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
https://www.mdedge.com/gihepnews/ar...induction-trough-levels-predicted-ustekinumab

 

[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
https://www.ncbi.nlm.nih.gov/m/pubmed/28365485/

 

[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.

 

[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?

 

[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

 

[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?

 

[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

 

[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

 

[my little penguin]

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

 

[my little penguin]

Good luck on the surgery
Glad your getting iv solumedrol before
It really helps my kiddo before scopes