Abstract
Background: Secondary immunodeficiency diseases (SID) are common among patients with hematological malignancies such as chronic lymphocytic leukemia (CLL) and multiple myeloma, putting patients at increased risk of severe, recurrent/persistent infections and contributing to morbidity and mortality. Pharmacotherapeutic options available to patients with SID include antimicrobial treatment and immunoglobulin replacement therapy (IGRT). Facilitated subcutaneous immunoglobulin (fSCIG) is a dual-vial unit of immunoglobulin G 10% and recombinant human hyaluronidase (rHuPH20) approved in the European Union for patients with SID. rHuPH20 depolymerizes hyaluronan in the extracellular matrix to transiently increase local subcutaneous tissue permeability, allowing for fSCIG infusion at rates, volumes, and frequencies comparable to intravenous immunoglobulin with better systemic tolerability. Aims: To provide insights on the real-world utilization and tolerability of fSCIG for up to 3 years in a broad population of patients with SID and assess any impact of older age on use. Methods: FIGARO (NCT03054181) was a European prospective, observational study in 14 sites. Patients (n=156) who received ≥1 fSCIG infusion for primary immunodeficiency diseases or SID and provided informed consent were included and followed for up to 3 years. Study initiation was December 2016; database closure was May 2021. Here we report final data for the overall cohort of patients with SID, together with further subgroup analysis for patients aged 18–64 years [adult] and ≥65 years [older adult]. Results: The SID cohort included 31 patients; 1 pediatric (not reported as age subgroup), 15 adult, and 15 older adult patients. At study close, 1-, 2-, and 3-year follow-up data were available for 25, 13, and 11 patients, respectively. The most common indications for IGRT were CLL (n=20) and non-Hodgkin lymphoma (n=6); the most common supportive therapies included Pneumocystis jirovecii pneumonia prophylaxis, virostatics, and antibiotics. In the year prior to inclusion, 10 (32%) patients had experienced ≥1 acute severe bacterial infection. At the inclusion visit, fSCIG was most recently infused at home (61%) or a medical facility (39%) by the patient (58%) or a nurse (42%), with a tendency of adult patients to more self-application than older adults. Most patients received fSCIG every 4 weeks (71%), infused into a single site (most commonly upper abdomen in adults, and lower abdomen in older adults). Over the 3-year observation period, the median monthly dose of fSCIG, and median monthly infusion volume per patient remained consistent at 30 g and 300 mL, respectively, in both the adult and older adult groups. All patients received the full dose as planned, except for 1 patient at the 36-month follow-up visit who experienced infusion/technical problems. Two patients (in the adult group) each reported 1 adverse drug reaction (ADR; infusion site inflammation and headache) at the inclusion visit, with no ADRs reported at any of the follow-up visits. No acute severe bacterial infections were reported during the study. Summary/Conclusion: These data provide insights into the long-term feasibility and tolerability of fSCIG administration at home or in a medical facility in patients with SID primarily due to hematologic malignancies, including in older patients aged ≥65 years.
Published Version
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