Herbert Struemper1, Thomas Murtaugh2, Jane Gilbert3, Matthew E. Barton4, Joseph Fire5, James Groark4,6, Norma Lynn Fox5,7, David A. Roth4,6, David Gordon4,6
1Parexel, Research Triangle Park, NC, USA.
2Quintiles, Overland Park, KS, USA
3GlaxoSmithKline, Hertfordshire, UK
4GlaxoSmithKline, King of Prussia, PA, USA
5GlaxoSmithKline, Potomac, MD, USA
6GlaxoSmithKlineKing of PrussiaPAUSA
7GlaxoSmithKlinePotomacMDUSA
Tóm tắt
AbstractIntravenous belimumab is approved for the treatment of systemic lupus erythematosus; subcutaneous self‐administration would enable greater patient access. This study assessed relative bioavailability, tolerability, and safety of 1 subcutaneous dose of self‐administered belimumab by healthy subjects using a single‐use autoinjector or prefilled syringe. Subjects (randomized 1:1:1:1) self‐administered belimumab 200 mg subcutaneously (abdomen or thigh) by prefilled syringe or autoinjector. Pharmacokinetics, adverse events (AEs), injection‐site pain, and administration errors were recorded. Of 81 subjects, 5 experienced administration errors and were excluded from pharmacokinetic analyses. Mean serum belimumab concentration profiles were similar for both devices, with a weak trend toward higher concentrations for thigh injection compared with abdominal injections. Maximum observed serum concentration was slightly higher with the autoinjector (27.0 vs 25.3 µg/mL) and area under the concentration–time curve slightly lower (701 vs 735 day · μg/mL), compared with the prefilled syringe. Incidence of AEs was 51% (41 of 81 subjects; headache was most common), with no serious or severe AEs. Median injection‐site pain scores were low (0 after 1 hour). Device handling was reported as acceptable by ≥95% of autoinjector users and ≥90% of prefilled syringe users for each characteristic assessed. These results support the use of either device for belimumab subcutaneous administration.
