Pharmacokinetics and Safety of Intravenous and Subcutaneous Auto-injector Single-dose Belimumab in Healthy Chinese Volunteers: A phase 1, Randomized, Open-label Study

Systemic lupus erythematosus (SLE) is a long-term autoimmune disease that affects patients’ quality of life. Belimumab is an antibody used in several countries in combination with standard therapy to treat patients with SLE. Belimumab can be given monthly either via a vein (intravenous, IV) or weekly under the skin (subcutaneous, SC). In China, only the IV belimumab has been approved for the treatment of patients with SLE. Therefore, we carried out a study in healthy Chinese volunteers to compare the concentration of a single dose of IV or SC belimumab in the body over time, and to investigate the safety of SC belimumab to assist its approval in China. In our study, the concentration and safety of both administration methods were similar; however, more volunteers from the SC treatment group had urinalysis-related side effects compared with the IV treatment group. All of these side effects were of mild intensity and did not require treatment. These results suggest that SC belimumab could be used for the treatment of Chinese patients with SLE.