Need article on IVIG maintenance dosage

Hi laurel,
Nice to hear or should I say read from you!! Some studies as well as at the Chicago sympos. suggest frequency is more important than quantity. If you think about it, it makes sense because it keeps the titers more balanced. We did go down by 10 g every period. Currently, we get a maint. dose, which is half of a load, every month, but we split it. So we get 35 grams one day every 2 weeks. As usual, we are sick, so we are causing an immune response, therefore using the ivig faster, so I think we may need a load in between. Contemplating this. I am also going to ask about adding low dose naltrexone, so many readings about its benefits with ms. There is a new study that usues albuterol to put ms into remission too!! Looking into that. Anyway, off topic, sorry! Good luck!

Hey Laurel,

I never did find any credible info on the web on how to reach a maintenance schedule. For Emily we are spacing out the infusions instead of decreasing the amount of IVIG. That has always been what has worked for her…but we know she’s not a normal CIDP’er.

Sorry I couldn’t be of more help. I really hope you can find the info on it.

Kelly

Let me start with my frustration. To say there is a total dose of say, 100g, has very little meaning. Whew, now I said it.

And here is why I say it. The ‘standard’ dose is .4g per kg where g = grams of IG fluid and kg = your body weight in Kilograms. Now, the infusions of Ig that I’ve had were 10% solutions. What does that mean? I’m about 175 lbs = (about) 80kg, therefore for my 32 grams of Ig, there are 320 total grams of solution.

As a non-chemist and certainly not a math whiz, I can only tell you that my 32 grams worth come mixed in a 300 ml bag. Or a bottle of 300 ml, two bottles of 10ml, and one bottle of 2.5 ml.

So, what’s the point? For most of us the initial dose is 5 days worth, or .4g/kg each day, for 5 days.

I’ve been to Cleveland Clinic, Ohio where they said IVIG would probably not be successful. I’ve been to Mayo Clinic, Rochester where they said my IVIG was neither often enough nor aggressive enough.

Based on what? Some report written somewhere? No, based on my own personal situation.

Jump forward in time to right now. I am seeing a specialist at UCSD La Jolla, Ca. He ordered 5 days of treatments once per month for three months.

However, I was to be re-evaluated three weeks after the first session. No, he did not run any electrical or laboratory tests. He merely tested my limbs’ strength with his own hands prior to the first set. After the first set, on the 3 week appointment he tested me again. I was markedly stronger in leg lifts, thigh lifts, arm shrugs and head tilting.

He immediately canceled the next two 5 day treatments because results had been demonstrably obtained. He modified the schedule to 3 days, in a row, every three weeks. Guess what, I was on 1 day every week. Isn’t that the same, about, dose?

“No,” he said, “I want you to have more all at once, more often.”

So, what’s my point? An on-line report of somebody’s, or somebodys (plural) results doesn’t do us individuals any good. The doctors all have a push me-pull me scale to measure muscle strength. If you are on IVIG and are not getting stronger, take action.

By the way, at least he (UCSD), Chicago and Mayo agreed that results from Imuran would take 1-2 years.

In addition, he (UCSD) looked at my labs, specifically the lymphocyte levels, and said “No, I don’t want to be any more aggressive on knocking down your immune system. Let’s leave it at these levels.”

My final answer? Don’t look for reports, look for a specialist.

Sorry, I didn’t intend for it to be condescending and unhelpful.

Laurel
Where in Canada do you live. I am in the lower mainland of bc and have a great neurologist now based out of Vancouver general
Maintenance doses on ivig vary and not to be demeaning sadly the doctors will follow the doses as directed unless your neurologist will go to battle
I am past ivig and am doing chemo. Wish I could offer more advise. If you have any more questions just yell

[QUOTE=Dawn Kevies mom]Hi laurel,
Nice to hear or should I say read from you!! Some studies as well as at the Chicago sympos. suggest frequency is more important than quantity. If you think about it, it makes sense because it keeps the titers more balanced. We did go down by 10 g every period. Currently, we get a maint. dose, which is half of a load, every month, but we split it. So we get 35 grams one day every 2 weeks. As usual, we are sick, so we are causing an immune response, therefore using the ivig faster, so I think we may need a load in between. Contemplating this. I am also going to ask about adding low dose naltrexone, so many readings about its benefits with ms. There is a new study that usues albuterol to put ms into remission too!! Looking into that. Anyway, off topic, sorry! Good luck![/QUOTE]

I myself am going to ask about LDN on thursday when i go back to the lahey clinic. Ive been dooing a lot of reseaerch on it and it seems to be working for a numerous amount of auto-immune conditions in the dose of 4.5 mg. Am curious as to what the response was when you asked—keep us posted. I’ll post what i find out on thurs. about it. Lori

I guess this info from Aetna on “Clinical Policy Bulletin: Parenteral Immunoglobulins” (gosh, don’t let that name throw you) explains how to go about it. In-directly. Let me copy and paste some of the article here.

[I]”…Notes: The following criteria are considered in assessing the medical necessity of IVIG for the indications listed above.

1. Clinical monitoring takes clear precedence over laboratory monitoring. If clinical improvement is evident, then laboratory monitoring solely to guide IVIG therapy is not considered medically necessary.

2. In some situations, IVIG may be used for medically necessary indications listed above for a person that has rapidly progressive disease in which a clinical response could not be effected quickly enough using conventional agents. In these situations, IVIG therapy would be given along with conventional treatment(s) and continued administration of IVIG is not considered medically necessary once conventional therapy takes effect.

3. Once treatment is initiated, there must be adequate documentation of progress. If there is initial improvement, and continued treatment is necessary, then some type of objective quantitative assessment to monitor the progress is required. Any accepted metric assessment may be used for objective monitoring of progress, such as the Inflammatory Neuropathy Cause and Treatment (INCAT) scale*, the Medical Research Council (MRC) scale ** and activities of daily living (ADL) measurements. Changes in these measures should be clearly documented. Subjective or experiential improvement alone is generally insufficient to either continue IVIG or to expect coverage.

4. Previous treatment failures must be documented.

5. The diagnosis of the disorder must be reasonably certain, and based on a thorough history and examination, and appropriate laboratory testing (e.g., electromyography (EMG), spinal fluid tests, serum tests and biopsy findings).

6. There should be, depending on the diagnosis and clinical circumstances, an attempt made to decrease/wean the dosage when improvement has occurred. There should be, when clinically appropriate for the diagnosis, an attempt to stop the IVIG infusion if improvement is sustained with dosage reduction. If improvement does not occur with IVIG, continued infusion may not be considered medically necessary.

* The Inflammatory Neuropathy Cause and Treatment (INCAT) scale is used to access functional disability of both upper and lower extremity components in CIDP. The INCAT scale has upper and lower extremity components, with a maximum of 5 points for the upper extremity (arm disability) and a maximum of 5 points for the lower extremity (leg disability), which add up to a maximum of 10 points (where 0 is normal and 10 is severely incapacitated). The INCAT scores may be used to evaluate the effectiveness and need for IVIG. IVIG may be discontinued when there is a lack of clear clinical improvement (i.e., a decline in INCAT disability score or failure to improve by 1 point at six weeks following the initial infusion or return to baseline at anytime following initial improvement of 1 point).

** The Medical Research Council (MRC) scale is used to grade muscle strength. Scale: 0 = no muscle movement; 1 = flicker of muscle movement; 2 = trace movement but not able to fully overcome gravity; 3 = just able to overcome gravity, but not against resistance; 4 = moves against resistance, but weak; 5 = full strength against resistance….”[/I]

So, to begin the analysis, look at Item #3. Pay particular attention to: “…Any accepted metric assessment may be used for objective monitoring of progress, such as the Inflammatory Neuropathy Cause and Treatment (INCAT) scale*, the Medical Research Council (MRC) scale ** and activities of daily living (ADL) measurements. Changes in these measures should be clearly documented. Subjective or experiential improvement alone is generally insufficient to either continue IVIG or to expect coverage….”

First, they tell how to measure progress, or lack of it, in specific clinical (clinical means in the Doctor’s office) terms.

Specifically, [I]”The INCAT scores may be used to evaluate the effectiveness and need for IVIG. IVIG may be discontinued when there is a lack of clear clinical improvement (i.e., a decline in INCAT disability score or failure to improve by 1 point at six weeks following the initial infusion or return to baseline at anytime following initial improvement of 1 point).”
[/I]

Therefore, in case of the INCAT score, you want to see maintenance of the original score and, certainly, no more than a one point drop when beginning the tapering process. But, even a return to ‘baseline’ would be cause to discontinue the taper.

Second, they tell us “nope, your opinion (subjective) doesn’t count.

Third, Look carefully at #6. Ah ha! ‘You better show progress or we’ll stop the authorization.’

Now, then, how does this become an article on dosage?

Inversely.

By that, I mean, what the UCSD Dr. told me. “OK, you’ve improved on 5 days of IVIG. Now I want you to take several cycles of IVIG 3 days in a row every three weeks.” Here is what he said, verbatim, “I explained that it might be that he (me) needs to have high dose bursts of IVIG less frequently rather than low dose frequently.” (whew)

Continuing, the UCSD Dr. said “Ideally, I would like to taper him completely off IVIG….”

The way to control the dosage for the taper is by trial and error (tailored for each patient, of course) based on the criteria set forth in the Aetna article.

And, that’s what I wanted to say before. Cut the dose or increase the time between doses and measure what happens. By measure, I mean the clinical criteria set forth by INCAT and the MRC.

the article is here: [url]http://www.aetna.com/cpb/medical/data/200_299/0206.html[/url]

[QUOTE=laurel]Does anyone have an article on the best protocol for reaching a maintenance dosage of IVIG? i.e. from what I have read on this forum, it seems that decreasing the IVIG dosage slowly and keeping the same administration time frame is the most successful method. So for example if you get IVIG every 3 weeks at the dosage of 100 G., it is best to drop it 10 G. at a time and carry on at the 3 week interval until you get down to about 60 G every 3 weeks.

We keep getting frustrated with hubby’s neurologist who seems to be all over the map with this issue. Now the neuro. is suggesting increasing the time frame versus the decreasing the amount. i.e. If you take IVIG 100 G every 3 weeks, start getting it every 4 weeks at same dose, then every 5 weeks at same dose, every 6 weeks at same dose, etc. This seems to fly in the face of everything I have read here. We are going to be changing neurologists due to our frustration over many issues, but it sure would help if we could find an article from a credible source that talks about the best way to decrease the IVIG.
Thanks for any help with an article that may be out there.
Laurel[/QUOTE]

Laurel, I can understand your frustration but what I can offer is that it REALLY seems to be physician dependent and related to their training and experience. You could ask 3 different neurologists and probably get 3 different answers.

The fact that yours is “all over the map” is what is more concerning. Typically they have a “general” way in which they do it, depending on their own experience, level of expertise, & specific patient-related issues, history and characteristics. It also seems to vary by regions of the country/world.

My physician is the lead neurologist at one of the “7 Centers of Excellence in CIDP treatment” in the world right now.
I can’t offer literature, but I know that his approach would be to increase the time frame before adjusting the dose when weaning, or as he said “just pull the band-aid off all at once and see how the patient does”.

I know that doesn’t answer your question, but it gives you another perspective to look at. My main concern is that your hubby’s dr seems to have no established protocol the HE follows.

Best of luck to you all!!!

[QUOTE=yuehan]I guess this info from Aetna on “Clinical Policy Bulletin: Parenteral Immunoglobulins” (gosh, don’t let that name throw you) explains how to go about it. In-directly. Let me copy and paste some of the article here.

[I]”…Notes: The following criteria are considered in assessing the medical necessity of IVIG for the indications listed above.

1. Clinical monitoring takes clear precedence over laboratory monitoring. If clinical improvement is evident, then laboratory monitoring solely to guide IVIG therapy is not considered medically necessary.

2. In some situations, IVIG may be used for medically necessary indications listed above for a person that has rapidly progressive disease in which a clinical response could not be effected quickly enough using conventional agents. In these situations, IVIG therapy would be given along with conventional treatment(s) and continued administration of IVIG is not considered medically necessary once conventional therapy takes effect.

3. Once treatment is initiated, there must be adequate documentation of progress. If there is initial improvement, and continued treatment is necessary, then some type of objective quantitative assessment to monitor the progress is required. Any accepted metric assessment may be used for objective monitoring of progress, such as the Inflammatory Neuropathy Cause and Treatment (INCAT) scale*, the Medical Research Council (MRC) scale ** and activities of daily living (ADL) measurements. Changes in these measures should be clearly documented. Subjective or experiential improvement alone is generally insufficient to either continue IVIG or to expect coverage.

4. Previous treatment failures must be documented.

5. The diagnosis of the disorder must be reasonably certain, and based on a thorough history and examination, and appropriate laboratory testing (e.g., electromyography (EMG), spinal fluid tests, serum tests and biopsy findings).

6. There should be, depending on the diagnosis and clinical circumstances, an attempt made to decrease/wean the dosage when improvement has occurred. There should be, when clinically appropriate for the diagnosis, an attempt to stop the IVIG infusion if improvement is sustained with dosage reduction. If improvement does not occur with IVIG, continued infusion may not be considered medically necessary.

* The Inflammatory Neuropathy Cause and Treatment (INCAT) scale is used to access functional disability of both upper and lower extremity components in CIDP. The INCAT scale has upper and lower extremity components, with a maximum of 5 points for the upper extremity (arm disability) and a maximum of 5 points for the lower extremity (leg disability), which add up to a maximum of 10 points (where 0 is normal and 10 is severely incapacitated). The INCAT scores may be used to evaluate the effectiveness and need for IVIG. IVIG may be discontinued when there is a lack of clear clinical improvement (i.e., a decline in INCAT disability score or failure to improve by 1 point at six weeks following the initial infusion or return to baseline at anytime following initial improvement of 1 point).

** The Medical Research Council (MRC) scale is used to grade muscle strength. Scale: 0 = no muscle movement; 1 = flicker of muscle movement; 2 = trace movement but not able to fully overcome gravity; 3 = just able to overcome gravity, but not against resistance; 4 = moves against resistance, but weak; 5 = full strength against resistance….”[/I]

So, to begin the analysis, look at Item #3. Pay particular attention to: “…Any accepted metric assessment may be used for objective monitoring of progress, such as the Inflammatory Neuropathy Cause and Treatment (INCAT) scale*, the Medical Research Council (MRC) scale ** and activities of daily living (ADL) measurements. Changes in these measures should be clearly documented. Subjective or experiential improvement alone is generally insufficient to either continue IVIG or to expect coverage….”

First, they tell how to measure progress, or lack of it, in specific clinical (clinical means in the Doctor’s office) terms.

Specifically, [I]”The INCAT scores may be used to evaluate the effectiveness and need for IVIG. IVIG may be discontinued when there is a lack of clear clinical improvement (i.e., a decline in INCAT disability score or failure to improve by 1 point at six weeks following the initial infusion or return to baseline at anytime following initial improvement of 1 point).”
[/I]

Therefore, in case of the INCAT score, you want to see maintenance of the original score and, certainly, no more than a one point drop when beginning the tapering process. But, even a return to ‘baseline’ would be cause to discontinue the taper.

Second, they tell us “nope, your opinion (subjective) doesn’t count.

Third, Look carefully at #6. Ah ha! ‘You better show progress or we’ll stop the authorization.’

Now, then, how does this become an article on dosage?

Inversely.

By that, I mean, what the UCSD Dr. told me. “OK, you’ve improved on 5 days of IVIG. Now I want you to take several cycles of IVIG 3 days in a row every three weeks.” Here is what he said, verbatim, “I explained that it might be that he (me) needs to have high dose bursts of IVIG less frequently rather than low dose frequently.” (whew)

Continuing, the UCSD Dr. said “Ideally, I would like to taper him completely off IVIG….”

The way to control the dosage for the taper is by trial and error (tailored for each patient, of course) based on the criteria set forth in the Aetna article.

And, that’s what I wanted to say before. Cut the dose or increase the time between doses and measure what happens. By measure, I mean the clinical criteria set forth by INCAT and the MRC.

the article is here: [url]http://www.aetna.com/cpb/medical/data/200_299/0206.html[/url][/QUOTE]

Laurel, I most certainly WOULD NOT go by anything in this article, as it written by an insurance policies protocol. They are [B][U]strictly[/U][/B] cost related/based, not patient care related.

Aetna is a medical insurance company in the US. (I am an RN that works with insurance issues).

The point is what I tried so hard to explain.

Use the Inverse of their logic to monitor your progress during the taper using the INCAT and MRC muscle test scores to detect if you have declined during the taper.

[QUOTE=yuehan]The point is what I tried so hard to explain.

Use the Inverse of their logic to monitor your progress during the taper using the INCAT and MRC muscle test scores to detect if you have declined during the taper.[/QUOTE]

For anybody that has been on IVIG and/or had this disease for any length of time…You don’t need to use the inverse of their logic to monitor progress. Your progress, or lack of is very clear to the patient and they can name specific symptoms, etc.