The National Association of Experts in the Field of Primary Immunodeficiencies shared the results of a study evaluating the effectiveness of subcutaneous immunoglobulin administration in patients with impaired immunity. The 12–month study involved 233 subjects, including 217 patients under the age of 18. Only 14% of the patients who received subcutaneous injections of immunoglobulin missed work or study due to infectious diseases in the first six months, and as few as 6% in the subsequent six months. For comparison, 28% of those who received the drug intravenously missed classes or work due to infections. The average number of days missed also decreased in the group that received the subcutaneous version. Scientists have also recorded improvements in mental and emotional health and academic performance in children and adolescents who received subcutaneous injections.
Experts say that subcutaneous administration of immunoglobulin in Russia «was limited to a few patients» until recently. Due to a number of factors, including the COVID-19 pandemic, which required optimizing the cost of substitution therapy, the effectiveness of the subcutaneous immunoglobulin injection method required confirmation according to the standards of evidence-based medicine.
The results of the study were first published in 2024 in the Russian Journal of Allergy and in Hematology/Oncology and Immunopathology in Pediatrics. The ratio of men and women who participated in the study was 2:1. Six months after the start of the study, 33 patients were excluded for various reasons. Because of this, the final analysis of the results involved 200 participants. The study was performed by researchers from Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, Institute of Immunology, Moscow City Scientific and Practical Center of Allergology and Immunology at City Clinical Hospital No. 52 and other medical centers. Experts from 27 institutions located in 39 Russian regions worked on the study.
In the retrospective phase of the study, participants received replacement therapy with intravenous immunoglobulins. In the prospective part, all patients included in the study received subcutaneous injections with an equivalent dose of Swiss Octapharma’s Cutaquig (normal human immunoglobulin for subcutaneous administration, 16.5%).
The total number of intravenous infusions over the six months of the study was almost 1,400, 99% of which were performed in a hospitals. During the 12 months of analysis, 8,800 subcutaneous injections were performed, with less than 10% of them administered in hospitals. In the second group, almost all patients over the age of 18 administered the infusion themselves at home. Subcutaneous injection of the drug was done without assistance by 34 adolescents, while the rest of the participants were assisted by parents or family.
To track changes in the quality of life of patients who had immunoglobulin injected subcutaneously, at the end of the study, participants and their parents were asked to complete the Pediatric Quality of Life Inventory Russian version questionnaire. Patients over the age of 18 filled out the Short Form-36. When comparing the final scores, the researchers noted statistically significant improvements in the psycho-emotional and social status of the underaged participants who received subcutaneous injections. Children performed better at school and an had an increase in physical activity. The drug administration method had no significant influence upon the aspects of life of adults (such as physical and social activity, general health, and mental health).
Experts believe that the improvement in the psychoemotional state in children may be due to the fact that they had injections in familiar settings at home, and no venipunctures were needed. One reason for improved academic performance may be school attendance without regular absences because of hospital visits for intravenous immunoglobulin administration. Moreover, subcutaneous administration of the drug has made it possible to avoid exposure to infections in a clinic, and this also contributed to fewer illnesses that would result in missing classes or work. 74% of the patients who received immunoglobulin through subcutaneous injections would like to continue using this method.
However, in patients over the age of 18, there was no significant difference in quality of life depending on the method of administration of the drug, which may be due to the small number of adults in the study group, scientists believe.
In August 2024, the All-Russian Public Organization of the Disabled, the Russian Rheumatological Association Nadezhda, conducted a survey among patients with systemic lupus erythematosus (SLE) in the form of a checklist for self-assessment of the severity of the disease. According to the data obtained, 56.8% of participants with SLE reported the presence of serious side effects from therapy, and 57.4% of respondents had exacerbations within 12 months of treatment.
In March of the same year, the Russian Government stated its plans to increase funding for drug provision for patients with hepatitis B and C and HIV. For these purposes, 1.1 billion rubles from the federal budget will be allocated annually to the Federal Center for Planning and Organization of Drug Provision for centralized drug procurement. The additional installments are expected to last for three years.
