Abstract
Objective: To study self-administration and pharmacokinetics (PK) of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE). Methods: Patients previously treated with belimumab self-administered belimumab 200 mg SC weekly for 8 weeks using an autoinjector. The primary endpoint was the proportion of patients able to self-administer their first and second dose (weeks 1 and 2) in the clinic. The proportion able to self-administer at weeks 4 and 8 (clinic) and weeks 3, 5, 6, and 7 (home) were secondary endpoints. Belimumab PK, safety, and injection-site pain were assessed. Results: 91/95 patients completed the study (withdrawals: adverse events (AEs): 3; lost to follow-up: 1). 93% were female, and mean (SD) age was 44.8 (12.50) years. The majority (99%, 89/90; no attempt, n = 5) successfully self-administered belimumab SC at weeks 1 and 2 (5 had clinic staff assistance), and 98% (85/87) successfully self-administered at weeks 4 and 8. Home-administration success rates were high (93%, (81/87) at weeks 3, 5, 6, and 7). Week 8 median trough concentration was 113 µg/mL. For patients with a ≤ 1.5-week interval between IV SC administration, week-1 concentrations were higher vs. week 8 (+ 51% median) but within a range observed with IV dosing; those with a ≥ 2.5-week interval had median differences close to 0. AEs and serious AEs were low, with no deaths; pain levels were low and decreased with subsequent injections. Conclusion: Patients with SLE successfully self-administered belimumab SC using a novel autoinjector; the PK profile was stable following a switch from IV with acceptable AE and pain levels. The recommended dosing interval between IV to SC dosing is 1 – 4 weeks.
Highlights
Systemic lupus erythematosus (SLE) is a chronic, autoimmune, inflammatory disease that causes considerable burden to patients and society [1]
Patients with systemic lupus erythematosus (SLE) successfully self-administered belimumab SC using a novel autoinjector; the PK profile was stable following a switch from IV with acceptable adverse events (AEs) and pain levels
Four weekly doses of belimumab 200 mg SC were well tolerated in healthy volunteers, and it was predicted that weekly administration would achieve exposures comparable to the approved IV dosing regimen [16]
Summary
Systemic lupus erythematosus (SLE) is a chronic, autoimmune, inflammatory disease that causes considerable burden to patients and society [1]. Devices for subcutaneous (SC) delivery of belimumab, which are safe and easy to self-administer, would be a significant advance for patients with active disease. There is a high level of patient acceptance with autoinjector devices in RA, including patients with severe hand disability [11]. Musculoskeletal and mucocutaneous manifestations, such as fatigue, joint pain, and swelling, are common in patients with active SLE, in the fingers, hands, and wrists, and can impact the patient’s ability to carry out day-to-day tasks [12, 13, 14]. As patients with SLE have similar therapeutic needs to patients with RA, autoinjector usability should be studied in these patients. A novel single-use autoinjector has been developed for SC delivery of belimumab. In a single-dose study of healthy volunteers, the autoinjector demonstrated good usability,
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