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Kevzara and prednisone effectivness
Polymyalgia Rheumatica (PMR) | Last Active: 2 hours ago | Replies (42)Comment receiving replies
@dadcue I’m perplexed as to why Prednisone is “still” not FDA approved for PMR. Why?
Kevzara was in 2017, but the trial for GCA was halted.
Actemra was for GCA, but no trial for PMR that I have found.
Both are similar (IL-6) Inhibitors, with a slight chemical
It’s Wac-a-mole medicine!.!.!!.!!!.!..!!.!!!
The name PMR,
Polymyalgic Rheumatica, is a misnomer at best.
Many muscles pain caused by discharge and build-up of one or more of the bodily fluids “humors” (flux).
Replies to "@dadcue I’m perplexed as to why Prednisone is “still” not FDA approved for PMR. Why? Kevzara..."
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@stonewheel
Prednisone is an old medication and was used for PMR before the FDA required rigorous testing---it was more or less grandfathered in and given a pass as a treatment for PMR
Kevzara was FDA approved for RA in 2017. Trials were underway to get it approved for GCA but enrollment was interrupted because of Covid. Results of the Phase 3 SAPHYR clinical trial met the criteria for the FDA to approve Kevzara for PMR in 2023.
Actemra was never studied to treat PMR because its patent expired. Now we have generics that compete with Actemra. When a patent expires on a medication there isn't much financial incentive to do expensive clinical trials.
The GIACTA study for Actemra to treat GCA was in 2017 when the FDA approved it for GCA. I remember how excited my rheumatologist was in 2018 to offer me Actemra. I had refractory PMR without GCA with no hope of ever tapering off Prednisone. My rheumatologist didn't know Actemra would work for me --- it was just a hunch that Actemra should work for me.
My rheumatologist wanted to know if I would be willing to try Actemra if he could get it approved for me. I asked another doctor what the chances were that Actemra would be approved and he said -- no chance it would ever be approved so I didn't think it mattered that I agreed to try it.
I inquired about Actemra on another PMR forum. I was surprised by all the negative feedback I received even though nobody had any personal experiences to share. It was all about how great prednisone was and how bad Actemra would be. I knew prednisone wasn't that good!
When Actemra was approved I almost refused it but I felt I had made a commitment to try it. I told my rheumatolgist about the negative comments about Actemra. His famous words were, "I wouldn't know if I didn't try it to see." It made perfect sense for me to try Actemra rather than listen to someone who didn't know anything about it.
At the time, I was under the impression that I would be getting a monthly infusion. My rheumatologist started to explain some details about the GIACTA study. Then he said he decided to start me out with injections. The scary part was when he told me to do injections every two weeks instead of weekly to "play it safe!"