Third Time Lucky

Between October 2015 and September 2017, I started Vedolizumab three times.

The first time – October 2015 until February 2016, I was the second patient – first female – at my hospital to receive Vedolizumab as it was only NICE approved that summer and available on the NHS from September. It was a definite bridging medication to get me into 2016 where we had time to develop a surgical plan.

The six months afterward, I had gone through two major surgeries, four non surgical admissions and three bowel infections. An executive decision was made to ensure my clinic picture continued to improve post subtotal colectomy, I would restart Vedolizumab within six weeks post op. I noticed an immediate change in my symptoms, in my healing and my general demeanour. It was the most well I’d felt since Diagnosis Day back in 2011.

That ‘cycle’ ended in January 2017 as we hit clinical remission and it was decided no longer needed. I was keen to see if my body would calm down without its disease colon and my small bowel could sort of heal itself with good nutrition.

Sadly, within another six months; I had a huge flare, two large blockages and several instances of twisted small bowel which resulted in returning to Vedolizumab.

Why Vedolizumab that time?

  • I hadn’t lost response to the drug early on in the year.
  • I wanted to go back to a some what familiar routine.
  • My new hospital could easily pick this up and monitor me; ensuring a good bridge of continuation of care.
  • We wanted to save any of the ‘new’ drugs at the time – see Ustekinumab – for when / if I lost response.

Following that third restart, I had some issues right off the bat – the first and most scary one was really high WBC [white blood count] and Neutrophils – the blood markers for infection within my body – on my second loading dose. Once we had repeat blood work after a delayed infusion date, things settled down; until Infusion #4 & #5 which brought out a huge facial abscess which needed draining twice within two weeks. I also went on to need to see a Dermatologist for delayed Adult Acne as a wonderful side effect of the medication too.

Despite all this, I am still receiving eight weekly infusions of Vedolizumab with no additional medical therapy for my IBD. Even my acne settled down and only flares when I am stressed – which is frequently with my anxiety!

I was still willing to have my Vedolizumab despite these side effects because the other side of the grass was not greener. I had seen what not having medication did to me – see, March to August 2017 for a huge reason! – and I knew the risks and benefits of this drug before starting it.

What is having Vedolizumab like?

  • Up to 2 days after infusionhigh [lots of energy, want to organise and clean & make plans!]
  • The first full week low [low energy and motivation. feel about IBD – joint pain, abdominal pain, nausea & changes in stoma output]
  • The next four weeks – are without issues; taking it to 6 weeks total
  • The last 7-10 dayslow + issues [fatigue, less sleep, low energy, some abdominal pain, eating softer foods to avoid blockages, keeping on top of hydration: as more at risk & increase in watery output]

What is the difference/s after two years?

  • Good to note here that this is the longest I’ve been on a medication without any major problems.
  • How does this differ with a stoma / without? When I first had Vedolizumab in 2015-16, I did not have my stoma. Thinking back now, it definitely felt different. I’m unsure if it didn’t work because my awful colon was keeping all the drug for itself, but I did not get any of the high feeling but almost always the low feelings. With a stoma I can actually feel the drug in my system; sort of an amped up version of the commonly described ‘infusion hangover’ but only while in the clinic.
  • always plan a rest day after Vedolizumab, even if I do feel really well because there is no guarantee that that feeling will last. I usually stay home and rest on the sofa and keep up my fluids.
  • I’ve found the best ways to keep myself hydrated pre-infusion and I’ve gotten so much better at instructing the nurses at which veins are good to use! I sometimes get the same one, but I always remember who got me poked first time without much pain.
  • I’ve become very good at predicting and tracking my symptoms alongside Vedolizumab. I like to know that what I am feeling is medication related or something new. Makes it easier to not panic when I’m unsure, because this happens only a few times and I’ve usually written it down, or made a note of it.
  • I know that at some point it will be withdrawn. But I am enjoying it until that happens. I go into my infusions with the optimism I know I need.

How is it’s success measured?

  • Bloods – prior to each infusion, I am required to have my bloods done to check that I am okay to have my next dose. This happens between 7-10 days beforehand to ensure they can be reviewed and any repeats done before my medication. There is a 3 days window to getting the medication ordered and into the infusion clinic ready for my appointment time, so 48 hrs prior is the very latest I can have bloods done. This will be CRP [C-Reactive Protein, a primary indicator of inflammation and one of many results for active disease], U&Es [Creatinine and Electrolytes, to check my kidneys are functioning and my fluid balance is correct], FBC [Full Blood Count, to assess if I have an infection or any abnormalities] and finally ESR [Erythrocyte Sedimentation Rate, checking anti coagulate levels and is a non specific inflammation marker]
  • Calprotectin – Faecal Calprotectin is a protein marker found in stool. The level of this in stool can be strong indicator of inflammation. It’s role in IBD and thus in medications taken for IBD is that is more actuate than blood work, nearly 99% of patients who have active IBD have elevated faecal calprotectin levels. For me, this gets repeated once a year in line with my review period but is also requested when I have prolonged issues with my stoma output.
  • Review –

What does a review entail?

  • A review is part of the NICE guidance with taking most biologic drugs with IBD. They vary slightly between CD and UC but this is my experience and the review process when having Crohn’s Disease.
  • I have repeat blood and calprotectin ordered a month prior to my appointment with my consultant.
  • I notify my IBD team these are done so they can pull them through and add to my file.
  • I get weighed and attended a normal outpatient clinic appointment – for me this happens in September.
  • We discuss my current issues [if any] and decide on the treatment plan for the next twelve months.
  • Considerations here are given to my results from the recent requests, my previous 6 months of medical history and current status.
  • To submit for the funding for Vedolizumab for another year, they must provide disease scores [Mayo for UC and HBI for Crohn’s], blood results, calprotectin levels, endoscopy or MRI results ot show the drug is working.
  • If there is total remission and no signs of active disease, they will then consider a trial withdrawal of the biologic with option to restart if the disease flares again.
  • Here is the information from the NICE guidance for reference:

 

“1.2 Vedolizumab should be given as a planned course of treatment until it stops working or surgery is needed, or until 12 months after the start of treatment, whichever is shorter. At 12 months, people should be reassessed to determine whether treatment should continue. Treatment should only continue if there is clear evidence of ongoing clinical benefit. For people in complete remission at 12 months, consider stopping Vedolizumab, resuming treatment if there is a relapse. People who continue Vedolizumab should be reassessed at least every 12 months to decide whether continued treatment is justified.

Patients currently receiving Vedolizumab whose disease does not meet the above criteria should be able to continue treatment until they and their clinician consider it appropriate to stop.”

 

Where am I now?

At this point in time, I am waiting to see if a withdrawal of my medication is the right thing to do.

There are alot of things to consider and most likely some further procedures to get new results before we go forward with a withdrawal.

I always get nervous when this type of appointment comes up because I always wonder if I should or could go without my medication. It is not a matter of fighting for the funding like it has been before, but its more about how my body and disease will cope without medication. It is a catch 22 situation of whether I would be better off without it as it could be deemed unnecessary as I am in ‘clinical remission’ or would it be smarter to continue on what is clearly maintaining a level playing field for me?

Only time wil tell.

 

Do you have any questions or queries? Or just want to share your own experiences? 

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Further Reading

Reference:

NICE Guidance – Vedolizumab for Treating Moderately to Severely Active Crohn’s Disease after Prior Therapy [26.08.2015]