Guideline topic: Pharmacological management of asthma
Evidence table 4.23: Anti IgE in asthma

Milgrom¹

1999

Randomised double-blind, placebo-controlled parallel group

12 weeks high (5.8 µg/kg/ng IgE per ml) or low dose (2.5 µg/kg/ng IgE per ml) anti-IgE vs placebo, at constant steroid dose,

then 8 week steroid reduction

+

317 atopic asthmatics aged 11 – 50 yrs (mean 30 yrs), 54 between 11 and 17 yrs

184 females and 133 males. FEV₁ 71% pred. (29-129).

> 12 % reversibility to beta2 agonist

n = 35 on oral steroids < 20mg/day, median =10mg/day.

n = 382 on inhaled corticosteroids 200-4000 µg/day (mean 800 µg/day) triamcinolone

Symptom scores at 12 and 20 weeks

Reduction in eta2-agonist puffs/day

Increase in PEF at 12 and 20 weeks

Improvement in quality of life score

% of patients achieving 50% reduction in ICS dose

Reduction in free IgE

% of patients (n=35 in total) achieving 50% reduction in oral steroid dose.

High dose vs placebo

2.8 vs 3.1
2.7 vs 2.9

1.8 vs 0.8

30.7 vs 11.3 L/min
29.9 vs 10.2 L/min

1.4 vs 0.8

51% vs 38%

97.1 % and 95.5 % for high and low dose anti-IgE.

785 vs 33 %

p = 0.008
p = 0.048

p = 0.02

p = 0.007
p = 0.02

p = 0.001

p = 0.07

p = 0.04

Effect of humanised mouse anti-IgE infusions every 2 weeks studied in atopic asthmatics. Results for low dose infusion not shown but between high dose and placebo. Significant reduction in free IgE achieved with few side effects although 14/212 cases of urticaria reported following anti-IgE infusion. Results for high and low dose anti-IgE very similar.

Minor improvements in asthma symptom scores, PEF, quality of life and beta2-agonist useage reported.

Despite fact that mean beta2-agonist use was > 7 doses/24 hours at end of study steroid reduction had been attempted in all groups with higher degree of success in groups on anti-IgE.

Very small numbers only on oral corticosteroids initially, therefore very difficult to interpret.