Brian Warner

New AS injectable?

Posted by Brian Warner

May 4, 2009

I was cruzing the web as I am oft to do and came across a new treatment. Anybody heard anything about this one? From Medscape:

The US Food and Drug Administration (FDA) has approved golimumab (Simponi, Centocor Ortho Biotech Inc) for monthly subcutaneous injection in the treatment of adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

“Today’s approval provides another treatment option for patients with these three debilitating disorders,” Bob Rappaport, MD, director of the Division of Anesthesia, Analgesia, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. “And the steps we’re taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class.”

The mechanism of action of golimumab is to target and neutralize tumor necrosis factor alpha (TNF-alpha), a protein that is overexpressed in chronic inflammatory diseases, mediating inflammation and injury to bones, cartilage, and tissue.

…A boxed warning for golimumab notes the risk for tuberculosis and invasive fungal infections, as is the case with other TNF-alpha blockers. A risk evaluation mitigation strategy was also required for the drug, including a medication guide for patients and a communication plan to advise prescribers regarding the risks of golimumab and of other TNF-alpha inhibitors.

What I find interesting is that it’s being cleared for AS right up front . . . from what I can tell, the other injectables were cleared for some of the more well known arthritis conditions, and then later cleared for AS. It’s nice that we’re starting to see some of that rock-star treatment :) . Post up if you know anything about golimumab. I also found this on About.

3 Comment

    • About to start humira.
      Also a TNF blocker or disease modifier.
      Really hope it helps.
      Getting to class is sofa king hard.
      Like a shark,
      gotta keep movin.

    • Comment posted by Tony Voskuhl on July 16, 2009 at 11:00 pm
    • I am currently pushing for Humira. Currently taking a bucket full of different medication to kill the inflammation like Arcoxia and Naproxen. I suppose thats the price you pay for having a super human spine!

    • Comment posted by Kenny on July 23, 2009 at 3:38 am
    • I have some friends that are using Simponi for early stage AS with good results. I use Enbrel, but am staying in touch with these people, and may be pushing my rheumy towards Simponi if for no other reason than its a once a month injection, not weekly.

      Also some folks are having great results with Low Dose Naltrexone not an injection but another tool..

    • Comment posted by Chris Scott on January 3, 2010 at 5:23 am

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