Purpose The management of patients with atopic dermatitis (AD) is often difficult. We hypothesized that repeated intramuscular administration of autologous total immunoglobulin G (IgG) could induce clinical improvement in patients with AD through immune modulation. This clinical trial was conducted to evaluate the efficacy, safety, and immunomodulatory effect of the intramuscular administration of autologous total IgG in patients with AD. Methods In this randomized, double-blind, placebo-controlled trial, 51 adolescent and adult patients with moderate-to-severe AD were randomized to receive 8 weekly intramuscular administrations of autologous total IgG 50 mg (n = 26) or saline (n = 25) over a 7-week period and were followed up to week 16. Changes in the clinical severity score (Eczema Area and Severity Index), affected body surface area, patient-reported Dermatology Life Quality Index (DLQI) score, laboratory biomarkers, and incidence of adverse events from baseline to week 16 were assessed. Results The intramuscular administration of autologous total IgG, compared with saline, decreased the clinical severity score (−64.8% vs. −20.3%, P < 0.001), reduced the affected body surface area (−53.9% vs. −19.1%, P < 0.001), improved the DLQI score (−35.4% vs. −14.4%, P = 0.015), increased serum interleukin-10 and interferon-γ levels ( P = 0.011 and P = 0.003, respectively), and reduced the incidence of AD exacerbation (11.5% vs. 48.0%, P = 0.004) from baseline to week 16. No serious adverse events were observed. Conclusions The intramuscular administration of autologous total IgG provided clinical improvements and a systemic immunomodulatory effect in adolescent and adult patients with moderate-to-severe AD without significant side effects. Trial Registration Clinical Research Information Service Identifier: KCT0001597

The management of severe recalcitrant atopic dermatitis (AD) is a challenging issue for clinicians and patients. We hypothesized that repeated intramuscular injections of autologous immunoglobulin (autologous immunoglobulin therapy: AIGT) might induce clinical improvements in patients with AD by stimulation of the active immune response to antigen-binding-site of pathogenic antibodies. We tried AIGT in 3 adult patients with severe recalcitrant AD whose clinical conditions could not be effectively controlled by medical treatments (including oral cyclosporine) for more than 2 years. Autologous immunoglobulin was purified from the autologous plasma by affinity chromatography using Protein A. The patients were treated by an intramuscular injection of 50 mg of autologous immunoglobulin twice a week for 4 weeks. A clinical severity score of AD (SCORAD value) showed a decrease greater than 30% at 8 weeks after the initiation of AIGT compared with the baseline before the initiation of AIGT in all 3 patients with severe recalcitrant AD. No significant side effects from treatment were observed. Further studies with larger numbers of patients are required to evaluate the clinical usefulness of AIGT for AD.

This report evaluated long-term changes in clinical severity and laboratory parameters in 3 adult patients with severe recalcitrant atopic dermatitis (AD) who were treated with intramuscular injections of 50 mg of autologous immunoglobulin G (IgG) twice a week for 4 weeks (autologous immunoglobulin therapy, AIGT) and followed up for more than 2 years after the treatment. We observed the following 4 major findings in these 3 patients during the long-term follow-up after AIGT. (1) Two of the 3 patients showed a long-term clinical improvement for more than 36 weeks after AIGT with a maximum decrease in clinical severity score greater than 80% from baseline. (2) These 2 patients also showed long-term decreases in serum total IgE concentrations and peripheral blood eosinophil count for more than 36 weeks after AIGT with a maximum decrease in the two laboratory parameters of allergic inflammatory greater than 70% from baseline. (3) No significant side effect was observed during the 2 years of follow-up period after the AIGT in all 3 patients. (4) Serum levels of IgG anti-idiotype antibodies to the F(ab')2 fragment of autologous IgG administered for the treatment were not significantly changed after AIGT in all 3 patients. These findings suggest that AIGT has long-term favorable effects on both clinical severity and laboratory parameters in selected patients with severe recalcitrant AD. Further studies are required to evaluate the clinical usefulness and therapeutic mechanism of AIGT for AD.

The safety of accelerated schedules of allergen immunotherapy (ASAI) in patients with bronchial asthma (BA) has been reported but there are little data on the safety of ASAI for patients with atopic dermatitis (AD). In this study, we investigated the safety of ASAI in patients with AD. Sixty patients with AD and 18 patients with BA sensitized to house dust mites (HDM) were studied. A maximum maintenance dose of HDM extract, adsorbed to aluminum hydroxide, was administered to patients by subcutaneous injection with either a 3-day protocol (rush immunotherapy) or 1-day protocol (ultra-rush immunotherapy). Systemic reactions were observed 4 of 15 patients (26.7%) with AD during rush immunotherapy, 13 of 45 patients (28.9%) with AD during ultra-rush immunotherapy, and 4 of 18 patients (22.2%) with BA during rush immunotherapy (P > 0.05). No severe or near fatal systemic reactions occurred in 78 subjects of this study. Systemic reactions developed within 4 hr after administration of the maximum allergen dose in 20 of 21 patients (95.2%) with AD and BA who showed systemic reactions during rush or ultra-rush immunotherapy. In conclusion, ASAI was safe and well tolerated in patients with AD. ASAI can be a useful therapeutic option for AD.

PurposeThe clinical usefulness of subcutaneous allergen immunotherapy (SCIT) in the treatment of atopic dermatitis (AD) is still controversial. We analyzed the clinical efficacy of SCIT in patients with AD and the clinical characteristics of patients showing a favorable clinical response to the treatment.Materials and MethodsTwo hundred and fifty one patients with AD sensitized to house dust mite (HDM) were treated by SCIT using HDM extract. The clinical severity of AD was measured using the standardized clinical severity scoring system for AD (SCORAD) at baseline and 12 months. A favorable clinical response to SCIT was defined as a decrease in SCORAD value at 12 months greater than 50% compared to baseline value. Severe AD was defined as a baseline SCORAD value above 50.ResultsA favorable clinical response to SCIT was observed in 73.6% of patients. The proportion of patients showing a favorable clinical response to SCIT was significantly higher in patients with severe AD (90.6%) than patients with mild to moderated AD (63.7%) (p<0.001). Patients with severe AD showing a favorable clinical response had a significantly shorter duration of AD (12.3±8.5 years; mean±SD) than patients with severe AD showing no significant clinical response (20.6±10.9 years) (p<0.05) at baseline.ConclusionSCIT could be a clinically useful therapeutic option for patients with severe AD sensitized to HDM. Early initiation of SCIT might provide a favorable clinical outcome in patients with severe AD sensitized to HDM.