So, some of you know my story but if you're new here, a brief summary ...
After having symptoms for over 2 years I was finally diagnosed with RA last summer and started mtx in last August. I've been having steroid injections (4 in total now) to keep me going until the mtx started to work, but it hasn't yet and my das score yesterday is now at the very high end of moderate. This in itself was quite a surprise as I thought my RA was mild, so still reeling a bit from that one!!
So having been told about the increase in my das my consultant started to talk through my options, which were as I was expecting, to add another drug, sulfasalasine in this case, to the mtx and see if it that does the job. Usual stuff, takes time to work etc.
Then the consultant went onto to say that as although my bloods are high, they are not very high and because of this it's unlikely I'd ever qualify for biologics. However they are trialing a new drug called Baricitinib which is very similar to Humira and that I would be suitable for the trial, subject to screening of course.
The trial will have 3 study groups and I will be randomly selected to go into 1 that neither I or the doctors will know which it is. The groups will be one group will take the new drug, another will take humira and the last a placebo. All groups will continue to take their mtx. The trial is for 52 weeks and if after 16 weeks there is no improvement, if you are in the placebo group they will switch you to the new drug. In any event they switch you to it at 24 weeks. At the end of the trial period there is the option for an extended trial period of 2 years. I can leave the trial at any point I want to and resume normal meds. All my expenses are paid for.
Side effects appear no worse than anything else we all take. Would be tough if I ended up in the placebo group as I'd have nothing other than the mtx for 16 weeks. This new drug, like humira, is meant to work more quickly than drugs like sulf and mtx.
It's a big commitment in some respects as you have to go to the hospital 18 times during the 52 weeks and often for several hours. It's about a 4 hour round trip for me to the hospital, so it's a whole day thing. I work part time and have 1 day off which I don't want to give up to be going to hospital, but don't think my work will like me taking the time off every 2-4 weeks, maybe there's a compromise there somewhere.
On the plus side, I will be getting very careful monitoring which is reassuring when trying to control your RA instead of having to wait 3-6 months in between appointments.
So, instead of being at my appointment, asking all the right questions etc, this really threw me and I sat there like a bit of an idiot! He definitely said that the drug would be very useful for those like me that fall just short of the biologics criteria. Then I think he said this, but I'm not sure and this is really very crucial, I think he said he doubted that the mtx and the sulf would actually be enough to control my RA. But I'm not sure if I'm now imagining that it's all so blurry!!
I think I'm leaning quite strongly towards going for the trial but wondered if anyone else had been offered this, has been on a drugs trials before or can think of any questions that would be good for me to know. Sorry for the ramble, that was quite helpful putting it all down, and I think I've covered it!!!
Thanks, Rosie x
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Yes you bet I will be, although currently enjoying a nice takeaway curry, glass of wine then might even have some chocolate later to help the thinking process along lol xx
I am feeling much better in myself thanks, so not as fatigued. But I think the injection has only eased the pain a little. So I will wait a few more weeks then see how it is then.
Let us know what you decide to do.
Wow! one one side that sounds exciting but it's a huge commitment!
Rosie good luck with your decision - I can see why you need some time to think it through properly. Would your employers be any use to discuss this with? If the drug makes a big difference to your health in the long term it could be of benefit to your employers too as you wouldn't be off sick so often? And the feeling of being closely monitored would have many benefits too I feel.
Partly the reason why I was so reluctant to continue taking injectable MTX or starting Leflunomide was because I am seen so rarely and so much is left to my GPs - who readily admit to not being experts in rheumatology or the drugs we take.
It is difficult being at the high end of moderate RA because it's not mild enough to ignore nor is it severe enough to meet Biologics criteria so we worry that damage is occurring slowly but surely. The only thing I would say is that some people here are on three DMARDs, usually MTX, Sulfa and Hydroxy - and they seem to work very well - especially if you could switch to injectable MTX which is supposed to be more effective? So if you decide that the trial is too big a commitment perhaps you could ask your rheumy about triple therapy? Tx
Thanks Tilda, yes I asked about injecting mtx as I'd heard people did better on it but he said that it was not more effective at treating RA! He did agree to swapping me though as I said I was still getting nausea and gastro problems. Then he changed his mind and said to reduce the mtx down to 15 to counter the nausea as I would be adding something else in. Then he mentioned the trial, and now I haven't got a clue what I'm meant to be doing. This is what I mean when I said I didn't ask the right things and have things very clear in my mind. He said he'd ring me the week after next to get my decision and I'll have to ask him them about that.
I think they like to add the therapies 1 at a time, which makes sense as you'll not know what helps or might might be causing any reactions. So I suppose that might mean 4-6 months on mtx and sulfa before they would let me try the hydroxy in with it. I have taken hydroxy and failed on it. I'm not too sure, but I think that's how they do it. It all just takes a long time and then it might not work. There's so many factors to consider.
I'm seeing occ health on Tuesday so I will ask them about perhaps alternating my visits, 1 in my time and 1 in theirs. There's a lot of visits to start with so maybe I could start by whilst I'm still off sick. I think they said I could go up last week in feb. Also, they are only taking about 6 on the trial, I think it's an international trial with about 1250 on it but only 4 or 6 from my hospital, so I don't want to hang around too long, as I might miss the opportunity. I'm talking myself into this aren't I!!!
Back to the wine and brain food chocolate for me, thanks for replying T,
Rosie x
Enjoy you brain therapy Rosie and try not to panic - I'm sure things will become clearer with wine and choc and hopefully a relaxing weekend too. X
HI Rosie.... wow a lot to think about!
.... I think its a case of writing up the pro's and cons in lists next to each other and visually see what makes more sense. Sounds like the doc wants you on it because you may not have the chance to go on biologics if the MTX and SSZ dont stop the progression of the RA so thats a big pro. I think I would probably trial the drug but my reasons arent necessarily your ones so you might need to work some things through with your family and work in order to feel comfortable with any decision you make.
Wine? Who offered a glass of wine? My choice would be a whole bottle if it didnt make me want chips and savories with it ... Oh and the chocolate has to be Lindt balls - actually if we are being picky then the green ones with the mint inside will add to my waist nicely. If I have to have more insulin then I may as well make it worth it and go out with a smile on my face
Ha ha I did possibly have slightly more wine than I should have last night but it was worth it :)) oh and I'm sooo with you with the Lindt balls, although I had to make do with a Lindt choc bar instead which was nearly as good. Tired this morning tho!
Yes I have to say that I'm 80% decided that I'm gonna go for it. My husbands going to read up this weekend, and as he's a biology teacher will probably understand it better than me and give me a different perspective. So if he thinks its a good idea and I can sort it out with work I am probably going to do it.
Sounds like a good rheumy who's looking after your interests, and thinking laterally about how to treat you with different drugs knowing that you wouldn't get funding otherwise. I've known a couple of people on here that have gone down this sort of route, but can't remember the details. Bit I don't recall anything bad.
And since MTX is said to be the most effective of the first line drugs, then it does sort of make sense that if MTX isn't doing enough for you then adding extras may not be enough either? I started on MTX alone, and it worked about 75% so rheumy suggested adding in Hydroxy. That made a little improvement, say to 85%, and so sulpha was then added in. And with all three I'm 95% normal. But if's the MTX that has made the most difference, so if that's not the case for you then more drugs on top may not be the answer. I did have a small rebellion last year as I was feeling so fine, so with consultants' agreement started dropping doses of sulpha & Hydroxy. And I ended up just having constant small niggles - not huge flares but every day there was a bit of me hurting. So I know they're doing something, but for me it's just round the edges. (Needless to say after a couple of months I went back on them!)
Presumably this drug is quite far down the development route if it's now being tried on real people, so maybe you could ask a bit more about how useful it been so far. Me being me I'd also want to know the bad side, but sometimes better not to ask!
Hi helix, good to hear from you and as always you talk such sense.
Actually, having spoken to friends and family, none of whom have RA, I think the points you've made, particularly about the mtx have been the most helpful I've had so far, thank you. My rheumy suggested that the mtx may have flattened the RA a little and it may have been much worse without it, but we will never know that. What I do know if that whilst on it the disease has got worse.
Yes it is getting to the final stages of testing. I've googled it and results so far are that you can feel benefits as early as in the first 1-2 weeks and I think everyone felt some improvement within 12 weeks. This continued to improve through to 24 weeks. So it does sound promising. It is one of the new jak inhibitor drugs they're introducing.
I could of course be randomly picked and end up with humira rather than the test drug. I've asked what then happens at the end of the trial and they've said that if I've done well on the drug it wouldn't be ethical to stop me taking it.
Like you helix, I want to know the ins and outs of this and every possible outcome for any eventuality during the trial. However my husbands first question when I told him was will this affect your life insurance, cheeky beggar!!
Thank again helix, I really hadn't thought or realised the points you've made about the mtx. I'll let you know what I decide, although I think I'm now pretty nearly there on going for it. Rosie xx
I have just got to the end of a trial that lasted a year, to compare rituximab as opposed to 2 anti-tnfs for 2nd stage treatment. I was randomly selected to go on to rituximab which had risks. However these were clearly set out, and explained before I went ahead. Eventually I had to stop it when had a bad reaction to the 2nd course of infusions.
I'm was switched to enbrel, the jury is out on whether it is helping.
I had to go to hospital about 15 times during the year
The big personal benefit was monthly monitoring, which is so reassuring when trying a new drug.
The other factor for me was that I felt I was giving something back, having benfitted from drugs that other people had trialled in the past
Hi M, that's really encouraging to hear, thank you for replying. I do hope the enbrel does start to work for you soon.
The trial drug I've been offered is in tablet form, which somehow I feel happier about than an infusion. Not too sure why, possibly the idea of an infusion generally would make me feel less in control.
I am now at the point in decision making that I'm still open to what others have to say and I definitely want to discuss it more and as much as possible. However, the more I hear from others and the more I discuss it the more I am certain that I will do it. So unless anyone points out a reason not to do it I'm pretty sure that's what I will be doing. Thanks so much for sharing your info M and good luck with thy enbrel Rx
This was all an interesting discussion. Thank you for presenting it. I am trying to find the proper fix for my RA as MTX and hydroxy seem to be doing almost nothing. I see my Rheumy on Friday and will ask about this trial. God bless your decision and hope it will have good results for you.
Best of luck with that. It is a worldwide trial so you never know, there may be one near you. If not, there are some other new biologics being trialled out there. They all work in slightly ways but hopefully there might be something your rheumy can offer.
I've decided to go for it. My work has agreed to allow me time off to attend my appointments which is great. I really think I have little to lose, but masses to gain.
After seeing the doctor, I feel rather dumb....He sort of spanked me (in a nice way) because I had quit taking naproxen. I stated that I felt like it was making me retain water and that I had heard that it wasn't safe to take it along with mtx. He said that it is one of the safest NSAIDs. So I have gone back to taking it. It has helped, though I feel like the ache and discomfort will never completely go away. After all that, I didn't even bother to ask about any drug trials. My good friend is in a trial for Xeljanz, which I see that the UK won't even approve. You never really know what to do.
I hope you are confident in your decision and that you are doing well!
Hi sehyo, thanks for taking the time to let me know how you got on. I'm glad you're back taking the naproxen, it always really helped me but upset my tum so I hate to stop it.
Typical that your consultant distracts you so you forgot to ask about the trial!!
Yes I've hear about the dug your friend is on. It works in a very similar way to the drug I'm to trial but, looking at the information provided by the European medical committee, it hasn't proved to be effective enough and the side effects possible too serious. Although it has been approved in the US so maybe it's not so bad. Like you say, difficult to know what to do.
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