At this point, there are an estimated two dozen patients world-wide on my pulsed therapeutic plasma exchange (PPE) protocol. As my research fellowship at the Univ. of Wisconsin ended a couple of years ago and I am now retired, I am no longer able to continue with my research efforts to better understand the mechanisms of action behind this experimental “off-label” use of a standard treatment (therapeutic plasma exchange/TPE) as a treatment for systemic sclerosis. I now usually learn about a new patient who has started on my protocol when the patient emails me with a question or comment. Many started recently so it is too early to see how well the protocol will work for them, but others have been on the protocol for several years at this point.
I am the first patient on my protocol (developed back in 1993) and have been on it now for more than 30 years. It has been established on a few occasions that as long as I stay on the protocol, I remain in full clinical remission, but if the protocol is stopped (e.g., for COVID), I gradually start to become symptomatic again after four to six months, as would be expected given how PPE appears to work. I have centromere antibodies and was diagnosed formally with limited systemic sclerosis (old name CREST) in 1990 with initial symptoms starting in 1985. Currently, many of the patients who have started on PPE also have centromere antibodies. (In 2022 I presented a research poster at a medical conference on four patients with centromere antibodies who saw significant improvement in GI symptoms after being on PPE for two years or longer. Interestingly, GI improvements do not occur with immunosuppressive treatments. Here is a link to the handout from the conference if you want to learn more about this: http://sclerodermainfo.org/pdf/ASFA-2022-Poster-Handout.pdf.)
However, the second patient on PPE has U3-RNP (fibrillarin) antibodies, a rare antibody generally classified as a diffuse systemic sclerosis antibody. The two more common diffuse antibodies are Scl-70 and RNA polymerase III. She started early in the disease process and has now been on PPE for about six years. I will share below a summary of her story, written by the patient. As in my own case, COVID lead to an interruption of the normal PPE protocol and she also started to see return of symptoms as a result before she was able to resume the protocol. Pregnancy was also a complication for a while. (There is no research data on how pregnancy impacts the PPE protocol.)
My takeaway from her story and what I know about the status of other patients is that, as expected, since systemic sclerosis is a chronic disease, a treatment like PPE that appears to work by interrupting the disease process at a very early stage, needs to be continued indefinitely to remain effective. It is also clear that starting early in the disease process is very important to see maximum benefit from the protocol. PPE appears to work similar to the way insulin prevents later damage in patients with Type 1 diabetes, and anti-retroviral drugs generally prevents HIV patients from developing AIDS. As a result, it only leads to reversal of some symptoms. Once certain types of systemic damage has occurred, the body is unable to heal that damage, even if the active disease process is interrupted. It is worth noting that in my own case, while PPE led to elimination of early lung damage over a several year period, this would likely not have occurred at a later state with more severe lung damage.
Ed
Here is her story (unedited):
2014
- First onset of symptoms in 2014. Symmetric pain in feet and hands.
2015
- Rheumatologist prescribes Prednisone. Lab without identification of the related U3-RNP antibodies (they did not look for them).
2016
- No diagnosis. Progressive symptom development. We treat it with Ibuprofen. Intermittent flare-ups with increased symptoms.
2017
- Still symptoms.
- U3-RNP / Scleroderma diagnosis in Septmeber
- Discovered Scleroderma Education Project/Ed/PPE
2018
- First PPE treatment in February
- Symptoms recede very quickly
- 8-week intervals between PPEs
- Mostly no symptoms. Very noticeable improvement to previous years.
2019
- Continued PPE with 8-10 week intervals
- Mostly no symptoms at all. Scleroderma is not a topic for us. Life is good.
2020
- Last PPE session in January.
- Lockdowns/Pandemic/Travel Restrictions in Turkey
- No PPE until July (6 month break). In the meanwhile worsening symptoms. We’re controlling them with Ibuprofen.
- Restarting PPE in July with 8-week intervals.
- Pregnancy starts in October. Less symptoms during PPE, albeit short-lasting with only 1-2 weeks relief after 4th session.
2021
- No Ibuprofen during pregnancy. Rather strong symptoms (pain) almost at pre PPE/2018 levels.
- Short-lasting relief during / after PPE sessions.
- June 2021. Baby is born.
- Symptoms treated with Ibuprofen.
- Maintaining 8-week intervals all year.
2022
- We lower the intervals between sessions to five weeks after January 2022.
- Lung function and kidney tests etc. are all very good.
- Continuous improvement in pain symptoms.
- Since July 2022 mostly symptom free at 2018/2019 levels again.
- Increased intervals to 8 weeks between PPE.
2023/2024
- No symptoms
- All lung function and kidney tests are good.
- Mostly doing 8-week intervals between PPE.
It is currently very challenging to get a rheumatologist to try this, even though it is much safer than standard immunosuppressant meds. The first step is determining if your insurance company covers it. Most do, but not all. To check, call your insurance company and ask if they cover therapeutic apheresis, CPT code 36514, for the treatment of diffuse systemic sclerosis, ICD-10 code M34.0, or limited systemic sclerosis, ICD-10 code M34.1, whichever is appropriate in your case.
How can i get into a program like this?