Standard drug level for Stelara?

[twob]

Does anyone know what the level is suppose to be at for Stelara. My son's is at 2, we are thinking it is to be higher, more like 4 or 5. he has just switched from remicade and not sure it is working. thank you.

 

[my little penguin]

FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
For patients with Crohn’s disease, therapeutic drug monitoring helped identify early primary nonresponders to induction with ustekinumab, according to researchers. The report is in Clinical Gastroenterology and Hepatology.
At week 8, median trough levels of ustekinumab were 6.0 mcg per mL (interquartile range, 3.1-8.0) among patients who achieved a primary response to induction at week 16, versus 1.3 mcg/mL (IQR, 0.9-5.6 ) among primary nonresponders (P = .03). An 8-week ustekinumab trough level cutoff of 2.0 mcg/mL distinguished week 16 responders from nonresponders with an area under the receiver operating curve (AUROC) of 0.75, wrote Ninon Soufflet of University Claude Bernard Lyon 1 in France, and associates. The researchers recommended “dedicated studies” to assess whether escalating the dose of ustekinumab can benefit patients with lower trough levels at week 8.
Few studies have explored biomarkers for response to ustekinumab induction therapy. Hence, the researchers assessed the relative utility of ustekinumab trough levels, C-reactive protein (CRP) levels, and fecal calprotectin levels for predicting early primary nonresponse. All 51 study participants had active luminal Crohn’s disease and received body weight–based intravenous infusions of ustekinumab at baseline, followed by subcutaneous injections of 90 mg. Primary nonresponders did not achieve steroid-free clinical and biochemical remission at week 16, defined as a Harvey-Bradshaw Index (HBI) of 4 points or less, a CRP level under 5 mg/L, and a fecal calprotectin level under 250 mcg/g. Week 16 was chosen to account for any delayed responders, the researchers noted.

A total of 32 patients (63%) achieved remission to ustekinumab induction therapy by week 16. An 8-week trough level of 2.0 mcg/mL was found to be optimal and distinguished primary nonresponders from responders with a sensitivity of 87%, a specificity of 66%, a positive predictive value of 82%, and a negative predictive value of 75%. In prior studies, optimal thresholds exceeded 3.3 mcg/mL for achieving remission and 4.5 mcg/mL at week 26 for achieving endoscopic response, the researchers noted. They said that this discrepancy might reflect different time points for evaluation, assays for measuring ustekinumab, patient populations, and a lack of endoscopic data in their study. “The relatively small sample size and the short period of follow-up evaluation [were] substantial limitations” they acknowledged.

From

Induction trough levels predicted ustekinumab response in Crohn’s disease

An ustekinumab trough level of 2.0 mcg/mL or higher distinguished responders from nonresponders with an area under the receiver operating curve of 0.75.

www.mdedge.com

 

[my little penguin]

RESULTS: At week 26 or beyond, 80.7% of patients had a clinical response, 66.1% were in clinical remission, 50.0% were in steroid-free clinical remission, 58.9% had an endoscopic response, and 19.6% were in endoscopic remission. The mean trough concentration of ustekinumab at this time point was higher in patients with an endoscopic response (4.7 μg/mL) than without (3.8 ug/mL; P = .03). An optimal ustekinumab threshold trough concentration at week 26 or later was found to be 4.5 μg/mL (area under the curve, 0.67). A greater proportion of patients with trough concentrations of ustekinumab above 4.5 μg/mL at week 26 or later had an endoscopic response (75.9%) than did patients with trough concentrations below this level (40.7%; P = .008). Patients with trough concentrations of ustekinumab above 4.5 μg/mL at week 26 or later also had a lower mean level of CRP (12.6 mg/L) than did patients with trough concentrations below this level (mean level of CRP, 23.9 mg/L; P = .04). We did not detect antibodies against ustekinumab in any patient.

CONCLUSIONS: Ustekinumab therapy was effective in patients with CD who had not responded to or were intolerant to treatment with a TNF antagonist. Maintenance trough concentrations of ustekinumab above 4.5 μg/mL at 26 weeks or later were associated with biomarker reduction and endoscopic response.

From

Association Between Ustekinumab Trough Concentrations and Clinical, Biomarker, and Endoscopic Outcomes in Patients With Crohn's Disease - PubMed

Ustekinumab therapy was effective in patients with CD who had not responded to or were intolerant to treatment with a TNF antagonist. Maintenance trough concentrations of ustekinumab above 4.5 μg/mL at 26 weeks or later were associated with biomarker reduction and endoscopic response.

www.ncbi.nlm.nih.gov

 

[my little penguin]

Keep in mind Stelara takes 6-12 months to be effective
Ds needed Stelara at 90 mg every 4 weeks but it works

 

[Kannassee]

Well 4 weeks after the injection the level was 3.9……….the Dr ordered the test since my Calprotectin level went from the 200’s before Stelara to mid 300’s now….
The good thing is that I don’t have antibodies to it.
Probably I am not a super responder….but I wish this thing will work…..Remicade calprotectin went less than 50 but I was all the time with colds….so far with Stelara no colds…..let’s see maybe if he increases the dose?

 

[Kannassee]

Actually I started Stelara around 6 months ago, still not a year. Actually if I follow a strict diet and If I dont eat much I won’t have loose stools episodes….but when that begins, that’s it…..prednisone and no eating for a day or two.

 

[Lynda Lynda]

Been on Stelara since October 2021.
90mg every 8 weeks.
Going to have my levels checked again next week to see if I may have to inject every 6 weeks or 4 weeks.

 

[Kannassee]

Hey hopefully if you need it your insurance will cover it.!!!
My insurance refused to cover it every 4 weeks.
I still don't know how this will end.
I could try to change to another insurance company.
I wonder if there is a way of knowing if an insurance company will cover it every 4 weeks. Is that FDA approved?

 

[asadmom]

Well 4 weeks after the injection the level was 3.9……….the Dr ordered the test since my Calprotectin level went from the 200’s before Stelara to mid 300’s now….
The good thing is that I don’t have antibodies to it.
Probably I am not a super responder….but I wish this thing will work…..Remicade calprotectin went less than 50 but I was all the time with colds….so far with Stelara no colds…..let’s see maybe if he increases the dose?

What was your level after the initial IV infusion?

 

[Lynda Lynda]

Hey hopefully if you need it your insurance will cover it.!!!
My insurance refused to cover it every 4 weeks.
I still don't know how this will end.
I could try to change to another insurance company.
I wonder if there is a way of knowing if an insurance company will cover it every 4 weeks. Is that FDA approved?

For the first year ( 2022 ) the Johnson & Johnson Patient Assistance Foundation was funding my Stelara. I collect SSD and have Medicare / UHC health insurance and live in the USA. Starting in 2023 the JJPAF was only assisting people with no health insurance, this is when Janssen took over with funding my Stelara. I don't take this assistance for granted, I am truly blessed that I was approved to get financial help.

 

[Lynda Lynda]

What was your level after the initial IV infusion?

I do not remember.

I go to Sonora Quest Laboratory for the Stelara blood draw, but it is a "pass through" test and is sent to Prometheus for processing. This means that my test results for this blood draw is not located on the Sonora Quest Lab patient portal for me to look at, but the report is sent to my Gastroenterologist office. I can get copies of all my Stelara blood draw results from my Gastroenterologist office so I can look at them.

[ My infusion was in October 2021. ]

 

[Scipio]

I wonder if there is a way of knowing if an insurance company will cover it every 4 weeks. Is that FDA approved?

No, not FDA-approved. I believe the FDA has approved only the standard 8-week dosing for Stelara, although many docs use it "off label" at 6 or 4 weeks.

 

[my little penguin]

Definitely not fda approved at 4 weeks
But my kiddo has been on that dose for almost 6 years
Insurance is hit or miss on what they approve

 

[Lynda Lynda]

Is this a good or bad Stelara level? This is dated Dec 2022. Recently had it taken again in April 2023 but have not been informed of the 2023 results. My infusion was 2021 October. Injection every 8 weeks.

 

[asadmom]

Is this a good or bad Stelara level? This is dated Dec 2022. Recently had it taken again in April 2023 but have not been informed of the 2023 results. My infusion was 2021 October. Injection every 8 weeks.

I think it's an absolute bad if the level is undetectable or you have developed resistance to it. How are you feeling otherwise?

My son is up for his injection this week so I have you on my mind. I hope you are doing well.

 

[Scipio]

The exact cut-off for Stelara has not been established, but 4.5 is generally regarded as a solid number. And the further good news is you don't have antibodies against the drug.

So with sufficient drug on board (or at least it was last December) and no antibodies, the drug should be controlling your disease. If it is not you may need to think about switching to something more effective. Your more recent drug level test should be informative.

 

[Kannassee]

What was your level after the initial IV infusion?

They did not checked it

 

[Kannassee]

Hey hopefully if you need it your insurance will cover it.!!!
My insurance refused to cover it every 4 weeks.
I still don't know how this will end.
I could try to change to another insurance company.
I wonder if there is a way of knowing if an insurance company will cover it every 4 weeks. Is that FDA approved?

They will deliver the pen tomorrow, Actually they approved it every 4 weeks for a year…..26 k per injection…..12 injections around 300.000.
It should not bother me I know but something is not right….

 

[Kannassee]

Is this a good or bad Stelara level? This is dated Dec 2022. Recently had it taken again in April 2023 but have not been informed of the 2023 results. My infusion was 2021 October. Injection every 8 weeks.

Was the Stelara blood level test before the injection or after the injection?

 

[Lynda Lynda]

Was the Stelara blood level test before the injection or after the injection?

Stelara level blood draw done 1-2 days before Stelara injection

 

[Lynda Lynda]

The exact cut-off for Stelara has not been established, but 4.5 is generally regarded as a solid number. And the further good news is you don't have antibodies against the drug.

So with sufficient drug on board (or at least it was last December) and no antibodies, the drug should be controlling your disease. If it is not you may need to think about switching to something more effective. Your more recent drug level test should be informative.

My GI is going to increase Stelara to every 6 weeks if approved by Janssen ( I am getting it free through Janssen.) NP at GI office took me off my 3mg daily Budesonide in March, was sick for over a month, went to Hospital, started on Prednisone to be tapered down and back to 9mg Budesonide a day. It's obvious that just the Stelara alone is not keeping my Crohn's under control. So after tapering the Prednisone back to Budesonide my Crohn's meds will be exactly the same as they were 2 years ago ( except Stelara every 6 weeks instead of 8 weeks.) Of course with my current dose of Prednisone ( today 30mg ) I have a great appetite and no diarrhea so I'm not panicked. Thanks for all your help. Will hopefully get my updated Stelara levels soon.

 

[my little penguin]

Please call Mayo Clinic
If you start the conversation woth then now
When things are where your ready to go
It will be a few months later 5-6 months
Then if you are good you can cancel

We did that for my kiddo so much better than calling when you need it and being told to wait 5-6 months

 

[Kannassee]

My GI is going to increase Stelara to every 6 weeks if approved by Janssen ( I am getting it free through Janssen.) NP at GI office took me off my 3mg daily Budesonide in March, was sick for over a month, went to Hospital, started on Prednisone to be tapered down and back to 9mg Budesonide a day. It's obvious that just the Stelara alone is not keeping my Crohn's under control. So after tapering the Prednisone back to Budesonide my Crohn's meds will be exactly the same as they were 2 years ago ( except Stelara every 6 weeks instead of 8 weeks.) Of course with my current dose of Prednisone ( today 30mg ) I have a great appetite and no diarrhea so I'm not panicked. Thanks for all your help. Will hopefully get my updated Stelara levels soon.

I was reading the second and third message in this thread and it seems that 4.5 is a good Stelara level

 

[Lynda Lynda]

Please call Mayo Clinic
If you start the conversation woth then now
When things are where your ready to go
It will be a few months later 5-6 months
Then if you are good you can cancel

We did that for my kiddo so much better than calling when you need it and being told to wait 5-6 months

I clicked on the link provided here and sent a request to Mayo for information. Got a call from the Central Appointment Office and he confirmed that they don't accept my Health Insurance. He gave me their Tax ID # for future use. I would not be able to change Health Insurance plans until enrollment period this Autumn 2023. Anyhow, that is all I have done so far. I need my follow up appointment with my GI or NP at my GI's office so that they can answer a few questions for me. Going to call Prometheus back tomorrow so that they can e-mail me or send a paper copy of my recent Stelara level testing. I cannot access these results online at Sonora Labs due to it being a "pass through" test." Honestly, the less I have to communicate right now by phone or patient portal to my GI office is best for me. My GI office is working on my Stelara every 6 weeks instead of 8 weeks, I would like to have that done / approved by my financial support at Janssen so I can do my next injection on June 2nd which is 6 weeks from my April injection. The wheels turn slowly at my GI's office. Of course my bowels are behaving right now because of the Prednisone, so my mood is light. I will enjoy this time while I have it. Ate chocolate candy today .
Thanks to everyone for their help.

 

[Lynda Lynda]

From

Association Between Ustekinumab Trough Concentrations and Clinical, Biomarker, and Endoscopic Outcomes in Patients With Crohn's Disease - PubMed

Ustekinumab therapy was effective in patients with CD who had not responded to or were intolerant to treatment with a TNF antagonist. Maintenance trough concentrations of ustekinumab above 4.5 μg/mL at 26 weeks or later were associated with biomarker reduction and endoscopic response.

www.ncbi.nlm.nih.gov

I haven't read this yet, as I only have phone screen print and not computer sized print. But my simple math skills ( ) say 26 weeks on Stelara every 8 weeks is 182 days. I have used Stelara every 8 weeks for 288 days ( or 18 months. )

 

[Lynda Lynda]

Well this sucks. I am now at the hospital emergency room for severe abdominal pain and they did another CAT scan. They gave me morphine but that does not help the pain in the my abdomen, it just makes my head feel wonky. I tried all morning to poop and I couldn't, I pushed so hard that my hemorrhoids are swollen up and bleeding and I pushed so hard that I just kept throwing up everything in my stomach. My theory is this, my poop is hard and will not come out of my body and that is why I am terrible pain and my sigmoid colon area down to the rectal area. I really want them to give me an enema to get that poop out of my body. When I was in the hospital 2 weeks ago I was there because of diarrhea. Now I'm on the prednisone still and my take on this abdominal pain is that now I'm probably constipated because of all the steroids, but I'm not a doctor so I don't know what the heck is going on. My landlord must think I'm crazy because I've been to the hospital twice this month and I've only lived at her house for less than 4 months. My landlord is a very nice person and a Christian lady and so she genuinely cares about her tenants , but I do not want to be an inconvenience to her so I hope she understands that I am doing my best to feel better. I have been moving around a lot the last 3 years and I'm 62 years old and tired so I want to stay at my current address for as long as possible because really it is a good place to live. I normally just sit around in my recliner all day and relax and nothing significant usually happens, but this month is an exception. I wish doctors could figure this stuff out. So I am either having diarrhea and end up in the hospital or having abdominal pain probably from constipation. I hate it in the hospital emergency room where they immediately save blockage and surgery and they don't even know who I am. They gave me morphine so I'm a bit chatty, more chatty than usual. My gastroenterologist does not have privileges at the hospital I am at right now, but I don't care because he just wants to get rid of me and send me Mayo Clinic. My sister has money and so maybe I can go to the Mayo Clinic for one appointment to be evaluated and she would pay for that one appointment because all she wants for me is for me to be happy. Mayo is a 40 mile round trip from my current residence. Maybe I'll lose some weight with this Crohn's craziness, I weigh 200 lb and have a fatty liver and bad bones so weight loss would be a blessing. Later.

 

[my little penguin]

Sending lots of hugs your way
The prednisone shouldn’t have constipated you
But any pains meds may have
Hope they figure it out soon

 

[Lynda Lynda]

Sending lots of hugs your way
The prednisone shouldn’t have constipated you
But any pains meds may have
Hope they figure it out soon

I had called an ambulance and the ambulance had to take me to the closest hospital which is not the hospital where my GI has privileges so it was a waste of time last night and early this morning going to that hospital only to go home feeling the same way as when I left. So believe it or not this morning I packed up a tote bag with Hospital stuff in it and my purse and I called a cab and took the cab to the hospital that is farther from my house but the hospital that my GI has privileges. So I've been getting all sorts of testing done and evaluation and IV medication and stuff like that and now they're going to put me upstairs for observation. My current symptoms are abdominal pain and cramping and my rectum is either inflamed or enlarged or something like that. So these are totally different symptoms that I had from the beginning of May. Yesterday morning I had sat in the bathroom for at least 2 hours pushing and pushing to have a bowel movement and nothing happened nothing happened except I vomited up everything in my stomach because I was pushing so hard to have a BM in the BM never happened . So of course now my rectum hurts. This morning I laid down in this hospital bed to take all the pressure off of my rectum then I no longer had the abdominal pain and cramping. Not quite what sure they're going to do during observation or what kind of medicine they're going to give me but one of the nurses came into my room down here in the ER to get my detailed prednisone tapering schedule so we can get all that started up again today. Now that I know that the fire department in the city I live in is very diligent about not taking me to the hospital I want to then I will just start calling a cab and go to the hospital that I'm supposed to which is farther away from where I live. Last night was a waste of time at that other ER Hospital place because they just sent me home like I was cured or something.

 

[my little penguin]

Glad your being seen now
Hope they get to the bottom of it

 

[Lynda Lynda]

I will have CVS order the hydrocortisone suppositories and proctofoam, I called 3 CVS locations and it's not in stock. Of course ER Doctors give me a paper prescription and it doesn't get sent electronically. Only had liquids for two days now. Will try soft food tomorrow .... but may need the foam and suppositories before I eat that ?
My arse is almost swollen shut.
Cream of Wheat and also applesauce should be ok.
I did pass one very small good looking poop today.
That expensive OTC tube of Preparation H with lidocaine is worthless. Heating pad for my tummy and sitz bath for my arse arriving soon from Amazon, and adult diapers and adult diaper plastic bags.
Mostly bloating since nothing's in my stomach.
Took the waffle foam pillow thing from the Hospital, it's comfy.