As some of you may know I have been trying to understand why my consultant has deviated from standard NICE prescibing guidelines for RA and missed out Anti TNF and gone straight for Mabthira biologic treatment. Last night I stayed up really late searching the web. ( when my consultant mentioned Mabthira I thought it was an anti TNF.. Only became clearer last night)
In case you are interested or may ever find yourself in this situation.
I came across a media release by Roche 17 June 2010.
Experts at 2010 Europeans league against Rheumatism ( ELUR) annual congress highlighted to Rheumatologists " that targetted treatments in RA, through the testing of specific blood markers at the time of diagnosis ,could have a significant impact on treatment decisions, resulting in an improvement in patient quality of life."
OK good. So what are the bio Markers then?
Rheumatoid Factor RF and Anti -Cyclic citrullinated peptide ( anti CCP) two characteristic autoantibodies produced by over reactive B cells are found in apparently 80% of people with RA. In other word Sero Positive. Sorry if this is old hat to long suffering RA people but this realisation it is breaking ground to me. I think others have tried to explain it but sometimes we need things in bite sized peices or arent listening properly.
immmm. So I possibly have over reactive B cells???
" As selective B cell targetted therapy , Mabthira is the first and only targeted treatment options available for RA." Roche Media Release 17 June
Rituximab is actually a therapeutic antibody, which bind specifically to the CD20 molecule on the surface of B cells thereby putting these cells out of action.
This morning there was a message from my biologics nurse specialist. It went something along the lines of... the consultant does not want you on Enbrel he wants you on Mabthira. Ive booked you in for the 6/6/2011 and you will be recieving a letter.
So why has my consultant deviated from standard NICE protocol in my case?
Well I think he is trying his hardest to achieve a remmisssion for me to enable me to stay in work which at this stage is what I have asked him to help me with.
Assuming I am sero positive ( i must be to justify the risks of B cell depletion) what are my odds with Mabthira compared to someone who is sero negative?
According to the Issacs,J et al. Biomarkers Study presented at EULAR conference 2009" At week 48 seropositive patients were over 3x more likely to achieve a 70% improvement in symptoms (ARC70) compared to seronegative patients."
Im really afraid to take Mabthira. Why? because if there a medical event it always seems to happen to me. The rarer the more likely !!!
However there is nearly a decade of safety analyis and the evidence is that there is no increased risk with a different biologic ( such as an Anti TNF) following discontinuation with Mabthira.
So I have taken the decision unusually I suspect to treat my RA aggressively and to have some blind faith in my consultant to some extent.
I will write another blogg in 6 months time to report on my Remission status and quality of life and most importantly for me at the moment whether I am in work.
Thanks for sharing this Fiona. I'm following all t his avidly because I've just had my 59th infusion of infliximab and worry that it'll stop working sometime.
I always worry that my bloggs are not chatty and a bit serious but I guess we are all made differently and manage our RA best for us. I am great believer in facing the facts and then doing all you can to deal with it positively. Can be a bit like a dog with abone though when I get my teeth round something. Good thing about this site is that if you dont want to read /engage with someone you dont have too it is a personal choice. So any one who prefers a lighter blogg can skipp me.
Re your 59 th infusion what a fantastic story. Its really good that you have responded so positively to biologic therapy and if you ever need another will hopefully do so again.
x
thats great Fiona hope it works give i a shot and keep is posted it wouldnt by the look of your info be suitable for sero negative ra?
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Yep think thats right Ali xx
Hi Sparkie. Your research is fantastic and the knowledge you are acquiring is empowering. On top of that of course is the fact that because you are sharing this, others in your situation can learn so much more. You shouldn't worry about the fact that you think your blogs aren't chatty enough. We all deal with things differently, and this is exactly, like you say, the good thing about this site. You have all sorts of people imparting all sorts of knowledge. I am a newbie at Ra I was only diagnosed last October and it looks like for the time being Mtx is doing it's job. So I think I am lucky and do not, for the time being have to worry about failed treatments. But boy if I do, then I know exactly where to come, because your experiences and those of others, who have indeed been long-suffering with RA, have been made known to us and it's a wonderful source of information support and comfort. I wish you well with your decision, it sounds like it is as it should be a well-informed decision. This is such a far cry from the attitude of my rheumatology department, who only seem to give information on a "need to know" basis, the base line being, I don't need to know - apparently! Only the other day as I have never been told my blood results,for anything, and I asked my nurse about it, and she found a little white book with mine name on it, which I should have had given me 8 months ago, in which they tell are supposed to write my blood results. Good eh?
So you keep going gal, good on you and all the very best with your treatment.
Julie xx
Hi Fiona, I know I said to you yesterday that I had tried the three Anti-Tnf's but what I didn't mention was the fact that my consultant had no choice, I had to go onto treatments as they became available, or licensed if you like.
That's how its been all the way through my RA, at the start of my RA treatments were scarce only Sulphsalazine and then Cyclosporin. Nothing like Anti-Tnf had ever been heard of, that was why I spent so much time in hospital, trying to get it under control with a combination of bed rest/joint injections and infusions.
Then as soon as something new became available I went on it,then when it stopped working I went onto the next one in line, and that's how it continued,
Whereas now you have more choice which is great so I presume your consultant puts you on the right one for you according to your blood results!
I've been on Rituximab about three years I believe, and it's working for me, having another one soon.
Good luck, I'm sure you will be fine.
Mandy xx
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This makes me appreciate how fortunate i am to have more choice. when I read your bloggs mandy I realise just what you have endured.
When is your next infusion?
Fiona xx
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Well, nurse wanted me to have it a few months ago but I wanted to give it a little longer. Phoned the nurse today as not been well the past few days have got to see her on Friday. The only thing is my white cells are low so have to wait for them to come back up, on saying that though by the time I've been given the ok to have it they will probably be back up.
The other thing is I have to stay in over night as I have a slight reaction and they like to keep a closer eye on things(don't panic on that!!)So all being well in about two weeks I'll be having my fifth course of it.
You have one infusion over about 7 hrs then another one two weeks later.
Mandy xx
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thanks mandy- is anyone else here on Mabthira that you know of?
xx
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To be honest I'm not sure. Just to add that the reaction was just my temperature rising slightly and blood pressure coming down and as my blood pressure is normally quite low it's just a precaution. They start you off with small prednisolone infusion,lasting about 30 minutes then the infusion starts off slow at just 25ml over 30 minutes, they do all the normal observations and if your feeling ok they increase the infusion and that's how it goes. Because I'm awkward,lol!, the infusion goes through at just 75ml for the whole time, the slower the better, as soon as they increase it for me that's when the reaction starts so better for me that way. Only thing is it can then take up to 10 hours.
As long as it's working though and the reaction isn't to bad that's ok by me.
Mandy xx
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I agree 100 %. can you eat with it and drink normally?
F xxx
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Yes, when you go for the infusion just take yourself something to read/eat/drink/!
I've read the same info and im actually relieved to know that some consultants are willing to deviate from NICE protocols for their patients. It gives me hope that hands arent as tied as they would appear to be with regards to treatment options for RA patients.
Again.. awesome post!
Joy
Hi Joy
Thankyou for the postive feedback really appreciate it
Quick question, I've just been told (after 3yrs) that I'm sero-neg. Does that mean that I'm limited in my choice of treatments if the mtx fails to do it's job? I'm totally in the hands of my Consultant and RA nurse when it comes to all of this although I am learning that knowledge is power, so keep posting blogs like these won't you? Oh, good luck xx
Hi Jo, I believe that it used to be said that patients who were sero-negative were generally thought to have a less severe form of RA so therefore treatments weren't so aggressive, and patients who were sero-positive had the aggressive form and more treatments available.
However, this does not seem to be the case as most of us now from experience. They now tend to rely more on tests such as the Anti-ccp test which gives a more accurate picture of RA, and of course the patients themselves. that's why I always say to tell your consultant exactly how you feel so he can make a proper diagnosis.
Hi Mand, I only ever seem to be asked for the bog-standard blood tests before Consultant app's - should I ask to have these other tests so they can see in more detail what's happening? Most of my tests come back low or even negative so even though I'm feeling rough and the RA for me is bad they look at the blood work and say it's all fine. It's so frustrating because I feel then like I'm asking for things they think I don't need! When I asked what the next step would be my nurse mentioned Embrel which is onto the anti-tnf wrung, I'm not sure I'm ready for that yet when there are other drugs I could take alongside Mtx...I guess I'll find out in Aug when I return with a bucket load of questions!! xx
Hi Jo, they may have done the Anti-ccp test but then again all consultants work a little differently and go along with certain blood tests. There's no harm in asking if they did the Anti-ccp test and if they haven't ask them why. Don't be afraid to ask it's your body after all.
I have my bloods done every four weeks now and that's just standard testing.
I'm having my Rituximab soon and I know I'll have some different tests done then.
Keep making a note of those questions Jo, its' good to have RA knowledge.
Take care
Mandy xx
Hi Jo
In answer to question no i very much doubt it. Think you would have a choice of drugs you could consider if you need to discontinue methotrexate or step up treatment.
NICE has an preferred/suggested order for Rheumatologists to prescribe these drugs in.
I will try and find it and link it. Trouble is I havent worked out how to do it ( doh!) From memory its a kind of step up step down treatment plan. I think the NICE recommendations/protocol is meant to be based on clinical factors not financial.
3:Anti TNF ( TNF protaginists) like Enbrel / Humira
4 therapeutic Antibody treatment ( like mabthira) only one that is B cell targetted
I think that what I am going for makes sense because of my Bio markers, the fact I have Sjogrens ( its being used for Sjogrens in trials) and want to stay in work.
Hope you are feeling ok and the increase in methotrexate is working?
Hi Fiona, thanks for your reply. I guess I just expected to be put on mtx and that would be it, RA knocked on the head...well, that was the impression I got when I started it. I'm learning that that isn't always the case though so it's good to know what the future holds drug wise. Nurse has mentioned going onto Embrel but I'll have to wait til Aug and then I expect I'll know more. I'm not sure mtx increase has kicked in yet, I'm still struggling, especially on the more hectic days when I have to be up and about walking here and there, hanging onto umbrellas in gale force winds It sounds like you've made up your mind about your treatment and I really hope it works out the way you want it too. In the same way you want to stay in work, I want to be an active, involved Mum so we're all working towards something that at the moment is near impossible to do xx
enbrel sounds good option! i believe you are sero negative? like your self dont think mab therapy as we call it the trade is licence approved for sero negative artthrits it is about the only one not deemed suitable
would like to get hands on enbrel if only nhs glos hand any money left.. duchess of wessex opens it today sophie.. edward inew womens centre !!
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new build womens centre opened by minor royal today... budget blown.. zero pennies for drugs
Very interesting post Sparkle! AS you know from my posts last week I had problems with MTX causing really low white cells (had to be taken off it even though it worked really well for me), and leflunomide seems to be doing the same. However I know I am anti-CCP positive, so this may be an option when needing to look at other alternatives!
I'm also determined to stay in work (have really supportive employer and so far my career hasn't been affected too much as I can work from home as and when required) - will read up more on this tre4atment though!
Hi Fiona
Rituximab is not normally used as a first line Biologic treatment. In majority of cases, patients respond well to one of the five standard anti-tnf therapies. These are almost like a broad spectrum drug which give a better chance of dealing with cells that are over active and in particular the tumour necrosis factor which is present in all cases of RA. As a specialised therapy which depletes only the 'B-cells' Rituximab is not suitable for everyone and especially anyone who is sero-negative as these particular cells are not found in abundance. It is a genetically engineered mouse-human chimeric monoclonal antibody which operates specifically against the B cell-specific antigen CD20 which is present on the cell surface of all preplasma cell stages of B cell differentiation. This is one step beyond anti-tnf whose sole purpose is to block the tumour necrosis factor protein and thereby reduce inflammation without causing side effects by blocking other important processes. Presumably your profile has shown raised B-cells with the presence of CD20 which is why it is felt that Rituximab is an appropriate therapy for you.
The guidelines set out by NICE are just that, guidelines. They are not enforcable protocols and it is solely up to rheumatology depts to decide their own way forward. Most do follow the guidelines because they are based on very much tried and tested theories and practice. Only few patients are unsuccessful on anti-tnf and will need to move to more specific B and T cell depletion therapies or IL-6 moderators.
Steroids are not normally the first port of call these days as everyone is very aware of their long term side affects. More usually patients are started on one of the many anti-inflammatory drugs before being assessed for DMards such as methotrexate, sulphasalasine, hydroxychloroquine etc. Most people reach a state of controlled diseases on combination DMard therapy without needing to progress further. Next are the five anti-tnf drugs, Infliximab, Humira, Enbrel, Cimzia and Simponi. Followed by specific B cell depletion, Rituximab, IL-6 receptor Tocilizumab followed by the T-cell moderator, Abatacept.
Like Mandy, being diagnosed such a long time ago, I have only been able to move forward on treatment as drugs have been licensed. I have had the ups and downs of disease, joint destruction and failed treatments. I have been offered Rituximab and turned it down as I am not happy with the long term outcomes compared to those of a standard anti-tnf. Returning to anti-tnf is not always successful after depletion therapy and the thought of 'closing doors' is not a route I want to go down just now. However, each to his own !
In your case Fiona I would be very concerned by your rheumatologist's choice so early in your treatment. The way forward is to achieve disease control with the very minimum of treatment. You will have missed one complete stage (giving you possibly two drug choices) and moved directly to an engineered depletion therapy possibly cutting back future options significantly. Rituximab was only licensed for RA in the UK in 2006 and long term outcomes have as yet little history. It is not necessarily more aggressive, it is a different type of therapy.
Hope you are able to get more relevant information from your rheumatologist before proceeding on this path. Good luck with whatever you choose
Lyn, thank you for bringing together all the possible treatment regimes in one easy to read and understandable response - it really deserves a blog of its own.
I didn't expect to see you on here! Thank you for your comments.
I might do a blog on treatment specifics when I get a bit of time! Although I tend not to blog often as I find possibly hours of work referencing tend to get buried very quickly ... never to see the light of day again!
Lyn x
Hi Lyn
As you are disagreeing with my rheumatologists advice it would be helpful to reference if you can find the time.
My understanding from reading is that it is possible to take other biologic treatments after discontinuing Rituximab. There is no conclusive evidence as yet B cells do not return after cycles of Rituximab.
Genovase,m et al. Rate of serious infection in RA patients who recieve biologic treatment after discontinuing Mabthira presented at EULAR 2010
"In this updated analysis the, the rate of serious infection was evaluated in patients to determine whether the B cell depletion following treatment with Mabthira may have an impact on the safety of treatment with a different biologic following discontinuation with Mabthera.( the majority of which were TNF anatagonists) the rate of serious infection SIE was not increased. overall the types of infections were typical for RA patients and consistent with rates seen in other other safety analysis."
What woud the other reasons be why you could not take ant tnf after mabthira?
I will discuss with my rheumatologist team the points you raise. ( if I can access my consultant)
However I do respect his view and technical knowledge and fundamentally believe that there is a clinical case for mabthira to be the choice of drug and in my best interests at this stage.
I think that the fact I have Sjogrens syndrome is also factored into the equation.
So possibly the treatment is being taylored to treat both conditions.
Rituximab is now being used as treatment for Primary Sjogrens . I feel that you have answered this as someone who only has RA .
I know that the specific treatment is not necessatrily more aggressive but I do consider that the treatment plan adopted by myself under the advice and supervision of my consultant would be considered aggressive because I would have missed out on one stage in the NiCE tried and tested guidelines.
ps I think some consultants/health authority are constrained by the prescribing guidelines due to cost of expensive infusions.
Thanks for your thoughts and experiences on this lyn they will definately added to the melting pot. Who knows after I have raised them with my hospital maybe I will decide to step down to Anti tnf ?
keep you posted as I may be the experiemental guinea Pig !
Fiona x
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Hi Fiona
I'm sorry if my response came across the wrong way it was not my intention to be seen as disagreeing with your rheumatologist. Indeed rheumatologists who have a progressive,forward thinking attitude and are prepared to deviate from the accepted 'normal' can be a real benefit to their patients. You will note that I did say "Presumably your profile has shown raised B-cells with the presence of CD20 which is why it is felt that Rituximab is an appropriate therapy for you."
I was trying to get across a point without suggesting that you were part of a rheumatologist's "experiment" . However, you have put that into words yourself! This is what concerns me. After Rituximab you are left with limited choices having jumped two possible options (as in two anti-tnf treatments) along the way.
I answered as someone with RA because that's what I'm diagnosed with! I can't comment on Sjorgrens because I don't really have sufficient background on it and am not totally familiar with all the treatment options.
You're right about some authorities not having sufficient budgets to fully utilise patient choice when it comes to Biologics and this is where it is important that we raise awareness of RA for the good of all.Many people are missing out on treatments that may offer them a much improved experience of living with RA.
One of the reasons I'm not blogging at the moment is because I don't have the time to do the referencing required to substantiate my thoughts.
Lyn x
Hi Sparkle
I am also on Rituximab although came to it through a different route which was a major arthritic reaction to Embrel with CRP shooting up to >200 after initial good three weeks and hospitalisation. Apparently the chances of another anti-TNF working for me were consequently reduced so I was put on Ritux and have had three doses so far and over all they have worked much better than anything else. I have low blood pressure so also have to have the infusion quite slowly and I tend to feel really washed out for the week following each of the infusions and it also takes a few weeks to work properly. However the good news is that once it does work I have months where life is pretty normal and I can garden, work, walk etc. So in my reckoning my having a life now compared with a rather non-life when the disease was very active is worth it. It also has the benefit that in between infusions (which cannot be more than every 6 months after the two infusions per treatment 2 weeks apart) you have fewer drugs to take!
Your research showing how they are beginning to work on understanding why different people develop RA and the different markers for this - apparently the disease may occur for different reasons in different people hence them needing different treatments is what I understand from my very good rheumatology team. I have also been assured there are other things they can try if this stops working.
It is your decision what to do but I have to say it has made a massive difference to me for the last two years and am hoping continues to do so!
Good luck with it all
Skippy
Thanks for your encouragement skippy- Think im going to ask for slow infusion as mand has it slowley too and that works better for her too.
Although there are general guidelines its interesting how we are so individual in terms of the disease. Nice to have fewer drugs to take! what about blood tests though? forgot to ask about that? how often are they?
Fiona x
agree with lyn. she is our expert patient. mab thera. not suitable unlicensed for sero negative arthritis .this lady nows so much.. I know general drugs but very little about ra drugs learning rapidly as possible.. thanks to lyn/ nras, internet and good reading material..
will be an expert on inflammatory bowel conditions well hopefully.. workshop mid june.. so can help with bowel .issues !!
Alison
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Thanks for your kind comments Alison I try to read as much as possible and keep up to date with changes in treatment etc.. I am lucky to have access to several online medical journals through a family member and this provides a lot of key information that I can then follow up through other channels.
Good luck with the workshop Alison, hope you enjoy it
Take care
Lyn x
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fortunately I am sero positive! so 70% more likely to work for me than someone sero negative. Thats the whole argument about bio markers !!!! And why the treatment is predicted to be more likely to work for me.
Also clinically significant, I have sjogrens and rituximab is used to treat primary sjogrens.
Lyn I quite understand why you answered from the point of someone with RA but I think it demonstrates the fact that none of us no matter how knowledgable we may have become, can ever fully understand the individual clinical factors involved in each persons disease as well as the Rheumatology team.
The value of this site for me is that there is that we are learning together and are all equals.
I do think however that my treatment plan is a bit of an experiment and therefore the outcome although a reasonably good bet, remains unknown.
Fingers crossed ( like most of us trying different RA drugs!!)
At the end of the day we are all individual as is our disease and our reactions to drugs whether good or bad are very individual.. best case scenario is drug x works for y people with only a, b.. c side effects in 1./1000/.1./10,0000 etc
I don't know if this helps but my consultant was looking at Rituximab as a first line of treatment too. The reason was because I have chronic nerve pain - a little like MS - but it's not. The worry with the anti-TNFs was that it can make nerve pain very serious and cause paralysis if you already have demylination. Once we got the ok from my neurologist we decided to try Humira first, which has in fact been very successful - so far (3 months in). My bit of paper (from the consultation) also says etancept - avoid - but I can't remember why.
So it may be that there are other factors that your consultant is also considering for you... perhaps not voiced.
Hope that hasn't added any more complications for you!
HI
thankyou for your response its added a wider dimension still. Good healthy discussion thats a good thing ! Although there are general protocols on lines of treatment your case and mine pehaps go to show that individual treatment plans have to take into account our varying individual clinical needs. Nice to know my consultants not the only one ( unless we have the same consultant !!!! )
I have huts read your post and all the comments relation got it. I have to say that I am sero negative but anti ccp positive. I was diagnosed in November 2011 and have tried a multitude of grubs including anti tnf's Humira , enbrel and another one I can't remember the name of. I was started on rituximab last April and had my second cycle in October just gone. My bloods showed that the first cycle did not have a positive impact as there was no depletion in B cells. I was still in agony so was given a steroid injection into my wrist. I went back in December and my inflammatory markers were still raised quite high so they have upped my oral steroids to see me through Xmas holidays. I am starting to reduce the dose this week & can feel that my RA is still active. I suppose my point is is that rituximab is not just for seropositive people... Hope this helps anyone who is considering rituximab x
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It sounds like you've made up your mind about your treatment and I really hope it works out the way you want it too. In the same way you want to stay in work, I want to be an active, involved Mum so we're all working towards something that at the moment is near impossible to do xx
Has anyone started on a new treatment regime during lockdown?
Anti-CCP (elevated) - aggressive RA and aggressive treatment?!
Sero negative or sero positive?
can I have info on people with sero negative arthritis for my consultant meeting
