Information provided on this site does not constitute medical recommendation or advice. The site exists only to try to help individuals as they search for information; never should anything on this site replace what everyone needs: consultation with and treatment by a doctor or appropriate health care professional. I make no representation with respect to the contents of this site and specifically disclaim any warranties, including but not limited to expressed or implied warranties of merchantability or fitness for any particular usage, application or process.










Blog Posts on this website

Writing About Lupus
By A. G. Moore


Nothing Ventured

Acetylation
Tacrolimus for the Skin? 2/14/2014
The Lupus Gene 2/1/2014
Mineral Oil and Lupus
SLE and Cancer Risk 12/30/2013
Where Does It Hurt? Peripheral
      Neuropathy and SLE     12/21/2013

Flu Jab; Flu Shot; Lupus       12/13/2013
Illness and Choices 12/1/2013
Lupus and Clinical Trials 11/23/2013
Multiple Autoimmunity 11/8/2013
Prednisone Withdrawal 10/28/2013
MAS, More Common in SLE 10/18/2013
To Treat or not to Treat 10/9/2013
Plasmapheresis for Lupus 10/1/2013
HPV and the HPV Vaccine 9/27/2013
Does IVIG Offer Promise? 9/16/2013
Just Another Patient 9/13/2013
Communication Matters 9/7/2013
The Fall Equinox and UV
Treatable, if Identified
Is Belimumab Effective?
Autoimmune Encephalitis
Family Links and SLE
Osteoporosis and Steroids
Rare, But Serious in SLE: Guillain-Barre
5/27/2013 Sticky Blood, Hughes, APS
5/23/2013 The Skin and Lupus
5/14/2013 ANAs in the Lupus Puzzle
5/10/2013 The Older Patient

4/28/2013 Lupus: Signs and Tells
4/20/2013 A Good Night's Sleep
4/8/ 2013 Brain Fog

3/29/2013 Lupus and Travel
3/20/2013 Lupus Patient Compliance
3/11/2013 Lupus and Drug Allergy
Sulfonamides (Sulfa Drugs)

3/1/2013 Lupus Pancreatitis
2/16/2013 Lupus and Sulfasalazine
2/9/2013 Lupus and the Gut
2/1/2012 Lupus and Stress
1/26/2013 Lupus: Assessing
          Disease Activity

Lupus and the LUMINA Study
Living in a Lupus Bubble
1/2/2013 CNS Lupus and Emotions

Lupus Treatment
12/28/2012 NSAIDs
    A Cautionary Tale

12/20/2012 NSAID/Cipro
     Interaction

12/10/2012 IL-6, Lupus and
    Tocilizumab: Cytokine Storm

12/8/2012 Medication Alert
12/5/2012 Rhupus
 
11/28/2012 A Gene For
     Autoimmunity?
11/24/2012 Infection and Lupus
11/14/2012 Zebras, not Horses


Archived Blogs

10/25/2012 Prednisone

        Equivalents

10/25/2012 Prednisone and

        
HPA Suppression
10/24  Lupus and Hair Loss

10/23 Lupus Panniculitis
10/21 Prednisone and
 
     Drug Interaction
10/20 Weight Gain
      and  Prednisone
10/18 Lupus, Fatigue
        and Muscle Weakness
  

Autism and Lupus 8/2012
Azathioprine
   9/2012   
Hospital Rankings U.K.
9/2012
Hospital Rankings U. S.                                                                               
Lupus Book 10/2012
Lupus Breakthrough 9/2012
Lupus Causes 9/2012
Lupus and Emotions 9/2012

Lupus and Epstein-Barr 8/201
Lupus and Gender 9/2012
Links
10/2012
Lupus Nephritis Update 10/2012
Lupus and Pesticides  9/2012  
Lupus and Prednisone 10/2012

Lupus and Vaccines
9/2012
Lupus and Vitamin D 9/2012
Methotrexate 9/2012
Mycophenolate 9/2012
Neutrophil Extracellular Traps
Periodontitis and Lupus 9/2012

Photosensitivity 8/2012
Plaquenil 9/2012
Plaquenil and Quinoric 9/2012
Rituximab 9/2012
Staph and Lupus 9/2012
Lupus Symptoms
What is Lupus?
10/2012
X Rays and Lupus 
9/2012

A. G. Moore
                         
Information provided on
this site is for informational
 purposes  only; nothing on
the site is meant to substitute for a
doctor's advice. My articles do
not suggest a course of treatment
nor do they prescribe  medical
care. They are written to
encourage patients to educate
themselves and to have a
productive dialogue with their
doctors. No  website mentioned
on these  posts is either 
explicitly or implicitly endorsed
.












































































































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.

*European Medicines Agency

*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

Is Belimumab Effective?

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