Belimumab with Standard Care Works in Lupus Patients

Jan 26, 2016

Belimumab combined with standard of care continues to show positive improvements for patients with systemic lupus erythematosus.

Researchers writing in the Jan. 11 issue of Lupus Science and Medicine report that belimumab, combined with standard of care, continues to show positive improvements for patients with systemic lupus erythematosus (SLE).

Belimumab (Benlysta, GlaxoSmithKline), a monoclonal antibody that inhibits a B-lymphocyte stimulator protein, was approved by the FDA in 2011. It was the first new drug for lupus in more than 50 years. Existing treatments were considered inadequate and they were associated with many risks and side effects.

Led by Christopher Collins, M.D., of the MedStar Washington Hospital Center in Washington, D.C., the study will be featured in a live Rheumatology Journal Club Twitter chat from 4-5 p.m. and 10-11 p.m. EST, Jan. 28.

The study included 501 intent-to-treat patients at baseline (446 female, mean age 43.3 years old) with moderate to severe lupus and who had received at least eight infusions of 10 mg/kg belimumab, plus standard of care:  oral steroids (77.0%), anti-malarials (69.7%) and immune suppressants (58.9%) such as methotrexate (23.2%), mycophenolate mofetil (19.2%) and azathioprine (18.6%). The results of the study are based data for 277 patients who completed 24 months of belimumab treatment.

Belimumab was initiated for 71.3 percent of patients who did not respond to standard of care treatments. Of these patients, 56.7 percent of patients experienced worsening symptoms under standard of care treatments.

Researchers found that after six months of belimumab therapy, SLE severity decreased and patients continued to improve - or maintain - over the course of 24 months. They found that belimumab added to standard treatments, led to a reduction in the SELENA-SLEDAI score, flares and overall disease control – which are the hallmarks of a good response to belimumab treatment.

After belimumab was added to the treatment regimen, 48.7 percent of patients experienced an improvement in their condition at six months and they continued to show signs of improvement at six-month check-ups.

At baseline, 77.0 percent of patients received steroids at a mean (SD) prednisone equivalent dose of 19.9 (14.39) mg/day, which was decreased to 8.4 (7.35) mg/day at month 6 and 6.1 (9.31) mg/day at month 24 -which is a key factor since prolonged steroid use is associated with long-term damage and morbidity, the researchers write.

Also, patients continued to improve over the course of 24 months as shown by improved laboratory values a reduction in Healthcare Resource Utilisation (HCRU) over the course of the study.

 

References:

C E Collins, M Dall’Era, et al.

"Response to belimumab among patients with systemic lupus erythematosus in clinical practice settings: 24-month results from the OBSErve study in the USA,"

Lupus Science and Medicine

. doi:10.1136/lupus-2015-000118 

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