started Besremi but worried about autoimmune diseases.

[Yarw]

Hi, Happy New Year to you and your loved ones ❤️. Underwent full assessment for the ECLIPSE PV trial. Incidental findings: ANA antibodies 1:80, Anti-RNP 2.2 (confirmed twice), and thyroid antibodies (Hashimoto's). Asymptomatic, low risk. Started Besremi preventively for any future progression. Top rheumatologist doubts connective tissue disease due to lack of symptoms. My MPN doctor is coordinating closely with rheumatologist and endocrinologist here in Toronto. On third Besremi injection, with some stomach discomfort. Worried about Besremi triggering autoimmune disease. Any similar experiences?

[Ggrana3192]

I developed hemolytic anemia and needed blood transfusions because hg dropped to 4.

I went from having too much blood to none very quickly , but I was at high dose of 500

[Yarw in reply to Ggrana3192]

I’m so sorry to hear. How are you doing now?

[EPguy]

That's great to have your Rheum issues under close surveillance. Interesting that the trial is screening for autoimmunes, this should be standard practice I think.

The trial is testing more aggressive dosing I recall. This could increase your risk if it's more than you need.

The worst outcomes are very unlikely but you asked our experience. I have suffered one of the worst possible immune outcomes on Bes, it's one of the items in the FDA black box. You can read my posts of the past year. It did work perfectly otherwise.

I most likely had no autoantibodies at the time, but a flu vaccine triggered them along with what I believe was too high of dosing of Bes. (140, I needed half that to hold CHR)

Your Rheum is likely watching the ANA closely, it's a catch all for various A-Immune conditions. From my single experience the autoimmune complication can hit with little warning, I missed mine. My main troublesome indication was vague malaise. I will post more thoughts on that next month.

[Yarw in reply to EPguy]

I’m so sorry that it triggered your auto immune disease. Grateful I’m being closely watched.

[Mostew]

Hashimoto is an autoimmune disease . If its been confirmed it won't be besremi triggering it .

I would read up on Hashimoto and natural things you can do to try help prevent future decline .

Speak to your consultant about concerns. If you feel you arnt being listened to find someone who will.

Best of luck

[EPguy in reply to Mostew]

It seems thyroid autoimmune is a connected to Bes. The FDA label has:

"New or worsening autoimmune problems. BESREMi may cause autoimmune problems ... including thyroid problems... These toxicities may include worsening hypothyroidism and hyperthyroidism"

This complication was reported at 3-4.5% in the trial according to the label.

accessdata.fda.gov/drugsatf...

But according to the Euro label the concern is limited to thyroid conditions that cannot be controlled-

"Do not use Besremi: if you have thyroid disease that is not controlled with medicines"

ema.europa.eu/en/documents/...

Implication is it applies only to uncontrollable symptomatic disease. But there is unexpected frequent mention of thyroid in the labels so close Rhuem monitoring seems to be indicated if Hashimotos is present.

[Mostew in reply to EPguy]

I shouldn't have pocked my nose in when I don't really know what I'm talking about ..I was thinking of when I asked about interferon and was told by Professor Harrison that if I already have underactive thyroid it would be OK to have .

Thanks for above info

Happy New Year everyone

[EPguy in reply to Mostew]

From what I can figure, Thyroid is among the less worrisome autoimmunes since it has some very good treatments and various mild forms. The label seems to address the less common un-treatable sorts.

I suspect new neurological troubles are esp worthy of attention if my experience is a guide.

[Bikecrazy in reply to EPguy]

Sorry to hear you've experienced a terrible issue with Besremi and autoimmune problems. Thank you for sharing.

I have just started my journey with Besremi for PV with Jak2 mutation.. only 4 injections so far, low dose (50 mcg).

I have the same fear that the treatment will cause or worsen autoimmune problems. Currently, I have a clinical diagnosis of Sjogrens and Raynauds. Not on meds. I also have untreated Hypoparathyroid issues. There actually is no treatment for this yet. Crossing fingers I can continue with no worsening issues.

[EPguy in reply to Bikecrazy]

Sjo and Raynaud's are often together. Yours is mild I assume. You may have seen my detailed post on my experience, so no need to labor that subject.

I see your prior post your blood counts are ok without treatment. So staying at 50 may work for you, what is your Dr's opinion? I think I could have used 50 and been ok. (was at 140)

[Yarw in reply to Mostew]

You are right, I already have it, subclinical. I hope it doesn’t make it worse! Hope all is well

[Mostew in reply to Yarw]

Focus on what you can do , like not stressing , eating anti inflammatory food (mainly!! ) etc.

[mhos61]

I note that you are young, and hopefully interferon will halt your disease at a deep molecular level rather than just treat the effects of the disease. I hope this is the case for you.

The positives are as part of a trial you will be well monitored. Likewise, it’s encouraging that there is a healthy liaison between MPN Specialist/rheumatologist/endocrinologist. Advocate well to make sure that is maintained!

I do understand your concerns about the ‘possibility’ of Besremi triggering an autoimmune response, but I am not sure what your ANA and Anti-RNP levels indicate, is it considered a positive or borderline result? I believe you can have a raised ANA and no autoimmune disease.

I’ve just looked up this trial you are participating in and posted the link below for anyone who is interested

It appears that many members on the forum who are on Besremi seem to like the ‘low and slow’ approach rather than the accelerated dosing. Hopefully, you’ve been assigned the ‘current labeled dosing’. I think if there’s suspicion around the possibility of an autoimmune response ‘low and slow’ would be smart. This is just my opinion!

google.com/url?sa=t&rct=j&q...

“The study, which will enroll approximately 100 patients with PV in the United States and Canada, will randomly assign patients to receive either the accelerated dosing or the current labeled dosing of 50 µg or 100 µg with 50 mcg titration every 2 weeks. Patients assigned to the accelerated dosing arm will receive a starting dose of 250 µg, then 350 µg at week 2, with a target optimal dose of 500 µg at week 4. Subsequent dosing will remain fixed at the highest tolerated dose for the rest of treatment.”

[Yarw in reply to mhos61]

Thank you so much. My titers are low and I don’t have symptoms. But I’m being watched closely because I’m on interferon which I’m grateful for.

[KLCTJC]

my thyroid has always been sub-clinically low. Starting Bes it put me into full hypothyroidism. We just treated it. And now it is normal. Bes benefits outweighed treating my thyroid. And I feel great! To be honest when I found out I cried because I was afraid I would have to stop it. Luckily I didn’t and thyroid is currently controlled. It was likely I was going to need treatment anyways. Risks are higher as we get older. Hope this helps.

[Yarw in reply to KLCTJC]

I totally agree with you. Mine is subclinical as well. I felt exactly the same, I was worried it would disqualify me from the study. I’m on my third injection and doing great.

[KLCTJC in reply to Yarw]

Yeah!!!

[josup26]

Hello there and Happy New Year,

I have been on Besremi for 2 years and have had very small sides affects. I did have some stomach issues at first but they have passed and I get occasional bone discomfort that comes and goes. I hope you have great success on Besremi It has really helped me.

[Yarw in reply to josup26]

Thank you so much. This is so reassuring. Thanks for sharing