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Golimumab Update

Discussion in 'Research' started by joshualevy, Oct 30, 2018.

  1. joshualevy

    joshualevy Approved members

    Dec 30, 2008
    Golimumab (sold as Simponi) is an immune system modulator, which has been approved in the United States and many other countries for treatment of several autoimmune diseases, so testing it on type-1 diabetes makes a lot of sense. Simponi has already been approved to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis.

    Golimumab is a monoclonal antibody, which is an artificially created antibody which targets one very specific molecule in the body. If a disease is caused by that molecule (or a cell marked by that molecule), then using a monoclonal antibody to target it is promising. Golimumab targets tumor necrosis factor alpha (TNF-α) which causes inflammation, and is well known to be involved with type-1 diabetes.

    There are three on-going clinical trials of Golimumab (Simponi):

    T1GER: SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes
    Who: 84 people aged 6-21 with honeymoon type-1 (first 100 days)
    What: 52 weeks of treatment
    When: Started Aug-2016 and expects to finish May-2020 (fully enrolled in Aug-2018)
    Where: 33 sites in the USA (but they are no longer recruiting)
    Run by: Janssen Research & Development

    SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic T1D
    Who: 30 people aged 6-21 with two or more autoantibodies, but no "classical" symptoms of T1D
    What: 26 weekly injections
    When: Started Oct-2017 and hopes to finish July-2021
    Where: Colorado, Finland, Sweden (they are still recruiting new people)
    Run by: Janssen Research & Development

    Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D
    Who: 30 people aged 18-50 who have had type-1 for more than 3 years
    What: 8 weeks of treatment
    When: Started Aug-2018 and hopes to finish June-2020
    Where: Idaho and Washington (they are still recruiting new people)
    Run by: Benaroya Research Institute

    I like this as a complete program. These three studies cover Golimumab from many different points of view: people before they are diagnosed, honeymooners, and people with longstanding type-1. Two of the studies are for children 6-21 years old, and one for adults 18-50. All are reasonable size.

    The downside, is that we have to wait until 2020 to see results. The good news is that by 2021, we'll have results from three different studies to look at.

    Curing type-1 diabetes in people with established type-1 is generally thought to require two successes. First the autoimmune attack must be stopped, and second beta cells must be regrown. Golimumab targets the autoimmune attack, but is not known to regrow beta cells. By itself, such a treatment might cure presymptomatic or homeymoon type-1 (because those people still have some beta cells), but is unlikely to cure established type-1.

    Clinical Trial References:
    * https://clinicaltrials.gov/ct2/show/NCT03298542
    * https://clinicaltrials.gov/ct2/show/NCT02846545
    * https://clinicaltrials.gov/ct2/show/NCT03632759

    Drug Web Page: http://www.simponi.com/
    Drug Wikipedia Page: https://en.wikipedia.org/wiki/Golimumab
    TNF Wikipedia Page: https://en.wikipedia.org/wiki/Tumor_necrosis_factor_alpha

    Joshua Levy
    publicjoshualevy at gmail dot com

    All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Bigfoot Biomedical news, views, policies or opinions. In my day job, I work in software for Bigfoot Biomedical. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.
  2. katerinas

    katerinas Approved members

    Apr 20, 2010
    Thank you Joshua for keeping us informed! I used to do my own Research on type 1 diabetes but the last 4-5 years have given up and just read what you write. I guess I am a bit disappointed! I am really glad that keep doing it! Thank you again!!

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