Prefilled syringes for immunoglobulin G (IgG) replacement therapy: clinical experience from other disease settings

Abstract

Introduction: Ready-to-use prefilled syringes for drug delivery are increasingly used across a broad spectrum of clinical specialties. For patients with primary immunodeficiencies manifesting as antibody deficiencies, immunoglobulin G (IgG) replacement therapy (IgRT) by subcutaneous administration is an established treatment modality. Expanding IgRT administration options through the introduction of prefilled syringes may further improve its utility. Areas covered: Here, we collate experience with prefilled syringes from other clinical settings to inform on their practicality and suitability for IgRT. In addition to discussing drug characteristics such as stability, pharmacokinetics, and efficacy, we focus on treatment delivery, physician/patient experience, costs, and the importance of education for the use of prefilled syringes. Expert opinion: Perceived benefits of prefilled syringes include accurate dosing, sterility, and reduced treatment time, while offering patients greater choice, convenience, and ease-of-use. Our review of clinical experience with prefilled syringes supports this consensus. Relatively few studies directly compare prefilled syringes with conventional administration, and robust studies of cost-effectiveness and health-related quality of life are needed on a drug-by-drug basis. Growth in the availability of prefilled syringes will continue, encouraged by the importance of patient choice and treatment convenience, toward the goal of individualized treatment regimens and improved quality of life.

Subcutaneous immunoglobulin in primary immunodeficiency – impact of training and infusion characteristics on patient-reported outcomes

“…Ease of training and total training time variables varied significantly (p = 0.01 and p = < 0.001, respectively) between the four training locations (home, hospital, doctor's office, or other) ( Table 7). Overall, the median rating (interquartile range [IQR]) for ease of training was higher for respondents trained in hospital or a doctor's office (7 [6,7] for both locations), compared with respondents trained at home (6 [5,7]) or in other locations (6 [4,7]). The total training time was lowest in those trained in hospital, with a median time of 1 h, whereas in all other locations (home, doctor's office, and other), the median time was 4 h. No significant difference was found between the knowledge of trainer and the different training locations (p = 0.21).…”

“…Quality of life (QOL) assessments typically focus on disease-related aspects of patient well-being but can also reflect the impact of treatment on patients [5,6]. Chronic diseases place a long-term burden on general satisfaction, physical function, emotional well-being, work productivity, and family life [7].…”

“…Regular long-term treatment regimens interfere with daily life and can act as constant reminders of disease [8]. Arguably, the associated treatment burden increases with treatment complexity and duration; endeavors to make long-term treatments simpler, easier, and more convenient can have a favorable effect on patients [5].…”

Subcutaneous immunoglobulin treatment for chronic inflammatory demyelinating polyneuropathy

“…35,45,46 As patients with CIDP are often elderly and/or can have muscle weakness in distal limbs, using PFS may be beneficial for patients with decreased dexterity, vision, or coordination. 1,55 Studies in other disease settings show that PFS can reduce preparation time, medication errors, and drug wastage and are often preferred by patients as a simplified self-administration method. 55 SCIg infusion time is typically around 1 h. 16 It has been reported…”

Subcutaneous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy – Neurologist, Nursing and Patient Perspectives

“…For patients with dexterity issues, syringe holders can be used to make infusions easier to manage; the availability of pre-filled syringes in certain regions has been shown to be of great benefit to patients with dexterity issues to reduce errors in preparation of infusion equipment. 24 One of the major advantages when switching from IVIg to SCIg is the avoidance of IV infusions; SC infusions require minimal training, can be completed by patients in their own homes and ensure that patients with IV access issues can benefit from Ig therapy. 25,26 In the PATH study, most patients found the subcutaneous administration technique easy to use and all patients or caregivers learnt to effectively administer IgPro20 or placebo by themselves after four or fewer training sessions.…”