Efficacy of a House Dust Mite Sublingual Allergen - Stichting Napro
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19 sep Efficacy of a House Dust Mite Sublingual Allergen

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IMPORTANCE

The house dust mite (HDM) sublingual allergen immunotherapy (SLIT) tablet is

a potential novel treatment option for HDM allergy–related asthma.

OBJECTIVES

To evaluate the efficacy and adverse events of the HDM SLIT tablet vs placebo

for asthma exacerbations during an inhaled corticosteroid (ICS) reduction period.

DESIGN, SETTINGS, AND PARTICIPANTS

Double-blind, randomized, placebo-controlled trial

conducted between August 2011 and April 2013 in 109 European trial sites. The trial included

834 adults with HDM allergy–related asthma not well controlled by ICS or combination

products, and with HDM allergy–related rhinitis. Key exclusion criteria were FEV1 less than

70%of predicted value or hospitalization due to asthma within 3 months before

randomization. Efficacy was assessed during the last 6 months of the trial when ICS was

reduced by 50% for 3 months and then completely withdrawn for 3 months.

INTERVENTIONS

1:1:1 randomization to once-daily treatment with placebo (n = 277) or HDM

SLIT tablet (dosage groups: 6 SQ-HDM [n = 275] or 12 SQ-HDM [n = 282]) in addition to ICS

and the short-acting β2-agonist salbutamol.

MAIN OUTCOMES AND MEASURES

Primary outcomewas time to first moderate or severe

asthma exacerbation during the ICS reduction period. Secondary outcomes were

deterioration in asthma symptoms, change in allergen-specific immunoglobulin G4 (IgG4),

change in asthma control or asthma quality-of-life questionnaires, and adverse events.

RESULTS Among 834 randomized patients (mean age, 33 years [range, 17-83];women, 48%),

693 completed the study. The 6SQ-HDMand 12SQ-HDMdoses both significantly reduced the

risk of a moderate or severe asthma exacerbation compared with placebo (hazard ratio [HR]:0.72

[95%CI,0.52-0.99] for the 6SQ-HDMgroup, P = .045, and0.69 [95%CI,0.50-0.96] for the 12

SQ-HDMgroup, P = .03). The absolute risk differences based on the observed data (full analysis

set) in the active groups vs the placebo groupwere0.09 (95%CI,0.01-0.15) for the 6SQ-HDM

group and0.10 (95%CI,0.02-0.16) for the 12SQ-HDMgroup. Therewas no significant difference

between the 2 active groups. Compared with placebo, therewas a reduced risk of an exacerbation

with deterioration in asthma symptoms (HR,0.72 [95%CI,0.49-1.02] for the 6SQ-HDM

group, P = .11, and0.64 [95%CI,0.42-0.96] for the 12SQ-HDMgroup, P = .03) and a significant

increase in allergen-specific IgG4.However, therewas no significant difference for change in

asthma control questionnaire or asthma quality-of-life questionnaire for either dose. Therewere

no reports of severe systemic allergic reactions. The most frequent adverse eventswere mild to

moderate oral pruritus (13%for the 6SQ-HDMgroup, 20%for the 12SQ-HDMgroup, and 3%for

the placebo group), mouth edema, and throat irritation.

CONCLUSIONS AND RELEVANCE

Among adults with HDM allergy–related asthma not well

controlled by ICS, the addition of HDM SLIT to maintenance medications improved time to

first moderate or severe asthma exacerbation during ICS reduction, with an estimated

absolute reduction at 6 months of 9 to 10 percentage points; the reduction was primarily due

to an effect on moderate exacerbations. Treatment-related adverse events were common at

both active doses. Further studies are needed to assess long-term efficacy and safety.

TRIAL REGISTRATION clinicaltrialsregister.eu Identifier: 2010-018621-19.

JAMA. 2016;315(16):1715-1725. doi:10.1001/jama.2016.3964



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