Kosin Med J.  2024 Mar;39(1):51-59. 10.7180/kmj.24.101.

Clinical efficacy and safety of autologous serum intramuscular injection in patients with mild-to-moderate atopic dermatitis: a prospective, open-label, uncontrolled study

• Choi GS
• Park JB
• Kim YH
• Kim HK

• KMID: 2556798
• DOI: http://doi.org/10.7180/kmj.24.101

Abstract

Background
Autologous blood therapy (ABT) has been used to treat atopic dermatitis (AD) for over a century, even though evidence supporting its efficacy is lacking. We aimed to investigate the effectiveness and safety of autologous serum intramuscular injection (ASIM), which is a modified form of ABT, in treating mild-to-moderate AD.
Methods
This study was a 12-week, open-label, prospective, uncontrolled trial. Following a 4-week run-in period, 22 out of 25 screened patients received ASIM once a week for 4 weeks in conjunction with standard treatment. The primary outcome measure was the Eczema Area and Severity Index (EASI), while the secondary outcomes included the Scoring Atopic Dermatitis (SCORAD) score, Dermatologic Life Quality Index (DLQI), and patient ratings of pruritus, sleep difficulty, disease status, and treatment effectiveness. Safety parameters were also assessed.
Results
EASI scores showed a non-statistically significant trend toward improvement during ASIM intervention. Patients with at least a 50% improvement in the EASI score at 4 weeks were older and had lower peripheral eosinophil counts (p<0.05). Secondary endpoints, including the SCORAD score, pruritus, sleep difficulty, and DLQI, demonstrated statistically significant improvements at week 4 compared to baseline (p<0.05). No significant adverse reactions were observed.
Conclusions
This pioneering study suggests that repeated ASIM may improve the clinical symptoms of mild-to-moderate AD, particularly in terms of pruritus and overall quality of life. However, further research with a larger sample size is required to establish the clinical significance of these findings.

Keyword

Autologous serum injection; Clinical trial; Dermatitis, atopic

Figure

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  Fig. 1. Summary of the study design.

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  Fig. 2. Changes in the EASI score (A), SCORAD score (B), and DLQI score (C) during the intervention. The EASI score demonstrated a non-significant tendency to improve during the ASIM intervention, while the SCORAD and DLQI scores showed significant improvements. Data are presented as the mean±standard error. The statistical significance of differences was assessed by the t-test. EASI, Eczema Area and Severity Index; SCORAD, Scoring Atopic Dermatitis; DLQI, Dermatology Life Quality Index; ASIM, autologous serum intramuscular injection.

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  Fig. 3. Changes in perceived overall treatment effectiveness (A) and disease status (B) during the intervention.

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  Fig. 4. Changes in IL-13 (A), IL-31 (B), and IFN-γ (C) levels at the time of autologous serum intramuscular injection (ASIM) and during follow-up. There were no meaningful changes in the level of IL-13. IL-31 demonstrated a slight increase after ASIM. IFN-γ tended to decrease during treatment and increased during the follow-up period; however, no statistically significant changes were observed between the two time periods. Data are presented as the mean±standard error of the mean of duplicate results from two independent experiments. The statistical significance of differences was assessed by the t-test. IL, interleukin; IFN, interferon.

Reference

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