Asthma diagnosis and treatment
Successful management of mite-allergic asthma with modified extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae in a double-blind, placebo-controlled study

https://doi.org/10.1016/j.jaci.2006.07.043Get rights and content

Background

Mite sensitivity is highly prevalent in tropical and subtropical regions, such as the Canary Islands.

Objectives

To evaluate the clinical efficacy and safety of a depigmented polymerized allergen vaccine containing a 50% mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae.

Methods

Sixty-four patients participated in the study. It was prospective, double-blind, and placebo-controlled, with random allocation of patients to receive active treatment or placebo. The active group received a mixture of modified allergen extracts containing 50% D pteronyssinus and 50% D farinae; the control group received placebo. All individuals were diagnosed with mild/moderate asthma and rhinoconjunctivitis caused by sensitization to D pteronyssinus and D farinae. Bronchial provocation test (BPT) was considered the main outcome to document clinical efficacy.

Results

Fifty-four patients completed the study. The active group experienced a significant improvement in BPT (P < .001), whereas the placebo group did not (P = .648). At the end of the study, 20 patients in the active versus 9 in the placebo group (P = .013; odds ratio, 5.71 [1.76, 18.51]) needed more than twice the amount of allergen to obtain a positive BPT. The median improvement in the active group over placebo was 53.76% in total symptom and 58.09% in medication scores.

Conclusion

Immunotherapy with a mixture of modified allergen extracts of D pteronyssinus and D farinae is safe and efficacious to treat mite-allergic asthma.

Clinical implications

This immunotherapy modifies the natural course of the illness because it improves all clinical outcomes measured and prevents the worsening of specific bronchial hyperreactivity.

Section snippets

Study design and patient assignment

The study was prospective, double-blind, placebo-controlled, and randomized. The active group received a mixture (50%:50%) of modified allergen extracts of D pteronyssinus and D farinae, whereas the control group received placebo. The placebo contained aluminum hydroxide, phenol, and saline solution with the exception of the modified allergen extracts. The duration of the study was 54 weeks. This study was approved by the Ethics Committee of the University Hospital “Virgen de la Candelaria,”

Patients

Fifty-four patients (84.4%) completed the trial; 5 abandoned in each group. Withdrawals were not caused by lack of efficacy, worsening of the disease, or adverse reactions. One patient withdrew because of pregnancy. Each patient who completed the study received 18 injections (5 in the build-up phase and 13 in maintenance).

Safety

There were 4 local reactions (2 in each group). All these reactions were with the maintenance dose (0.5 mL of vial number 2), and all were immediate with a diameter smaller

Discussion

In the current manuscript, we describe the results of a double-blind, placebo-controlled study using a modified therapeutic vaccine containing a mixture of D pteronyssinus and D farinae extracts. The results of the study demonstrate that the treatment was efficacious and well tolerated. The BPT was used as an objective method to document the clinical effect and to calculate the sample size. BPT has good reproducibility when using FEV1 as an objective marker of obstruction42, 43 not affected by

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    Disclosure of potential conflict of interest: E. Fernández-Caldas and M. Casanovas are employed by Laboratorios LETI, SL. The rest of the authors have declared that they have no conflict of interest.

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