumab Combined with Oral Immunotherapy (OIT) in the Treatment of Cow's Milk Allergy (CMA): Safety of Dosing
Tuesday, March 4, 2014: 2:45 PM
Room 8 (Convention Center)
Jennifer S. Kim, MD FAAAAI, , , , , , , ,
Rationale: Determine whether the addition of omalizumab reduces dosing-related side-effects in subjects with CMA undergoing milk OIT. Methods: Fifty-seven milk-allergic subjects (7-32 y/o) confirmed by DBPCFC with a milk-specific IgE >0.35 kUA/L and/or positive PST were randomized 1:1 to receive blinded omalizumab or placebo for 16 months. Open-label milk OIT dosing was initiated after Month 4 of omalizumab/placebo with an escalation to maintenance over 22-40 weeks; goal - 3.84 g milk protein/day. Results: At enrollment, there were no statistically significant differences between the omalizumab/placebo treatment arms for age, milk specific-IgE (39.4 vs. 42.0 kUA/L), milk PST wheal (10.0 vs. 8.0 mm) or OFC dose at first symptom (20 vs. 20 mg). Three subjects withdrew prior to OIT dosing. Significant differences between the omalizumab (n=26) and placebo (n=28) groups were seen for dose-related symptoms per subject during dose escalation and maintenance therapy through 16 months (median: 5.0 vs. 47.5; p=0.0001), dosing reactions requiring treatment (median: 1.0 vs. 12.0; p=0.0003), and need for epinephrine (1 time in 1 omalizumab subject vs. 17 times in 9 placebo subjects). Significantly fewer doses were required to achieve maintenance dosing in the omalizumab group (median: 198.0 vs. 224.5; p=0.01) resulting in a shorter escalation phase with omalizumab (25.9 vs. 30.8 weeks; p=0.01). Conclusions: This is the first randomized, double-blinded, placebo-controlled OIT trial demonstrating that omalizumab significantly reduces the dosing symptoms and treatment requirements, including epinephrine, of OIT-related side-effects and reduces the time to achieve maintenance dosing. Future DBPCFCs will determine whether omalizumab improves the induction rate of desensitization and tolerance.