Intermittent Prednisone Treatment

I've read that quite a number of syndromes are treated with intermittent does of Prednisone (e.g. Duchene's Muscular Dystrophy, Obstructive Pulmonary Disease, some forms of Rheumatoid Arthritis, some Asthmas etc.) and that Prednisone has been widely used on millions of people over the past 50 years. Yet I don't see intermittent Prednisone usage as a possible treatment for ITP. I know that some people have significant side effects after prolonged usage of this med, but many others don't seem to be as troubled. Has anyone used this approach and/or has there been any research specific to intermittent (and/or low dose) Prednisone as a possible treatment for ITP?

The problem with taking Prednisone short term is that it normally won't hold counts up. You could take it for a week or two, get a platelet response, and counts will probably fall within a few days or weeks. Then you are right back where you started.

Most people who do get a remission from Prednisone take it for months and taper slowly. Some have counts that stay up and some people start to drop as the dose is tapered. Everyone is different, but all a short term stint will do is bump counts up temporarily.

A handful of people take low dose Prednisone long term just to keep safe counts (20k or 30k), but that is not done very often. The long term side effects can be serious and most do not respond well to a low dose.

Thanks for the quick reply Sandi! I guess I am one of those "handful of people" in that my numbers seem to jump significantly after just one Prednisone tablet. I am currently in the "watchful waiting" mode--after failing the intensive Prednisone trials--and run in the low 20's, so you can see why I'm interested in any research or experience on the topic. My Doc doesn't consider this as an option, but I'm wondering if it's because there's really been no empirical study of the issue (as far as I know). If anyone has actually used Prednisone intermittently over a longer period of time for ITP, I'd be very interested in your comments and experience. Thanks!

Luca:

I respond very well to Prednisone also, and I can tell you from experience that short term doesn't work. I thought that was my answer years ago too. I tried it several times without my doctor's approval (which I don't suggest you do). I always had left over pills from the long term treatment times and would take enough to bump me up so I could avoid a longer round or counts under 10. All I did was start, stop, start, stop and that got old. I gave up and went to Rituxan. This was over a span of 8 years (but I did have a 3 year remission after doing 60 mg's in that time).

I don't know of any studies, but I have observed people here on the Forum every day for 15 years. I'd guess that there are no studies because it's not worth studying; won't work. Also, doctors don't prescribe that way because, won't work.

Like I said, I responded well. My counts on 40 mg's after a week would be around 350k. I didn't like that dose and after once starting at 60 mg's and once starting at 40 mg's (both times for months), I did negotiate with my doctor to do 20 mg's for a few weeks. It didn't keep my counts up and wasn't worth the effort. After that, I did the self-treatment mode and got sick of that.

What doses of Prednisone have you tried, how long, and at what dose?

I'd guess that if you failed the higher doses, a low one won't work either. What exactly does 'fail' mean?

"Fail" means I tried the higher doses of Prednisone (gradually up to 80 mg/day) over a 4 week period, with my count going only as high as 75K and then decreasing again despite the Prednisone.

As for dosage, when I take 40 mg in a day, my numbers go up to about 50K; not great but better than 20K!

I am now at the Retuxan decision stage, with my Hematologist recommending it, while I give it some more "watchful waiting." So far, I have not had any major bleeding issues, so my attitude has been "why fool with it if it's not broke." I was diagnosed 8/11 so I'm almost 2 years at 20-30K. I'm hoping that this trend will continue indefinitely, so I'm still looking for the "least" treatment option(s). I've tried diet changes with no luck, increased exercise (no changes) and now am considering some of the supplements mentioned in the non-conventional approaches. I guess we all have to through these stages before we make the hard decisions...

20 - 30 is a safe count. If you don't have a risky lifestyle or bleeding, it would be reasonable to just monitor counts.

If you did take 40 mg's of Prednisone to bump up to 50k, how often do you think you'd have to do that?

I have no idea! That's why I was looking for some research on the subject. Also, I've noticed that a facial cream my dermatologist gave me--which I rarely use--is also a corticosteroid, and now I'm wondering if that has bumped my numbers on the few times my numbers got up into the 30's. Obviously, I'm going to have to be more scientific about when I use these things and the effect that they most likely create.

I don't think the cream would have any effect. I've been on steroid nasal sprays and steroid eye drops many times....too minimal to make a difference.

Continuing this discussion, Sandi, I just finished my 2nd Dex pulse and my numbers jumped to 79K for about a week. So I researched the literature on Dex and there are 3-4 articles (Korean, Chinese, Italian) that claim a fairly high remission rate from 4 trials of Dex pulses! I ran this by my MD, who said he would never allow it as "some people have died from Dexamethasone.!" Needless to say, I gave up on the idea of continuing the pulses as a possible route to remission in a hurry! BUT, I also get the impression my MD is both very conservative and maybe hasn't researched the literature in awhile. Has anyone had a remission from Dex in the US that you know of, or are these foreign reports overblown?!

Luca:

There have been a handful of people here who have attempted the six month Dex pulse that has been described in research. It cracks me up because the research articles always state that "Dex was well tolerated". Let me tell you, that's NOT what the people here have said. Most of them couldn't get through the whole six months and by month two or three, they thought they were dying. I don't think I would attempt the 40 mg's for a few months after reading the stories.

It is supposed to be a credible way to achieve remission according to the articles and I haven't heard of any deaths, but it seems like a method of torture to me. I don't hear about it as often as I used to, so that treatment method seems to be dying off a bit.

Wait - is this right? Your hemo gave you two months of Dex but wouldn't give four because people have died? That extra two months killed them?

PS. There are plenty of articles and studies here in the US.

www.nejm.org/doi/full/10.1056/NEJMoa030254

bloodjournal.hematologylibrary.org/content/109/4/1401.full

clinicaltrials.gov/ct2/show/NCT00451594

www.nejm.org/doi/full/10.1056/NEJM199406023302203

Hi Sandi; Thanks for the citations; I'll check them out. As for your question about Dex, yes, my hemo claims that peopled have died from Dex, but he did not say that it was after a Dex pulse. Unlike the others you mentioned, I seem to do fine on Dex; my worst symptom so far was a "spacey" feeling after stopping on day 4, but otherwise, I seem to tolerate it well. Now that I'm doing a trial of Promacta--because my doc poo-pooed the Dex route--I don't think I can try this option until/unless the Promacta doesn't work for me. Yet another example of the doctor saying things that I haven't seen written in any of the articles I've found online...but, then again, I'm not the MD!

You've been lucky with the Dex side effects!

Luca, if your count only goes up to the 70s on dex then I'd guess that doing several pulses would not work. It works when the count goes way up each time.

I did fairly low dose pulses of prednisolone while waiting for an Nplate trial to start. I would take 15mg for a few days and then either do a quick taper.. 10mg.. 5mg and off or just stop after a few days. I did that for something like 8 months and then started Nplate. I had a count of 2 when I started Nplate so I'd say that for long term the pred didn't work.

Ann; as I understand it, Dex is much stronger than the prednisone versions (like 20 times), which is why it's only given for 4 day "pulses." I too tried the prednisone route as my first treatment, and my numbers went up to the 70's, and like you, decreased immediately after the tapering. With Dex, you don't need to taper, and I haven't read any explanation or theory as to why it works for some people...that's why I still think it should be an option. The trouble with sites like this is that most of those people who have had a successful remission (like on DEX) probably don't bother to check back in or write until their numbers drop again, which could be years. So we really don't get "objective" data and what worked for others.

No, we wouldn't have any solid statistics on Dex remissions, but I can tell you what I've observed. 1 - Dex pulses are not prescribed often at all, and 2 - I have seen one or two remissions but I couldn't tell you how long they have lasted.

Most people have reported that it's not worth the effort and what I deduce from all of that is if it was at least moderately successful, more people would be doing it.

Sandi; I guess you are right in that there really isn't much supporting Dex as a definitive treatment (nor much research). I checked out the citations you sent; one is from Hong Kong and claims a good remission rate; one is from Italy and claims a great remission rate; one is a US trial which never published its results (and was completed in 2010?) and the last is a small group of 10 patients from Detroit who the author says had a good response. That's it. I've searched for additional studies, but these are the ones that pop up. Bottom line; like most ITP treatments, it may have worked for someone somewhere, but there's little science to predict for whom and for how long...

Ha! I was responding to your question at the beginning of the thread where you asked about prednisone pulses.

I know what dex is all about, I did one go of it and felt so bad for a week afterwards that I refused to do it again. And I only took half the normal dose. I've been here a long time and haven't seen many try it long enough to see if multiple pulses work.

I say "ha" too, because as bad as this sounds, you only have the words of Ann and I to go by (in addition to the few studies). Sorry.

Years ago, I was able to come up with a lot of articles about Dex and how "well" it worked for remission and how "well" it was tolerated. I haven't seen any articles in a long time, nor have I seen (in 16 years), more than two who actually did it for the required number of months and were happily in remission.

Considering that there is no pharmaceutical megacorporation with a huge potential for financial gain, the amount of research into the effectiveness of pulsed dex treatment is pretty significant. The Italian study had a 2/3 long term response rate (median = 26 months), and that seems pretty decent. I would prefer a larger sample size... but who is going to pay for it, without a big profit motive?

Ellen's experience with pulsed dex is that it was fun on the way up but unpleasant on the way down... nothing too terrible, though, and no more unpleasant than a longer course of lower dosed prednisone she would take to break a migraine cycle. She did not get a very lasting platelet response to pulsed dex and so the strategy was abandoned. (Has anyone actually studied whether intitial response predicts likelihood whether multiple pulses might be eventually effective? seems intuitive!). Does anyone have data comparing pulsed dex vs. prednisone for sustained response? My understanding is that there is some indication that dex is substantially better.

In terms of potential for remission, Rituximab appears to offer somewhat better results, but perhaps not by a lot; I do not know the relevant risks of infection, and other side effects.

Given the relative costs, however, pulsed dex does not seem to me to be an unreasonable first approach, at least one course to be re-evaluated depending upon individual initial responsiveness and ability to tolerate side effects.

Blood. 2007 Feb 15;109(4):1401-7. Epub 2006 Oct 31.
Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience.
Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, Rodeghiero F, Amendola A, Baronci C, Carbone C, Quattrin S, Fioritoni G, D'Alfonso G, Mandelli F; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Thrombocytopenia Working Party.
Source

Dipartimento di Biotecnologia Cellulari ed Ematologia, Università degli Studi di Roma La Sapienza, and Divisione di Ematologia, Ospedale pediatrico Bambino Gesù, Rome, Italy. mazzucconi@bce.uniroma1.it
Abstract

In idiopathic thrombocytopenic purpura (ITP), corticosteroids have been widely recognized as the most appropriate first-line treatment, even if the best therapeutic approach is still a matter of debate. Recently, a single high-dose dexamethasone (HD-DXM) course was administered as first-line therapy in adult patients with ITP. In this paper we show the results of 2 prospective pilot studies (monocentric and multicentric, respectively) concerning the use of repeated pulses of HD-DXM in untreated ITP patients. In the monocenter study, 37 patients with severe ITP, age at least 20 years and no more than 65 years, were enrolled. HD-DXM was given in 4-day pulses every 28 days, for 6 cycles. Response rate was 89.2%; relapse-free survival (RFS) was 90% at 15 months; long-term responses, lasting for a median time of 26 months (range 6-77 months) were 25 of 37 (67.6%). In the multicenter study, 95 patients with severe ITP, age at least 2 years and no more than 70 years, were enrolled. HD-DXM was given in 4-day pulses every 14 days, for 4 cycles; 90 patients completed 4 cycles. Response rate (85.6%) was similar in patients classified by age (<18 years, 36 of 42=85.7%; >or=18 years, 41 of 48=85.4%, P=not significant), with a statistically significant difference between the second and third cycle (75.8% vs 89%, P=.018). RFS at 15 months 81%; long-term responses, lasting for a median time of 8 months (range 4-24 months) were 67 of 90 (74.4%). In both studies, therapy was well tolerated. A schedule of 3 cycles of HD-DXM pulses will be compared with standard prednisone therapy (eg, 1 mg/kg per day) in the next randomized Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) trial.