Thursday, December 20, 2012

Tabalumab at the ACR 2012 in Washington



Tabalumab is an anti-BAFF Monoclonal Antibody. http://rheumatologe.blogspot.de/2012/06/tabalumab-ly2127399-anti-baff.html. I’ve been very sceptical about benefits of tabalumab in RA.

Maria W. Greenwald et al. presented: "Long-Term Safety and Efficacy of Tabalumab, an Anti-B-Cell Activating Factor Monoclonal Antibody, in Patients with Rheumatoid Arthritis: A 52-Week, Open-Label Extension Study" (Abstract No. 447). The study doesn’t give a conclusion. In my eyes it’s a weird study, it’s unclear if all patients from the RCTs are included in this extension study or only responders.

There’s another study by the same authors: Abstract No. 1276. W. J. Komocsar and colleagues presented: "Gene Expression Profiling and Pathway Changes Associated with Clinical Response to Tabalumab Blockade of Membrane Bound and Soluble B Cell Activating Factor in Rheumatoid Arthritis" Conclusion: “Tabalumab treatment reduced total B cells, mature naive B cells and serum Igs, while memory B cells were increased. Total B cells were only partially depleted and recovered in all pts during the post treatment follow -up period. There was no indication that reductions in B cells or in serum Igs below the LLN were associated with an increased frequency of infections. […]”

Wendy J. Komocsar and colleagues presented further results in abstract No. 1315: “Gene Expression Profiling and Pathway Changes Associated with Clinical Response to Tabalumab Blockade of Membrane Bound and Soluble B Cell Activating Factor in Rheumatoid Arthritis.” The authors observed “changes in genes related to B cell development and maturation”. I observe a study, which seems to have only the purpose to link tabalumab to rheumatoid arthritis.

The same applies to the next study, abstract No. 1321 by Ernst R. Dow and colleagues: “C-Type Lectin Domain Family 4, Member C Gene Expression Level Helps Predict Future Clinical Response to Tabalumab Blockade of B Cell Activating Factor in Rheumatoid Arthritis.” In conclusions the authors hint at a “large phase 3 clinical trial of tabalumab”.

I am very disappointed. I can’t help but think that these studies only try to keep the interest in the drug alive. Maybe I am mistaken.

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