Open-label maintenance after milk oral immunotherapy for IgE-mediated cow's milk allergy

Currently, the standard of care is strict food avoidance, although there have been several recent studies with encouraging results using oral and sublingual immunotherapy for the treatment of food allergy.1-8 One such study evaluated the safety and efficacy of oral immunotherapy for cow's milk allergy in a randomized, double-blind, placebo-controlled trial, and this report summarizes the subsequent open-label phase of this study.8 Participants who successfully completed the double-blind portion of the milk oral immunotherapy (MOIT) study were continued on measured dairy intake at home daily.    Milk threshold (mg) End-point titration SPT (dilution) CM IgE (kUa/L) CM IgG4 (μg/mL) Patient Age (y) Sex Baseline Post-MOIT Follow-up (mo)[low *] Baseline Post-MOIT Follow-up (mo)[low *] Baseline Post-MOIT Follow-up (mo)[low *] Baseline Post-MOIT Follow-up (mo)[low *] Active-treated group 1 6 F 40 8,140[dagger] 16,000 (5)[dagger] 1:100 Negative  9.8 11.4 6.5 (14) 4.8 68.1 601.5 (14) 3 15 M 40 4,140 16,000 (9)[dagger] 1:100 1:5 Negative (15) 31.4 496 58.5 (15) 5 24.2 618.2 (15) 4 6 F 40 4,140 10,000 (12) 1:100 1:100 1:1 (10) 42 27 7.7 (17) 3.9 24.4 61.4 (17) 5 8 F 40 8,140 16,000 (6) 1:5 Negative Negative (12) 0.9 1 0.6 (12) 1.5 5.1 11.3 (12) 6 8 F 40 8,140[dagger] 16,000 (4)[dagger] 1:10 Negative Negative (10) 5.6 2.3 1.1 (10) 7.7 730 908.3 (10) 7 11 M 40 8,140[dagger] 16,000 (3)[dagger] 1:50 1:1 Negative (12) 29.9 36.9 6.1 (12) 2.6 16.1 404.1 (12) 8 6 M 40 6,140 16,000 (4) 1:5 1:1  20.4 24.1 20.3 (4) 3 30.1 143.1 (4) 9 10 M 40 6,140 16,000 (17)[dagger] 1:100 1:1 Negative (14) 30.8 31.1 14.2 (15) 2.3 23.1 69.1 (15) 11 6 M 40 8,140 16,000 (3) 1:50 1:5 Negative (9) 13.5 10.3 10.4 (9) 1.6 4.8 80.6 (9) 12 10 M 40 4,140  1:10 1:5  84.3 66.2 30.9 (5) 4.6 33.7 121.9 (5) 13 7 M 140 8,140  1:50 1:100 1:5 (8) 28.4 26.3 13.4 (8) 0.3 1.7 1.3 (8) 14 9 M 40 8,140[dagger] 16,000 (3)[dagger] 1:100 1:1  8.2 7.5 5.6 (3) 2.4 7.4 13.7 (3) 17 6 M 140 3,140 3,000 (3) 1:100 1:5  34.8 40 43 (3) 5 17.2 66.5 (3) 23 16 M 140 4,140 6,000 (5) 1:10 Negative Negative (14) 57.5 74.4 41.8 (5) 18.9 261 337.9 (5) 25 7 F 1,340 8,140 3,000 (9) 1:1 1:1 1:5 (9) 53.5 26.7  8.3 10.6  Median  40 6,140 10,000 (3) 1:50 1:1 Negative (11) 29.9 26.7 11.9 (9.5) 3.9 23.1 101.3 (9.5) P value (baseline to follow-up) .001   .0091   .0355   .001 P value (post-MOIT to follow-up) .0034   .0688   .0035   .0012 Off-protocol subjects 2 11 F 40 1,340  1:100 1:1  119.6 59.7  22.8 133.5  10 12 F