Clinical Trials, Abscesses and Fistulas.

Clinical trial enrolment

In late December 2018, I began the process of entering a clinical trial for a new biologic called Risankizumab. The first thing anyone looking to enrol in a trial will likely have to do is a “washout period”, basically where you stop taking all other treatments for about 6-8 weeks to ensure that you start the new drug as a clean slate. In the new year I was then able to begin the screening process of the trial which involved lots of tests like bloods, x rays and colonoscopies as well as meetings with the research team. This was only my second time having a colonoscopy with sedation rather than a general anaesthetic and, although I was told that some people respond really well and practically sleep throughout the whole procedure, I felt no different after they had given me several injections through my canula. All I remember was how unpleasant the experience was; firstly, because this was the very first time I had the chance to actually watch the live footage being captured by the scope on a wide screen. It was like a virtual reality tour of my insides and believe me, they were not pretty! And secondly, because the last thing anyone with severe active disease and impassable strictures wants is someone shoving a tube through their colon. I spent about 40 minutes in agonising pain squeezing the hand of one of the nurses. At one point it was almost unbearable, and the doctor said that he could stop if I wanted, but I needed the test results to enrol in the trial, so I had to grin and bear it.

In line with how painful the procedure was, the results showed severe and widely distributed inflammation and several tight strictures- exactly the severity it needed to be for me to enter the trial. I had to sign a whole bunch of paperwork and I was told on leaving the hospital that it would take a couple of months to process all of my data before I could be properly enrolled. In the meantime, I had to start a patient diary which I would have to continue throughout the whole trial. This was basically an old remodelled phone in which I had to input daily data like my pain level and how many times I’d been to the toilet- these also needed to be over a certain number for me to qualify. Despite the incredibly loud and unpleasant alarm that went off at 8pm each day to remind me to fill in the questionnaire, I got used to it.

In terms of my symptoms however, I was struggling more than I had for years. Because being on an exclusive liquid diet excluded me from entering the trial, I had to go without any treatment at all for the 3-month screening period and during this time I experienced the worst flare up I had ever had. I had terrible joint pain and awful abdominal cramps, I was vomiting constantly and I was going to the toilet over 20 times a day, so I only managed to sleep in 30-minute increments before having to rush to the toilet again which meant that I was permanently drained and exhausted. I was futilely still trying to stomach a small amount of food, but I had lost so much weight and my anaemia had reached rock bottom; I looked like a shell of a human being and felt like one too. I couldn’t even take a proper shower as my legs couldn’t handle it, and I was so dehydrated that I kept collapsing and had to lie down all of sudden to try and prevent myself from passing out.

This was a very difficult and emotional time for me. I went to bed each night dreading waking up the next day and having to relive this nightmare over and over. I woke up wishing the new day would be easier but knowing that it wouldn’t be. Everything felt so futile. I was barely surviving; I certainly wasn’t living. The most I could manage to do in the few hours that I was actually able to keep my eyes open was to lie in bed watching some pointless tv show to try and take my mind of the pain and discomfort. I was also so lonely, something I’m sure you’ll understand if you have a chronic illness. Sure, some of my old friends from university messaged me occasionally, but I was never in a good enough place to talk on the phone or skype them, and most of the time I wasn’t even in the mood to text message. I tried to carry on being supportive of them despite what was going on in my life, but in all honesty it was hard always being the one who was forced to sit on the side-lines and congratulate everyone else on their successes whilst being stuck in an endless cycle of incapability. As sad as it sounds, it made me feel like a bit of a waste of space. It’s not that I didn’t want to do anything (I even naively sent out some cover letters for internships later on in the year), I just couldn’t. Not only was I missing out on the fun of being a teenager as I had so many times before, I felt like I was getting even more behind in life overall.

Luckily, I finally got a call saying that I’d been the third successful candidate to be entered into the trial from my hospital and my first infusion would be next week. I was obviously relieved- it couldn’t have come soon enough! But I was also apprehensive; I didn’t know if I was going to be getting the actual drug or just a placebo for the first 12 weeks! Then after this induction phase, I would either be moved to a maintenance trial if I’d been given the drug and responded, or if I hadn’t gotten the drug in the first place, I would then finally be given it. I just wanted to get the first dose over and done with. The only problem was that I was in such bad shape that travelling was almost impossible. It took 4 days of complete starvation to “empty” myself enough to even make the trip, and even then it was a struggle. But upon arriving at the hospital, I was quickly left devastated. It’s not like I was naïve enough to expect this infusion to be an immediate cure-all, but I had obviously considered the possibility that this may be the first step to feeling something other than absolutely terrible after months of suffering. But when we got to the trial lab, no one was there. I soon got a call from my main research consultant and she explained that there had been some kind of “mix up” and the only person authorised to administer my infusion was on holiday, so I couldn’t have it today. I can’t even explain how gutted I was for so many reasons, and my mum was far from amused. Although I could easily have made a scene, I knew it was no use. So, to make up for that gut-wrenching disappointment, the researchers who were there offered to pay for our taxi halfway home. I know, how generous. Another two-hour car ride later, I was at home again, no closer to getting treatment.

Abscesses and fistulas

I got a call the following day saying that I would have to go all the way back to the hospital the week after to have the first infusion, hopefully for real this time! So that meant a couple of days of miniscule portions of food followed by more starvation for the journey. But a day or two into that week in-between, I started to notice something a bit unusual. Being someone with a chronic illness who has experienced a plethora of symptoms over the years, I had become quite au fait with knowing my body and noticing new developments. And I began to find it a little uncomfortable to sit down. I know, that sounds really strange and I myself couldn’t put my finger on it. So, I went with the default approach: keep an eye on it for a few days and make sure it’s a “thing” before telling someone- I didn’t want to cry wolf after all, particularly as my place on the trial was conditional. But it soon became clear that this definitely WAS a “thing”. And unfortunately, given all my previous research on Crohn’s disease, I was pretty positive I knew what this “thing” might be. Literally within a couple days I couldn’t sit down at all. Seriously, it felt like I had a golf-ball sized and INCREDIBLY painful lump on my bum (sorry, there’s not exactly an elegant way to explain that…). I walked like I had really bad chaffing and had this strange rushing sensation to that area. I couldn’t believe this, on top of everything else, I now couldn’t do the one thing that I spent most of my time doing, sitting down! That’s when I emailed my research consultant and suggested that I thought I had an abscess and possible fistula. She sounded pretty surprised as it seemed to have sprung out of nowhere, but I kept quietly confident that this was what was going on. She told me to come up to the hospital as planned for my infusion anyway and she would have a look.

So, I did my four days of starvation and crouched awkwardly in the car for 2 hours and eventually made it back to the hospital again. My consultant “examined” me to say the least (OUCH!) and the look on her face suggested she was actually starting to believe that this may be something pretty bad. She told me that to be safe, she would take me down to the surgical department and get someone more experienced to examine me as well, as I couldn’t be given the first trial infusion with an abscess because the drug may expand it, or even burst it. Fantastic. So down I went to be examined again and the surgeon said that he thought it was likely an abscess as I’d suggested and told me that I needed an urgent pelvic MRI to find out the exact size and location. Great. Was it just me, or was the universe trying just about everything in its power to prevent me from having the trial drug!? My consultant then suggested that I be permanently admitted to hospital anyway as things were pretty diabolical all round at this point, but I knew that hospital food would only make my symptoms worse, as would the fact that it is basically impossible to get any sleep on a ward. Plus, there was NO way I was sharing a bathroom. There wasn’t anything they could do for me anyway, other than give me IV fluids. I liked my chances better at home.

Soon I was called for my MRI- the only plus side being that, as it wasn’t an abdominal scan, I didn’t need to drink any disgusting fluids. Always a silver lining. And a few days later I got the results. Turns out I had a 5mm intersphincteric abscess as well as a 1.5cm subcutaneous abscess with complex fistulae tracks going on down there. I was then told that I would need to be admitted to hospital as soon as they had a surgical slot for an EUA (examination under anaesthetic), during which the surgeons would decide what to do to sort it out. This delayed my trial enrolment even further as having any untreated abscesses was an exclusionary factor. In other words, they needed to be confidently dealt with before I could receive the drug. And before they could be dealt with, I needed a surgical pre-assessment to make sure I was fit enough to even have the procedure and to explain the potential outcomes- as they wouldn’t know what to do until after I’d been knocked out, I would have to consent to a number of possible procedures.

The pre-assessment wasn’t anything too exciting, they mainly just explained that the most likely option was drainage of the abscesses and the placement of a seton- a loop of string which would be threaded through the fistula tracks and left indefinitely to allow any remaining fluid to drain. Obviously this wasn’t a particularly appealing prospect, but I didn’t have much of a choice and I just wanted this sorted so I could finally get some treatment for everything else! And soon I finally got an admission date for the procedure: March 15^th 2019, six days before my 20^th birthday.

Looking back

The first thing which strikes me when remembering all this is about friendships. Although we’re great people obviously, friendships can be difficult when a chronic illness is involved. I was lucky in that I had a couple of close friends who really tried to understand and stood by me even though I was far away. But at the same time, I would be lying if I said that my battle with my illness hadn’t affected some friendships, and in certain cases ended them. Some people, quite understandably, just don’t know what to say. That isn’t necessarily the issue. The issue is when people don’t know what to say and consequently try to compensate by giving some (I’m sure well-meant) advice about how you should deal with your struggles like “being more positive” or sleeping it off. Yawn. This got rather tedious for me.

I had other friends who felt bad for me and guilty for confiding in me about their own problems. They thought the trivial nature of their concerns paled in comparison to mine and eventually they stopped sharing them with me, which ended up creating a real distance between us. I even had one friend who, after a rough patch in our friendship, flat out told me that being friends with me was (and I quote) “a lot” and she couldn’t deal with me talking about my health anymore. Well, sorry I thought, that’s part of my life, so if you can’t handle it don’t be friends with me. It’s true, friendships are complicated when one person has a chronic illness. But that doesn’t mean that all of these friendships are doomed to fail. There are people in existence who are sympathetic without feeling pity, who try to understand and support you whilst accepting that they will never fully relate to what you go through. You just have to find them and hold onto them! One thing I always make sure I do though is to tell new friends that despite whatever is going on with my health, they can always talk to me about anything and that, just because I battle with my health more than a lot of people, it doesn’t mean that their issues aren’t equally important.

Another important thing to take away from this time in my life is about knowing your body. Whether you have a health condition or not, being able to keep tabs on your body and notice when something is different is always essential. Whilst you don’t want to be calling your doctor every other day if you notice a tiny spot (they may not take you seriously after a few false alarms!), you do want to be vigilant and proactive in monitoring yourself and reporting any concerns if they persist.