Rapid Subcutaneous IgG Replacement Therapy is Effective and Safe in Children and Adults with Primary Immunodeficiencies—A Prospective, Multi-National Study

Abstract

Sixty patients (16 children, 44 adults) participated in the study aiming at evaluating: (i) IgG levels when switching patients from intravenous IgG (IVIG) infusions in hospital to subcutaneous (SCIG) self-infusions at home using the same cumulative monthly dose, (ii) protections against infections, and (iii) safety of a new, ready-to-use 16% IgG preparation. All children and 33 adults had received IVIG therapy for >6 months at enrolment. Ten adults who had been on SCIG therapy for many years served as controls. Mean serum IgG trough levels increased in the pre-IVIG children from 7.8 to 9.2 g/L (non-inferiority: p < 0.001) and in the adults from 8.6 to 8.9 g/L (non-inferiority: p < 0.001). Totally 114 respiratory tract infections occurred, 90% of them mild. One serious bacterial infection (pneumonia) was reported for one adult. The annualized rate of serious infections was 0.04 episodes/patient. In total 2297 infusions were given and 28 (1%) systemic adverse reactions occurred, none of them severe. Local tissue reactions declined over time, this being particularly distinct after 8 to 10 weeks. In conclusion, the SCIG administration route was safe. High IgG levels were easily maintained resulting in a very good protection against infections.

Subcutaneous immunoglobulin in lymphoproliferative disorders and rituximab-related secondary hypogammaglobulinemia: a single-center experience in 61 patients

“…Considering systemic adverse events, as expected, SCIg therapy resulted in a lower frequency of episodes (Table 3), resembling the situation already described in PID. [19][20][21][22][23][24][25] Interestingly, one of our patients experienced a severe anaphylactic reaction following IVIg but tolerated substitutive therapy with SCIg. Again, this observation is consistent with the favorable safety profile of SCIg therapy already reported for PID.…”

“…SCIg can be self-administered at home, do not require venous access or systemic pre-medication, is characterized by a gradual absorption of the drug and a decrease in the incidence of systemic adverse effects (AEs). [22][23][24] Local reactions, which are specific for subcutaneous treatment, are usually mild and do not affect the good tolerability of the treatment. 25 In this study, we evaluated the efficacy of SCIg therapy in 61 patients with LPDs and secondary hypogammaglobulinemia.…”

Use of subcutaneous immunoglobulin in primary immune deficiencies

“…In terms of clinical efficiency, the frequencies of acute severe bacterial infection of the two approaches which did and did not use the coefficient mentioned above were not found to be different (18,20). The number of other infections was found to be lower when the coefficient was used (21).…”

“…The approaches are different in Europe and America in terms of specifying the monthly SCIG dose. In Europe, the IVIG dose used currently is used subcutaneously (14,18). On the other hand, the American sources recommend to multiply the current dose with a coefficient which varies by the concentration of the product and which is derived from the area under the curve pharmacokinetically (x1.37 for 16% and 1.53 for 20%) (16).…”

Subcutaneous Immunoglobulin Use in Children

“…İmmünglobülin tedavisi ile bildirilmiş yan etkiler Tablo 2'de özetlenmiştir. Literatürde SIG ile ilgili sistemik yan etki oranı ≤%3 olup, yaşa-mı tehdit eden anafilaktik reaksiyon bildirilmemiştir (6,7,24) . İntravenöz uygulama öncesi sıklıkla antihistaminik, asetaminofen ya da sistemik steroidler ile premedikasyon gerekirken, SIG infüzyonu öncesi böyle bir uygulama gerekmemektedir (21) .…”