April update

I feel a complete fraud writing about my most recent infusion visit because there just isn’t anything to write about!  Having arrived in the department around 9am last Monday morning, I climbed onto the scales to be weighed and that, dear reader, was the ONLY thing I had to do, except for the beloved suicide questionnaire (still no successful attempts to report).  I thought it might be a long morning, but actually once I’d had a bit of a doze, umpteen cups of coffee and chatted with the nurses as they came in and out, it was soon lunch time.  It was a bright sunny day in London so after lunch I decided I would go and stand just outside the door and watch the world go by – quite an adventure for me, as I never voluntarily go outside, so Colin came with me and I found a nice spot to lean against the railings.  It didn’t turn out to be one of my better ideas, as the walkway was very busy and I was a bit worried about getting walloped in the shins by the folks in wheelchairs going past me, so fairly shortly we headed back inside.  Just inside the main door I heard footsteps close behind me and I froze, and braced myself against Colin.  Sure enough, someone bumped into me with their huge canvas backpack and if I hadn’t been ready for it I would surely have gone down like a sack of spuds.

That crisis averted, we were greeted back in the department by the news that the drug had arrived, and I was hooked up to the drip in no time.   We decided to use a vein in my left wrist that has proved to be very co-operative in the last few months, and my left arm lifted itself from my lap up onto the pillow on the arm of the infusion chair without any help from my right arm whatsoever.  My nurse and I looked at it in amazement, and I did it again, just to check.  The nurse trotted off to get the study doctor to witness my new ability – my left arm has been pretty much useless for years!   This most dramatic event was entered into my notes, while I grinned and kept lifting my arm up, just in case it forgot how to do it.  Once the excitement had subsided, the infusion was done and we were on our way by about 2.15pm.  It was a horrible journey back from London in quite heavy rain, and it was still raining when we got home.  Colin helped me out of the car and I broke all speed records walking up the drive to the front door – I suppose I was so intent on getting out of the rain I forgot to be scared of falling over.  Anyway, I got up the steps and into the house with no problems and that was all done for another month.

So, onto this month’s facts and figures, and I must ask my friend Margaret Creech to please sit down now because I don’t want you getting giddy!  Here goes:

Time taken to get dressed: 5 minutes 11 seconds, down from 5 minutes 55 seconds last month

Time taken to walk to kitchen and come back with coffee:  4 minutes 46 seconds, down from 5 minutes 19 seconds last month

This month’s mark on the door frame is higher again, just by an inch or so

And the foot lift measurements are: Right 4.75 inches (up from 4 inches) –                                                           Left 3.75 inches (up from 3.5 inches)

What does all this tell us?  I don’t know really.  For me personally it illustrates that my mobility is improving – whether or not that is because of extra strength, whether it is due to the effects of the drug, or exercise, or a combination of both, is unknown at this stage but the reasons don’t matter much to me at all.  I’m doing better than I was a couple of months ago, and when you’ve got a progressive muscle disease that’s pretty amazing in itself.

As I prepared to post this entry, a Facebook friend posted a link to an article stating that this drug, BYM338, has failed to produce the results expected in trials with sIBM.  At present there are no plans to discontinue the ongoing trials, and I guess all we can do is hope for the best.  I have no medical knowledge whatsoever, but it seemed to me from the outset that the doses being used in this phase of the trial are far too low – 10mg, 3mg and 1mg per kg of patients body weight, compared with 30mg per kg body weight in the initial ‘proof of concept’ phase.  Perhaps this made sense to somebody, but it never made any sense to me.  There are no plans to cancel the ongoing clinical trials at present, but obviously the financial implications of this result for Novartis place a huge question mark over the whole thing.  If I hear anything at all through the official channels I will post an update here.

 

 

BYM338 trial update March 2016

My second infusion of the extension trial came round really quickly, and Monday morning saw us up with the lark and ready to set off for London at 6 am.  Traffic was no worse than usual and we arrived in Queen’s Square just after 9’clock.  We found a parking space not too far from the hospital entrance and I hobbled in using my crutch and Colin’s arm for support.  I was in the middle of a bout of sinusitis and felt a bit wobbly on my feet, but we made it safely into the department and really that was the hardest bit of the day over with.

There is really very little to do nowadays – I have to be weighed so that the drug can be made up accurately, but there are NO blood tests, NO blood pressure/pulse rate tests, NO urine tests, so all I had to do then was sit down and have breakfast.  We don’t have to fast any more, but it’s far too early for me to eat or drink before we leave home and I don’t want to have to make toilet stops on the way so I took my breakfast with me and enjoyed it with plenty of coffee.  During the morning I saw the study doctor for a chat, but no physical examination, and we did the beloved suicide and protein questionnaires.  Then I had yet another ECG – that’s no problem at all, in fact it’s quite nice because you get to lie on a nice comfy bed and relax.  I understand that some of the trial patients find this a bit uncomfortable, something along the lines of ‘sticky electrode pads + hairy chests = Ouch!’ but this isn’t a problem for me.  No, honestly, it isn’t.

After that lovely bit of relaxation, the physio lady came for a chat and she went through a few of the exercises with me just to check where I am with them at the moment.  She never pressurises, but gently encourages us to do more when we feel able, and to always stay safe and not overdo it.  After that, I had a bit of lunch and settled down to wait for the drug to come – it arrived nice and early at just after 1 o’clock, the nurse got the cannula in (first needle of the day, really weird!) and we were all done and ready to leave by 2.15pm.  The journey home was uneventful and we were home by about 4.30pm.  I was fairly tired because it had been a long day, but nowhere near as exhausted as trial days used to leave me.

So, onto the important stuff and the effects so far.  I timed myself getting dressed on Tuesday morning and it took 6 minutes 16 seconds, compared to 11 minutes 18 seconds last month. This seemed pretty unlikely, so I repeated the process on Wednesday and achieved the even more unlikely time of 5 minutes 55 seconds.   I don’t think this illustrates any great improvement in strength, but my muscles definitely feel more relaxed and easier to move around, and the ability to lift my feet even a few millimetres off the floor means it’s not nearly such a performance to get my trousers on.

I’ve been trying really hard this week to walk independently (no crutch, walker or hanging onto the furniture) around the house whenever I can.  I think I’ve made some progress already and  sometimes feel quite steady as long as I concentrate fully on my walking.  If I forget to concentrate, my balance disappears instantly.  My timed walk to the kitchen for coffee today came in at 5 minutes 19 seconds, compared with 6 minutes 22 seconds last month.  This is obviously using my 3-wheeled walker, I don’t know whether I mentioned that last time.

This month’s mark on the door frame is this much higher 🙂

This surprised me, I didn’t feel as if there’d been any improvement at all which just illustrates how important it is to record these measurements when progress is so gradual that you don’t really notice it.

This just leaves the foot lift measurements – no change since last time, 4 inches right foot, 3.5 inches left foot.  I’ll give this particular exercise more attention this month and see if I can report an improvement next time.  See you then 🙂

 

New beginnings

  
Here we go again on the next round of the BYM338 drug trial, which should lead straight into a successful licensing application and availability to everyone with IBM. We had a break in our infusion schedule between October and February and I definitely struggled during the last few weeks, feeling weaker, more fatigued and generally stiff and achey. Winter isn’t an easy time for anyone, and I think we all suffer with the cold and damp, the Christmas stodge and the lack of sunshine. I was feeling so fed up with myself that I absolutely couldn’t wait to get started with the infusions again, and eventually the first treatment date came around and we were off!
It’s a very easy routine this year and I’m not going to bore you with an account of the weigh-in, blood tests, urine test, ECG and physical check up with the trial doctor – all very routine and straightforward. Since we left early and got there at about 8.30am, and the drug didn’t arrive till just after 2pm, there was a lot of waiting around and I dozed for much of the morning. There was a lovely atmosphere in the department that day, the nurses were chatty and the other patients were interesting. I was really touched when my nurse said that she’d been so happy when the first patient on this Extension Trial was finally dosed that she celebrated that evening with a glass of champagne, and I think that sums up the excitement and optimism about this drug now.
I don’t ask the staff many questions because they’re not really supposed to tell us anything and it’s not fair to put them on the spot, but I did ask if anyone had shown any big improvements over the past year or so, and the nurse said that those who had exercised most had had the best results, including over the winter months when we hadn’t had treatments. I must say this reflects my own experience, as during the first few months I was quite enthusiastic about doing the exercises and noticed quite fast improvements. Then the novelty must have worn off and I only did the bare minimum, and nothing much seemed to improve. After I had the flu at the end of December I hardly exercised at all due to one excuse after another, and everything just got weaker.
Anyway, I thought I would try to be a bit more factually based this year and report some real facts and figures rather than just telling you what I think is happening. But what could I measure? My activity level is so low that I struggled to come up with anything meaningful, but finally I decided on the following:
Time taken to get dressed in normal clothes – underwear, stretchy trousers, T shirt/vest top and cardigan – was 11 minutes 18 seconds the day before the infusion last week
Time taken to go to kitchen and get coffee, from sitting at lowest point in riser chair in the sitting room, to putting coffee down on the table next to my chair was 6 minutes 22 seconds.  
I’ve put a mark on the doorframe at the highest point I can lift my left (weaker) arm to, unaided.

**A good suggestion from a friend also on the trial – measurement of how high I can lift each foot off the ground, standing on one leg holding onto support – measured today:  right 4 inches, left 3.5 inches measured at heel
My theory is that if I can improve on these, my daily life must be getting easier and ultimately that’s what we all want. If you can think of some more things that I can measure to demonstrate an increase in strength I’ll be really happy to add them in. Apparently it’s important to set goals too, so my first goal is to be able to walk steadily all the way down the hall to the kitchen sink without having to hold onto anything. Exciting stuff 🙂  

BYM338 (Bimagrumab) Extension Trial 2016

  

A very Happy (if belated) New Year to you, and welcome to a very upbeat and optimistic edition of my BYM338 trial blog. My planned screening visit for the extension phase of the trial went ahead as planned on Monday 18th January, although I managed quite a dramatic fall over the weekend and wondered for a while whether I would be able to make it. Happily no serious injuries, just a black eye, carpet burns to one side of my face, a cricked neck and a bruised shoulder. As always, it looked far worse than it was, but it got me a fair bit of sympathy from the staff at the Leonard Wolfson Centre. A week later now, the bruises and carpet burns have healed, the cricked neck and shoulder are still very apparent, but the worst thing is a mouth ulcer the size of Hong Kong where I must have bitten my lip as I fell. Obviously I have complained about that at every opportunity.
So we left for London at around 7am after giving the cat her fluid injection and lactulose medicine – which she detests with a vengeance and can now put up quite a fight about. We got to the hospital just after 10 o’clock, and the first job was to go through the the consent forms for the new phase of the trial. Once those were signed, blood tests were taken and urine test provided. Coffee and biscuits were then very welcome, my height was measured (1 cm taller than last year – what’s that all about?), followed by blood pressure & pulse rate readings and a climb onto the weighing scales (no comment). Then I had an ECG, and a chat with the physio lady who had really wanted to go through the exercises with me but I was too stiff and achey so we’ll do it next time. The doc arrived to do the usual physical check up and a few questionnaires including the beloved suicide one (still no successful attempts to report).  
After a sandwich lunch, we did the usual strength tests and unusually the machinery worked straight away. I don’t know how they compared to last time, they’re not supposed to pass any comment so it’s not even worth asking. Physio lady came back as she wanted to see me doing the 6 minute walk – it wasn’t my best performance but not bad considering I couldn’t see out of one eye and all the other aches and pains. Balance tests and the hilariously-named speed tests passed without incident. Basically at that point we were finished, but they kept us busy with a few more questionnaires while the lab finished testing my bloods just in case they needed to do any retests. All was well, so they gave me my treatment schedule for the year and we were away.
Now the important bit – what is happening next? This trial consists of two parts – Treatment Period 1, when we continue to get the same dose of the drug as we’ve been getting up to now, will last for 6-8 months while Novartis analyse their data, decide which dose has performed best, and prepare to submit licensing applications. They have taken the precaution of stating that this period could last for up to one year, just in case it takes them longer than anticipated. As soon as they have determined the best dose, Treatment Period 2 will start and we’ll all be given the best dose until the end of the trial. Treatment Period 2 will last for one year, but may be extended after that if Novartis still need further information. As soon as we report that we’ve moved into Treatment Period 2 you can be confident that the drug applications have been submitted and the final countdown to BYM338 being available to everyone who wants it will have begun 🙂 It’s worth mentioning that the trial might run on after that time, it won’t necessarily end when the drug hits the market.  
Most of us trial participants have noticed that we’ve felt weaker in the 3 months since our last infusions – those who’ve noticed no difference are probably on the placebo which confirms what they’ve thought all along. Some people who thought they might have been on the placebo have been surprised to note that they actually do feel weaker without the infusions, and have revised their opinion to perhaps being on a low dose. I didn’t feel much different until around Christmas time, but I had a nasty flu bug for a couple of weeks just after Christmas and of course that can leave you a bit wiped out for a while. My normal exercise routine has also gone to pot and as we know, you soon slip backwards when you stop exercising. Whatever the reason, I don’t like this feeling of weakness and plan to start exercising again as soon as my neck and shoulder allow, but more importantly I absolutely can’t wait for 15th February when the 4-weekly infusions start again.  
The bottom line to all this is that the trial has proved successful enough for Novartis to continue to invest in the drug and push it through the approval system. Since there are no other treatments available for IBM, it has been designated for fast-tracking through to approval. I was tempted to say that ‘it won’t be long’ before it’s out there for everybody but then I thought how long it seems until February when I can have my next treatment and realised that it would be unbearable if I had to wait just a few more months or even a year for it. I’m really sorry if you’re enduring this wait. If it helps you to know that help is it’s on its way, I truly believe that this drug works and will benefit you. In the meantime please stay healthy, eat well, take vitamins, exercise if you can manage it safely, and above all please don’t fall. Wrap yourselves in bubble wrap if necessary so that as soon as you can have treatments you’ll be in tip top condition to get the most benefit from it.  

BYM338 trial update December 2015

 

Welcome to this very festive edition of my BYM338 trial blog.  There’s not much to say about my hospital visit on Wednesday this week, as it was the final end-of-trial follow-up visit and there wasn’t really much to do.  There was no urgency to get there at the crack of dawn so we got up at 7 am, ‘did the cat’ (yes, she’s still doing well, and has increased her weight from 2.45kg to 2.65kg since October) and set off just before 8 o’clock.  For the first time in several months, I was able to climb over the front door threshold with no help from Colin, so it was starting to look like a very good day.  Apart from a couple of nasty accidents on the M40 near to High Wycombe which held us up for about half an hour, traffic was flowing really well and we were in Queen Square at around 11 o’clock.  Unfortunately I still don’t seem to be able to get out of the car by myself but we’ve developed quite a good system where Colin grabs the waistband of my trousers at the back and heaves while I push up with my arms.   As he so eloquently puts it; “If I’m holding yer britches you can’t fall down”.  Quite.

Blood samples were taken successfully – found the vein at the first attempt again J – and urine sample provided.  After a bit of breakfast, we trotted off to one of the nice comfy bedrooms for my ECG, and the study doctor came to do my check-up.  We chatted for a bit about the next phase of the trial, which has been a little bit held up by the Ethics Committee who haven’t got round to giving it their approval just yet, but since it is much the same as the phase that’s just finished there’s no reason to think that it will be refused.  We know that Novartis are pushing ahead now to analyse all the data provided by trial participants from all around the world, so that they can decide which dose gives the best results for the least side effects and make their applications to the drug licencing authorities in each country.  Back in 2013 when we first heard about the drug being developed, it was announced that it had been designated for fast tracking through the approval system as there are no other medications currently available for IBM.  I haven’t been able to find any useful information about the UK’s drug licencing process, but in the USA it would normally take around 12 months for a new drug to be approved.  Under the fast track system, they aim to process applications within 6 months.  They estimate it will take around 6 – 8 months to work through all the data and prepare the applications, and once that process is complete all those taking part in the trial will be put onto the dose that will become commercially available.  That will continue until the drug is available for general use in the country where the trial is being conducted, at which point presumably we’ll be handed over to the NHS to continue the treatment at our local hospitals.  In the meantime, once Ethics approval has been obtained for the next phase, we’ll all carry on having whatever dose we’ve been having up to now.  It’s really interesting to note that there doesn’t seem to be any doubt that the drug is working, and that it will eventually be licenced.

We also chatted about my anxiety, and this appeared to be one of Natalia’s favourite subjects and she was happy to give us a few tips about consciously limiting the time I spend worrying about things to just a few minutes a day, and taking regular work breaks to go and grin at myself in a mirror.  I’ll let you know……

We moved on to complete the suicide questionnaire (still no successful attempts to report) and my exercise sheet was photocopied for physio to look at, as she was tied up somewhere else all day and couldn’t get across to see me.  I had some lunch, and since it was quiet in the department that day, we just dozed until it was time to go across to the big hospital for my (hopefully) final heart scan.  The lovely Flowie came with us, and that was all very easy and straightforward – with Colin and Flowie helping me to undress and dress again we were done in no time.  We had a short wait for Michael the ambulance driver to pick us up to take us back to Queen Square, so we took a few photos while we waited, and we were finished for the day and on our way home for a Chinese takeaway and an early night.

It’s nearly 8 weeks since my last drug infusion and I can’t say that I feel any weaker in general, but I notice that it seems to take a bit longer to make a fist and my fingers get tired after a lot of typing.  Walking is still a bit up-and-down and can be affected by all sorts of factors such as the weather, hunger, tiredness, anxiety levels and lack of concentration.  I wouldn’t say I’m any worse than I was a year ago, which is a pretty good result when you’ve got a progressive disease.  I know a lot of people on the trial have been disappointed not to see dramatic improvements but the truth is that the drug just doesn’t work like that.  It’s not an artificial muscle-building agent.  It re-activates the body’s natural repair mechanism that gets switched off when you have IBM.  That’s why we have to exercise in a very controlled way, to break down the muscles just a little bit to encourage our bodies to repair them in exactly the same way that healthy people’s bodies do.  If we over-exercise, our repair mechanism isn’t up to the job and we won’t recover fully from the break-down of muscles.  If we don’t do any exercise at all, there won’t be any muscle break-down and the repair mechanism won’t be triggered so we won’t get stronger.  The exercise programme we were given was devised to give us the best possible results and was an important part of the trial in the same way as eating properly and turning up regularly for the infusions.  My guess is that exercise is going to be a feature in the treatment programme when the drug is generally available, and seeing progress with these very gentle and safe movements is a really exciting and encouraging thing.

The only negative thing I can say about the trial is that after the first few months I suffered terribly with anxiety almost to the point of agoraphobia, but I seem to be slowly regaining a bit confidence and feeling a bit more positive about things now that I’ve had a bit of a break from the drug.  It will be interesting to see if those feelings come back when we restart the infusions.  I haven’t heard anyone else mentioning this, so it is probably just one of those things.  I had also put on about half a stone in weight over the year, but have lost a couple of pounds in the last few weeks without changing my eating habits in any way.  Drug related?  Of course, I don’t know.  Nobody else has mentioned this.

So Merry Christmas to everyone reading this, I hope you remain safe and well (and upright) throughout the holidays, and I’ll see you in the New Year for reports on the screening tests for the new trial – mine are provisionally booked for 18^th January but subject to change depending on how soon the Ethics Committee get their paperwork done.  Is it ethical to keep people waiting longer than absolutely necessary for this essential drug?  I think not.

 

BYM338 end of maintenance visit November 2015

I’m a bit late with this blog, and I apologise for that but the first drafts looked more like London traffic reports than anything else so I thought it best to wait until I had calmed down a bit before carrying on. The visits were actually scheduled for 23rd and 24th November, a couple of weeks ago now, and although a 2 day visit with all scans and tests to be completed, it should have been fairly relaxed and easy because there was no drug infusion this time, and therefore no need to get to the hospital at the crack of dawn to get it ordered. It was half term, and experience has taught us that this makes quite a difference to the traffic so when we set off at 8 o’clock on the Monday morning, we were hoping to make the journey in no more than about 2 hours. Ha! Everything was fine until the last 3 or 4 miles, at which point traffic came to a virtual standstill and we crawled the rest of the way, finally arriving just after 11 o’clock. It didn’t really matter, because the only fixed appointment that day was for my echo-cardiogram at 4.10 pm, but I was fasting and getting a little bit hungry by the time we got there!

Luckily, the nurse hit a vein first time and managed to fill all 12 test tubes straight away. We felt triumphant, and really that set the tone for the day – everything went smoothly and we got everything done except the strength tests before we were picked up by Michael, our usual ambulance driver, to take us round to the big hospital for the echo scan. Traffic was still horrendous, and Michael told us that many of the roads were closed for installation of cycle lanes, and others had been made one-way while the work was going on and that was why things were chaotic. The lovely Mayor of London, Boris Johnson, has invested an awful lot of money in making the city centre a safer place for cyclists, and he has made 3000 bikes available to the public in ‘bike-ranks’ where you put your money in to release a bike (a bit like Morrisons’ shopping trollies), ride it to wherever you want to go and then park it in a bike rank at that end, where you get your money back. They call them Boris Bikes, and it seems a very popular scheme. It makes sense to keep as much traffic out of the city centre as possible I suppose, because although they do impose a congestion charge as a deterrent to motorists (disabled Blue Badge holders are exempt from charges), the roads are still permanently busy with normal traffic fighting their way along one lane while the Bus Lane remains largely empty….
Anyway, the heart scan was completed by 4.30pm, the ambulance took us back to Queen Square and we set off back to Banbury with instructions to be back on Tuesday morning by 10.00am so that we could get the strength tests done before heading off to the big hospital for my DEXA scan at 10.45am. Knowing that the traffic would be heavy, we decided to leave home at 6.30am thinking that would give us plenty of time. Ha! The M40 was stop-start all the way down, the A40 was chock-a-block, and the Marylebone Road eventually ground to a standstill. We sat patiently (not really, Colin was fuming) in traffic from 9 o’clock, just inching our way along until finally we could see the road that we needed to turn right into to take us up to the hospital. The traffic lights turned from red to green, and back to red again, and nobody moved. More worryingly perhaps, there was a bus that appeared to be turning into ‘our’ road, but that didn’t move either. We sat like that for about 45 minutes, then the traffic in front of us in our lane started pulling into the other lane and that held things up as well! Finally, at just after 11 o’clock, we made it to the road junction, and a van driver yelled across to tell us that there had been a big accident and our road was closed. Police were at the junction, turning traffic around. We pulled out around a lorry that had evidently decided that he was going to have to go up that road and was going to sit it out, and across the road to where the police were. At that moment my nurse rang to see where we were, so I told her what was happening and she tried, along with Michael, to think of another route. She would suggest a road, and I would hear Michael in the background saying ‘No, that’s closed’ or ‘That’s one-way now’. In the meantime, Colin was having much the same conversation with a policeman who said there was no way round and we should turn back. My poor nurse was less than impressed, and suggested that we drive instead to the big hospital and wait for the ambulance driver to bring our nurse ‘escort’ to us there – but there is absolutely nowhere to park at UCH and we wouldn’t have been allowed to wait in the drop-off area, and it would have taken ages for Michael to battle his way through the traffic, if he could get there at all! She finally had to concede that we simply couldn’t do it, and that she would have to submit incomplete data for this trial visit.

So we came home, getting back at around 12.30pm after 6 hours sitting in the car for nothing. I haven’t heard anything from the hospital since. I don’t know whether this will exclude me from taking part in the extension trial that might start in January/February, as the trial doctor did say that only patients who had completed this phase of the trial will be invited to take part. At the moment I feel that the stress of travelling to and from London far outweighs any benefit I might have got so far from the drug, although of course after a few months it is expected that all trial participants will be given the drug on an open label basis so we will all be sure of what we are getting, and perhaps then the benefits will be easier to see. I am a worried that without the drug I will quickly get weaker again, although it is now 6 weeks since my last infusion and I’m happy to say I haven’t noticed any weakening yet, in fact if anything my legs feel a little stronger and I am still easily managing 30 minutes on my pedalling machine. My next scheduled appointment is 16th December, which also entails yet another heart scan and an ECG but not much else, hopefully they will have sorted out the dates for screening for the next phase, and hopefully they will let me take part, although Colin has absolutely reached the end of his tether with it and would be happier if we just gave it all up now.
Oh yes, of course you are only reading this to find out how the cat is doing!  Well I am really happy to report that she’s still with us, eating well and coping with the twice-daily fluid injections. I would say that her quality of life is similar to that of any other 19 year old cat, she just eats and sleeps really, but the nicest thing is that, although we always give her injections while she’s sitting on my lap, she still comes and sits on me quite voluntarily and purrs and head-butts me just the same as she’s always done, and is still quite capable of jumping up and stealing food off my plate before I even know she’s there.

As an afterthought – I wrote my Christmas cards today.  Last year I couldn’t even hold a pen, let alone write legibly.  

Final trial visit Part 2

  
The Tuesday visit should have been very quick and straightforward. The plan was that we would arrive at Queen Square at about 9 o’clock, do the fasting blood tests straightaway, do the strength tests that we couldn’t do on Monday due to the machinery not working, and possibly have the infusion – which had been ordered the day before and would arrive at about 9 am – all before hospital transport arrived at 10.45 to take us to UCH for my DEXA scan. Then we would be all finished and on our way home. Hurrah! Well obviously, it didn’t go quite like that.
Had a very poor nights sleep despite going to bed early on Monday night. Had to get up a couple of times to go to the loo, and woke up feeling extremely hungry when the alarm went off at 6 o’clock. However, couldn’t eat or drink anything as I was fasting, so we did the cat and set off. Traffic was very quiet again and we arrived just before 9 o’clock. For some reason I couldn’t stand up to get out of the car, so Colin hauled me to my feet and suggested getting the wheelchair out and pushing me into the department. I must have felt pretty rough because I agreed! The nurse was ready and waiting with my sample pot and once that was provided we headed off to the treatment room to do the blood tests. At that point, it stopped being a good day completely! There didn’t seem to be any blood in my veins. The nurse very effectively found my veins but they didn’t produce anything at all. After a few goes in the backs of my hands, she found a vein in my arm that yielded enough to fill one test tube before it dried up – and we needed to fill eleven. We thought it might help if I drank some water, but 3 cups didn’t make any difference. Reinforcements were called in, in the form of LiYing and she immediately looked at the inside of my wrists, but I was already starting to feel nauseous and faint so I said I didn’t want her to use those. However, after she’d had a few unsuccessful tries elsewhere I said it would have to be the wrist. She got just one test tube full before that dried up too. Time was getting on, so Edwina the head nurse was called, but she could get nothing either despite several attempts. She said we would just have to shelve the idea, and do non-fasting bloods later on instead. The ambulance driver arrived to take us to UCH and I’d still had nothing to eat, so I had a protein bar on the way there and started to feel a bit better.
There were no Healthcare Assistants in the department so the nurse escorted us. It was really nice chatting to her away from the hustle and bustle of the department, and I told her how exhausting I was finding the travelling, the fasting and the early morning starts, and how we’d toyed with the idea of giving it all up. She was very understanding, and said that the next phase of the trial is going to be much easier, with fasting blood tests only every 6 months and scans just at the beginning and end of the trial. We won’t have to get there until about 9.45, and apart from check ups with the doctor and obs there will be very little to do. We felt a lot better once we knew that, and decided that the we may as well carry on since we’ve come this far. The DEXA scan was trouble-free as it always is, but the nurse and the radiographer couldn’t get me up off the table and a rather burly paramedic was called in to shift me. Very nice too 🙂
We got back to Queen Square at about 12.30 and we all had some lunch. Then Laura had another go at taking blood and this time there was no problem. She got the cannula in for the infusion equally successfully, and I’d soon had the drug (or placebo, who knows?) and the glucose flush-through. This was my first, and last, dose on the Maintenance phase of the trial, and this will have to followed up with all the tests, scans etc. again in a month’s time, to satisfy drug trial regulations. This just left the strength tests, and we headed back down to the treatment room for those. All went smoothly, and we were finished at last at around 3.30pm. Traffic was fairly heavy as there’d been an awful accident on the M25 and people were having to find alternate routes, which of course clogged up the M40 as well as all the other local roads. But we didn’t care how long it took, we were on the way home!
So that’s my year on the drug trial finished. It’s been an interesting experience, I’m glad I’ve done it. As to which dose of the drug I’ve been having, if any, I’m actually now a bit undecided about what I think. I saw very noticeable improvements in my hands and arms almost right from the beginning, but could that have been due to the physio exercises? The ‘IBM grooves’ down my forearms disappeared fairly early on, so that might be new muscle. I can make a passable fist with my right hand, pull the flimsy plastic cover off a new bottle of milk, and open ring-pull cans with very little difficulty. My neck and core muscles seem stronger, I can drop my head right back and lift it up again easily, and I no longer flop about like a rag doll in the car but can hold myself steady around corners and during heavy braking which is a useful skill when Colin is driving. I can operate the electric car window button with one finger of my left hand, instead of having to reach over and use my right thumb. If anything, walking is about the same as it was before. Perhaps on a good day I can walk a few yards further before I’m exhausted, but on a bad day it’s a struggle to put one foot in front of the other. I haven’t fallen though, despite a few near misses. I think I’m more stable, and seem to be able to compensate if I find myself a bit off balance. Over the year, it has actually become more difficult to step up into the shower and over my front door threshold, partly due (I think) to the injuries to my knees when I fell in the ambulance – whereas I only had one dodgy knee prior to that, I now have two very stiff and painful knees that never feel safe when I’m standing on just one leg. I’ve got much better at using my pedalling machine, 30 minutes is no problem at all. 2 minutes used to be a struggle. Some trial participants talk about side effects but other than the tummy issues I haven’t noticed any at all, certainly not the weight loss that has been mentioned by a few – in fact over the year I’ve gained about 7 pounds which I’m not happy about. I’m sure I would move around more easily if I was lighter. At nights I seem to have a very itchy scalp – some patients have eczema in their hair but I don’t, just the itching. I haven’t had any muscle cramps, aches, pains or spasms, no headaches, no hint that I’m having the drug rather than the placebo – except that some bits of me are stronger than they used to be…. And that’s pretty amazing.
So, looking ahead to the Extension Trial, which we hope will kick off in January subject to successfully passing screening again, it seems that it won’t be anywhere near as exhausting, and as soon as Novartis have decided which dose works best we will all be given that dose. I don’t know whether they will tell us what dose we were receiving up until that point, but it would be interesting to know. The patients on the first human phase of the trial received 30mg of the drug per kg of body weight, and all noted quite dramatic improvements after their single dose. On this phase of the trial, we have been given just 10mg, 3mg, or 1mg of drug per kg, and nobody reported much at all in the first few months, although just one or two people have talked about improving their walking distance by quite respectable amounts after several months. I’m hoping that I’ve been receiving one of the lower doses, and that Novartis decide 10mg/kg, or even some higher amount, will be the optimum dose. It is expected to take just 6 – 8 months for them to make that decision, and at that point they will submitting applications to the relevant authorities in the hope of getting approval for general use. Here in the UK it seems a foregone conclusion that the NHS will fund treatment. Patients in other countries are less sure, but I can’t see that Novartis would invest billions in developing this new product unless they were confident that they could market it in sufficient quantities to make it profitable. BYM338 is by no means a miracle cure, but it’s all we have at the time of writing, and it’s definitely better than nothing. My good friend Val Foreman has written to her MP lobbying for the Government to implement fast track approval of this drug, and will be happy to forward a copy of her letter to anyone who’d like to do the same. Her email address is available via the Myositis UK IBM Discussion forum under the heading ‘A little knowledge is a dangerous thing’, or if that isn’t available to you please comment below and I’m sure Val will get in touch. I’m sure I speak for every trial participant when I say we can’t wait until this drug is out there working its magic for every IBM patient. If they want it, of course.

BYM338 end of trial visit October 2015

  

Some of you might know that we have a very elderly, much-loved cat called Jasmine. On October 13th she suddenly became very poorly, and a visit to the vet revealed that she’s in final stage kidney failure – quite a common condition in old cats. They recommended euthanasia. We said no, quite emphatically, and we implemented Plan B – an overnight stay at the vets with 24 hours on intravenous fluids to rehydrate her and various medications to stabilise her and make her comfortable. The veterinary nurse rang us the following morning to say that she’d eaten a good breakfast and seemed quite perky, so we brought her home that evening with supplies of medicine and bags of fluid to Inject under her skin twice a day. To date she’s doing ok, eating her special renal food with some enthusiasm, using her litter box, and purring happily at us when we do her treatments. She’s very old, 19 years and 5 months, so we don’t expect miracles but we’re happy that we’re giving her a few more good quality days/weeks to snooze in her favourite places.
Why have I told you that? Well really just to explain why we decided that for our 2 days at hospital this week we would set the alarm for 6 am instead of the usual 5 am, ‘do the cat’, and set off when we were ready instead of panicking and rushing about. We were lucky with the traffic as it was half-term, and on Monday we arrived at Queen Square at around 9.30 am. It wasn’t a fasting blood test day, so I had breakfast in the car on the way down and felt pretty much on top of things when we got there. I had a cup of coffee and they did my blood pressure and pulse rate – far too high as usual, but a bit of deep breathing and calm thinking sorted that out. I saw the trial doctor for my check up, food questionnaire and suicide rating (still no successful attempts to report) and she explained that this would be the last infusion until the extension trial starts, which will hopefully be in January, although I will still need to go for the usual 4-weekly visits in the meantime. We were supposed to be doing the strength tests, but the machine wasn’t working so we got straight on with the ECG. Normally this is a comfortable, relaxing experience, but this time all the beds were occupied and somebody needed to use the infusion room so I had to go down to the treatment room where it was suggested that I lie down on the examination couch. Sounds silly but it completely threw me because it was the opposite way round to my bed at home and I couldn’t think how to do it. I asked if Colin could come and help me, but was told very firmly that there was no need and that nurses are trained to move patients around properly. Suitably chastised, I asked the nurse to raise the head end a bit, and she helped me to lower my head onto the pillow before she lifted my legs up – job done. Getting up again seemed problematic, so again I suggested Colin might be the best person to help me up, and again the nurse was having none of it, and with a bit of shoving and puffing she did finally manage to get me sitting upright, although I can’t really remember how!  
Next was a chat with the lovely physiotherapist about the exercises, and she decided she’d like to see me do the 6 minute walk test, so the nurses cleared the corridor and stationed someone at the far end by the door to fend off marauders. The test went well, I managed 3 full lengths of the corridor plus another 6 or 7 meters – a vast improvement over last time, when my walking ability had been severely hampered by using a rollater walker. Then we did the balance tests (physio was suitably impressed) and the speed test (if only!) and it was lunch time. There were a few questionnaires to fill in on the laptop about physical capabilities such as how difficult it is to get off a toilet, up 5 steps, walk a block on level ground etc., and then hospital transport arrived to take us off to the large University College Hospital on Marylebone Road for my echocardiogram. It’s a weird place, absolutely no parking facilities at all and the ambulances have to pull up wherever they can get, only to be approached by security staff telling them to move on! Anyway, one of the Healthcare Assistants, Flowie, had to come with us as Colin won’t go in lifts (elevators, for my American readers), so after Colin had helped me out of my wheelchair he headed off to wait in Reception and Flowie and I waited for a lift to the first floor. It takes me ages to waddle into a lift, using my crutch and hanging on to Flowie’s arm, and some woman put her hands on my hips! Frightened me to death, I thought she was going to push me over and my legs turned to jelly. I think she was only trying to help, but honestly! Having found a safe place to lean, joy of joys the lift doors wouldn’t shut and we all had to pile out again. It took ages for another lift to arrive but we finally made it up to the right department, Flowie booked me in and asked where I would be seen, and the receptionist directed us to wait outside a particular consulting room. After a few minutes a young girl appeared on the far side of the department and called me in. Finally we got into the room, and I was invited to lie on the examination couch! Now this was particularly disappointing because I’ve had two of these scans before, once on a nice comfy adjustable chair similar to a dentist’s chair and once on a very squishy hospital bed. So for the second time in one day I was faced with the problem of how to get on to a flat, narrow couch. I sat on the edge and started to say “I don’t think I can do this”. “Oh we can help you” they cried cheerfully, grabbed a leg each and flung them up onto the couch. They didn’t realise I didn’t have the strength to lower my back and head gracefully, and I fell backwards quite heavily. “Ouch” I said, or words to that effect.  
Happily the scan didn’t take very long as it was really quite uncomfortable, and I was worried about how they were going to get me up again, but between the two of them they managed relatively easily. We had a very short wait for hospital transport to take us back to Queen Square, and we were finished for the day just before 4 pm. The journey home was uneventful, we got home at about 6 o’clock, had a quick jacket potato tea and ‘did the cat’. Colin took the dog for a quick walk around the block and we had an early night ready to do it all again on Tuesday.  
To be continued……………

Whatever infusion it was …… I’ve lost count. 13th?

The view looking down the stairs into the treatment room

A difficult day on Monday.  I’d felt generally ‘off” all weekend – I wondered if it was because it was well over 4 weeks since my last infusion and maybe my body was missing the drug, but I think it was probably a bit of a tummy bug.  Whatever the reason, I didn’t feel particularly well when we got up at 5 am on Monday morning ready for the ‘rush hour’ crawl into London.  When we got to Beaconsfield Services, I really should have gone to the loo, but it seemed such a long walk through the building to the disabled loo at the back of the building, and I was worried that I wouldn’t make it without having ‘an accident’ – something I dread every time I leave the house.  So I didn’t, and consequently felt sick and faint with a dreadful tummy ache for the rest of the journey.  We arrived at Queen Square just after 9 o’clock and I just didn’t have the strength to get out of the car, so Colin manhandled me to a standing position, assembled my stupid 3 wheeled rollater walker, and we set off up the ramp to the main door.  I couldn’t do it.  Colin ended up pushing the walker and I hung on to him on one side and the handrail on the other, and we finally made it into the Leonard Wolfson Research Centre.

First job (luckily) was to go to the loo and provide the routine urine sample.  All went well until I dropped the sample pot down the loo, complete with the paper towel I was holding it with.  Next time you go, there will be a stroppy notice on the wall instructing you not to put paper towels down the loo.  That will be my fault, but I didn’t mean to. Colin rescued me from that disaster and the sample was eventually obtained.  Then into the treatment room to be weighed, and blood tests taken.  Luckily Laura found a vein at the first attempt and there weren’t many tubes to fill this time so I was soon eating my breakfast protein bar and drinking my first cup of coffee since teatime on Sunday.  Blood pressure and pulse rate readings were the next job – 3 sitting, followed by 3 standing.  My pulse rate was even higher than normal with readings around 120 bpm, so I had to do some serious chilling out to get it down to an acceptable 100 bpm or thereabouts.   Dr Natalia came round with her beloved Suicide Questionnaire (still no successful attempts to report) and did the usual physical exam and a few strength tests.  She made some quite encouraging ‘ooh’ noises at the strength in my fingers, but of course can’t really say anything.  She had very little new information from Novartis as to what is going to happen now that the official trial is completed, but she was able to confirm that I will be getting an infusion next month.  What happens afterwards appears to be anybody’s guess but they are hoping that we will carry on getting our infusions until they are ready to go ‘open label’, whenever that might be.

We went to the examination room at the other end of the corridor for the official Novartis strength tests, and the machinery actually worked first time so it didn’t take long to get the grip test, pinch test and thigh strength tests out of the way. The we did the balance tests – standing with feet together, then with one foot halfway in front of the other, and finally one foot in front of the other heel-to-toe, 10 seconds each time.  No problem with any of those.  After a short break, we decided to do the 6 minute walk test.  A 20 meter length is marked out on the corridor floor, and you walk between the two markers for 6 minutes.  This is slightly more difficult than it needs to be because the corridor is on a slight slope, and I can’t walk on slopes.  Apparently able-bodied people don’t notice the slope at all, but I do!  Because I started the trial walking with a crutch, I have to carry on using a crutch for the walking tests to give a fair comparison – but since I got the stupid rollater walker 6 weeks ago I haven’t walked with a crutch at all, and it was really hard work.    I’ve always been able to complete 3 lengths of the corridor plus a bit more, but this time I didn’t even manage 3 lengths which confirmed what I’d suspected – walking with the stupid rollater walker has slowed me down, and because I rely on it too much, I no longer even try to teeter around unsupported and my balance has suffered too.  A short break and a cup of coffee later, and we did the hilariously named ‘speed test’ – walking a marked 4 meter distance along the same corridor, twice.  Needless to say, I didn’t break any records.

Back in the nice comfy chair in the treatment room, I did a couple of questionnaires on the lap top and ate my sandwich lunch.  All the hard work was done and we just had to wait for the drug to arrive, and see the physio lady.  I was still feeling pretty rough, so I was hoping that the drug (and physio) might come early, but it was not to be.  The drug was late, and for some reason the nurses didn’t start trying to get the cannula into me after it was made up ready for use.  My veins weren’t in any mood to co-operate and completely defeated the first 2 nurses. The cavalry was called in, in the form of LiYing who takes no nonsense from veins and soon had me hooked up to the drip.  Whilst the drug was running through we discovered that the physio lady actually wasn’t in, so Dr Natalia would have to stand in for her.  The last blood test was taken – an easy job as my veins were all plumped up with the drug infusion followed by a bag of glucose solution to flush through, and Natalia went through the exercise forms with me and we were finished for the day.  I had wanted to talk to physio about the stupid rollater walker, but I think I can work out for myself that it isn’t helping me so I’m not going to use it any more.

We got away around 4 o’clock just in time for the school traffic all the way through London, but once we got onto the M40 it was a pretty clear run and we were home just after 6pm, absolutely shattered.  Had a very early night but still felt like death warmed up on Tuesday with the added bonus of the dreaded diahorrea.  I didn’t dare stray too far from the bathroom so mostly stayed in bed.  Wednesday was a slightly better day, and I’ve felt better as the week has gone on.  Now begins the countdown to the next visit, which will be over 2 days as I have to have a DEXA scan and a heart scan at the big hospital, not something I look forward to at all.

https://www.ucl.ac.uk/lwenc/crf

This is the place where this all goes on – click the link to have a look at the Research Centre’s website.  If you click ‘The Facility’ at the top left of the screen, and the ‘Our People’, you will see a bit more information about some of the people I’ve mentioned in these blogs.

BYM338 12th infusion

Colin making himself comfy

I can hardly believe that this was my 12th treatment, the time has gone so fast!  I will be having one more infusion to complete the year-long trial – and then what?   When I was at Queen Square a week ago, Novartis had still not issued any specific instructions about what is going to happen next and we kind of assume that we will carry on as we are for the next few months, with everybody getting the same dose as they have done all along.  There is speculation that this will lead into an ‘open label’ phase of the drug development process, with everybody getting a dose of the actual drug, but there is no official confirmation that this will happen.  It seems strange to keep us all in the dark like this, as the hospitals obviously need to organise their schedules in advance and even us patients would like to plan ahead to a certain extent, but this appears to be the way Novartis like to do things where this drug is concerned.  Everything is shrouded in secrecy, and details only revealed at the last possible minute on a ‘need to know’ basis.

I don’t think there’s any doubt that the trial data is going to reveal positive results and I have read a lot about how Novartis will gain approval in 2016 and we will all be on the drug (if we want it)  in x number of months depending on the writers’ own interpretations of very sketchy information.  I hope that’s true, although I would prefer it if we were all on the drug NOW!  My results seem pretty good compared to some that I’ve heard about, I massively salute the ones who’ve kept going through the year whilst seeing no benefit whatsoever.  I’m not sure that I would have been so generous with my time and energy because it has really been quite hard work.  It is a lot to ask of poorly, weak people to show up at distant hospitals having eaten and drunk nothing since the night before, for fasting blood tests and a day of physical strength testing and walking assessments.

Having said that, my visit this time was one of the easy ones with nothing to do except produce lots of blood, keep my pulse rate at a reasonable level whilst they were checking my blood pressure (3 times sitting and 3 times standing) and complete the beloved suicide questionnaire whilst waiting for the drug to arrive, which it did at about 1.30pm. The lovely doctor Natalia was kind enough to comment on how strong my neck and thumbs have become, and I’d thought myself that my neck was less wobbly so it was nice to have that confirmed.  It was very quiet in the department with a lot of the nurses away on holiday and only (I think) one other patient in for treatment for a different condition so it was a lovely relaxed day.  I noticed that I could quite easily open the heavy toilet door and let myself in and out, whereas until quite recently I had to holler for someone to open the door for me.

So after the drug was given and the usual glucose flush through to get every last drop of dug out of the tubes and into my veins, we just had a quick chat with Alex  the physio lady and we were away before 3.30pm.  I told Alex that I had discovered some Chair Salsa videos on Youtube, and how much I enjoyed my attempts at doing the moves.  She was going to have a look at them, so if she ever suggests them to anyone, you’ll know it’s all my fault.  It’s good fun, if you like that sort of thing.  We had an uneventful 2 hour drive home, and I had quite an upset stomach that evening.  I had an early night but still felt quite strange and washed out the following day.  When Colin came home from work I asked him if it had been snowing, which seemed like quite a reasonable question to me at the time (in August!) but it amused him.  I don’t think confusion is one of the side effects of the drug, I think I’m just getting old.