The Missing Data

Atacicept blocks BAFF and APRIL B cell growth factors and Makes MS Worse

Tabalumab (LY 2127399) is an anti-B-cell activating factor (BAFF) blocking (not APRIL) human monoclonal antibody designed for the treatment of autoimmune diseases and B cell malignancies.Tabalumab was developed by Eli Lilly and Company.

A phase III clinical trial for rheumatoid arthritis was halted in Feb 2013.In September 2014, a second phase III trial focussing on treating systemic lupus erythematosus, was terminated early as the study failed to meet its primary endpoint.

What happened in MS?

A Study of Patients With Relapsing Remitting Multiple NCT00882999 involving 245 people in 63 centres in USA and Europe.

They say the Study was Completed what happened?

Was it like atacicept and it made things worse? or did it not do nothing? It can’t of worked or surely we would of heard.

Was it completed as said in June 2012 by the company or was it “Aborted” (the rest was written in German..does it mean completed) as linked to a comment by Norman Putzki (Biogen & Now Novartis).

FYI Qunitiles is a contract research organisation that monitors and co-ordinates trials

You sent a link to the Lily site that states

Lilly believes companies must act to earn the trust of the public they serve. To support this, Lilly supports responsible sharing of clinical study data and will continue to be an engaged partner in ongoing industry-wide discussions toward this goal.

Here are 7 ways in which we are committed to responsibly disclose our clinical trial data results for the benefit of patients and future research:

Whether favourable or unfavourable, Lilly posts the results of all Lilly-sponsored Phase II, Phase III and Phase IV clinical trials of Lilly marketed products conducted anywhere in the world that were initiated on or after October 15, 2002. I GUESS UNFAVOURABLE OR IT WOULD BE TALKED ABOUT……WAS IT MARKETED?

Results from all Phase III clinical trials and any clinical trial results of significant medical importance are submitted for publication. 

We don’t just do this for medicines that have met their clinical goals and been approved for use – we also disclose results for investigational medicines whose development have been discontinued.

We register all Lilly-sponsored Phase II, Phase III and Phase IV clinical studies, conducted anywhere in the world, that were initiated on or after October 15, 2002, on

Lilly also registers all Phase I clinical studies commencing on or after October 1, 2010 on

Lilly, along with the industry as a whole, has started posting results to the European database Our first results were submitted on 21 July 2015. We are updating results for trials conducted in the EU on our marketed products back to trials from 2004. This is a 2 year process and will be completed in 2016.

Lilly discloses results of Lilly-sponsored clinical trials for compounds whose development terminates on or after October 1, 2009.  FITS WITH THIS
This includes Lilly-sponsored Phase I clinical trials in patients that initiated on or after October 1, 2009 and Lilly-sponsored Phase I clinical trials in healthy volunteers that initiated on or after October 1, 2010.

We have an online portal to facilitate requests from legitimate researchers for clinical trial data

Enquiry 1683 – Tabalumab (LY2127399) in multiple sclerosis – Feasibility of providing data from studies of interest

Lilly is sharing data from clinical and interventional studies in patients for medicines and indications approved in the United States and the European Union. This study is not in scope for data sharing as tabalumab has not been approved as a treatment for any indication.
Kind Regards,
Data Sharing Team

So went direct-Response
I received your request for the anonymized tabalumab data, and your request was discussed with a number of my Lilly colleagues. At this time, we have decided not to support the proposal. Please feel free to reach out to me if you have any questions.

Senior Medical Director, Biomedicines Core Team
Eli Lilly and Company

245 people were reported to be involved in this trial. 

Don’t they deserve to know what has happened?

There are over 60 sites across Europe and USA, somebody knows if it did nothing (maybe APRIL is what we need to focus on) or WORSE (then its BAFF).

I’ve reached out again

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  • Fear of publishing and admitting failure, either by the drug doing nothing positive against the disease or by the people involved have the disease aggravated during the trial …

    • By not publishing they have admitted failure alraeady

      At the time of the MS trial, the drug was still being developed in Lupus and so a black mark from MS, would dent the Lupus programme and investor interest. That was dropped in about 2015 as it didn't work good enough.

      But what we really want to know is are they hiding harm. If you read reviews then another anti-BAFF could have considered for MS.

  • It's neither APRIL nor BAFF or they would be ringing our (and investors) ears full of jolly good news while the trials were still ongoing. My guess would be that it was a miserable fail and people got worse.

  • Re Eli Lilly site
    'We don’t just do this for medicines that have met their clinical goals and been approved for use – we also disclose results for investigational medicines whose development have been discontinued.'
    So just do it then! Honestly it's not difficult and it is wrong wrong wrong of you not to Eli Lilly 🙁
    So best of luck MD with reaching out again and don't you just love all the corporate speak?
    If this fails is it worth a blog post asking if anyone remembers being in a trial in 2009? Failing that any good lawyers willing to volunteer services for free? Or go straight to the top?!

  • Here's the German bit, not that it's any help at all just says cancelled.
    So, my brother lives in Germany, his wife is German (and a research chemist) and he's pretty bilingual. What does he do? Use Google translate 😉 hahaha

    Subcutaneous multiple doses of LY2127399, a human anti-BAFF antibody, in patients with relapsing remitting multiple sclerosis

    short version This Phase II study is designed to provide data on dose finding to LY2127399 in subcutaneous (sc) injection in patients with relapsing remitting multiple sclerosis (RRMS). LY2127399 is a human antibody directed to the messenger substance BAFF (B cell activating factor), a protein for which overexpression appears to play a role in the pathogenesis of MS. The efficacy of LY2127399 on MS lesions is assessed by magnetic resonance imaging (MRI), peripheral blood B cells, inflammatory / immunological / regulatory molecules, and clinical efficacy. Changes in the number of B cells and other biomarkers of the immune system serve as evidence of the biological activity and could facilitate the definition of the lower limit value for the biologically relevant dosage range of LY2127399.
    Project partners Quintiles GmbH, Zweigniederlassung Basel
    Type of research project clinical research
    status Canceled
    Project start 2009
    Projects 2011
    Studiendesign Phase II, double blind, placebo controlled
    Responsible person / main examiner at KSSG Dr. Norman Putzki

    • Good to see our team of investigative journalists are on the case.
      Fess up Eli Lilly, you know it makes sense!

    • Norman Putzki is now one of the head honchos at Novartis, via Biogen. He now in USA.

      Lilly say completed, but it is was cancelled then it is more concerning.

      If we get the results of this study it may help us understand the disease mechanisms of MS better.

      We have requested information from a number of companies that may help us understand. Some are doing the work for us, so they are not all bad.

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