Efficacy and Safety of Octanorm (cutaquig ^® ) in Adults with Primary Immunodeficiencies with Predominant Antibody Deficiency: A Prospective, Open-Label Study

Abstract

Aim: To evaluate efficacy and safety of octanorm (16.5% subcutaneous immunoglobulin) in adult patients with primary immunodeficiencies. Patients & methods: Primary immunodeficiencies patients (18–70 years) previously treated with intravenous immunoglobulin were included in this Phase III study. Octanorm was administered subcutaneously once weekly over 8 months. End points included infections, adverse events and quality of life. Results: 25 patients (mean age 35.2 years, female 60.0%) were recruited, 24 completed the study. Mean dose of octanorm was 0.11 g/kg/week. No serious bacterial infections occurred. Three patients (12.0%) had an adverse event (mild) assessed as related to octanorm. Both the mental and physical summary 36-item Short Form Health Survey scores were improved. Conclusion: Octanorm is effective, safe and improves quality of life. Clinical Trial registration number: NCT03988426.

The Choice between Intravenous and Subcutaneous Immunoglobulins: Aspects for Consideration

“…SCIG has been evaluated in patients with primary immunodeficiency diseases (PID), CIDP [50][51][52][53][54][55][56], myositis [57,58], small fiber neuropathy related to Sjögren's syndrome [59], MMN [60], and epidermolysis bullosa [61] as both induction and maintenance treatment. In all these studies, SCIG was safe and the main AEs were associated with mild and self-limiting local reactions at the site of administration such as pain, edema, swelling among others as a result of relatively high injection volumes [17,41,62].…”