I haven't abandoned you ...

Happy New Year, everyone.  So sorry I've been away for so long!  It's been a crazy time.

Ok, here's where I'm at.  After I withdrew from the Apremilast trial, I was not on any medications for a few months.  At first, we were waiting for my insurance to approve the change of drugs and when that finally happened, I was sick and could not begin.  Needless to say, my psoriasis had a field day during this pharmaceutical hiatus. 

Fast forward to present time, I've done my 2nd injection of Symponi.  I was supposed to do it 4 weeks after the first injection, but I got a cold (2nd one of the season), which turned into a sinus infection (2nd time this season) and on the day that I was supposed to do my 2nd injection, I was sitting in my doctor's office getting a prescription for antibiotics.  After I finished the course of antibiotics, I waited a few days and then did my second injection.  Ok, so that brings us up to the present.

The injections themselves are really pretty easy.  My former experience with injections was with injectable Methotrexate.  I had gone to injectable MTX when the oral was totally making a mess of my tongue.  I hated filling the syringe, getting the bubbles out and finding a spot on my arms or thighs to inject.  To this day, I still get nauseas when I see liquids that are "Methotrexate Yellow".  The smell of alcohol swabs has the same effect on me. 



Symponi "Pen"



Big difference now - it's once a month, not once a week.  I take the pen, press it against my leg and press a button.  So ... much ... easier.  And less painful - both physically and psychologically.

Am I seeing results?  In a word, yes. (I promise to post pics soon).  I haven't been using topicals and some of my plaques are drying up and breaking up.  Much less build-up and flake. With just 2 doses, I am seeing better results than in 6 months on Apremilast.  Actually, MUCH better! Am looking forward to seeing the results after my 3rd dose and probably after that I will add oral Methotrexate (if needed).

Am looking forward to the possibility of clear skin in time for shorts and tank top weather.

I hope all of you are doing well and I promise to post pics soon.

Juls

Wrapping It Up ...

Last week Celgene denied my doctor's request to allow me to add Methotrexate to my protocol.  As I was not seeing improvement - especially with the psoriasis portion on my disease, I withdrew from the trial.

This diptic to the left is my left forearm at the beginning and the end of the trial and is fairly representative of the results on the rest of my body.  Am glad I photo-documented this, because I would not have remembered the size of my plaques at the beginning of the study.  As you can see, there was a significant size increase in this plaque.  The rounded plaque at the center engulfed the smaller plaque to the upper right of it.  Below this plaque, you can see the significant amount of space between it and the plaque at my elbow.  In the ending picture on the right, note the thin gap of unaffected skin between the enlarged forearm plaque and and my elbow.

My doctor has seen a lot of success with other patients, but many of them were already taking Methotrexate when they began the Apremilast trial and were able to take it as a part of a combo therapy.  I had stopped taking Methotrexate several months before when I got pneumonia.  In hindsight, I probably should have started it again prior to entering the trial and I would have been able to enter the trial doing combo therapy.

Why Celgene does not permit individuals to start combo therapy at 24 weeks and track those results, is beyond me.  If someone out there (including Celgene) knows a reason for this - please post it as a response here.  I would very much like to understand the rationale.

So, on to the next protocol ... for now, I'm supposed to be back on Methotrexate and folic acid - but last week I came down with a cold/sinus infection, so I'm not going to do anything until I'm fully recovered.  The plan is to do a combo therapy of MTX and Symponi - a once a month injectable.  I know there are quite a few new drugs in the pipeline, including a current RA drug that is being tested for PA and I'm hoping to have even more options in the coming months and years.

When I start my MTX and Symponi protocol (hopefully within the next two weeks), I will document my progess here (even though neither of these drugs is in clinical trials), hoping to provide more information for my fellow psoriasis and psoriatic arthritis sufferers.

Until then, flake on and stay moisturized!

The Great Oz has spoken ...

It's been a long time, but I wanted to see where things were going to go.  My psoriasis plaques are in general at least double the size of what they were when I started on Apremilast.  I have a lot of new psoriasis plaques that did not exist when I began the trial.  My joints are still swollen and tender.

At 24 weeks, my Dr. asked if I could add Methotrexate to the regimen, as I'd had success previously with dual modality therapy (900 mg of Remicade and 15 mg of Methotrexate).  Bear in mind, that a lot of people are currently on dual modality therapy of Methotrexate and Apremilast (they began the trial on both), but the Brain Trust (clearly, choking on my sarcasm) at Celgene will not permit me to add it to my regimen to see if we could achieve success.  Beyond me why they would say no. 

We already know Apremilast alone does not work for me.  Guess it's not important for them to collect data on people adding a second modality and what success, if any, could be achieved.   I would think that would actually give them just as "clean" data as that of those who began the study with Metho and Apremilist (maybe even cleaner because there would truly only be one variable).  But then again - a 30 yr.career of setting up and analyzing test and control cells makes mining data more important to me than to others.  Clearly.

I am heading out for a few days - but when I come back, I will post photos of what my skin looked like at the beginning of the trial and at the end.  Am glad I photodocumented this, because as much as I "wanted to see" - oh look I can see a freckle or I can almost see a patch of skin breaking through there - when I look at the photos, the reality is, that plaques are significantly bigger now and there are a lot more of them.  And they didn't clear.

I really wanted this to work.

So, now the search is ... what's coming down the pipeline that's not a heavy duty immunosuppressant that maybe I can piggyback with Methotrexate (from the start) this time.  Does anybody know of anything else in trial right now that is not as harsh on the immune system, as say, a Remicade?  If so, please leave a note here or email me.

Thank you for joining me on this journey ... I hope it's been informative and I'll let you all know what my next steps are going to be in fighting the Psoriasis/Psoriatic Arthritis war ... this was only a battle ... and I just wish the opposing General had a better tactical strategy.

But for now Toto ... we're outta here ...

No News Is Not Necessarily Good News ...

Day 39

Yes, I know it's been awhile ... but I don't have a whole lot to report.  There has been no change.  I am still covered with psoriasis - in fact, I've got new patches sprouting up everywhere. Three new ones on the front of my upper right arm (a place where I've never had psoriasis before) appeared yesterday, out of nowhere.

My joints are starting to bother me - my right wrist blew out yesterday, my feet are becoming painful and I fear as winter gets closer that my skin is going to be in agony, as I am covered in psoriasis.

I am bummed.  I am really bummed.   I know other patients that my doctor has enrolled in the trial are doing beautifully.  I still look like I did when I started in the trial.  No, that is not true - I look worse.  All my existing psoriasis plaques have spread, new ones have appeared and stayed, none have disappeared.

The only way to get a valid read on the efficacy of Apremilast for me would be to set up an Apples-to-Apples test for me (years of direct marketing and setting up test cells makes me a stickler about setting up head-to-head tests with only one variable to determine the success or failure of that variable.  More than one variable and there is no way to get statistically valid results). 

If anyone from Celgene is reading this (or if your PR agency is doing a media sweep for you and picks this up) ... here is what I'd like to propose - a valid test of what a high dosage (30 mg) of Apremilast plus Methotrexate would do for a person who had formerly been on high dosage Remicade (900 mg) and Methotrexate.  Then the only variable would be swapping out high dosage of one drug for another and would give you a head-to-head test on Apremilast vs. Remicade for high dosage users (most people are not taking anywhere near 900mg.of Remicade, as I was).  To really look at efficacy, is doing combination therapy with MTX.  I know that MTX alone works on my joints, but doesn't have a significant effect on my skin disease.  Remicade in combination does a good job with both aspects of the disease, but when I get lax about taking the MTX, the skin flares.

So what about it Celgene?  There is some good and interesting data that we can glean from this, since I appear to be somewhat of an aberration as far a both results and atypical dosage amounts.  We've both invested nearly 6 months in this ... please don't let me go through a painful winter ... I'd like to make this work, wouldn't you?

As we all know, PR guys will always tell you "all press is good press" ... let's truly make this good press and another Apremilast success story - I think we've still got that opportunity by employing proper therapy ... and if it doesn't work, at least we know that no stone was left unturned and some good learning came from that, too.

ClinTrialnTrib@aol.com

Every Picture Tells a Story ...

Day 19



Top: Left and Right Forearms
Bottom: Left and Right Knees

 Both my doctor and the study coordinator looked at me at my last visit and said, "I think you're on placebo".  I know they are comparing me to the fabulous results they have seen with their other patients.  But I'm not sure they are right. 

My gut tells me that I have been on actual medicine all along - but in the test prong with the lower dosage.  Why do I say that? Months and months of diarrhea is why I say that.  My wonky stomach has finally settled down and did not act up when I "Early Escaped" out of Phase 1 and began taking what we know is real medication.  The only issue I've been having is headaches - but I think those are coming from my neck and studying.

Yes, I know these photos were only taken at Day 19 of what we know is confirmed medicine.  But you tell me - do I look ANY better to you?  I'm not seeing it.  What do YOU, my faithful blog readers, think?  What is the story you are taking away from these pictures?  The story I'm taking away is if my skin doesn't clear before winter sets in, I'm going to be hurting big time! 

My fear is that I am on (and have always been on) the lower dosage of the medicine - which at my level of disease severity, is like putting a bandaid on a severed artery.  Doesn't quite do the trick.  I was being infused with 900 mg. of Remicade in conjunction with Methotrexate to keep my skin mostly clear (elbows, knees, scalp and other assorted areas had some psoriasis) - so being on the lower dosage of Apremilast is probably not enough to manage my disease successfully.

I flared during my period and my plaques got red and raw and my scalp went haywire.  It's calmed down some since then.  New patches continue to develop and no patches have disappeared.

Yes, I know it's not even a month since my Early Escape - but with the lack of GI issues, I really think that I did not just start actual meds 19 days ago.  I could be wrong, but that is rare (ask my husband :-)  ).  For once, I would love to be proven wrong and walk in to my doctor's office showing the same success as the other patients in the trial.  If only I could just PhotoShop my pictures and my skin to tell a different story ...

Time May Change Me, But I Can't Change Time ...

Day 5

Yes, you read that correctly ... Day 5 ... Day 5, you say - scratching your head, how can that be?  How can she turn back time ... Ahhh ... that so brings back memories of the Thin White Duke himself ....

Many, many moons ago ... sometime in the mid-to-late '70's, my college compadres and I got tickets to see one of our very favorite artists, David Bowie, at the LA Colisseum.  We would spend hours in our dorm rooms singing Rebel, Rebel, Young American, Ziggy Stardust, Changes and many other great Bowie tunes - so we were really psyched up for this concert.  At some point early in the show, one of my close friend's younger sister found us at our seats.  She had dropped a hit of acid and was freaking out that time was moving forward and she wanted it to stop and go back - and when I say freaking out, I mean freaking out.  She had launched into this diatribe and her sister and I tried talking her down and talking some sense into her. It wasn't long before her sister got sick of it, and she and her boyfriend left, leaving me with this crazed, time-obsessed tripper.  Although her sister had left her to go enjoy the concert, I didn't feel right about leaving her alone.  I missed most of the concert trying to talk her down, and finally, well into the concert, the only thing that was worn down was my patience.   Bowie's band struck the first chords of Rebel, Rebel and I just needed to sing along, I need to be in the present, I needed to join the energy in the room. Finally, I turned to my friend's babbling, freaking-out sister and firmly said, "Enough.  You need to be quiet now!"  Her eyes grew large and she silenced.  I couldn't turn back time and enjoy the bulk of the concert that I had missed ... but I could embraced the time that was left to enjoy the show and lose myself into the magic that is David Bowie live.

Now, I know, I still have not answered your question ... how did you get from Day 100-something to Day 5?  How did she turn back the clock, you may be wondering.  It's called Early Escape.



Day 5 - Redux
Left & Right Forearm
Left & Right Knee



Turns out I have not seen a significant enough improvement in the number of joints affected or the percentage of clearing of my skin.  So, if I was in fact on placebo, I no longer am - I am on real medication.  My Doctor and study coordinator think that I was on placebo, based on what other patients involved in the study look like.  I am not so sure.  But time will tell.  We will know, if time changes me and I hope it does .... so I have reset the clock and turned back time.  Today was Day 5 of being certain that I am on medication.  Let the clearing begin ... turn and face the strange ch-ch-changes.

Gone, but not forgotten



Forgotten Pumps of the Past
Classical Gas Museum, NM



School started a week ago for both me and my son - so, time has not been a commodity.  I just shot some pics of my knees and elbows this morning and after I study today, I will try and sit down this evening and write a blog post (unless I am still studying).

Thanks everyone for following.  Hello to all the followers from InvestorVillage.com - hope you are getting the info you need from my journey.  Just remember, I am only one person and how my body responds is different than any other person's experience with the trial.  As a reference point, to keep my psoriasis and psoriatic arthritis at bay, I have taken as much as 900-1000mg of Remicade in conjunction with Methotrexate.  That is a HUGE amount of Remicade - triple, in fact, of most people's dosages.  So, given that, I am already not your "normal" subject.

Ok, off to study ... more to come.  Promise I won't forget.