Lupus Drug Seems Safe for the Long Haul

Lupus patients on long term Benlysta treatment had similar or lower adverse events after 4 years

/ Author:  / Reviewed by: Chris Galloway, M.D.

(RxWiki News) Benlysta (belimumab) is the first drug in more than 50 years approved for adults with lupus. Studies have shown Benlysta to be an effective tool for fighting lupus. Now, research shows the drug may be safe for long-term use.

After taking Benlysta for up to 4 years, lupus patients had similar or lower rates of complications, according a recent study.

"Ask your doctor about the side effects of your lupus drugs."

Benlysta is used to treat people with lupus who are already taking other lupus medications. While the drug is known to cause some serious side effects, researchers are still unclear about the risks of long-term use.

Joan T. Merrill, MD, of the Oklahoma Medical Research Foundation, and colleagues set out to study the safety of long-term Benlysta treatment in people with active lupus.

They looked at rates of:

  • adverse events (harmful side effects)
  • severe or serious adverse events
  • infusion reactions
  • infections
  • malignancies (cancer)
  • laboratory abnormalities
  • discontinuations due to adverse events (when patients stop taking the drug)

The researchers found that the rates of these harmful side effects and other complications remained stable or declined over the 4-year study period.

The most common adverse events were:

  • arthralgia (joint pain)
  • upper respiratory tract infection
  • headache
  • fatigue
  • nausea

Serious infusion reactions were rare, with only one serious reaction during the 4-year study.

After long-term use of Benlysta, rates of serious infection dropped from 5.9 infections per 100 patient-years to 3.4 infections per 100 patient-years. No specific type of infection was more common than other types of infection.

According to the authors, these findings suggest that "[Benlysta] can be administered long term with an acceptable safety profile."

For their study, Dr. Merrill and colleagues assigned 364 lupus patients to take injections of placebo or 1, 4, or 10 mg/kg of Benlysta plus standard treatment for 52 weeks. Of the 364 patients, 345 continued for 24 more weeks and 296 continued Benlysta treatment for 4 years.

Dr. Merrill and other study co-authors reported receiving fees and/or honoraria from GlaxoSmithKline, the manufacturer of Benlysta and funder of the study. Some of the study's authors have also received fees from Human Genome Sciences, Inc. - the other funder of the study.

The study was published September 27 in Arthritis & Rheumatism, a journal of the American College of Rheumatology. 

Reviewed by: 
Review Date: 
October 3, 2012
Last Updated:
October 8, 2012