Clinical and immunological changes of immunotherapy in patients with atopic dermatitis: randomized controlled trial

Abstract

Background. Immunotherapy has proven to be an useful tool in the management of allergic respiratory diseases; however, little has been studied in atopic dermatitis. Objective. To evaluate the clinical and immunological impact of immunotherapy with mites allergen extracts in atopic dermatitis. Methods. Patients with atopic dermatitis were assigned with computer-generated randomization to either of the following groups: (a) controls received only topical treatment with steroids and/or tacrolimus and (b) actively treated patients received topical treatment plus immunotherapy. Levels of serum total IgE, mites-specific IgE and IgG4 were assessed at study start and after one year of immunotherapy. Results. 31 patients in the active group and 29 in the control group completed the study. Symptoms and medication scores were significantly reduced in the active group after six months. Three patients in the control group showed new sensitizations to mites, while 3 patients in the active group showed neosensitization to shrimp with negative oral food challenge. We observed significant increase of mites-specific IgG4 levels in active group. Conclusion. Specific allergen immunotherapy induced a tolerogenic IgG4 response to mite allergens associated with favorable clinical effects in atopic dermatitis patients.

Figure 1

Study design: in both groups, patients were called monthly to evaluated use of medications and clinical control of symptoms. Each 3 months a complete clinical evaluation was due. Immunotherapy injection was due each month.

Figure 2

Change in symptoms evaluated with objective and subjective scales at different time points. Blue: Active group. Red: Control Group. SCORAD: Scoring Atopic Dermatitis, VAS: Analog Visual Scale, SS: Subjective Scale. P ≤ 0.05; n = 60; Mann-Whitney U test, Wilcoxon test.

Figure 3

Use of topical immunosuppressors in baseline and after 12 months of treatment. Points were assigned according to dose, frequency of use, and relative potency of the steroid used. Blue: Active Group. Red: Control Group. *P ≤ 0.05;  n = 60; Mann-Whitney U test, Wilcoxon test.

Figure 4

Control of atopic dermatitis according to improvement in SCORAD and reduction in pharmacology treatment in the last 6 months of the study. Blue: Active Group. Red: Control Group. *P ≤ 0.05;  n = 60; Mann-Whitney U test, Wilcoxon test.

Figure 5

Change in IgE total (a) and specific IgE for Der p (b) and Der f (c) between active and control group before and after one year. Blue: Active group. Red: Control Group. *P ≤ 0.05.

Figure 6

Change in specific IgG4 for Der p (b), and Der f (c) between active and control group before and after one year. Blue: Active Group. Red: Control Group. *P ≤ 0.05.