A Clinical Trial – Patient Journey – Part IV

Catching up?

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!

Where Have I Been? I’m Glad You Asked!

I’ve been everywhere, man, as the song goes. In hospital, in MRI machines: all sorts of fun things.

I wrote last year about my right knee sending to me to the emergency department just before I started my clinical drug trial. It is important to emphasise here, I have two different forms of arthritis: psoriatic arthritis (for which I am on the drug trial) and osteoarthritis.

In 2014 my left knee got very grumpy. Total knee replacement was mentioned way back then, but we tried a Synvisc-One shot as a less invasive treatment. With that and the proper exercises, I got another five years out of that knee. However, it seems time is up. In October last year, after my right knee had recovered, the left knee went out in sympathy. Badly.

At Week 16 of the drug trial I was allowed an intervention: a steroid shot in the very cranky knee. I also had an MRI. This was November last year. Sitting in my GP’s office later, the conversation went like this.

GP (reading MRI report): “Hmmmm, Grade 4 osteo.”

Me: “How many grades are there?”

GP: “Four”

Me: “Oh”

Not exactly the best news, but we hypothesised that the flare in my right knee had increased the load on the left knee, so now it was reminding me to look after it – in no uncertain terms. The steroid shot, some exercise, I’d be fine. That was my thinking. All was progressing positively for about ten weeks after the steroid injection. I was thinking I could start activating Limberation again.

Then came Australia Day weekend (end of January for overseas readers). Friday I woke up, the knee was a little swollen and stiff. I went and did some hydrotherapy. Saturday it wasn’t any better so I went for a walk around the block to see if that would help. No. On Sunday, I had lunch, looked at the dishes and thought “I’ll just go the bathroom first.” As I stood up from the toilet, something at the back of my knee snapped or popped or did something. So painful I fell back onto the toilet. Sat there for a minute, thought, “OK, I can’t sit here forever, got to get up somehow.” So I very gingerly managed to get off the toilet. The excruciating pain of the pop had gone, but this was one very unhappy knee. And it got unhappier as time progressed. I took some panadol osteo – I may as well have taken jelly beans. By an hour later I decided hospital was the place to go.

The poor taxi driver was quite distressed, I think, because by the time we got to the hospital, I was in….. a lot of pain. The hospital staff got me out of the taxi, into a wheelchair and into triage. To cut a very long story short, I was admitted. Finally got the pain under control at 1 am Monday morning. I don’t think the nurses believed me, but I was adamant the pain was worse than when I woke from my hysterectomy. It wasn’t just the knee, but now my foot was excruciating and my glutes were spasming. Because it was a public holiday weekend I didn’t get my MRI (yes, another one, I am now dating the MRI machine) until the Wednesday morning.

You know that look doctors get when one of their patients has something interesting, unique? I recognised that look! My rheumatologist came into the ward, holding the results, with excited stars in his eyes. “I’ve never actually seen one of these myself”, he said. I don’t mind when they get all super excited because it means you are medically interesting!

The MRI showed, amongst other things, a cyst dissecting my popliteus muscle. Not a Bakers Cyst, I must emphasise. This is different. The idea at that point was we could perhaps remove the cyst with keyhole surgery. This was good news, as I didn’t (and don’t) want to get kicked off the drug trial for the other arthritis! Minimal is best, I was thinking. Here is an extract of the report if you are medically minded.

So off to see a surgeon. Surgeon was not happy that my quads weren’t working, I couldn’t flex my toes and my left foot was just one big blob of pins and needles. He also quickly killed the keyhole surgery idea. I needed a total knee replacement. This was a shock, not really something I was planning on. Surgeon sends me off for another MRI, this time of my lumbar spine to ensure my muscle weakness wasn’t coming from my spine. I was wheeled down to the MRI department to make an appointment and they very kindly fitted me in on the spot. Wonderful.

Next day the surgeon rang me. They found a cyst on my spine too, so now I needed to have electrophysiology testing. Off to see a neurosurgeon. Now, dear reader, over the years I’ve had a lot of medical poking, prodding, needles, tests, monitors – but electrophysiology testing would have to be my least favourite. Interesting to be sure, but not so pleasant. You know that old saying, there’s a fine line between pleasure and pain? No, just no. Honestly, it isn’t terribly painful, but it certainly is not pleasant. The second part, where they stick needles in the muscles is not nearly as bad as the first part (but then again, needles never worry me). However, all good, the cyst in my back is not a concern, too small and not in the usually problematic location, not causing any issues. Mind you, he hadn’t seen a cyst in that spot before. Why was I not surprised?

I was still a bit stunned about the whole total knee replacement thing though. So I sought a second opinion. Same advice, total knee replacement required. This surgeon did explain the situation in a way I was better able to understand the problem. In his opinion, the inflammation from the osteoarthritis, with maybe some assistance from dear friend psoriatic arthritis, was causing the cyst. The cyst isn’t in a particularly good position to try removal safely and in his opinion unless we fixed the knee, even if they did remove the cyst, I’d just get more cysts. Great. Not.

Then I had to decide which surgeon to go with. In the meantime, what else was going on? We were, by that stage, in early March. Covid-19 was ramping up around the world. I decided to go with the second surgeon, Mr T, and surgery was duly booked for April 8. I needed a pre-operative health assessment by a physician, the knee components had to be ordered, then another pre-op with Mr T and a rehabilitation prep session with the hospital. All were booked, I was good to go. I had the pre-op health assessment and was sent off from that for a raft of tests (blood, ECG etc).

Then on Sunday, March 22 I got a call from Mr T (my pre-op with him was for the following day). Please don’t come in. Shortly thereafter, of course, all surgery was cancelled.

Consequently, I am now in limbo. A bung knee that has somewhat settled since the end of January hospitalisation, but only if I am careful. I’ve worked out I should do about 2,500 steps a day, in small time blocks, evenly spread throughout the day. Too much activity, knee swells. Too little, knee seizes. I can get around the house now without the walking stick, but for excursions to the supermarket I need the stick.

On top of that, I am self-isolating because I am on an immunosupressive medication.

When surgery will start up again is an unknown at this point: all depends on our containment/management of Covid-19. The surgeon will call as soon as they know. So I wait.

My next article will be about my clinical trial progress, which is going very well (although there is a twist to the story). It was a toss up whether to write about the knee or the clinical trial first!

Oh, and STAY HOME: Social Distancing is critical!

Incommunicado Quads and Walking Sticks

I know I’ve been incommunicado – unfortunately the quads in my right leg also went silent – so silent I couldn’t move my right leg. At 1 am on a Friday morning, not knowing what was wrong, I’ll admit to being a little panicked.

This was a few days after I’d had some very minor, completely unrelated surgery, so it was a bit of a busy time. My knee was already playing up then, as the hospital had helped me into a wheelchair from the taxi on arrival for admission.

Initially I thought I’d just been lying funny and my leg had “gone to sleep” and would recover in a few minutes. When it didn’t, I was a little more concerned. I couldn’t actually make it out of the bedroom – every time I tried, using the windowsill as a walking stick, then swapping to the bed frame – I’d get halfway across the end of the bed and feel SO nauseous I’d have to lie down again. Took me three or four attempts to actually get out of the bedroom. The doctor later told me this would have been due to pain, yet I do not recall any pain, I just could not use my leg. Well, yes, it was very painful if I put any weight on it, but I was studiously avoiding doing that – or so I thought!

To cut a very long story short, I dragged my poor daughter out of her bed, a 40 minute drive away, to take me to the emergency department. By 10 am I could lift my leg about 1.5 centimetres off the bed in ED. By noon I could bend it 90 degrees! Yay! I did not want to be admitted because the following week I was starting a clinical drug trial and intervention at this point might very well have excluded me. More on the drug trial in my next article – it is FANTASTIC.

So I was allowed home with a prescription of rest and elevation. The knee was rather swollen. Something else I didn’t need. It was the swelling in the knee that cut off my ability to use my quads. I should have known: earlier in the week I’d used an ice pack. I remember thinking “This ice pack isn’t very cold” then popping in on my left knee for a moment and thinking “This ice pack is FREEZING”. Clearly there was already a bigger problem brewing than just a sore knee.

My quads shutting down had nothing to do with my psoriatic arthritis. This was just a new problem arriving with very bad timing.

An MRI later and the results were in: “significant osteoarthritis, particularly behind the patella”. Oh, great – just what I need – not.

I got one of those awfully boring grey hospital sets of crutches so I could get around. Of course I thought I’d only need them for a day or two. Umm nah. I did manage to get down to one crutch, but I hated the grey, the cuff didn’t fit properly over my denim jacket and I was about to go to a conference in Sydney (more on that in a later article too). So I bought a very pretty walking stick (see above). If I had to use one, I was going to at least be semi-stylish!

Second problem was how to rehabilitate this knee. My rheumatologist advised (just as well, really) exercise to build my muscle strength back up. With the challenges I’ve had since January with medication changes and the resultant psoriatic arthritis flare, my exercise had taken a temporary back seat. It doesn’t take long to lose strength, especially as we age! I am reasonably sure this contributed to the osteoarthritis letting me know it was not at all happy with me. In order to make 110% sure I was doing the right thing, I enlisted the help of an exercise physiologist, Jack. Yes, I’m a personal trainer, but in this specific case I wanted to triple check my approach was correct. Jack has higher qualifications than I do and I do not hesitate to call in the big(ger) guns if necessary. He did get me to start a little slower than I might otherwise have done (a good thing), but by the second appointment he essentially let me loose. I did pick up some nice new very specific rehab exercises from him and am very grateful for his guidance and expertise.

I retired my walking stick on August 29th after six weeks. Yesterday I was back on the leg press, high reps, low weights. VERY low weights. I did one set at 40 kgs and two sets at 60 kgs. I was doing 160 kgs last year! This picture won’t mean much to readers, but to me it was getting my mobility back!

I’ve also been doing hydrotherapy. I’m “allowed” to do as much hydrotherapy as I like. Jack was thrilled I was doing squats in the hydrotherapy pool, I was thrilled he was thrilled with my adaptation! I do them out of the pool as well, but in the pool is good, especially with this darn knee.

Back in 2014 I’d had a Synvisc shot in my left knee (which was great) but of course that strongly indicates that left knee is not all that wonderful. It also indicates (although I didn’t have an MRI of the right knee back then) that perhaps both knees were a little under the weather back then. I had an arthroscopy on this right knee many years ago and until now had no further issues. Well, now I know I have two knees requiring a little extra care and attention. With the extra load the left took while my right was on strike, by the time I retired the walking stick, my left knee was reminding me it is no longer a perfect 20 year-old knee. I threw my hands in the air and applied the rehab exercises to both knees.

I’m lucky – I have been able to retire the walking stick. Using one is like driving, it takes a long time before it becomes second nature. I felt I was on “L” plates the whole time. I’d drop it when trying to juggle bag, stick and anything else I happened to have – such as a morning coffee. Getting on and off trams was a challenge but at least I was no longer one of the invisibly ill and people jumped up to give me the special needs seats. I now had a badge. I never seemed to be able to lean it anywhere without it falling over – poor Cleo (my cat) nearly got whacked by the flying walking stick several times as it fell to the floor. I felt I just could not get it right. I also felt SO SLOW.

I have a new appreciation and understanding of those who use mobility aids permanently or semi-permanently. In the last week, I carried it with me, but used it less and less as my knee recovered – however then people look at you in very odd ways as you are carrying but not actually using a walking stick. I never thought of getting a folding walking stick – lesson learnt!

That particular situation is much better addressed by Kristen Waldbieser, who does not need her wheelchair 100% of the time.

Between minor surgery and the above, I hope you forgive me for being very quiet. I’m going to make up for that in the coming days. I have a drug trial and a conference to write about! Stay tuned!