Belimumab (Benlysta)

Belimumab is an antibody treatment that reduces the number of the antibody producing B cells in the immune system which produce the characteristic lupus antibodies. The Lupus Clinical trials unit entered 10 patients into this international study – the largest number recruited in the UK.

In all, over 1,600 patients were recruited from over 200 hospitals around the world. Patients were allocated to receive a dummy drug (placeo) or two different doses of belimumab (Benlysta). All patients also received their usual lupus treatments. The results showed that patients who received belimumab responded better than patients who were on the placebo and the drug was relatively safe and well tolerated.

This drug that has been licensed for use in patients with active lupus and it is available in Europe and the USA. While it is licensed in the UK, it has not been approved for use because it is too expensive according to the National Institute for Clinical Effectiveness (NICE).


Navarra SV, Guzmán RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK, Thomas M, Kim HY, León MG, Tanasescu C, Nasonov E, Lan JL, Pineda L, Zhong ZJ, Freimuth W, Petri MA; BLISS-52 Study Group. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Feb 26;377(9767):721-31.

Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzová D, Sanchez-Guerrero J, Schwarting A, Merrill JT, Chatham WW, Stohl W, Ginzler EM, Hough DR, Zhong ZJ, Freimuth W, van Vollenhoven RF; BLISS-76 Study Group. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011 Dec;63(12):3918-30. 

Other trials

Several other drugs are currently being tested in clinical trials including other drugs that affect B cells such as epratuzumab and others such as sifalimumab which targets cytokines (hormones) such as interferon.