Anyone have any updates on this? From what I understand the release date is supposed to be 3/21/14. I'm very interested in this as although I'm being treated with Remicade, the lack of nasty side effects with Apremilast looks appealing.
Would like to follow this. I also heard great news about the new IL-17 drugs!
The drugs so far aren't matching the hype. Remember not so long ago Celgene's stock took MASSIVE one day drop when the first Phase 3 trial day came in. There was a huge drop in efficacy from the Phase 2 to Phase 3 trials. There are literally thousands of "plants" of almost miracle like performance of this drug. Celgene hired a firm that specializes in causing buzz on the internet and planting reviews (a fairly common business practice these days - In my real life I have been recruited to write articles over the top of my name for several products. My wife daily gets contacted by "reputation management" firms for her small business)
All that aside Otezla which is what Apremilast will be marketed as is most like xeljanz. Which is technically a DMARD. It is in an entirely different class of meds called small cell inhibitors. They are used extensivly in new cancer treatment. They have identified small molecules with in larger cells that regulate the cell cycle. By introducing specific interaction with a variety of intracellular protein targets the can intrrupt disease proceses. Because they modify the disease process they are like DMARDs. Because they bind proteins they work a lot like some of the biologics.
Its believed that at some point we will be able to test for and identify specific small cells for a number of diseases and assign an appropriate small cell inhibitor. Its possible with some small cell diseases we will be able to customize a drug for each one effectivley building a immunization.
You may be familiar with some early work done with a cancer drug called melacine developed by Ribimmunochem.........
In any event I believe that while this drug may not be "the drug" I have believed for years that this is "the technology" when we are able to personalize the meds, we should be able to kick this thing.
Its likley to be approved (maybe not today) Celgene has their website up at http://www.otezla.com/ Don't get excited about the side effects just yet. There isn't the TB fear or the Cancer in teen age Chrons boys possible link. But it does have all the rest. They repeated the Phase 3 trials 3 times and submitted the fourth for the approval. The one thing that became clear in all the studies is that Otezla has been shown to be less effective than Humira or Enbrel the control drugs.
Hers MY opinion for what its worth. My greatest fear is that this drug will add another step to getting to the good stuff. (Step Therapy) Something between DMARDs and the more effective Biologics. It will be quickly duplicated, (BTW its an PDE-4 inhibitor) This may be great for some patients and really not so great for others.....
Then again approval be delayed as it was in Europe due to questions of cost/benefit. It did recieve orphan status to treat Behçet’s disease (sort of like compassionate approval in the US for experimental cancer drugs)
Thank you, tntlamb, for all of your insight. I read so much of what you write, and appreciate the terms in which you speak. I a, MOST INTERESTED in hearing about what else is available…I was lucky that my Rheumy started me on Enbrel right away, but had to take me off, as I had a side effect of my neck tendons and muscles freezing up and distend ing, tho this did not go away after I stopped the drug. She then started me on Humira, which I had good results from, that is, until I was diagnosed with MS, as well. Now this whole class of drugs has been taken away, much to my dismay, even tho I have FAR MORE issues with PsA than the MS. I have, most recently been started on Stelara, which does not have good reports on tx of PsA, but seems to be a good drug for Psoriasis. I am hoping that I’m one of the 20% of PsA patients who see a 20% improvement in symptoms, but so far, I’m still pretty darn miserable. Anyhow, I am trying to keep up to date with these meds, so that I can ask my Dr…You never know, maybe I will bring something to the table that she hasn’t thought of, one day. That would be a good thing, for both of us. Hope everyone’s having a good day! Kris
tntlamb said:
The drugs so far aren’t matching the hype. Remember not so long ago Celgene’s stock took MASSIVE one day drop when the first Phase 3 trial day came in. There was a huge drop in efficacy from the Phase 2 to Phase 3 trials. There are literally thousands of “plants” of almost miracle like performance of this drug. Celgene hired a firm that specializes in causing buzz on the internet and planting reviews (a fairly common business practice these days - In my real life I have been recruited to write articles over the top of my name for several products. My wife daily gets contacted by “reputation management” firms for her small business)
All that aside Otezla which is what Apremilast will be marketed as is most like xeljanz. Which is technically a DMARD. It is in an entirely different class of meds called small cell inhibitors. They are used extensivly in new cancer treatment. They have identified small molecules with in larger cells that regulate the cell cycle. By introducing specific interaction with a variety of intracellular protein targets the can intrrupt disease proceses. Because they modify the disease process they are like DMARDs. Because they bind proteins they work a lot like some of the biologics.
Its believed that at some point we will be able to test for and identify specific small cells for a number of diseases and assign an appropriate small cell inhibitor. Its possible with some small cell diseases we will be able to customize a drug for each one effectivley building a immunization.
You may be familiar with some early work done with a cancer drug called melacine developed by Ribimmunochem…
In any event I believe that while this drug may not be “the drug” I have believed for years that this is “the technology” when we are able to personalize the meds, we should be able to kick this thing.Its likley to be approved (maybe not today) Celgene has their website up at http://www.otezla.com/ Don’t get excited about the side effects just yet. There isn’t the TB fear or the Cancer in teen age Chrons boys possible link. But it does have all the rest. They repeated the Phase 3 trials 3 times and submitted the fourth for the approval. The one thing that became clear in all the studies is that Otezla has been shown to be less effective than Humira or Enbrel the control drugs.
Hers MY opinion for what its worth. My greatest fear is that this drug will add another step to getting to the good stuff. (Step Therapy) Something between DMARDs and the more effective Biologics. It will be quickly duplicated, (BTW its an PDE-4 inhibitor) This may be great for some patients and really not so great for others…
Then again approval be delayed as it was in Europe due to questions of cost/benefit. It did recieve orphan status to treat Behçet’s disease (sort of like compassionate approval in the US for experimental cancer drugs)
Yes, thank you Lamb.
You are always factual, current and succinct with information.
Do you have any info about Secukinumab?
I was on a trial study for Apremalist..did nothing for my PsA but I did get a very nasty dermatitis from it and B/P in the stroke range.
Talked with my rheumy this past Monday about apremilast. He is doing some research on it to see if it addresses the same aspects that the biologics do. If true, he is going to talk with his Celgene rep about it. We will then wait 6 - 12 months to see how others are doing. We may switch me at that point if things look good.
The prescribing information starts off with a warning about severe or worsening depression in patients prone to depression. That would be a deal breaker for me. I struggle enough with depression already.
That would be a deal breaker for me too, Mimi. I don’t want to be flirting with that.
mimiB said:
The prescribing information starts off with a warning about severe or worsening depression in patients prone to depression. That would be a deal breaker for me. I struggle enough with depression already.
Interesting read about whether Celgene is a good stock pick based on Otezla (apremilast). You can read it here. A couple of interesting points, albeit about Psoriasis not PSA:
- 72% of dermatologists said they would prescribe it (if on a preferred tier with Enbrel/Humira)
- of the 72% of dermatologists above, 40% said they would prescribe it as a first line systemic therapy "given the drug's benign safety profile in trials reported to date and the convenience of the drug's oral formulation"
- Given the "modest efficacy profile compared with Enbrel" it is likely that Apremilast will be used in patients with less severe psoriasis and not in "those who are biologics candidates"