Is Belimumab Effective?
The NICE Decision
By A. G. Moore 8/2/2013
Monoclonal antibodies for cancer.
Photo derived from CDC by Ch1902 vector
From Wikipedia, Public Domain
In answer to the question at the top of this article–I’m not qualified to say. Last week NICE, the body in the UK which sets treatment guidelines for the NHS, rejected belimumab for lupus treatment; the agency said the medicine simply was not effective enough to justify its cost. Meanwhile, in 2011 the US FDA approved the drug’s use and the US government, through Medicare, pays for it. The FDA’s approval comes with a strict recommendation about the way belimumab should be used: it is to be prescribed only as an adjunct therapy and only for a specific subset of lupus patients.
As the contrast between the FDA’s approval and NICE’s rejection reflects, there is not unanimous agreement about the effectiveness of belimumab (marketed by SmithGlaxoKline as Benlysta).
When belimumab was first introduced a few years back, the lupus community was excited about the new therapy. This monoclonal antibody belongs to a class of medicine known as biologics–drugs that offer therapeutic opportunities not only for lupus but also for other illnesses, such as cancer, MS and Crohn’s disease. Monoclonal antibodies are like bullets that target specific disease-associated cells or proteins. In the case of belimumab, the target is B cells, which proliferate in some kinds of lupus. (see: The Characteristics and Significance of Locally Infiltrating B Cells in Lupus Nephritis and Their Association with Local BAFF Expression/ and Nervous system lupus: pathogenesis and rationale for therapy). The idea behind targeting B cells is that, if B cell activity is curtailed, so too may the symptoms of lupus.
According to an article published by the journal Prescrire in June of 2013, high expectations for belimumab have not produced good results. Authors of the Prescrire article conclude that belimumab isn’t worth the money it costs; not only that, the authors go on to assert that using the drug isn’t in the best interest of patients. The Prescrire article states:“…belimumab add-on therapy simply complicates the treatment of systemic lupus erythematosus and should not be used“. The journal cites, in support of its conclusion, an increased risk of immunosuppression and a lack of demonstrated efficacy in clinical trials after the 76th week of belimumab treatment.
On the other hand, another respected journal, ARD, reports that quality of life measures for patients on belimumab therapy improved over a trial period of 52 weeks and that measures of mental competency continued to reflect improvements at the end of 76 weeks. The authors of this article conclude that use of belimumab as an add-on therapy results in “…reductions in disease activity”.
So what are we, consumers of medicine and lupus patients, to make of contradictory trial results and conflicting government assessments? I think we have to first of all keep in mind that if we are sick enough to be considered for belimumab therapy, then we should talk to our doctors and ask them about the research they have read and how this research has prompted them to recommend the drug. Then we should go to the journals and satisfy ourselves about the appropriateness of this treatment in our particular case.
Sometimes, there are no good choices. Sometimes, we roll the dice and hope a long shot works. But we should know, if possible, the relative odds; we should be informed about risks and benefits. When it comes to belimumab, there is controversy. Knowing that, we make an informed decision about whether or not to go forward with treatment.
More articles on belimumab are listed below. One thing that should be checked out is conflict of interest statements; if a trial is funded by GlaxoSmithKline or an affiliate, then there might be an unconscious bias toward positive results. If you are contemplating taking belimumab, go way beyond the articles mentioned here. There’s a lot of material available and you should sample a good portion of it.
*Effect of Belimumab Treatment on Renal Outcomes: Results from the Phase 3 Belimumab Clinical Trials in Patients with SLE
*Belumimab: a technological advance for systemic lupus erythemtosuspatients? Report of a systematic reiew and meta-analysis
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