Atacicicept (anti-BAFF & APRIL) made MS worse. SO what happened with Tabalumab. I guess we now find out
Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Study
multiple sclerosis (RRMS).
membrane-bound and soluble B-cell activating factor (BAFF). Inhibition of BAFF has been theorized as a
therapeutic option in the treatment of RRMS.
73-week study included patients with RRMS who received tabalumab (4, 12, 40, or 120 mg every 4
weeks, or 4 or 120mg every 12 weeks) or placebo subcutaneously. The primary endpoint, number of total
cumulative gadolinium (Gd)-enhancing magnetic resonance imaging (MRI) lesions (whether new, pre-existing,
unchanged, or enlarged from previous scans), summed over Weeks 12, 16, 20, and 24 was analyzed using oneway
MRI lesions averaged over Weeks 12, 16, 20, and 24 were 1.521 and 1.758 in the all-tabalumab and placebo
groups, respectively; differences overall or between any of the tabalumab groups and placebo were not
statistically significant. The proportion of patients reporting at least one treatment-emergent adverse event,
serious adverse event, and follow-up emergent adverse event was higher in the all-tabalumab group than placebo
(68.1% [n=143] vs 48.6% [n=17], 11% [n=23] vs 5.7% [n=2], and 41.9% [n=88] vs 34.3% [n=12], respectively);
however, this was not dose-dependent.
with RRMS versus placebo; no specific safety concern was identified.
Study Supported by: Eli Lilly and Company
So this treatment did not work, but as atacicept failed this is not surprising. This treatment was designed to get rid of plasma cells and also gets rid of naive B cells, but we were guessing it increased memory B cells. However the question was whether this actually made things worse. Maybe it did. There appearred to be more adverse effectsin the tabalumab group. But what were these effects? We will have to wait until it is published, if it ever is. This again shows you can’t just take an anti- B cell agent and expect it to work