18 Months In – Thank You Science!

My clinical trial rocks! No other way to describe it! If you are unfamiliar with the backstory, there is a series of articles, the first of which is A Clinical Trial – Patient Journey – Part I, exploring how I came to be on a clinical trial and the initial phases. In summary, I am on a clinical drug trial for a medication for psoriatic arthritis (PsA), a condition that affects an estimated 24 in 10,000 people (0.24% of the population).

I am now 18 months down the track, so thought it time for an update on progress!

No sore entheses! This is fantastic. The enthesis is the connective tissue between tendons/ligaments and bone. PsA rather likes entheses, unfortunately.

At my last injections I had ONE, let me say that again ONE, toe joint that glowed faintly when all the toe joints were tested. That’s a major improvement from 20!

No sore finger/thumb joints. Not one. The base of my thumbs used to be really painful. I am also no longer splinting my fingers at night on a daily basis to prevent waking up with my hands locked into fists. I find I may have to splint them about a week out from my next injections, but not always.

Left and right index finger splints

My shoulders are fine. Admittedly I do a series of exercises to maintain my shoulders which have helped considerably, but the reduced inflammation is fantastic.

My wrists, which would flare regularly, have not flared for months. I can’t remember the last time.

There has been no progression to other joints. There was no hip or elbow involvement, for example, and there still is no hip or elbow involvement.

My skin in 100% clear. Yes, 100%, clinically assessed.

My finger nails are back to being perfect, although two toe nails persist in having white spots and and the tell-tale ridges across the nails. But they no longer crumble off.

No dactylitis (sausage fingers/toes) this year.

I have lost the 20 kilograms I’d gained with all the various medication changes prior to starting the trial.

Energy levels are much improved. I won’t say back to normal, but much better than previously. This is evidenced by the that fact I am back working full-time. No, I did not take on a senior management role, that would have been too much, but I’m working.

The dreaded brain fog is also much improved, as I have noted before. I don’t like the term brain fog, as readers may already know, but everyone is familiar with the term.

No adverse side effects! After my previous experiences, this is yet another fantastic aspect for me personally.

At my latest appointment, one of the staff commented, correctly, I was lucky I don’t have any joint deformities, especially of the hands. I put this down to early medical intervention – I was lucky to be diagnosed early in my journey.

I’m not cured. I am as close to being cured as I probably ever will be and that is a great thing. The medication, risankizumab, isn’t the only weapon in this war though. I am, as is well known, I firm advocate of Movement is Medicine. I keep my muscles strong. I still wear my “special” shoes to help my back. I had a total knee replacement this year, osteoarthritis – not something risankizumab can fix. Overall, I am very happy with progress.

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A Clinical Trial – Patient Journey – Part V

Catching up?

Apart from draining trial participants of blood every visit, as I have mentioned before joints and entheses are assessed for improvement – or not.

For my first 26 weeks of the trial, the period we now suspect I was on placebo, there was no real change in my hands or feet. Other areas are assessed but for illustrative purposes, I am only going to talk about hands and feet. Many of the joints subject to assessment, such as hips and temporomandibular joints (TMJ), I have not had problems with, so not much point in talking about them!

Now if you don’t know how many joints are in your fingers and toes, let me tell you – quite a few! They test 28 total in the fingers and 20 total in the toes on my trial.

While my finger joints were never my major trouble spot, my feet were a different story. Every single joint would light up with pain when assessed. In some cases, big red siren type lights.

Four weeks ago there was certainly a reduction in the number of joints that lit up and most of the ones that did react to assessment, were as if the dimmer switch had been activated.

Today? Today only TWO toe joints lit up and even those were a faint glow. That is two out of 20!

The hands? Not one of the assessed joints lit up. NOT ONE! Yes, I am still splinting those two trigger fingers at night, but that is not a finger joint issue and they are also improving.

One of the other aspects I am very pleased about, given my past medication experiences, is NO SIDE EFFECTS! Obviously there can be clinical side effects from medications that I, as the patient, would not necessarily recognise, which is one of the reasons they take all that blood. Are my kidneys OK? Is my liver still happy? But from my day to day living experience I’m not having any side effects like I had with the four previous treatments I have been on.

From here on in, I only visit the research clinic once every twelve weeks. The hard part is over. I don’t expect to have any really news to share for the remainder of the trial, providing everything continues to go well. Yes, there is a possibility I could stop responding at some stage in the future, but I’ll cross that bridge if and when it happens.

That just leaves me with the problem knee, but there have been announcements this week surgery will be commencing again and joints are on the list so I am hopeful that will also be resolved ….. shortly. I’ve already been on the phone to my surgeon’s office, so I’m waiting for a date!

I am very happy with the results. I love the team at Emeritus Research, it really is like dropping in to see good friends. Very professional good friends: as a trial participant I feel very well cared for and valued. Great atmosphere. Just watch the coffee machine if you like flat whites, it can overflow!

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Looking After Your Shoulders While We #StayHomeStaySafe

My apologies for the colour quality! With all this self isolation, I am equipment restricted! I also apologise for confusing forearm and upper arm, but you get the drift!

Please note these little videos are meant as ideas and suggestions while we are all in isolation or quarantine at home.

Bear in mind I have not assessed you personally for the appropriateness of these exercises for you. Only attempt these if safe to do so.

Robyn Dunphy1 Comment

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!

Robyn Dunphy2 Comments

A Clinical Trial – Patient Journey – Part III

Catching up?

Post-Baseline

Nothing much changed in the first two weeks. Of course, I was expecting NOTHING to change, I was convinced I would “win” the placebo arm. I still might be on the placebo: psorasis and psoratic arthritis are funny conditions, they can go on holidays and they can roam around your body.

By week three my skin was starting to look different – but then again I see my skin every day, it is hard to detect subtle changes. Work colleagues mentioned my upper chest looked less angry. This was interesting, as it fitted with my own thoughts.

However, my boobs were itching me. I don’t just mean a little itch, I mean if I could have, I’d have divorced my boobs. Let me put that in context: I’ve always considered my boobs a better anatomical feature than my legs. If the choice was between a long but low cut dress versus a short dress with a high neckline, the long, low cut dress won every time. But I was ready to get rid of them, especially at night.

On the plus side however, I was sleeping slightly better. Although psoriatic arthritis is a systemic condition known to affect other organs, you will rarely, if ever, find urological symptoms mentioned. Yet after a lifetime of sleeping a sound, uninterrupted eight hours a night, I started waking frequently. This was SUPER ANNOYING! Also the disrupted sleep doesn’t help fatigue levels. Ah, you see – THAT’S why I slotted in that fatigue article! By Week 4 I was not waking as often – this mirrored my experience on methotrexate. In discussions with my GP and urologist, we agreed perhaps this was linked and we would take a wait and see approach in regard to urology.

Loading Dose

Week 4 is the loading dose of the ….. well we don’t know do we? Whatever I got on Day 1, I got again Week 4. After this, it is administered quarterly, with the exception of some tricky machinations at the six month mark as the placebo arm participants are switched over to the active arm, in order to ensure the secrecy is maintained.

The details of the day are pretty much the same as baseline, with the following variations:

  • The iPad questionnaire isn’t as long
  • Only have to wait one hour, not two in case of an adverse reaction

My skin involvement was assessed at a lower coverage percentage than at baseline.

We did discuss the itching and decided on trying the old staple of calamine lotion. It sort of helped.

Post-Loading Dose

  • By Week 6 my skin was 100% clear. Not 95%, not 90%. 100% clear.
  • My ankles were no longer painful.
  • My thumbs were no longer painful.
  • I was sleeping from 10:30 pm to approximately 5:30 am most nights.
  • I could wear my runners ALL DAY!
  • I remembered a 6 digit number for a whole 10 minutes without trying!

I am pretty darn pleased about all of the above. The boobs were still itchy, but it was subsiding, thankfully.

Remembering that number was so fantastic (to me) I emailed the clinical trial co-ordinator to tell her! I was in a meeting at the time and I was clearly excited. I was ecstatic! I have written before about brain fog – like fatigue, it is something many chronic illness patients battle with. I will write again soon, in a different context, about brain fog. I have to say, this sort of detail is not considered important to the trial powers that be in that far, far away place. But to ME? Wonderful!

Am I tempted to think I actually won the lottery and got the active intervention? The skin improvement is pretty indicative. I am seeing my dermatologist next week for a pre-planned check-up so it will be interesting to see his reaction. After all, he knows more about the behaviour of psoriasis than I do.

Week 8

Week 8 is a check-up visit, quite short. Very quick iPad questionnaire, temperature and BP, bloods (no urine unless you could be pregnant, so I’m safe from that one). Discussion of has the participant had any changes to anything, such as needed to see a GP, had any antibiotics been prescribed, any adverse events, any concerns. Consultation with a doctor and the joint and enthesitis assessments.

I asked about my CRP results from Week 4. Lowest it has ever been since 2014.

My skin was formally assessed at 0% coverage. ZERO! *participant does little happy dance* We discuss the ongoing, although much reduced, itchiness of the boobs. Suspect it may be a sign of healing, such as experienced after sunburn. Sounds reasonable to me.

My thumbs, while not sore in daily use at all now, do still react when clinically assessed. The ankles no longer do. Shoulders and all those darn toe joints still react. It sounded as if less were assessed as swollen, but honestly, without the paperwork, it is hard to keep track. To me some felt less sore than last time, but they were still sore. Still lots of “ouch” from me.

My left foot is still slightly swollen overall, but being able to wear my runners for a whole day is blissful. Means I can walk further for longer, go to the gym, exercise normally.

That’s it. Home time. Not even a coffee (very disappointing).

Now, I could share a photo of the same patches of skin as I shared in Part II but there is no point – it is just clear, bare skin – there is nothing to see other than healthy skin. Not even, which surprised the assessor, any hyperpigmentation marks. My nails have not improved in the same dramatic way as my skin, however I expect that the nail damage likely has to grow out. It has never been bad, I have been lucky, so I’m not concerned.

For the first time in my adult life I am NOT battling to control a flaky scalp. Even my hairdresser was impressed!

This is a four year drug trial. From here on in, my trial updates will be quarterly, unless anything unexpected eventuates. I’m getting back to exercise related articles!

In summary, yes, based on my skin improvement alone, it does appear I may have won the placebo versus active lottery. Placebo effect in the psorasis clinical trials was very low. However, I am reluctant to count my chickens before they hatch. I am still on a low dose of a DMARD – that could have contributed (unlikely based on my discussions with doctors unrelated to the trial). So now I wait and see. If my toes improve over the next few monthly assessments (I attend monthly until March 2020, thereafter quarterly) I will be ecstatic. In fact, simply no disease progression (i.e. not getting worse) will be perfectly fine!

How Do You Find A Clinical Trial?

If, having read this far, you wonder if there may be a clinical trial for you, I have to say finding one can be quite difficult. It took me months. There are, quite sensibly, ethics rules and regulations around recruitment of participants. The patient really has to be the one to initiate the contact, to reach out. Most of the big public hospitals and universities will be running trials and have trial participant registries – at one stage I registered with Monash, for example. You will notice promoted posts on Facebook and other social media announcing clinical trials.

There is the Australian New Zealand Clinical Trials Registry, where you can search for registered trials. The search feature is intuitive and simple, a sample result is shown below.

There is the government web site, Australian Clinical Trials. I found the search feature on this web site extremely difficult to use and not remotely intuitive. As it is sourcing all data from the above ANZCTR database, just use the ANZCTR.

Research4Me is an organisation that works in this space. I quote from the website: “Reliable information and access to opportunities to take part in and contribute to clinical trials should be available to everyone. People deserve the right to a choice as to whether a clinical trial is an option they’d like to try, or help improve.” I met the founder of Research4Me, Janelle Bowden, at the ARCS conference in August. 

Last, but by no means least: where am I doing my trial?

Emeritus Research. If you are interested, visit the website, check their Currently Recruiting page, drop them a line.

Emeritus Research are extremely professional, yet at the same time the participant feels almost like family. It is a very supportive and safe environment. I am very happy. They also have a great sense of humour, which I really like – laughter is the best medicine, after all. This is an Emeritus Research Instagram post, which appeared shortly before my loading dose appointment. NOT the word I wanted to hear at the time, but I couldn’t help but laugh.

Robyn Dunphy2 Comments

When Was the Last Time You Yawned?

Fatigue, lethargy, exhaustion, lack of energy – call it what you will, many chronic condition patients will experience varying degrees of lack of get up and go. Are you fatigued without ever (or rarely) feeling actually sleepy?

The Royal Australian College of General Practitioners describe fatigue as:

Fatigue is ‘that state … characterised by a lessened capacity or motivation for work … usually accompanied by a feeling of weariness, sleepiness, irritability or loss of ambition’.1 It is derived from the Latin fatigare, to tire. For the purposes of this review article, we regard fatigue as synonymous with tiredness and malaise.

Source: Fatigue – a rational approach to investigation

Most chronic illness patients learn to pace. I’ve written Pacing for Beginners and Pacing UP, Pacing THROUGH, Pacing DOWN so I won’t go into detail again. Pacing is critical so we don’t boom and bust. Yet none of that answers the question of WHY are we lacking energy? Why do we burn out so easily?

At one stage I researched the research. I couldn’t find anything that gave me a concrete answer. Many theories and ideas, but no solutions or treatments. Many writers suggest the fatigue or lack of energy is caused by pain. Of course, the experience of pain can be worse if we are tired. What comes first, the chicken or the egg? While that is very valid in many cases, as pain is indeed tiring, it doesn’t explain those of us who have minimal pain. I can go for months without pain, but the lack of energy was always there.

In some cases it is suspected fatigue is a side effect of medications. This will be the case in some situations. But fatigue was one of my first symptoms, prior to any medications. Admittedly, in my specific case, I had a hyperactive thyroid which is known to cause fatigue, at least partly through disrupted sleep. I also had undetectable levels of Vitamin D back then. Comorbidity can indeed complicate troubleshooting!

I read also of pain leading to depression leading to fatigue. Again, possible in many cases. So it IS complicated. I hear SO MANY fellow patients complain of fatigue when it seems their primary condition is well managed – aside from the fatigue. Some conditions (mine is one) do list fatigue as a known symptom, while other conditions do not.

The focus was/is primarily on improving/maintaining mobility, and pain management, I could find little about improving or minimising the fatigue levels. Yet so many of my chronic illness contacts are vocal about the impact on their lives.

There has certainly been work done on measuring fatigue. Measuring fatigue is an important starting point, for how can we treat something if we can’t measure it? But any measuring is going to have a degree of patient subjectivity. A bit like the pain scale, which we are all familiar with. An allied health professional shared with me recently it is not unknown to have a patient cite a back pain of 8, only to easily bend over and pick up something they had dropped on the floor. How can we measure fatigue objectively? Would the medical profession take it more seriously if there was a blood test for that? Yes, there are blood tests that may isolate a cause for fatigue: Vitamin D, iron, thyroid function to name a few of the more common. Assuming all those are A-OK, there is no objective measure of my level of fatigue as a psoriatic or rheumatoid arthritis patient compared to any other patient with the same condition or any other condition.

I was discussing fatigue with a doctor recently. She said many patients across the range of arthritic conditions say they can manage the pain, but not the fatigue. The fatigue affects their quality of life far more than the pain. What can we do about it? Can anything be done about it?

One of the main improvements I am hoping for from the clinical trial I am on is an improvement in my fatigue levels AND to prevent it getting any worse. I totally recognise my fatigue is NOT too bad – I am aware it could be way worse. Even so, it is sufficient that yes, I have to pace, I have to avoid the boom/bust cycle. I have to be careful.

Recently a friend invited me to her birthday dinner. It was on a Monday night and a fair drive away. I knew if I worked Monday, drove and socialised Monday night, I would not cope as well as I should on Tuesday at work. I declined. Yet before I acquired my new life partner, psoriatic arthritis, that would not have been a problem at all. Fatigue is a far bigger problem for other patients than it is for me personally (at this time).

We need to exercise (where appropriate and recommended): that takes energy. We need to work (those who are able): that takes energy. We need to take care of our homes: that takes energy, especially if you own a cat – all that vacuuming. We need to shop for proper food and cook: that takes energy. When energy is limited, something gets dropped. Usually exercise is the first to be let go. That then means we don’t sleep as well, likely exacerbating the fatigue we already feel. Our bodies decondition, as a result we feel more pain, more pain makes us more fatigued. It becomes a vicious cycle.

About two weeks ago I was sitting in my lounge in the evening and yawned. I don’t think I’ve yawned for possibly five years. Yawning can be a signal we are ready to sleep (or hungry or bored). I’ve been sleeping better of late: now I’ve started yawning again. There may be more to yawning than we think. This article in The New Yorker from 2014 discusses yawning is a broader context – it isn’t only related to sleep hygiene. Even so, most of us can relate to yawning when we are tired.

I remember once being advised by a psychologist to go to bed/sleep “when you start yawning”. I recall thinking at the time,”That’s odd, I never yawn anymore”. I didn’t mention it though and promptly forgot about yawning. I was told if you delay, it will be 90 minutes before you feel sleepy again.

Yawning made me think about my experience of chronic illness related fatigue. I rarely felt sleepy (with or without yawns). There is a difference between feeling very, very tired and actually feeling sleepy. I’d forgotten what feeling sleepy actually feels like. Tired, yes – sleepy no. Am I alone in this? 

Where am I going with all this? To be perfectly honest, I’m not really sure. I am very interested in hearing of others’ experiences. What can we patients do to raise the profile of fatigue as an issue we want fixed if at all possible? Yes, it is recognised, but what is happening to develop strategies or medications to relieve this debilitating symptom?

Please share your thoughts and experiences.

  • Do you, as a chronic illness patient, feel fatigue is seen as important by the medical profession?
  • Do you experience being really tired, but not sleepy?
  • Am I the only one who stopped yawning?
  • What impact does fatigue have on your quality of life?
  • Do you think in your case it results from pain, medications or is it a symptom of your condition?
  • Do you think your family and friends understand your fatigue?
  • If you are a family member of a chronic illness patient, do you feel you understand?
  • Anything else you would like to share?

Let me tell you something – writing about yawning makes a person yawn. A lot!

PLEASE NOTE: Fatigue can be caused by a great number of medical situations and can range from annoying to critically serious – this article is ONLY addressing where it is a symptom of an underlying condition. If you are concerned about ANY change in your fatigue levels, please consult your doctor.

Robyn Dunphy6 Comments

A Clinical Trial – Patient Journey – Part II

I mentioned at the end of A Clinical Trial – Patient Journey – Part I that I had originally planned not to share my experience until after the placebo arm was over. On reflection, I realised that would in fact be unintentionally biased reporting, because events during, and the experience of, that first six months, when I may or may not be on the active intervention, are valid when discussing clinical trials from a patient perspective.

I had convinced myself I would get the placebo. I do not have a history of winning at chance! The lottery? Yeah, nah. Raffles? Not a hope. Scratchies (are they still a thing)? Never! I did once win $100 in a work event of some sort, but that is hardly indicative of a great winning streak. Psychologically, it is easier to plan on having a further toughish six months than be disappointed if nothing happens. Makes sense, I think!

In Part I, I also mentioned I thought I may get an early indication based on any skin improvement. This graph is from psoriasis clinical trials.

Source: http://www.medicines.org.au/files/vepskyri.pdf

As can be seen from the above, results in the skin trials were seen very quickly. Although the trial in which I am participating is for the arthritic condition, the skin condition will also be treated.

Let’s pick up where we left off, at the baseline visit.

Baseline

After dealing with all the paperwork, doctor consultation, having bloods and urine taken, temperature and blood pressure checked, joint and enthesitis assessment and answering a lengthy quality of life type questionnaire on an iPad, it was time for the injections. I remember watching it go in (yes, I watch injections, apologies to squeamish readers) and thinking, “There’s my saline solution dose for the day”. One into the abdomen, one into the thigh.

From November 2018, I had been having UV B light therapy for the psoriasis. It really works well, but one of the criteria of the trial is no light therapy. Makes sense – the aim is to test the efficacy of the drug and that would be most difficult if certain other therapies (see explanatory comment below) were being employed at the same time. So I had to stop light therapy a specific period of time prior to the baseline visit.

The following two photos I took July 6. While with UV B and methotrexate it had reduced dramatically, once off both those therapies the skin had flared again. My baseline visit was July 17. I’d stopped the UV B therapy a little earlier than I otherwise would have, because I’d stopped in preparation for one trial, then ended up on the sister trial with a later start date.

These photos are embarrassing to share, nor are they anything like “clinical quality” as I just snapped them with my phone, but they are more meaningful that quoting percentages. If my articles are to be useful to readers, I have to be prepared to drop the mask of normality so many of us wear a lot of the time. I wanted my own baseline for comparison. We forget how things looked, over time: I wanted to be able to look at my skin further down the line on the trial and be able to see (or not see) any change. As this trial is for psoriatic arthritis, not psoriasis, no photos are part of the trial documentation.

The image on the left is a patch on my leg. The image on the right is my upper chest, just below the collar bone. You can see older images of my arm on “I am Medication Free! For Now, Anyway…”

The skin makes swimming and hydrotherapy embarrassing. Rightly or wrongly, I worry other swimmers are going to think I’m contagious. It just looks…..horrid. Worth mentioning, perhaps, this sort of skin involvement is new to me – when I say new, I mean I went through MANY years of my life with the odd tiny patch which would disappear, or absolutely none. I am not used to this.

I’ve shared this swollen foot photo before, this was February, just as DMARD number two washed out of my system. This is the psoriatic arthritis aspect. The right second toe is clearly also swollen – dactylitis. Yes, you may indeed compliment me on my choice of polish!

The joint and enthesitis assessment is quite lengthy because it involves an independent assessor testing the many finger and toe joints as well as, jaw (TMJ), feet, elbows, shoulders, sternum, knees and hips (SIJ). It seems as if, if you have a joint, they will assess it! I never think of my toes being sore, aside from the big toes, yet it is surprising just how sore they are when a relatively light test pressure is applied. I knew my thumbs were sore, but all those toe joints: ouch, ouch, ouch.  My fingers, aside from the thumbs, are OK. Even the thumbs are not bad – the soreness doesn’t stop me doing anything AT THIS TIME: however my concern is disease progression. I want, if at all possible, to stop progression.

The assessor also looks at and records the percentage of the body showing skin involvement.

At the point of the above photo, I could not fit my runners on at all – that makes exercise difficult as the gym frown on bare feet for safety reasons. The swelling had reduced a bit by July, but I was still struggling to wear runners for any length of time. The assessor, using a clinical approach rather than my layperson’s visual assessment, flagged many of my toe joints as swollen as well as sore. We get used to looking at our own bits and pieces and over time the abnormal can start to look normal.

Which injections you get is controlled by a mysterious person far, far away. To that mysterious person I am just a number. My co-ordinator emails the mysterious person, who I suspect at baseline tosses a coin to decide which arm I’m in: active or placebo. Of course I am joking – it is likely much more scientific than that. Now I’m curious – I must ask next visit!

An email comes back advising which two numbered boxes are to be used for my participant number. I wanted to keep the boxes as souvenirs (main photo) but they have to be kept for the trial auditors to check I was given what I was supposed to be given.

None of us, the investigator, or my co-ordinator, or I know what is in those syringes. It is a 50/50 lottery at baseline.

After the injections the trial participant (i.e. me) sits around for two hours in case of an adverse reaction.

Take a book or iPad or Kindle with you is my advice! You may have another participant, of your trial or another trial, to chat to or you may be sitting alone. Very comfy chairs, nice throw rug for colder days, but essentially a pretty boring two hours.

Then time to go home.

Please, PLEASE bear in mind that even if you were on the exact same trial as I am on, you may have a completely different experience to my experience. Your disease would not be at the exact same stage as mine, you may have more or less joints affected, you may have more or less skin involvement, you may suffer more or less fatigue than I do. So many variables. What I write is my specific experience. Your experience may be similar, or not.

The next stage in the loading dose. This happens four weeks after the baseline injections.

I know, I know, you want to know where I am on that graph! Can I fit my runners on now? Well, I gave the runner answer away in a recent article if you are paying attention. Be patient, all will be revealed in good time. I had to wait and see!

Explanation re Concurrent Therapies

Although light therapy is not allowed, participants may stay on up to two DMARDs while on the trial. After all, if the participant is in the placebo arm, if no concurrent therapies were allowed, those participants would effectively be receiving no treatment at all for six months. Each clinical trial will have restrictions specific to that trial.

I am also restricted in what other medications I can take, such as pain medications. Given I rarely take any pain meds (exercise is my pain management), that didn’t worry me. I can’t change my dietary supplements, although I can stay on the ones I started on e.g. Vitamin D as ordered by my endocrinologist, fish oil as recommended by my sports physician. There are rules around surgery during the trial.

These are all considerations when deciding whether to participate in a clinical trial.

Robyn Dunphy3 Comments

A Clinical Trial – Patient Journey – Part I

Background

After discovering last November (2018) that my second DMARD (disease-modifying antirheumatic drug) had to be retired from my treatment regime, I did two things. I tried going medication free. I also started researching drug trials. If being medication free didn’t work, what was going to be my next step? What choices did I have that might be outside the standard treatment pathway?

Why research drug trials in particular? The first DMARD I was prescribed was developed in the 1930s. The second was introduced in 1955, originally to treat malaria but was later found to have immunomodulatory properties. These drugs are as old or older than I – surely modern medical science had something better by now? Something I wouldn’t have reactions to?

Well, yes, there are newer drugs available. Biologics are available on the PBS (Pharmaceutical Benefits Scheme) – IF the patient qualifies. That qualification bar can be high. As a example, this link to the PBS has the qualification requirements for one biologic that may be used to treat psoriatic arthritis. Click on the red “Authority Required” link to see the qualification requirements. When would I qualify? When I was 80? Not really a very positive thought for me. Yes, a private script can be given, but at $1,049.69 for four injection pens that is a little outside my price range long-term. And that is one of the cheaper ones. $40.30 with PBS subsidy. The schedule is usually inject once a week, so that is a monthly cost.

After much researching I found a drug trial that appealed to me. I don’t know who thinks up drug names, but this is risankizumab. Before I learnt how to say it, I referred to it as the “Kazakhstan drug“! I had researched the drug extensively, then looked for trials in Australia. The drug had already been approved in some jurisdictions to treat the skin condition psoriasis, so there was plenty of information available. On July 23, 2019 it was announced this drug received TGA (Therapeutic Goods Administration) approval for use in Australia, but is not yet on the PBS.  Published results from those clinical trials were very informative and positive.

The trial in which I am a participant is to assess the efficacy for psoriatic arthritis.

So I had found a drug trial I was interested in for a drug that looked very promising.

What Was I Looking For?

At this point you may be asking what was I looking for by considering doing a drug trial. As odd as this may sound, I was looking for treatment stability. I am now on my fourth DMARD. Each one has not been the right medication for me. As noted above, some of these were not the newest drugs around. Plus there was this encouraging line on the patient information sheet of one: “It is not clear how [drug X] works.” Or this one: “It is not clear how [drug Y] works in inflammatory conditions; however it is thought to have an action on the immune system.”

There is my personality type to take into consideration. I’m one of those annoying yellow quadrant HBDI people – we are the experimental thinkers. This might make me a radical patient, I suspect! It means I’m always looking “outside the box”.

I’d also had the experience of having a Synvisc injection when it was very new – that experience had been extremely positive for me. Trying new stuff is not something that scares me in the slightest.

I have faith in medical science. No, we don’t always get it right, thalidomide being the classic example as I have discussed before. I don’t seem to qualify for the biologics currently on the PBS, yet I was desperate to at least try a medication younger than myself. A medication where the therapeutic action was actually known.

I wanted something that worked without the myriad of side effects I’d experienced to date. I was also looking for a medication that might address the fatigue that goes hand-in-hand with many chronic conditions, including psoriatic arthritis.

A Third and Fourth DMARD

There was an event that drove me even more in the direction of being involved in a drug trial. In March this year, while I was still mulling over the prospect of being a lab rat, I suffered an adverse reaction to my third DMARD. I was prescribed a fourth DMARD. It seemed if there was a reaction to be had from these DMARDs, I was unfortunately a person who was going to react. By this stage I had lost faith in DMARDs as a treatment for me. I must stress, they work perfectly well for many, many people. I’m just not one of those people, it seems. One of the DMARDs had worked wonderfully for the arthritis, but ruined my skin, for example. There was something with each of them.

Again, I stress, all these were the standard treatment pathway. I wasn’t being “mistreated” in any way.

Next Steps

I discussed the proposal with my GP, my dermatologist, my urologist and my pharmacist. All four were very supportive. I have since also brought my gastroenterologist up to speed and he is also supportive. I must make clear I was not asking them from a rheumatological perspective of course, I was seeking any concerns they may have for me in their field of speciality and/or any concerns they may have about MABs in general.

I signed up and waited for the screening appointment. While waiting I bit the bullet and got a second opinion. This rheumatologist was also supportive of my desire to do the trial. Disclosure time. Through sheer coincidence this professor happens to be involved with the drug trial. My GP had written the referral well before I’d found the trial I was interested in. My GP had not even known I was researching drug trials, I had never mentioned it. The fact there was a connection was serendipitous.

Screening

My initial screening appointment was on my birthday! That was in June. So. Much. Blood! They do take a lot of tubes of blood, let me tell you. At least for this trial. I failed the first screening. Probably because I’d been taking prednisolone to try to control the inflammation while DMARD four ramped into gear, my CRP (C-reactive protein) had dropped 0.15 below the cut-off. A month earlier it had been way over. Luckily there was a sister trial with different patient qualification criteria and those criteria I did meet. That meant a second screening appointment. That took place in July. Of course, at this later screening my CRP was back up again, well over the cut-off for the first trial, but the rules are the rules. I am on the sister trial.

You are weighed, height measured, vitals taken, blood tested, joint and enthesitis assessments are done. The skin is assessed. There is paperwork, lots of paperwork. A medical history is taken (I took in a typed history from birth to now). A consultation with a site doctor. All up the screening process takes about two hours.

When I cite visit durations, these are for this particular trial. Other trials for other medications may be longer or shorter.

Active or Placebo?

This is a double blind clinical trial. Those wanting further information on clinical trial protocols in Australia can read this link at Australian Clinical Trials. Yes, there is a placebo arm. While the trial goes for four years, the placebo arm only goes for six months, after that all participants are on the active intervention. My rationale was six months of placebo could not be more difficult than the last six months I’d been through and I would only have to manage for six months if I lost the 50/50 lottery. I had nothing to lose.

I also knew that results from the trials for treating the skin condition showed very little placebo effect and that results had been seen quite quickly. I felt I would have a very good indication before the six months was up of whether I was on the placebo or the risankizumab, based on my skin.

Baseline

My Baseline appointment, the appointment where you actually receive the drug or the placebo, also took place in July. This was a much longer appointment. Essentially all the steps of the screening appointment are repeated, plus the injection, plus the patient has to wait for two hours post injection to ensure there is no adverse reaction. The coffee is good.

How is it going?

I was originally not going to write about this until after the six months. The fact I am writing earlier should be a slight hint. This will be a series as there is way too much information for one article! Tune in later in the week for Part II!

Robyn Dunphy6 Comments

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!

Robyn Dunphy3 Comments

No Remission for Me – At Least Not This Time

My experiment didn’t pay off. Am I sorry I did it? Not really, because knowing me, had I NOT done it, I would have always wondered. That is a very personal characteristic: it would not apply to everyone! While I am a firm supporter of modern medicine, I don’t like taking any more medications than absolutely necessary – had I not done that three month wash-out, I would have always wondered was I taking medication when I didn’t need to. Now I know! I need a medication!

The one thing I have learnt is this autoimmune arthritis, currently considered to be psoriatic arthritis, has a tighter grip on me than I thought.

So what happened? I was fine until about two weeks before the three month wash-out period ended. First I got a sore toe on my right foot. I thought nothing of it as I had been wearing in some new shoes plus it was possible I’d stubbed the toe without realising it. Then I got a VERY sore brachialis origin – thought maybe I’d strained myself in the gym, but couldn’t quite figure out what I had done, given I am so careful. Plus my right shoulder was tiring when I was swimming.

A week before I was due to see my rheumatologist, my left foot started swelling. Right at the moment I have only one pair of shoes I can wear and that is only because they are sandals with adjustable straps! These are my feet compared after a day at the office.

Today, I have a sore toe on my right foot, a swollen left foot, my whole right shoulder and upper arm are causing me issues and the discomfort is radiating up my neck. My fingers are a little stiff, but nothing too bad. My knees are grumpy, both of them. I’d being trying to avoid prednisone, but I’ve capitulated. Only a small dose though, to tide me over.

On a good note, my skin and nails look fantastic!

Two weeks ago I started methotrexate. Too soon yet to feel any improvement: so far no side effects. My dermatologist will be very happy – he wanted me on it straight away.

I am sad I’m back on medication, but I am grateful there are medications that will help. This is my third medication since the start of 2015. I am hoping this one will improve the fatigue and the brain fog, both of which have always been a bigger problem for me than actual pain (until right now, that is).

The brain fog is partly why I haven’t been writing – thinking is actually a struggle, particularly at the moment. Aside from that, I was wary of writing that I was fine until the jury was in at the three month mark. I knew I was taking a risk and did not want to sound celebratory until I knew whether I had anything to celebrate!

Will I do it ever again? I think, given my age, probably not. If I can get the brain fog to lift, I’d be ecstatic, as it is the one symptom that I find really soul destroying. I’m  good at managing the level of pain I experience, it is the brain fog that drives me nuts. I used to be an avid reader – now I am not simply because the combination of fatigue and brain fog makes it a challenge rather than enjoyment. Mind you, it is all relative I suppose. I was speaking to a contact the other day, bemoaning the cognitive impact. The response was something along the lines of, “Well, I’m glad I didn’t have to debate you before you got sick, you’re sharp enough now!” Maybe they were just trying to be nice. But us sufferers, we feel the loss very keenly.

The fatigue is helped by exercise, but with swollen foot and dodgy shoulder, I’ve been instructed to rest for the moment. This is SO not me, I’m struggling with abiding with that instruction. Mind you, it is difficult to go to the gym when my runners don’t fit!

In another two weeks I can hope for some improvement. Regular blood tests are again the order of the day, something else to fit into my schedule.

I have four weeks of UV B light therapy to go. Although it only takes a couple of minutes, it does require careful scheduling and at three times a week I will be glad when it is over: I won’t have to dash from work to the dermatologist at a specific time. A little flexibility will be restored!

Yes, I’m disappointed, but I’m happy I had the opportunity to try. Many people are too unwell to even consider such a trial. The fact I could, I am taking as a positive.

Now, just let me get back in the pool!!! I miss my swims!

Robyn Dunphy2 Comments