Remicade levels low and antibodies present

I finally got my test results back.

My doctor's note with the results was this: "Infliximab (Remicade) level low, antibodies present. Explains your loss of response. Will need to switch to a different drug in the same class and consider Imuran for 6-12 months to reduce the chance of further ab formation. Probably will start prior authorization process for Humira, unless you want to do something different. Can discuss further at our f/u appt next week."

Results: Infliximab Drug Level 3.3 ug/mL
Note
In the presence of serum anti-infliximab antibodies, the
infliximab drug level reflects the antibody-unbound (free)
fraction of infliximab in serum.
Quantitation Limit: <0.4 ug/mL
Results of 0.4 or higher indicate detection of Infliximab.
COMMENTS:
- The optimal drug concentration depends upon patient-
specific factors including the disease and desired
therapeutic endpoint.
- Target trough ranges of 3 to 7 ug/mL and 5 to 10 ug/mL
have been studied in inflammatory bowel disease (1,2).
- In severe CD, higher trough levels (>10 ug/mL) may be
necessary to achieve fistula healing (3).
- In rheumatoid arthritis, EULAR responders had higher
trough levels (median 3.6 ug/mL) than non-responders
(0.5 ug/mL) (4).

Anti-Infliximab Antibody 40 ng/mL
Note
Interpretation:
The above result is a LOW Antibody titer.
Quantitation Limit: <22 ng/mL.
Results
of 22 or higher indicate detection of anti-
infliximab antibodies.
22 - 200 ng/mL: LOW antibody titer, little/no apparent
reduction in free drug level
201 - 1,000 ng/mL: INTERMEDIATE antibody titer,
variable reduction in free drug level
1,001 or greater ng/mL: HIGH antibody titer, notably
diminished or absent free drug level
Comments:
- Anti-drug antibodies may develop at any time during the
course of biological therapy.
- Low titer anti-drug antibodies may have little/no effect
on drug level/efficacy. Antibodies in low
titers may be transient and disappear overtime (5,6) or
they may progress to higher titers (6).
- High titers are likely to be more consequential, leading
to loss of drug efficacy by preventing drug binding to TNF
and/or increasing drug clearance (6,7).
- Maintenance of drug levels greater than 3 ug/mL may reduce
the risk of developing anti-drug antibodies (8).
- This
anti-infliximab antibody assay is not impeded by the
presence of infliximab in serum (up to 100 ug/mL), and all
positive antibody results are verified by a confirmatory
test.

My notes and questions: I was only on 3 vials of Remi (I should have been on 4 for my weight but they never bothered to weigh me) at the time this bloodwork was taken. I got 4 vials at my last infusion, on Oct. 31. I was able to get off prednisone right before my 3rd infusion and felt like I was in remission for 2 months. These antibody levels seem pretty low, so should my doctor be trying anything else, like increasing my dose and frequency before moving on to Humira and imuran? What are my chances of Humira being effective if I failed Remicade?

I'm currently taking 50 mg of pred and still having symptoms (abdominal pain, sometimes blood, painful BMs, but formed and leaning more towards constipation past 2 days! I can't win... ). It's been 2 weeks. I've never had such a poor response to pred before in my life.

Please help me decipher my results and figure out the next best step before my appt. Nov. 18. Thanks!

Also, please share any experiences with Humira or imuran.

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35 years old; diagnosed UC March 2007 (couldn't get scope all the way thru).
9-29-16: chronic and active proctosigmoiditis (infectious cause). Battled reoccuring campylobacter & c diff. Oct-Dec 2016. Remission since 12/25/16 until I started smoking again in 2018 after 9 yrs quit. Re-quit smoking. Maintenance: Delzicol, 6, 2xday; Rowasa nightly. Started Remicade 7/25/19. 50 mg pred 10/29/19.

Post Edited (Sara14) : 11/10/2019 7:59:18 AM (GMT-7)

Thank you. No, the only biologic or immunosupressant I've tried so far is Remicade. I'll keep it in mind.

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35 years old; diagnosed UC March 2007 (couldn't get scope all the way thru).
9-29-16: chronic and active proctosigmoiditis (infectious cause). Battled reoccuring campylobacter & c diff. Oct-Dec 2016. Remission since 12/25/16 until I started smoking again in 2018 after 9 yrs quit. Re-quit smoking. Maintenance: Delzicol, 6, 2xday; Rowasa nightly. Started Remicade 7/25/19. 50 mg pred 10/29/19.

Thank you for sharing your story. How did you live for 2 years without any relief? I'm just starting to wonder how do I work and make do if I may not feel well for months or a year? I can make do if I get pain meds and as long as the prednisone continues to help me somewhat, but without pain meds, I can't function like this, so I'm wondering what others do when they don't respond to meds for months or years.

Yeah, I know some people flare right before their infusion and then get relief. I was hoping that would happen to me but I haven't gotten relief and had to go on 50 mg pred. It's been 2.5 weeks since my last infusion so I don't think it's going to do anything.

I read your post about them giving you the biosimilar. I would be so mad. I know my insurance company and the mail order specialty pharmacy I was going through are required to inform me before any medication switches, including to a biosimilar. The hospital here tried to give me Inflectra once but I said no (it was a big mix-up on their end). I hope the Remicade works for you again.

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35 years old; diagnosed UC March 2007 (couldn't get scope all the way thru).
9-29-16: chronic and active proctosigmoiditis (infectious cause). Battled reoccuring campylobacter & c diff. Oct-Dec 2016. Remission since 12/25/16 until I started smoking again in 2018 after 9 yrs quit. Re-quit smoking. Maintenance: Delzicol, 6, 2xday; Rowasa nightly. Started Remicade 7/25/19. 50 mg pred 10/29/19.

Sara,
I’m sorry to hear about your test results. I’ve had great success with Humira—feel free to ask me any questions about it.
It took a few months for me to reach remission and I ended up increasing the dose to weekly injections (you start with every 2 weeks).
Personally, I prefer the convenience of being able to inject at home instead of having to go to a hospital/infusion center. The injection is 5 mins out of my week — super easy!
Wishing you well,
Lisa

How many mg/kg are you given and how often are your infusion? The max you can do is 10mg/kg at every 4 weeks. If you are there already, and your drug levels are this low, your body metabolizes the drug too fast and you need to move on.

I started on Humira but developed antibodies + my body was metabolizing it too fast, so once a week wasn't even working, so I switched to Inflectra (Remi biosimilar) along with Imuran. The imuran is to prevent antibodies. I've been mostly symptom free for a little over a year (randomly, a few days before I get my period, I have 1-2 days of bleeding, and I am not sure if it is because I have always gotten D with my period since I was a teen and it's irritating things, or if the hormone changes impact the UC). So you can definitely switch between the two and see one work and not the other.

suchatravesty said...
How many mg/kg are you given and how often are your infusion? The max you can do is 10mg/kg at every 4 weeks. If you are there already, and your drug levels are this low, your body metabolizes the drug too fast and you need to move on.

I started on Humira but developed antibodies + my body was metabolizing it too fast, so once a week wasn't even working, so I switched to Inflectra (Remi biosimilar) along with Imuran. The imuran is to prevent antibodies. I've been mostly symptom free for a little over a year (randomly, a few days before I get my period, I have 1-2 days of bleeding, and I am not sure if it is because I have always gotten D with my period since I was a teen and it's irritating things, or if the hormone changes impact the UC). So you can definitely switch between the two and see one work and not the other.

5 mg every 8 weeks. I've only had 4 infusions. I was also not being given enough the first 3 times based on my weight. They upped it to 4 vials this last infusion.

Thanks for sharing your experience about switching! I'm glad it is working for you!

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35 years old; diagnosed UC March 2007 (couldn't get scope all the way thru).
9-29-16: chronic and active proctosigmoiditis (infectious cause). Battled reoccuring campylobacter & c diff. Oct-Dec 2016. Remission since 12/25/16 until I started smoking again in 2018 after 9 yrs quit. Re-quit smoking. Maintenance: Delzicol, 6, 2xday; Rowasa nightly. Started Remicade 7/25/19. 50 mg pred 10/29/19.

Awesome. Thank you, Lisa!

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35 years old; diagnosed UC March 2007 (couldn't get scope all the way thru).
9-29-16: chronic and active proctosigmoiditis (infectious cause). Battled reoccuring campylobacter & c diff. Oct-Dec 2016. Remission since 12/25/16 until I started smoking again in 2018 after 9 yrs quit. Re-quit smoking. Maintenance: Delzicol, 6, 2xday; Rowasa nightly. Started Remicade 7/25/19. 50 mg pred 10/29/19.

Thanks so much, iPoop. That all makes sense and I agree. Yes, I seem to run into a lot of idiots. Lol. I'm starting to feel close to back to normal today after 2 weeks on prednisone. I went up to 60 mg on my own for a few days because the doctor's office never responded to my question about that (they will call back and respond to about half of what I've asked...). Anyway, I'll discuss this all with my doctor next week (they never responded about getting me in sooner either). I find it a little odd he is wanting to jump right to Humira, too.

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35 years old; diagnosed UC March 2007 (couldn't get scope all the way thru).
9-29-16: chronic and active proctosigmoiditis (infectious cause). Battled reoccuring campylobacter & c diff. Oct-Dec 2016. Remission since 12/25/16 until I started smoking again in 2018 after 9 yrs quit. Re-quit smoking. Maintenance: Delzicol, 6, 2xday; Rowasa nightly. Started Remicade 7/25/19. 50 mg pred 10/29/19.

I agree with iPoop ... increased dosage, closer together may very well be exactly what you need. You were doing so well after the loading doses, but before your first maintenance dose you lost response. Maybe changing to every 6 weeks and going to 7.5-10 mg/kg would be perfect for you. You don't want to just blow through biologics too fast.

Good luck!

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60 yo female diagnosed w/UC to mid transverse 1/1/13, now UC or Crohn's colitis. Remission on Entyvio 10/2016-12/2017 before losing response. Had response to Humira with loading doses in Nov 2018, but then lost response. Current meds: Remicade 3/15/19, Asacol HD 2 Tabs 3x/day, Capozide 1/day (hypertension). Dexilant.

I decided to go with the Humira and imuran. My doctor came in early and talked with me for 30 minutes and answered all my questions. He said I could try an increased dose of Remicade, but he thought Humira (or Entyvio) would be the better option since I already have antibodies (he didn't seem to think it mattered the antibody test was fairly low). He said I was probably already starting to develop antibodies after the 2nd infusion. I also didn't want to wait 3ish more weeks while still struggling to have another Remi infusion, then wait even longer to see if it works and even longer to have my antibodies and Remi levels checked again.

I just got a bunch of bloodwork done, including the enzyme test for imuran, CBC, iron, and CMP. He said I need bloodwork every week for the first month on imuran. He is starting me at 150 mg assuming my enzyme test comes back okay. He really hit home the lymphoma risk. I asked him if he had seen that in his patients and he said once. He said I the plan is to only have me take imuran for 6 months to a year. I think he must have lost that one patient. Very sad. He has only used Xeljanz once so far, which I found surprising. I guess it is fairly new.

He told me not to taper pred until at least my first Humira dose. So I guess I'm going to be on 50-60 mg pred for a while longer. He also refilled my Tramadol which made me feel relieved. It felt good to have someone validate how sick I am and not act like I am a drug seeker. He ordered a bone density scan after I asked if I should get another one. He also told me to get a pap smear and a dermatology check-up once a year since I'm now on immunosuppressants.

He told me colitis can be deadly. He said Crohn's doesn't usually cause mortality, but that UC can be very serious. I knew it could happen but have never had a doctor tell me that.

So now, I just wait on my bloodwork results and wait to get the Humira approved. Fingers crossed it works for me.

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35 years old; diagnosed UC March 2007 (couldn't get scope all the way thru).
9-29-16: chronic and active proctosigmoiditis (infectious cause). Battled reoccuring campylobacter & c diff. Oct-Dec 2016. Remission since 12/25/16 until I started smoking again in 2018 after 9 yrs quit. Re-quit smoking. Maintenance: Delzicol, 6, 2xday; Rowasa nightly. Started Remicade 7/25/19. 50 mg pred 10/29/19.

It sounds like a smart plan Sara. I hope you have luck with humira & imuran. If not, there are other options. On here, drugs like xeljanz seem popular, but in reality, I would imagine the # of people who don't respond to the other, more common options, is quite low. I am sure you will do well with Humira. Actually, Imuran alone, could get you into remission, so the combo may do the trick!

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Moderator: UC
Currently: no meds 6/15 Step 1 J-pouch Surgery Complete 9/15 Step 2 Complete 11/15 Step 3 Complete
From Sickly to UC Free
Give a man a fish and he will eat for a day; teach a man to fish and he will eat for a lifetime; give a man religion and he will die praying for a fish

Good luck, sounds like a good plan, keep us posted on how it goes! We're all certainly worried about you, flaring for so long and not getting relief (even at 60mgs of pred)! Unfortunately, there is no easy-button with this whole UC thing...

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Moderator Ulcerative Colitis
John, UC Proctosigmoiditis in Remission
Rx: Remicade @5mgs/kg/6wks; 50mgs 6MP; nightly Rowasa
This disease would be okay if it wasn't for the constant pain, pooping, and fatigue.

Thanks guys!

Got my CBC results back super fast: WBC is 14.8. I have slightly high immature granulocytes. I read that prednisone can also increase your WBC. Usually my bloodwork is pretty much normal even when I'm super ill.

Iron and ferritin are normal. Glucose is a little high.

Post Edited (Sara14) : 11/12/2019 8:32:38 PM (GMT-7)