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| AWARD ARTICLE |
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| Year : 2020 | Volume
: 86
| Issue : 6 | Page : 632--642 |
Exploring the safety and effectiveness of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy in chronic urticaria: An observer-blind, randomized, controlled study
Adrija Datta1, Somodyuti Chandra1, Abanti Saha1, Amrita Sil2, Nilay Kanti Das3
1 Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India
2 Department of Pharmacology, Rampurhat Government Medical College, Rampurhat, West Bengal, India
3 Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India
Correspondence Address:
Dr. Nilay Kanti Das
Department of Dermatology, Bankura Sammilani Medical College, Kenduadihi, Bankura - 722 102, West Bengal
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ijdvl.IJDVL_577_19
Background: Autologous serum therapy aims to supplement the existing pharmacotherapy in chronic urticaria by decreasing the antihistamine pill-burden and maintaining symptom-free interval. Subcutaneous autologous serum therapy further modifies the amount of serum (2 mL to 1 mL) and gauge of a needle (24G to 31G) to improve compliance and facilitate ease of application.
Objectives: To assess clinical effectiveness and safety of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy and to compare the quality of life in the two treatment arms.
Methods: Institution-based, assessor-blind, prospective, randomized, parallel-group, active-controlled trial with 32 patients in each treatment arm and analyzed on a modified intention to treat principle. After baseline autologous serum skin test, autologous serum was injected as per randomization every week for 9 consecutive weeks.
Results: Among the study population, conventional intramuscular autologous serum therapy and subcutaneous autologous serum therapy had a comparable duration of disease (P = 0.164, Mann-Whitney U test), autoreactive status (P = 0.796), urticaria total severity score (P = 0.637) and urticaria activity score summed up over 7 days (P = 0.982). Both urticaria activity score summed up over 7 days and total severity score along with antihistamine pill-burden reduced significantly (P < 0.001, Friedman's analysis of variance) in both subcutaneous autologous serum therapy and conventional intramuscular autologous serum therapy from first follow-up onwards (P < 0.05, Post hoc Dunn's test). Significant improvement was noted in patient's as well as physician's global assessment of disease activity improvement scale (P < 0.001, Friedman's analysis of variance). Intergroup analysis showed that there was no significant difference in urticaria activity score summed up over 7 days either at baseline (P = 0.982, Mann-Whitney U test) or at study end (P = 0.398, Mann-Whitney U test). Similar comparable results were found in the total severity score at the end of the study (P = 0.345, Mann-Whitney U test). Dermatology life quality index showed marked improvement with both types of treatment (P < 0.0001, Wilcoxon test), and the intergroup comparison showed comparable dermatology life quality index values (P = 0.994, Mann-Whitney U test). The pain score at the injection site was more with conventional intramuscular autologous serum therapy than subcutaneous autologous serum therapy (P = 0.0115, Mann-Whitney test). Younger age and lower baseline total severity scores were associated with a better therapeutic response. Baseline urticaria activity score added up over a period of 7 days and total severity scores and the diameter of lesions showed a positive correlation with response pattern.
Limitation: Basophil histamine release assay not done. Logistics could not support follow-up beyond the end of treatment.
Conclusion: Subcutaneous autologous serum therapy is not inferior to conventional intramuscular autologous serum therapy with the additional advantage of less pain and operational feasibility.
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