A Clinical Trial – Patient Journey – Part IV

Catching up?

• A Clinical Trial – Patient Journey – Part I
• A Clinical Trial – Patient Journey – Part II
• A Clinical Trial – Patient Journey – Part III

I last wrote in September about my clinical drug trial. So much has happened since! I did reach the conclusion, despite how good I felt by September, that I was on the placebo for the first 24 weeks. So why did I feel so good in September? To work that out we have to look at my specific treatment history. I’d failed three DMARDs when I started the drug trial and had just started a fourth DMARD. The rules of the trial were we could stay on up to two DMARDs during the trial.

Having adverse reactions to medications is not fun and while in each case I typically cite one prime adverse reaction, in reality there are probably other issues going on with the body as well.

Timing is the other factor in my case. Due to the adverse reactions to the DMARDs, by the time I started the trial my treatment regime had been a bit stop-start. To recap, November 2018 I stopped DMARD #2, did three month washout. Tried DMARD #3 in February 2019, but only lasted five weeks due to adverse reaction. Another small washout period, started DMARD #4, on a low introductory dose, in April 2019. By the time I started the drug trial in July 2019 I was really recovering from a lot of adverse reaction events and had not had continuous, effective treatment for almost eight months. It is therefore, to my mind, not surprising that I felt better in many ways! I was, if nothing else, recovering from the medications my body had not looked upon too favourably! When I wrote Part III (link above), I was also still on that low dose of DMARD #4 which may well have been having a positive effect on the psoriatic arthritis.

However, DMARD #4, like the previous three treatments, also resulted in an adverse event for me. My, shall we say, gastrointestinal activity started to go through the roof. I won’t go into details, I think you get the picture! It was not at all pleasant and worsened over time. After discussions with my gastroenterologist, rheumatologist and the research team we recorded yet another adverse event and I went off DMARD #4.

Around the same time the left knee, the topic of my last article, was starting to make its presence felt. I also developed trigger finger in late December and started splinting my fingers at night. I got different colours so I’d know which one was for which finger! These splints are from an great occupational therapist. So I had a few things going on.

While I could still fit my runners on, my feet were still slightly swollen. I developed a few clearly visible small nodules here and there: one on a pinky finger, one on a second toe and one on a big toe. These were new, small, and bothersome. The feature photo shows the finger one, completely gone now. The toe one below would now not be noticed by anyone else, I can just see where it was.

The joint assessment at my October trial visit still lit up all my toe joints and some finger joints. There really wasn’t any improvement in that joint assessment at all, even though I still felt better in many other ways as noted in my prior articles.

But what about the skin? Yes, it remained 100% clear. If I was on placebo AND off all DMARDs, wouldn’t my skin possibly flare? No, I don’t think so for the very simple reason my skin had never been a problem in the past, it came to the fore in a big way as a result of DMARD #2. Off that specific medication, my skin ultimately returned to normal. The timing just happened to coincide with the clinical trial. It was easy to look at my skin improvement and think, YAY, I got the good juice!

The bottom line is, by November/December 2019 I was saying to my doctors I think I’m on the placebo. If that was the case, then January 2, 2020 was to be my first active intervention injection. I certainly didn’t have long to wait!

After the January 2 injection, on the morning of January 16 I was vastly improved. I specifically noted the date in my symptom diary as I woke up feeling a switch had been flicked. I actually had to considerably tighten the laces on my runners! My feet had really shrunk! The trigger fingers had improved dramatically during the day. My shoulders, which had been grumpy, were also feeling better. Both knees were very good (bearing in mind the left one had had the rescue steroid shot in mid-November). I was very pleased. I was, if you like, now doubly improved!

Then we reached the end of January and the osteoarthritis in that left knee went haywire and I ended up in hospital (detailed in my immediately previous article).

I was therefore a week late getting my loading dose because my rheumatologist wouldn’t let me out of hospital to go and get it, even though I promised to come straight back! Also, due to the hospitalisation, the clinical trial medical monitor had to give clearance for me to continue on the drug trial. Clearance was granted, much to my relief!

I am due for my next injection in late April (injection every 12 weeks after the loading dose).

Aside from my osteoarthritic knee, my psoriatic arthritis is definitely improving. I am still splinting those two fingers at night but the hands are fine during the day. In fact the right hand is fine all the time now, just the one finger on the left hand is still an issue, but definitely improved. The small nodules I referred to above have almost disappeared and at the last two joint assessments, each time less joints have lit up. In fact, at this month’s assessment, I think from memory only two finger joints lit up (very slightly) and only about half my toe joints and even then they were much less painful than before. Shoulders are fine. Of course, my CRP was back up in early February (don’t have March results yet) but we’ve attributed that to the knee inflammation, which was pretty gross at the time.

Comorbidity makes things challenging. Like my CRP rising due to my osteoarthritic knee, even though my psoriatic arthritis is coming along nicely. Then there is the theoretical question of how much do osteo and psoriatic play together? I have this image of little psoriatic soldiers being sent on reconnaissance missions around my joints. They find the osteo damaged knees and the Sergeant-in-Charge decides it is a great place to attack where the defences are down! Not too sure what my doctors think of my visualisation but it amuses me! Obviously my knee didn’t get that bad or the cyst develop overnight – the aforementioned eight months of stop-start medications probably was a contributing factor and if I had been on placebo, the two conditions really had free range to play together.

One thing I am noticing is with the self-isolation required by Covid-19 AND the fact I can’t get out and walk due to the knee, I am missing my usual swimming and weight training. I’m doing remedial type exercises at home, but it is not the same as being in the gym. Medications don’t do everything, exercise is still a major part of condition management.

Oh, and STAY HOME: Social Distancing is critical!