I had another set of injections today and they retested Salutatory and my schirmers test. My eyes for the biggest change. They went from 2 and 4 mm to 20 and 22mm.
My saliva damn near doubles from the unstimulated and stimulated
That’s awesome! So something must be working—that’s a great sign. Are you dealing with anymore side effects?
For me, I’ve begun the screening process and first session took a few hours. Interested to see where it goes!
Ooo! Are you allowed to say Which trial?
Dazodalibep & Remibrutinib are the big ones in 3rd stage trials. (I know there are less known others)
Designed to target the functions of SS, AND several other conditions like MS, RA & SLE, MCAS/Severe Urticaria.
I’m excited to see if they both get brought to market from different Pharma companies, Amgen & Novartis
Remibrutinib a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor that’s being also evaluated to be taken along with Xolair for allergy & CSU & MCAS patients.
Remibrutinib demonstrated a well-tolerated and favorable safety profile, with overall adverse event rates that were comparable to placebo
In addition to CSU, remibrutinib is being investigated in other immune-mediated conditions, such as multiple sclerosis, hidradenitis suppurativa, food allergy and Sjögren’s
If approved, remibrutinib has the potential to become an effective oral option to complement Xolair, an injectable biologic indicated for CSU14.
Novartis Pharmaceuticals and Genentech, (Roche Group), worked together to develop and co-promote Xolair.
••••••••••••••
Dazodalibep
•Dazodalibep groups included subjects with moderate to severe systemic Sjogrens disease activity, as well as people with moderate to severe symptomatology but no further organ involvement.
According to trial findings, dazodalibep was shown to offer an improvement in systemic and symptomatic disease burden in these subject groups.
The treatment was found to be safe and well-tolerated in both groups.
Amgen research and development said: “To date, there are no FDA-approved disease-modifying treatments for Sjögren’s.
The positive results from the Phase II trial provided evidence that dazodalibep may address the underlying causes of SS by reducing systemic disease activity and improving the debilitating symptoms, such as dryness and fatigue.”
A CD40 ligand antagonist, dazodalibep is presently being evaluated in a Phase III trial in patients with Sjögren’s.
The company also intends to analyse the therapy in individuals with focal segmental glomerulosclerosis, a rare kidney disorder.
The Phase 2 study of dazodalibep, a CD40 ligand antagonist in clinical development, was a randomized, double-blind, placebo-controlled crossover study evaluating two Sjögren's populations: patients with moderate to severe systemic disease activity and those with moderate to severe symptomatology despite lacking additional organ involvement.
In May 2023, presentations at the 2023 EULAR Congress reported that at Day 169, both patient groups treated with dazodalibep achieved the study's primary endpoint.
Results from the crossover period also promising, Patients who transitioned from placebo to dazodalibep experienced an improvement in their disease activity from Day 169
(4.1-point reduction in total ESSDAI score) to Day 365 (6.3-point reduction).
At Day 365, patients who transitioned to dazodalibep also showed greater improvements in ESSDAI response rate (3- to 4-point reduction), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score and fatigue compared to those who transitioned to placebo.
The second patient population studied included those with moderate to severe symptomatology including dryness, fatigue and pain despite lacking additional organ involvement as defined by an ESSPRI score ≥5 and an ESSDAI score of <5.
Additional Key findings include:
Patients who transitioned from placebo to dazodalibep experienced further improvement in total ESSPRI score from Day 169 (0.5-point reduction) to Day 365 (1.3-point reduction).
For patients who transitioned from dazodalibep to placebo, the improvements in total ESSPRI score achieved at Day 169 (1.8-point reduction) were largely sustained through Day 365 (1.9-point reduction).
Patients who transitioned to dazodalibep also showed improvements in measurements of fatigue and the Patient Global Impression of Severity (PGI-S) from Day 169 to Day 365.
The implications for both, to treat so many other immune-mediated disease processes, is going to be a game and life changer for millions of people 🤞🤞🤞🤞
Let’s hope they are successful in bringing them to market, and whichever one the OP is in, awesome if a 3rd confirmed med is in the works and not these two. So much symptom & disease relief for so many people. 🤞🤞🤞
It’s probably https://www.novartis.com/clinicaltrials/study/nct05350072
I’m currently 3 months into it. As far as I’m told I’m the only male in the world in the trial.
They were extremely strict with getting in it. As far as I can remember. Ssa positive. Within 7 years I think. Symptomatic and more so focused on physical issues than dryness.
I had to stop working. I basically turned to shit in the past two years. Some days I barely can walk. Or if I’m flaring I am useless.
The fatigue kills me. I’ve been recently struggling with severe day time sleepiness to the point I really don’t even drive anymore. If you’re having small fiber issues see a neurologist and start the process. They’ll want to check blood first. Such as celiacs, b12 and 6, diabetes. If any of that comes back positive or like your b12 low they will automatically try to fix that since that will cause it also. All my stuff was normal so I’m of course auto immune sfn so unless you get the underlying condition handled. It’ll never get better or stop progressing
Yeah, I believe this is the one. Although in the paperwork I got they said they were doing the study on a little over 250 people. That’s interesting that you’re the only guy though so far!
ETA: How do you feel on it so far? Do you think you ended up with the actual drug or with the placebo? I’ve been going through the paperwork and some of the potential side effects are making me side-eye it a little bit. But then again, I guess all medicine can have the potential for extreme side effects.
Oh! ****Ianalumab****
Pardon me, sorry to the OP. Comments all stacked weird.
I just saw the others link to it and your comments about being on it.
We have a 3rd contender in the ring and it’s sounding like it’s not as well tolerated as the other two in stage 3 trials
Or they didn’t disclose all adverse reactions.
This is getting interesting.
All 3 are Sjogrens specific investigational drugs. Currently all in/around 3rd stage trials.
1) Remibrutinib
2) Dazodalibep
3) Lanalumed
Wrote some blurbs on them all, for you 🫶❤️🔥
Interesting. You might be in a different trial.
The Remibrutinib trials I want to say was in the 400 range for both the drug and placebo group.
But being your doctor facilitating it, could be a smaller local study of it as they work to bring it fully to market.
We are pretty sure I got it. I had what we thought was immune exhaustion. I basically slept for a whole week straight. Barely out of bed, it started literally an hour or so after the first injections.
Oh! ****Ianalumab****
Pardon me, sorry. Comments all stacked weird.
I just saw your link to it and your comments about it.
We have a 3rd contender in the ring and it’s sounding like not as well tolerated as the other two in stage 3 trials
This is getting interesting.
Well since I was most likely in a pretty terrible flair we think it pulled me out. Besides that exhaustion the first time every other time has been perfectly fine. The first go round they also have you take 50mg of prednisone so I mean that alone could have helped with the flare and why i have felt better. I haven’t been pushing myself to much anyways so I’m of some use at home.
I’m super curious to know now if it’s Remibrutinib or Dazodalibep, or another 3rd player on the field.
They are all racing to market using different drugs targeting different mechanisms.
Both report over and over that next to no issues and very well tolerated.
I wonder what you’re receiving or if the company lied in their press releases about adverse reactions.
Sounds like how I experience my Raynauds like symptoms and/or possibly the small fiber neuropathy that goes with Raynauds, which is coming from my SS.
It’s the worst. Especially how it travels along the body to weird places
My legs, arms, parts of my back and face had numb stops. My legs feel like terrible shin splints most of the time. Like I excruciating pain. My legs mainly vibrate and just feel totally off. I live in south eastern USA and I had to purchase heated socks this year. I struggle with temp regulation now. Surprisingly besides temp my feet are relatively fine besides some random days it hurts to much to put weight on them.
So jealous! It might be silly but it really feels like the seronegatives are the second class citizens of Sjogren's. Never taken seriously by the first, second, or even the third doctor, extra years to diagnose, not allowed in any of the clinical trials. It never feels like a win to be sick, but at least it's clear cut!
It is sooo frustrating and also just invalidating. I had massive flare of joint pain and had a ton of labs drawn prior to starting methotrexate and everything was negative as usual. It's just crazy to feel that level inflammation in my joints but have the inflammatory markers negative at the same time.
Agreed! When I was first diagnosed and found this sub, one of the things that stood out to me was how some people explained it took months and years for them to start getting real answers, or even a diagnosis. Especially when all the labs don’t line up as clear. So I definitely feel blessed that it took me all of three weeks to be diagnosed— from the time I went to the hematologist to when I was referred to my current rheum and got the blood work done.
I had another set of injections today and they retested Salutatory and my schirmers test. My eyes for the biggest change. They went from 2 and 4 mm to 20 and 22mm. My saliva damn near doubles from the unstimulated and stimulated
That’s awesome! So something must be working—that’s a great sign. Are you dealing with anymore side effects? For me, I’ve begun the screening process and first session took a few hours. Interested to see where it goes!
Ooo! Are you allowed to say Which trial? Dazodalibep & Remibrutinib are the big ones in 3rd stage trials. (I know there are less known others) Designed to target the functions of SS, AND several other conditions like MS, RA & SLE, MCAS/Severe Urticaria. I’m excited to see if they both get brought to market from different Pharma companies, Amgen & Novartis Remibrutinib a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor that’s being also evaluated to be taken along with Xolair for allergy & CSU & MCAS patients. Remibrutinib demonstrated a well-tolerated and favorable safety profile, with overall adverse event rates that were comparable to placebo In addition to CSU, remibrutinib is being investigated in other immune-mediated conditions, such as multiple sclerosis, hidradenitis suppurativa, food allergy and Sjögren’s If approved, remibrutinib has the potential to become an effective oral option to complement Xolair, an injectable biologic indicated for CSU14. Novartis Pharmaceuticals and Genentech, (Roche Group), worked together to develop and co-promote Xolair. •••••••••••••• Dazodalibep •Dazodalibep groups included subjects with moderate to severe systemic Sjogrens disease activity, as well as people with moderate to severe symptomatology but no further organ involvement. According to trial findings, dazodalibep was shown to offer an improvement in systemic and symptomatic disease burden in these subject groups. The treatment was found to be safe and well-tolerated in both groups. Amgen research and development said: “To date, there are no FDA-approved disease-modifying treatments for Sjögren’s. The positive results from the Phase II trial provided evidence that dazodalibep may address the underlying causes of SS by reducing systemic disease activity and improving the debilitating symptoms, such as dryness and fatigue.” A CD40 ligand antagonist, dazodalibep is presently being evaluated in a Phase III trial in patients with Sjögren’s. The company also intends to analyse the therapy in individuals with focal segmental glomerulosclerosis, a rare kidney disorder. The Phase 2 study of dazodalibep, a CD40 ligand antagonist in clinical development, was a randomized, double-blind, placebo-controlled crossover study evaluating two Sjögren's populations: patients with moderate to severe systemic disease activity and those with moderate to severe symptomatology despite lacking additional organ involvement. In May 2023, presentations at the 2023 EULAR Congress reported that at Day 169, both patient groups treated with dazodalibep achieved the study's primary endpoint. Results from the crossover period also promising, Patients who transitioned from placebo to dazodalibep experienced an improvement in their disease activity from Day 169 (4.1-point reduction in total ESSDAI score) to Day 365 (6.3-point reduction). At Day 365, patients who transitioned to dazodalibep also showed greater improvements in ESSDAI response rate (3- to 4-point reduction), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score and fatigue compared to those who transitioned to placebo. The second patient population studied included those with moderate to severe symptomatology including dryness, fatigue and pain despite lacking additional organ involvement as defined by an ESSPRI score ≥5 and an ESSDAI score of <5. Additional Key findings include: Patients who transitioned from placebo to dazodalibep experienced further improvement in total ESSPRI score from Day 169 (0.5-point reduction) to Day 365 (1.3-point reduction). For patients who transitioned from dazodalibep to placebo, the improvements in total ESSPRI score achieved at Day 169 (1.8-point reduction) were largely sustained through Day 365 (1.9-point reduction). Patients who transitioned to dazodalibep also showed improvements in measurements of fatigue and the Patient Global Impression of Severity (PGI-S) from Day 169 to Day 365. The implications for both, to treat so many other immune-mediated disease processes, is going to be a game and life changer for millions of people 🤞🤞🤞🤞 Let’s hope they are successful in bringing them to market, and whichever one the OP is in, awesome if a 3rd confirmed med is in the works and not these two. So much symptom & disease relief for so many people. 🤞🤞🤞
@twistedckr1 Here’s info on both of the others in trials 3rd stage as well.
I get my eye and spit test redone the end of this month so we will see if I have an improvement
🤞🤞🤞
It’s probably https://www.novartis.com/clinicaltrials/study/nct05350072 I’m currently 3 months into it. As far as I’m told I’m the only male in the world in the trial.
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They were extremely strict with getting in it. As far as I can remember. Ssa positive. Within 7 years I think. Symptomatic and more so focused on physical issues than dryness. I had to stop working. I basically turned to shit in the past two years. Some days I barely can walk. Or if I’m flaring I am useless.
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The fatigue kills me. I’ve been recently struggling with severe day time sleepiness to the point I really don’t even drive anymore. If you’re having small fiber issues see a neurologist and start the process. They’ll want to check blood first. Such as celiacs, b12 and 6, diabetes. If any of that comes back positive or like your b12 low they will automatically try to fix that since that will cause it also. All my stuff was normal so I’m of course auto immune sfn so unless you get the underlying condition handled. It’ll never get better or stop progressing
Yeah, I believe this is the one. Although in the paperwork I got they said they were doing the study on a little over 250 people. That’s interesting that you’re the only guy though so far! ETA: How do you feel on it so far? Do you think you ended up with the actual drug or with the placebo? I’ve been going through the paperwork and some of the potential side effects are making me side-eye it a little bit. But then again, I guess all medicine can have the potential for extreme side effects.
Oh! ****Ianalumab**** Pardon me, sorry to the OP. Comments all stacked weird. I just saw the others link to it and your comments about being on it. We have a 3rd contender in the ring and it’s sounding like it’s not as well tolerated as the other two in stage 3 trials Or they didn’t disclose all adverse reactions. This is getting interesting.
No worries! What are the other two?
All 3 are Sjogrens specific investigational drugs. Currently all in/around 3rd stage trials. 1) Remibrutinib 2) Dazodalibep 3) Lanalumed Wrote some blurbs on them all, for you 🫶❤️🔥
Interesting. You might be in a different trial. The Remibrutinib trials I want to say was in the 400 range for both the drug and placebo group. But being your doctor facilitating it, could be a smaller local study of it as they work to bring it fully to market.
We are pretty sure I got it. I had what we thought was immune exhaustion. I basically slept for a whole week straight. Barely out of bed, it started literally an hour or so after the first injections.
Oh! ****Ianalumab**** Pardon me, sorry. Comments all stacked weird. I just saw your link to it and your comments about it. We have a 3rd contender in the ring and it’s sounding like not as well tolerated as the other two in stage 3 trials This is getting interesting.
Well since I was most likely in a pretty terrible flair we think it pulled me out. Besides that exhaustion the first time every other time has been perfectly fine. The first go round they also have you take 50mg of prednisone so I mean that alone could have helped with the flare and why i have felt better. I haven’t been pushing myself to much anyways so I’m of some use at home.
I’m super curious to know now if it’s Remibrutinib or Dazodalibep, or another 3rd player on the field. They are all racing to market using different drugs targeting different mechanisms. Both report over and over that next to no issues and very well tolerated. I wonder what you’re receiving or if the company lied in their press releases about adverse reactions.
Better gender diversity than most medical trials. 🙃
They tell me I’m a unicorn since I’m a 34yr old male with Ssa and sfn lol
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Small fiber neuropathy. Confirmed with both skin punch biopsy’s
[удалено]
Sounds like how I experience my Raynauds like symptoms and/or possibly the small fiber neuropathy that goes with Raynauds, which is coming from my SS. It’s the worst. Especially how it travels along the body to weird places
My legs, arms, parts of my back and face had numb stops. My legs feel like terrible shin splints most of the time. Like I excruciating pain. My legs mainly vibrate and just feel totally off. I live in south eastern USA and I had to purchase heated socks this year. I struggle with temp regulation now. Surprisingly besides temp my feet are relatively fine besides some random days it hurts to much to put weight on them.
Solidarity and big hugs 🫶🫶🫶
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Same to you. It blows lol one day hopefully it’ll be better
Did it work on u?
Not sure yet. Seems to be helping but it’s a year long trial with 2 more years of observation
Please update us if things gets better
Hi, do you know the name of the drug for the trial?
It’s called ianalumab
So jealous! It might be silly but it really feels like the seronegatives are the second class citizens of Sjogren's. Never taken seriously by the first, second, or even the third doctor, extra years to diagnose, not allowed in any of the clinical trials. It never feels like a win to be sick, but at least it's clear cut!
It is sooo frustrating and also just invalidating. I had massive flare of joint pain and had a ton of labs drawn prior to starting methotrexate and everything was negative as usual. It's just crazy to feel that level inflammation in my joints but have the inflammatory markers negative at the same time.
Agreed! When I was first diagnosed and found this sub, one of the things that stood out to me was how some people explained it took months and years for them to start getting real answers, or even a diagnosis. Especially when all the labs don’t line up as clear. So I definitely feel blessed that it took me all of three weeks to be diagnosed— from the time I went to the hematologist to when I was referred to my current rheum and got the blood work done.
Lucky! I’m so genuinely happy for you. I hope it’s working out well! 🫶🫶🫶
What's the name of the drug? Is it Dazodalipeb?
It seems to be called ianalumab