Cladribine is a selective immune reconstitution therapy (IRT) and is the only IRT on the WHO List of Essential Medicines for treating multiple sclerosis.
Email comment: "I am extremely impressed by this. The level of detail is really high but still understandable, and this is something that is hard to find anywhere. I am a GP and would have loved to have this level of detail when making a decision about medications last November when I had a severe spinal cord relapse. I am wondering if you have a similar set of information about Ofatumamab?"
This is so great and thorough, I would have loved this when cladribine was proposed for me. I did my first two years, then needed to take a third year/set of doses in January 2022, and I have not looked back. I cannot tell you how “good” I’ve felt in the last 6 months, almost “normal”. I still have all my usual symptoms, but nothing worse. Reading about the mechanism of how it works, and details on its efficacy are so reassuring. You are changing the future of MS Dr Giovannoni, thank you.
Hi Jen, may I ask your approximate age? I’m 70. I’m looking to find some quality time via cladribine. I lost several years convinced to try IVIG by a neurologist. What a setback. Glad you are well!🌷
Late 30’s. It did affect my quality of life for many months while taking the drug, even more extreme fatigue, weakness, intense headaches, sore throat constantly, concerns about getting sick etc but coming out on the other end seems to have been worth it.
Email response: "What a great synopsis. Unfortunately it just reinforces why I'd like to be on cladribine despite being diagnosed with PPMS. I've not experienced much if any disability. My new neurologist almost wanted to call it CIS to be honest so I'd rather hit it hard now before I have disability. I'd even pay out of pocket if need be, that's how strongly I feel about it."
Thank you for all of this information. It gives me some confidence that I am on the right track for me. I am 1.5 years after two courses of cladribine/Mavenclad. I am feeling pretty good. I had a meeting with my neuro yesterday and he explained that while we don’t know how long my results will last, we won’t start a new DMT just because time has passed. He did not have a clear answer on why some people start a new DMT without symptom progression. He told me that I could not be treated with cladribine again in the future (not sure if this is because I am in the US) But, no new lesions as of my MRI this month and my gait has improved.
Hi Sheila, that’s great. I noted the upper age ranges in the study. I believe my blood work is sufficient for cladribine, but my Rx policy will need changed in the states to cover it. I’ve had one UTI after another and the new urologist has recommended stopping frequent cathing. If I can manage that, I’m pushing for this med. Happy to hear you are feeling well! Woo!🌷
I hope you are able to coordinate everything and give it a try! I am sorry to hear about your frequent UTIs😟I hope the new urologist is successful. It took awhile for my blood work to improve, but it has. Not having to rely on a suppressed immune system is a positive aspect of cladribine🐸
Hi Sheila, I hope so too! This urologist provided so much more education than “just cath”. I saw him due to a small stone stuck in a ureter. Found it only because I had to fight for a CT due to unusual symptoms from the UTI right before this one🙄! So far, my bloodwork is sound, I feel it’s high enough to try cladribine with careful monitoring. I would greatly love some years with the downward spiral slowed so I feel like a person.🙂Cheers!🌷
Regarding side-effects, I feel I was definitely more fatigued in the 12 months following each dose. Maybe it was related to immunosuppression fatigue, but that still means its related to the cladribine. Insomnia also crept in, but mainly increased fatigue, which for PwMS is already quite a factor. Worth noting as far as I'm concerned.
Regarding the 14 topics listed for the microsite it reads to me as if only the last one regarding parenthood and pregnancy is about life-style. I would like to see other sections covering life-long topics eg: initiating relationships and sex; also for example: late onset MS/ageing
There should also be a section aimed at parents of children diagnosed with MS.
Thank you. Your plan truly is amazing - and never ending. I feel lucky to have found my way here. I don’t recall how! (But then there’s quite a bit I can’t recall..)🌷
Hi Fiona, yes, there are issues with aging which are a real challenge. I am in the states and had an aggressive triple negative breast cancer 23 years ago. No estrogen dependence. Finally, a new urologist said use vaginal estrogen! I was astonished. Fell out of my chair! I’m in the states and no one would let us touch estrogen in any form. He claims it should cut back on UTIs significantly. Fingers crossed!🌷
Realy good Informations. Thank you! Would you choose Cladribin vs. B cell depleating Agent for every Patient ?my neuro offers Both And i Can Not decide, Thanks for your Support!
I truly appreciate the ease of understanding the drug, how it works, pros, cons, etc. A huge wow and one I needed right now. The age range on the study(s) particularly gives me hope. I have compromised immunity due to previous high doses of chemo (which, yes gave me years of remission). Cladribine seems safer in general considering my age. Question: In the event of derisking, (if that would be the correct term) and potentially having a significant dip of WBCs, is G-CSF ever used? I don’t know if that makes sense, but it occurred to me from cancer experience. In the past six months, I’ve had never ending UTIs which are increasing. New urologist recommends totally backing off catheters. If that works, cladribine is what my neurologist and I had previously discussed. Her theory is that with the worsening UTI situation, I never get out of a “relapsed” state, even though I am older and neida. You are much appreciated and give me reason to be hopeful. Yes! 🌷
Prof. Giovannoni, what do you think are the most promising new treatments in the future coming for ms? Do you think it will be the new T-CELL therapy that has been used on lupus? Or do you think Cladribine or Frexalimab would do the difference? Would love to hear from you!
Thank you Prof G, you’ve managed to cover all the questions and information a patient would need to be aware of and certainly helpful to anyone to support their decision about starting Cladribine. The only stumbling block from a lot of patients point of view, is if they would qualify for the drug under their current healthcare provider. Although, shared decision making is crucial, it can be often difficult, due to the qualifying rules for the medication(s).
When you are newly diagnosed - why start off, unless patient choice, with a therapy which is not as effective . Why not start off with the best (or one of) stop the disease potentially progressing.
For the 10+ year follow up am I reading this wrong but I thought based on the data that the total number of those who went the distance with no further DMT was quite small
“ The analysis focused on the long-term outcomes of 435 CLASSIC-MS patients, ages 32-79, who previously participated in CLARITY with or without enrolling in the extension study. All eligible CLASSIC-MS participants had received at least one course of Mavenclad tablets or a placebo in the previous studies.
A total of 394 (90.6%) patients were previously treated with Mavenclad and 160 of them completed the two-year regimen”
“ Over the 10.9-year median follow-up, more than half (53.1%) of the CLASSIC-MS patients didn’t further use DMTs”
Doesn’t that mean only 20% went the 10+ years with no further dmt?
394 in trial , 160 completed the 2 years and 50% of those didn’t need further DMTs.
Of those subjects who could be found and followed up, over 50% didn't need DMTs. We can't vouch for those who weren't found, recruited and followed up. The characteristics of those in the CLASSIC-MS study were similar to those who weren't enrolled. The problem is in many centres the PIs had left and hence the study subjects could not be traced.
Please can I contact you about a query regarding a possible long term adverse event with cladribine? I did ask a yellow card to be sent but not sure if they did.
I JUST went looking for this because I was considering asking about re-dosing cladribine in the paid-subscriber Q&A and didn't want to ask something that had already been answered. Thank you!
This is so helpful thank you. It seems like the cost of administering cladribine is significantly cheaper than Ocrevus or Kesimpta and they have the associated risk of longterm immunosuppression too,. So, given this, I wondered if you knew the thinking behind the NHS/NICE offering these instead of Cladribine as a first line therapy? It would be much easier to live life without chronic immunosuppression and the associated worry about this. Thank you :-)
Great question. I live in Canada and just started my 4th DMT, Kesimpta. I was never offered or ever spoken to about Cladribine. Hmmmm, after reading about Cladribine, it sounds like something I would have considered. I did check, and it is available in Canada. Blergh.
Email comment: "I am extremely impressed by this. The level of detail is really high but still understandable, and this is something that is hard to find anywhere. I am a GP and would have loved to have this level of detail when making a decision about medications last November when I had a severe spinal cord relapse. I am wondering if you have a similar set of information about Ofatumamab?"
The anti-CD20s including ofatumumab will be live next week.
This is so great and thorough, I would have loved this when cladribine was proposed for me. I did my first two years, then needed to take a third year/set of doses in January 2022, and I have not looked back. I cannot tell you how “good” I’ve felt in the last 6 months, almost “normal”. I still have all my usual symptoms, but nothing worse. Reading about the mechanism of how it works, and details on its efficacy are so reassuring. You are changing the future of MS Dr Giovannoni, thank you.
Hi Jen, may I ask your approximate age? I’m 70. I’m looking to find some quality time via cladribine. I lost several years convinced to try IVIG by a neurologist. What a setback. Glad you are well!🌷
Late 30’s. It did affect my quality of life for many months while taking the drug, even more extreme fatigue, weakness, intense headaches, sore throat constantly, concerns about getting sick etc but coming out on the other end seems to have been worth it.
Email response: "What a great synopsis. Unfortunately it just reinforces why I'd like to be on cladribine despite being diagnosed with PPMS. I've not experienced much if any disability. My new neurologist almost wanted to call it CIS to be honest so I'd rather hit it hard now before I have disability. I'd even pay out of pocket if need be, that's how strongly I feel about it."
Thank you for all of this information. It gives me some confidence that I am on the right track for me. I am 1.5 years after two courses of cladribine/Mavenclad. I am feeling pretty good. I had a meeting with my neuro yesterday and he explained that while we don’t know how long my results will last, we won’t start a new DMT just because time has passed. He did not have a clear answer on why some people start a new DMT without symptom progression. He told me that I could not be treated with cladribine again in the future (not sure if this is because I am in the US) But, no new lesions as of my MRI this month and my gait has improved.
Hi Sheila, that’s great. I noted the upper age ranges in the study. I believe my blood work is sufficient for cladribine, but my Rx policy will need changed in the states to cover it. I’ve had one UTI after another and the new urologist has recommended stopping frequent cathing. If I can manage that, I’m pushing for this med. Happy to hear you are feeling well! Woo!🌷
Thank you! Woo🙂
Hi
I hope you are able to coordinate everything and give it a try! I am sorry to hear about your frequent UTIs😟I hope the new urologist is successful. It took awhile for my blood work to improve, but it has. Not having to rely on a suppressed immune system is a positive aspect of cladribine🐸
Hi Sheila, I hope so too! This urologist provided so much more education than “just cath”. I saw him due to a small stone stuck in a ureter. Found it only because I had to fight for a CT due to unusual symptoms from the UTI right before this one🙄! So far, my bloodwork is sound, I feel it’s high enough to try cladribine with careful monitoring. I would greatly love some years with the downward spiral slowed so I feel like a person.🙂Cheers!🌷
Regarding side-effects, I feel I was definitely more fatigued in the 12 months following each dose. Maybe it was related to immunosuppression fatigue, but that still means its related to the cladribine. Insomnia also crept in, but mainly increased fatigue, which for PwMS is already quite a factor. Worth noting as far as I'm concerned.
Regarding the 14 topics listed for the microsite it reads to me as if only the last one regarding parenthood and pregnancy is about life-style. I would like to see other sections covering life-long topics eg: initiating relationships and sex; also for example: late onset MS/ageing
There should also be a section aimed at parents of children diagnosed with MS.
All planned. It is project that will never end, which reminds me I need a succession plan.
Thank you. Your plan truly is amazing - and never ending. I feel lucky to have found my way here. I don’t recall how! (But then there’s quite a bit I can’t recall..)🌷
Hi Fiona, yes, there are issues with aging which are a real challenge. I am in the states and had an aggressive triple negative breast cancer 23 years ago. No estrogen dependence. Finally, a new urologist said use vaginal estrogen! I was astonished. Fell out of my chair! I’m in the states and no one would let us touch estrogen in any form. He claims it should cut back on UTIs significantly. Fingers crossed!🌷
Realy good Informations. Thank you! Would you choose Cladribin vs. B cell depleating Agent for every Patient ?my neuro offers Both And i Can Not decide, Thanks for your Support!
It is horses for courses. The advantage of cladribine is that it has CNS penetration, unlike the anti-CD20 monoclonal antibodies.
I truly appreciate the ease of understanding the drug, how it works, pros, cons, etc. A huge wow and one I needed right now. The age range on the study(s) particularly gives me hope. I have compromised immunity due to previous high doses of chemo (which, yes gave me years of remission). Cladribine seems safer in general considering my age. Question: In the event of derisking, (if that would be the correct term) and potentially having a significant dip of WBCs, is G-CSF ever used? I don’t know if that makes sense, but it occurred to me from cancer experience. In the past six months, I’ve had never ending UTIs which are increasing. New urologist recommends totally backing off catheters. If that works, cladribine is what my neurologist and I had previously discussed. Her theory is that with the worsening UTI situation, I never get out of a “relapsed” state, even though I am older and neida. You are much appreciated and give me reason to be hopeful. Yes! 🌷
Prof. Giovannoni, what do you think are the most promising new treatments in the future coming for ms? Do you think it will be the new T-CELL therapy that has been used on lupus? Or do you think Cladribine or Frexalimab would do the difference? Would love to hear from you!
Thank you Prof G, you’ve managed to cover all the questions and information a patient would need to be aware of and certainly helpful to anyone to support their decision about starting Cladribine. The only stumbling block from a lot of patients point of view, is if they would qualify for the drug under their current healthcare provider. Although, shared decision making is crucial, it can be often difficult, due to the qualifying rules for the medication(s).
When you are newly diagnosed - why start off, unless patient choice, with a therapy which is not as effective . Why not start off with the best (or one of) stop the disease potentially progressing.
For the 10+ year follow up am I reading this wrong but I thought based on the data that the total number of those who went the distance with no further DMT was quite small
“ The analysis focused on the long-term outcomes of 435 CLASSIC-MS patients, ages 32-79, who previously participated in CLARITY with or without enrolling in the extension study. All eligible CLASSIC-MS participants had received at least one course of Mavenclad tablets or a placebo in the previous studies.
A total of 394 (90.6%) patients were previously treated with Mavenclad and 160 of them completed the two-year regimen”
“ Over the 10.9-year median follow-up, more than half (53.1%) of the CLASSIC-MS patients didn’t further use DMTs”
Doesn’t that mean only 20% went the 10+ years with no further dmt?
394 in trial , 160 completed the 2 years and 50% of those didn’t need further DMTs.
Am I reading this wrong?
https://multiplesclerosisnewstoday.com/news-posts/2023/04/11/mavenclad-benefits-ms-sustained-up-15-years-after-last-treatment/
Of those subjects who could be found and followed up, over 50% didn't need DMTs. We can't vouch for those who weren't found, recruited and followed up. The characteristics of those in the CLASSIC-MS study were similar to those who weren't enrolled. The problem is in many centres the PIs had left and hence the study subjects could not be traced.
So interesting but I'm guessing it doesn't work for PPMS?
Please can I contact you about a query regarding a possible long term adverse event with cladribine? I did ask a yellow card to be sent but not sure if they did.
Sure
About drug management it is complete
Some questions
-should I change my lifestyle because Multipla Sclerosis?
- there is any recomendatuon about my lifefestyle because or durring immuossupression períod?
Warm regards
Lívia Sousa
I JUST went looking for this because I was considering asking about re-dosing cladribine in the paid-subscriber Q&A and didn't want to ask something that had already been answered. Thank you!
This is so helpful thank you. It seems like the cost of administering cladribine is significantly cheaper than Ocrevus or Kesimpta and they have the associated risk of longterm immunosuppression too,. So, given this, I wondered if you knew the thinking behind the NHS/NICE offering these instead of Cladribine as a first line therapy? It would be much easier to live life without chronic immunosuppression and the associated worry about this. Thank you :-)
Great question. I live in Canada and just started my 4th DMT, Kesimpta. I was never offered or ever spoken to about Cladribine. Hmmmm, after reading about Cladribine, it sounds like something I would have considered. I did check, and it is available in Canada. Blergh.
Me, was it money? Just asking..🌷
I don't think so. Cladribine is cheaper than Kesimpta and I'm on the Exceptional Access Program for meds in my Province.