Pharma comes out

Last year we spent quite some time hastling  Eli Lilly about the fact that they had not published the data about tabalumab (anti-BAFF) in MS.

Atacicicept (anti-BAFF & APRIL) made MS worse. SO what happened with Tabalumab. I guess we now find out

Maria Silk , Eric Nantz

Efficacy and Safety of Tabalumab in Patients with Relapsing-Remitting Multiple
Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Study

Objective: This study (NCT00882999) evaluated the efficacy and safety of tabalumab in patients with relapsingremitting
multiple sclerosis (RRMS).
Background: Tabalumab is a selective, fully human immunoglobulin G4 monoclonal antibody that neutralizes
membrane-bound and soluble B-cell activating factor (BAFF). Inhibition of BAFF has been theorized as a
therapeutic option in the treatment of RRMS.
Design/Methods: This Phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group, dose ranging,
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
ANOVA model.
Results: Of 245 randomized patients, 197 (80%) completed the study. The mean total numbers of Gd-enhancing
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.
Conclusions: Treatment with tabalumab was not efficacious in reducing Gd-enhancing MRI lesions in patients
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

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  • First question: During the trial, did they collect samples that they could then analyze data for memory B-cells?
    Second question: You seem to imply that Eli Lilly is not publishing for a reason. Is it because there would be additional sunk costs in something that won't make it to market? Or do they feel they want to maintain a competitive advantage in the basic research side that they would be giving away if they published?

  • How long do QC checks take on Months? Someone did well to spot a poster 😉

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