Home » Will the new drug belimubab for the treatment of lupus meet the expectations of patients (and physicians as well)?

Will the new drug belimubab for the treatment of lupus meet the expectations of patients (and physicians as well)?

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Although the point we have reached in lupus treatment is very good compared to 10-20 years ago, I would like to regret to state that the desired treatment targets are still not achieved in terms of both effectiveness and less side effects.
Most of the drugs used today in the treatment of lupus are drugs designed or put into use for other diseases, and these drugs are somehow borrowed from other branches for use in SLE. As a good development, in recent years, disease-specific drugs have been tried to be developed by taking into account the lupus disease mechanisms.
It is known that a group of cells of the immune system responsible for creating antibodies, called B lymphocytes, play a role in the development of the disease in SLE. Various studies have shown that BLyS (B lymphocyte stimulator), a factor that stimulates these cells, is found to be increased in the blood of lupus patients and that there is a relationship between the level of this factor in the blood and disease activity. In this context, suppressing the effect of the factor BLyS
seems like a logical way to treat lupus. Belimumab is the first drug approved by the FDA (American Food and Drug Administration) for the treatment of lupus in the last 50 years, and it binds to a factor called BLyS and suppresses its effectiveness and therefore the activity of B lymphocytes.
The results of the new clinical trial (BLISS-76) conducted with belimumab in lupus patients are published in the December 2011 issue of Arthritis and Rheumatism. In this study, standard treatment (cortisone and imuran, cellcept, plaquenil, etc.) was given to some of the patients, and the improvement of disease activity at the 52nd week was measured by giving standard treatment to some patients and additionally belimumab.
In the first year of the study, disease activity was suppressed in 43.2% of the patients given belimumab, while the disease was suppressed in 33.5% of the patients who received only standard treatment. Although the difference does not seem large when viewed as a percentage, the results were found to be statistically significant. In other words, adding belimubab to the treatment was found to be more effective than the standard treatment.
Although the results are promising, the most important problem of this study (in my opinion) is that the patients participating in the study consisted of lupus patients whose joints, skin or blood cells were affected, which could already be improved with standard treatment. We can already treat this group of patients with the drugs we already have. Interestingly, lupus patients with neurological and renal involvement, the group in which we had difficulties in the main treatment, were not included in this study. Therefore, in the patient group where we need new treatment approaches, the question “Does this drug really work?” We still do not know the answer to the question and we need studies in which Belimumab is used in lupus patients with renal and neurological involvement.
Original article with link …
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.
http://www.ncbi.nlm.nih.gov/pubmed/22127708

Assoc. Dr. İsmail Şimşek

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