LUPUS UK
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Query re Rituximab and being licensed treatment for lupus?

This is a query for one of my support group members. She has given me permission to post this, as we can’t solve her situation ourselves.

So she has lupus and Sjögren’s etc.

History of miscarriages and strokes. Very bad headaches. Etc.

She has increasingly felt that her methotrexate isn’t working and her lupus isn’t under control.

She is suffering very badly from lupus related arthritis, all joints and hips especially and only has paracetamol to use, which isn’t cutting it.

It’s difficult because she has a reaction to Hydroxychloroquine and cannot take that.

So anyway, Rheumatologist actually agreed she needed more help and she was feeling positive and hopeful. She was told she needed a lot of bloods done and if everything was OK she would be given Rituximab infusion. She was delighted.

She then got a letter saying that all her the bloods were fine BUT Rituximab wasn’t licensed for lupus treatment and they would have to apply for funding.

She was VERY upset and telephoned the rheumatology nurse. She was told that she wasn’t even sure my ladies Rheumatologist was going to apply for the funding! It wasn’t to be taken for granted that the Consultant that would apply.

More dismay and disappointment.

None of this had been explained to her before. She was simply told if she passed the bloods she would get the infusion.

Today, she hadn’t heard back from the Consultant - a telephone call was promised from the Consultant.

She had been told lots of staff on holiday but rheumatology nurse says they won’t be applying for funding for Rituximab and she will be tried on MMF instead.

Needless to say my lady is upset and feeling deeply let down. Why tell her what they did and do for the bloods for Rituximab if they didn’t intend to follow it through?

Is Rituximab licensed for the treatment of lupus? Has anyone else faced these issues?

I’ll be on again soon as I have another query.

Thank you!

Wendy

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I’m in almost the exact same situation as this person Wendy. I was offered Rituximab in 2016, 18 months ago, and then it was abruptly withdrawn because it isn’t licenced for Sjögren’s - following some farcical UK wide trial where they only trialed Rituximab for oral and ocular dryness and fatigue on Ro positive SS sufferers. Never mind the multi-systemic problems affecting many sufferers.

The only thing is that I have now tried and failed 5 DMARDs so am now not even going to be able to take anything at all unless they find that i actually do have active RA after all.

So Rituximab is licenced for RA if your disease activity score is shown to be high enough and you have tried 2 DMARDs including Methotrexate for at least 3 months. But I’m not sure about Rituximab for Lupus. Maybe, like Sjögren’s, it is only used off licence?

Mycophenolate may be more suitable for your friend as she hasn’t yet tried it - let’s hope so? I certainly had no tolerance issues with it and I had severe reactions to Sulfasalazine, MTX, Hydroxichloraquine, Azathioprine and also to all pain meds apart from Paracetamol.

It’s awful having our hopes dashed all the time though. So I can certainly sympathise and will be doing my level best to persuade my rheum to make a case for me for Rituximab, on or off licence.

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Thank you so much for your detailed reply. I will pass it on. It’s so frustrating. For some reason, I thought methotrexate was stronger then MMF? I must be wrong. x

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I think it’s a lot more toxic than MMF but not sure about stronger - maybe around the same. Methotrexate is much more widely used for the reason that it the most effective DMARD there is for a wide range of rheumatic diseases. MMF is less commonly used - mostly for more rare conditions and I think it’s often used for longer term after a big gun has been used such as Cyclophosphamide.

It’s never used for arthritis at all so this is why it’s much less talked about or a popular first line med in rheumatology.

Mycophenolate is not a big gun drug like Rituximab - which is often used with Methotrexate as the MTX increases the effectiveness of the Rituximab.

I took MTX for 2 years for RA but it made me feel terribly sick 24/7 latterly. I think MMF is equally strong as an immunesuppressant but is at least not cytotoxic.

Anyway, unlike your friend, I’ve done them all and feeling very fearful of what awaits next. Like her I was given all the blurb to take away on Rituximab only to receive a testy letter from registrar saying I didn’t meet the criteria?! The implication was that I had asked for or was desperate for it. I was absolutely furious as I was actually asking to try MMF and had never mentioned Rituximab at all. But the rheum who diagnosed Sjögren’s, said he thought this big gun was warranted for my probable brain involvement. Then he retired leaving young registrar to get it all wrong with me!! This chap phoned me to apologise after I tore a strip off him in writing. X

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Hi I had rituximab and I have lupus had to apply for funding it .the bloods checks can be for other drugs as well so they could be trying that first.hopefully it will get sorted .x

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Thank you. I think the fact that didn’t tell her the whole truth in the beginning has really not been fair. A little honesty and openness and good communication goes a long way to help the doctor / patient relationship! x

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lupus.bmj.com/content/3/1/e...

lupus.bmj.com/content/4/1/e...

The first link seems to suggest that MOST therapies for SLE are off-label.

This

resources.lupus.org/entry/r...

says "Rituxan was initially developed for use in people with lymphoma (a type of B lymphocyte cancer), but the drug was subsequently approved for treating rheumatoid arthritis. Several clinical research studies looked at the use of Rituxan and a second generation antibody, known as ocrelizumab, to treat people with either lupus or lupus nephritis (lupus kidney disease). However, these clinical trials were not successful.

Many doctors still feel that Rituxan may be effective for certain manifestations of lupus and that the clinical trial failures were, in part, related to issues with trial design. A study of Rituxan as a treatment for people with vasculitis, an inflammatory condition of the blood vessels, led to approval of Rituxan for “ANCA-associated vasculitis.” Thus, Rituxan is now approved by the Food and Drug Administration as a treatment for rheumatoid arthritis and vasculitis. Rituxan may have a role for certain individuals with lupus, and further clinical research is being pursued."

I'm not terribly up on the process of drug approval nowadays. But it is very unusual for anything to be licensed for a specific disease without fairly solid clinical evidence. Which means successful clinical trials. And even when licensed, there is the further step of it being approved to be added to the list of drugs allowed to be used in a given healthcare system.

There are quite a few drugs which are used daily for RA or vasculitis in the UK but aren't approved for other things - in this case rituximab for SLE. I think (I don't know) that there has been a system to apply for funding on a case by case basis (Exceptional and Individual Funding Request Policy, I think) but it varies from region to region.

Some drugs are available in Scotland but not in England and this

nhsinform.scot/illnesses-an...

suggests that rituximab may be available in Scotland despite not being licensed in the UK.

On the other hand - belimumab IS licensed in the UK.

Hope this helps - although I doubt it is what any of you want to hear.

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Thank you very much for your reply. I’m really grateful. Still so much to learn about all of this, especially when trying to help a whole group of lupus sufferers. I will pass this info on. I myself am on mepacrine as recommended by Dr K in London and prescribes by my GP - which is an unlicensed drug. Thanks again. x

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Just occurred to me to look - a single course of rituximab, 2 infusions is about £3,500. Not sure how often they are given in lupus. Mepacrine is not licensed in the UK because there are very few patients on it (so it would not be cost-effective for a company to go through the process, after all they are not mutual benefit socities but businesses) and there is a special agreement with a company to produce it - as for quite a few drugs.

"What does “unlicensed” mean in relation to a drug?

An unlicensed drug is one that has not been awarded a Market Authorisation from the UK Medicines Healthcare Products Regulatory Agency (MHRA). A drug may be licensed in other countries, but not in the UK. Drug licenses in the UK are awarded following a rigorous process of evaluation by the MHRA after an application by a pharmaceutical company. Once awarded, the licensed drug can then be marketed and sold in the UK.

In the absence of a license, the drug may still be prescribed in the UK, provided there is funding available locally to pay for it. Additionally, there must be clear evidence to confirm that the drug is effective for the condition in question and that safety concerns have been adequately addressed. Even after such evidence has been supplied it is still a matter for the local formulary group (a multidisciplinary group who make decisions on the prescribing of medicinal drugs at a local level) to make a final decision on a case-by-case basis.

Mepacrine is widely used for lupus in many countries, including the UK and North America, but at the moment remains unlicensed and can only be obtained from a ‘Specials’ pharmaceutical manufacturer."

The whole point with the rituximab is probably that apparently there are no studies that succeeded in showing it worked reliably for many patients in SLE and it is pretty pricey over time. Possibly in previous studies they were looking for the wrong thing as an end-point. Of course - if it works for a particular patient that doesn't matter but they have to go to the effort of getting funding in the first place and when it doesn't work it is a bad mark against the drug.

In my first post it mentioned that "clinical studies are being pursued" - I wonder if there is one in the UK?

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I’m in a study - BILAG biological prospective cohort: The use of novel biological therapies in the treatment of SLE. I was signed up after the treatment though so getting the treatment wasn’t dependent on participating. It seems to just be questionnaires on various symptoms and how they change over time on the drug and looking at blood results etc but it might just be my hospital.

I think the original rituximab studies for lupus failed to meet their endpoints (probably due to lupus being such a diverse disease) but rheumatologists and patients seem largely very positive about it. It’s worked for me in many respects but seems a bit of a lottery who gets funded. Systems do need to be transparent and fair!

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I think you've hit the nail on the head really there Melba1.

If only these doctors were open, honest and transparent, there wouldn't be nearly as much fear, mistrust and disappointment! Why can't they see that??

Wendy x

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Thank you for all of that information. I have passed it all on to my member.

I will reply in full below but her situation is hopefully being sorted out in a way that she is happy with. Fingers crossed for her.

xx

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With history of miscarriage, strokes and bad headaches, has she been tested for Hughes Syndrome/APS/Sticky Blood

healthunlocked.com/hughes-s...

The GHIC Website:. healthunlocked.com/api/redi...

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I’m pretty sure she has it but it wasn’t diagnosed until after the miscarriages and strokes. Sorry. Forgot that bit.

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I was poorly managed on hydroxychloroquine and methotrexate and started rituximab 2 years ago. It is given off-licence for lupus and it’s a funded treatment in my NHS area (Swansea). I must say it’s made a huge difference to my arthritis joint and ligament problems and Sjögrens symptoms- but fatigue is still a challenge.

My Health Board Has switched to a different ‘brand’ from the original rituximab but it’s the same drug.

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Thank you so much for your reply. That is very helpful. So we are neighbouring health boards and yours has a different policy to ours. It’s frustrating enough that now with NHS Wales and NHS England etc, we are all different but when there are different policies within Wales as well, it just seems even more unfair. x

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Arthritis research have a booklet on rituximab which indicates it’s use for lupus and makes no reference to any Uk funding issues .

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Another good tip. Thank you. x

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I don't want to throw a spanner in the works, but I have been on RTX for RA since 2016......it has been alive saver for me, but now I have developed a terrible blotchy rash all over my torso,& have had biopsies to ascertain if I have Drug Induced Lupus. I have had RA since 1999, no other health problems.

Obviously it might not be the RTX causing my problem.....I take a pill for BP & a Statin - both of which could be the cause.....but if it is the RTX, maybe it is a known side effect & that is why your friend's Consultant, after some more research, is holding off applying for funding?

None of the literature I have read mentions RTX causing DIL.......there are a few cases of it causing Psoriasis, but my Dermatologist says my rash is definitely not that.

I would mention that nobody gets RTX at the drop of a hat. You have to have a DA score of over 51+ ....and have taken & failed on 2 or 3,Dmards inc Mtx......it differs with different health authorities, & after applying for funding it can be anything up to 6 months before a decision is made.My Consultant had to get permission not to include Mtx in my treatment because I'd had such a bad reaction to it.....So maybe in time things may turn out OK for your friend? Although maybe the Consultant should have applied for funding before telling her it would be available......that would have caused less upset.

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Yes, it’s not been handled well at all. The lack of communication and openness just disappoints and brings mistrust! My lady has been through hell and this would not be the drop of a hat situation at all. But I am very grateful for your input. I am passing all replies and info onto her, so that we can discuss this and move forward. Wendy x

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When I get the result of the biopsy I will post the result for general interest. I am praying it is not the RTX as I have run out of alternatives.

After nearly 20'years,I thought I was sorted drug wise!

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It’s frightening isn’t it. I have everything crossed for you and please let us know how you get on. x

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Hair loss/hair shedding is one of the side effects. Not something I would have liked.

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I have no hair loss or shedding...in fact apart from feeling a bit tired the day after the infusion I feel better than I have for years. I think everybody sheds hair sometimes & if you are expecting it because you are on any drug you will automatically blame that drug. I have post menopausal friends who are shedding hair & take nothing more than an aspirin.

Personally I'd rather buy a wig than give up on RTX....quite fancy being a Redhead!

I will be devastated if it turns out to be the RTX that is causing my rash. Both my rheumatologist & my dermatologist think it may be my BP meds....I really hope they are right,

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Rash is listed as mild-moderate side effects in 11% patients. Alopecia is listed under "mild" side effects.

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Maybe Alopecia induced by RTX is like DIL & improves once you cease infusions.......knowing how much better I feel I think I might decide to put up with the rash as it doesn't itch or hurt, & go to the beach in a Burka!

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Have you had any of these?

fever (48%)

chills (32%)

weakness (18%)

nausea (17%)

headache (13%)

itch (12%)

rash (11%).

Everything has side effects. If it's working well for you, then I can understand how you feel.

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The only thing I have experienced is the rash......I did have a bad cold ,& flu in January...but I put that down to "that's life".

I will really throw my toys out of my pram if I have to change RA meds......but maybe I will be one of the really lucky folk who go into remission? A girl can dream can't she?

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I'm pretty sure you had to put up with a lot before you got that treatment.

Enjoy the benefit from the treatment.

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I have just had a look at the Nice regulations regarding RTX & Lupus, & back in 2 013 it says less than 10% of SLE sufferers have the disease severely enough to require RTX. It also says funding differs in differing local area Health Authorities, so maybe investigating that would go some way to explaining the situation you are dealing with.

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Big thank you! So kind of you to go to that trouble. My lady will be grateful. x

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Further to our previous messages, I checked back with my member and she has previously had an extremely dangerous reaction to hydroxychloroquine, resulting in SJS. Therefore she cannot take hydroxychloroquine. She has also tried Cyclophosphamide A, Cyclophophamide and Methotrexate. So should qualify. I will reply further below.

Thanks again.

Wendy x

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Oh poor her -it doesn’t seem to have been handled well at all 🙁. I think almost all lupus drugs are off licence (except prednisolone) and because funding has to be applied for in each individual case it seems the success can be as much down to individual rheumatologists, hospitals and locations as much as patient need which just isn’t fair.

My understanding was that you needed to have have failed 2 immunosuppressants. I presumed it was for those in the severe organ/ life threatening category. I was told I was eligible last October (when I was quite ill) then when I went back in December and said I might think about it my rheumatologist said he wouldn’t be able to get the funding for me at that point because I’d recovered so well on the steroids. By January the neurolupus had returned and he did all the tests and got funding agreed within the week. There was a 2 month wait but I then deteriorated even further so had it quickly. I don’t think it’s a magic cure sadly but it does seem to help many more people than the trials suggest.

Like you say her consultant needs to have an open conversation about why she isn’t now allowed it and whether he could still try and apply for funding? When my consultant said he had to officially apply for the funding he then added that he had no concerns he wouldn’t get it so whether that was because he always gets it if he applies or because I was a bad case I’m not sure.

Hope she finds something that works for her x

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Replying further below. x

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I though two Dmards had to fail to consider Rituximub. Then factor in the bloods positive issue for certain areas. I really hope your lady can get some progress , good luck. Lou xxx

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Thank you xx

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Replying further below. x

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as far as I am aware it has to be funded, which is as usual a 'postcode' lottery!! x

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So, it seems...

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Wendy

I was diagnosed last year with lupus but prednisone and mycophenolate have done little or nothing to ease any symptoms after initial relief

My doctor said the same to me bloods would be done and transfusion but in my case that was actually happened, it’s awful for your lady that is not her experience- rheumatologist did say it is much more expensive than alternatives but there was no mention of funding applications etc

Seems like we’re on the postcode lottery again - I hope she gets it sorted soon

X

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Thank you for your reply. x

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Thank you all very much for your helpful and supportive replies. I really appreciate it. I will pass it all into my lovely member and we’ll see where she can go from here. xx

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Hi Wendy ,

I’m Mellisa this is my story behind my bio infusions and my MCTD.

I have lupus , sjogrens and arthritis.

Once I had tried my usual daily hydroxy 400mg daily and still do. Still had a lot of bad joint pain. Then I was put on Methotrexate injections 20mg.

I had to try this for up to about a a year I think , then I was on crutches and then in wheelchair , my inflammatory levels were very high, I was literally stuck in my bedroom the pain was so bad. Then out of the blue my Rhuemy said there could be something else we can try , so was offered Rituximab, they said there was only 2 bio infusions available to me ( in that hospital) as a lot of other bio infusions will actually cause a lupus/ Sjogrens etc to flare VERY BADLY which we know can be very serious organ/vascular etc wise, as I’ve lost/damaged a lot of mine.

So Rituximab was tried and I had a serious reaction within 10mins, so then heart broken just didn’t want to continue anymore with a life with this much pain but 3months later I was then tried on Abatacept , I’ve been on it for the last year or so and it’s changed my life, joint wise. I still get joint pain and get flare ups like anyone will, but no crutches , no wheelchair anymore . I can only speak for myself on my story and am not a trained medical professional, also I can only speak for my treatment at my hospital Rheumatology and obviously we all have different issues.

If she gets no more support ask for them to tell her exactly why she can’t, as other people can, maybe another factor that makes it dangerous for her.

Their NHS hospital may not be able to fund it if you don’t fit in the criteria , ask them what she needs to fit into their criteria !

If not ask GP to refer her to another hospital , maybe one of the ones classed as hospital of excellence for treatment of lupus.

Good luck I feel so badly for your friend as I’ve been there, I’m sure a lot of us have at some point and you just want to give up the pain is so bad.

What a great support she has in you, I would of loved to have had someone with my disease to be understanding and care so much. I knew no one with it, thank goodness I recently found all these wonderful people online.

Please send her our love and support

Mellisa 🌸

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Thank you for your very helpful and supportive reply Melissa. It's much appreciated. I have passed on all replies for my member to read.

My member's lupus is advanced and she too has a history of severe reactions - she had SJS after hydroxy and this has made her a complex case with advanced lupus.

I have replied in full below, but I am pleased to report that our local rheumy department have agreed to refer her to a lupus expert in Birmingham for a second opinion on her treatment. This is a great result for my member. She hopes that this expert, whom she was under previously and knows her history, will push for the Rituximab infusions for her.

I started this group last September and now have been in touch with 31 or more lupus sufferers. Unfortunately a lot of them had never met anyone with lupus before, face to face, just contact on line, as you. I hope that my group continues to grow, as we all seem to find it very helpful. Here in Pembrokeshire, we are really struggling to get heard with the local health board. Assembly members from the Welsh Assembly (Welsh NHS is devolved) have admitted that there is a Gate Keeper Policy in place, blocking referals over the border into England, despite the fact that there is no Centre of Excellence in Wales and nor any recognised Lupus Expert practising at any NHS hospital. So unless we all work together, our situation will only get worse. It's bad enough dealing with this illness, let alone the politics involved too!

I hope you have a good day.

Wendy x

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Hi Wendy, just reading this post. I was given Rituximab two years ago after waiting three years to be given the funding. I was turned down several times because it isn’t licensed for lupus.

I have Mixed Connective Tissue Disorder (lupus, SLE) which has damaged my lungs. My Pulmonalogist wanted me to have the drug to stop the inflammation of my lungs.

There was no clinical trials done in the UK to show if the drug would work to slow down the inflammation of my lungs so the funding couldn’t be given even when I ring to plead.

Eventually my Rheumathologist reapply using a different tactic and we got the funding for the drug.

Now I am on clinical trials from Manchester.

To apply for the drug your consultant will have to fill out pages of questionnaire.

Tell her to in touch with your consultant’s secretary.

I pray she will be successful in getting the funding.

God bless

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Thank you for your reply Maureen. My member has now been referred to a lupus expert in Birmingham, whom she was previously under before and is hoping that this will really help more her forward in a positive way.

I think that fact that she was mislead in the first place hasn't helped at all. A little honesty goes a long way to build a good patient / doctor relationship, with trust on both sides.

Let's hope she is successful in getting the infusions with the influence of this expert.

Have a good day.

Best wishes

Wendy x

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I agree with Melissa .....it would probably be best not to put too much emphasis on encouraging your member to put all her hopes on getting Rituximab infusions. There are many conditions which will preclude it.

Wait & see what the Consultant in Birmingham decides .....as we don't have any knowledge of how the conditions besides Lupus your member has.....even if RTX was sanctioned off licence, one of her other conditions may mean it's contra indicated. It's the same with most Biologic drugs. I only had the choice of two....so if I fail on RTX it's the Last Chance Saloon option!

Maybe you can explain this so that she won't be completely devastated if she isn't prescribed RTX.

But as she knows this doctor in B'ham, & has faith in him let's hope something is available....even if it's not Rtx.

I would say she is a very lucky lady to have you in her corner.

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I had Rituximab at the beginning of last year for lupus (as well as 11 years previously for TTP, another auto immune condition) the process of applying for funding was very strange -, my rheumatologist went through a list of symptoms and scored me on each- there was a strangely large amount of points given for seemingly minor symptoms like splinter haemorrhages in my fingernails and it all seemed quite random. To be honest I think my rheumatologist only considered it as it looked like the TTP was also about to flare and my haematologist was keen to use it to prevent a relapse. (although I did eventually get it through rheumatology dept) I was also signed up for the Bilag study. Incidentally after no problem with the infusion 11 years ago, and no problem with the first of the 2 infusions more recently, I had a strong allergic reaction to the second infusion, with vomiting, wheezing and a purple rash all over... I'm not sure how effective it was for me in the end, my lupus was behaving itself until fairly recently, when I had a flare, although this could be pregnancy related....

All the best to your friend I hope she finds a treatment that works for her x

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Thank you very much for sharing your experience with us. I have passed on all of the replies to my lovely member and she is grateful.

She is a complex patient, with a history of reaction to hydroxychloroquine - resulting in a serious case of Steven Johnson's Syndrome and therefore her lupus is advanced.

She will now see an expert in Birmingham for a second opinion on how to move forward. She is feeling more positive now.

I have replied in full below, to update everyone.

Best wishes

Wendy

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Hello everyone.

Thank you so much for all of your replies. It is much appreciated.

Further to our previous messages, I checked back with my member and she has previously had an extremely dangerous reaction to hydroxychloroquine, resulting in SJS - Steven Johnson Syndrome. Therefore she cannot take hydroxychloroquine. She has also tried Cyclophosphamide A, Cyclophophamide and Methotrexate. So should qualify as she has tried two DMARDS.

Unfortunately her lupus is advanced and her extreme SJS has had a hand in this. She is complex and has a history of reactions to medication.

She was eventually able to speak to her Rheumy on the telephone and explain why she felt so frustrated, let down and fearful of what would happen next.

Fortunately, her Rheumy saw sense and has agreed to refer her out of area, to her former Rheumy in Birmingham, who knows her history and whom she trusts whole heartedly. This is an amazing breakthrough for my member. She is very happy about this and just hopes that no one goes back on their word again. She is still waiting to see any of this in writing. I'm guessing because she is so complex they are worried about starting infusion of Rituximab in case something goes wrong.

Through my running of our support group we only have 1 member who has been referred out of area for second opinion / treatment advice, since the Welsh NHS devolved and so this is only number 2. We are seeing this as an extremely positive thing for my member and hopefully a realisation from our local rheumies, that an opinion from a lupus expert is sometimes needed.

Thank you.

Wendy x

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This is fantastic news for your member and for the region too. Well done. I will keep my fingers crossed. Lou xx

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Thank you Lou. Yes, fingers crossed! Must keep chipping away at them. I hope you are doing OK. x

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Hi. I don't think Rituximab is licensed here. The consultant mentioned it briefly at an event I was at. That said, I have had a couple of rounds when I had my last flare up, but that was under extreme circumstances; I had been in

ICU and had various life threatening complications, so I was given it. I remember they covered it with a browm paper bag, while it was on the ward

For me, it was very potent with drastic side effects, hence now I could never have it again.

It is quite expensive and maybe after all considerations, they decided not to proceed. Nevertheless, they shouldn't have got her hopes up like that. Very unprofessional.😡

I hope she can get stable soon.

Regards, Ruby

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