TSORA, there
had been lots of interest in this study on patients with rheumatoid arthritis
and inadequate response to methotrexate. These patients were randomized to
Trichuris suis ova (2500 eggs in a capsule every two weeks vs. placebo). The
study aimed at N=25 in each group and had been registered in October 2013.
Primary endpoint had been disease activity measured by DAS28 after 24 weeks.
The study was a pilot study at Klinik Immanuel Krankenhaus, a clinic for
rheumatic diseases as well as natural medicine / phytomedicine in Berlin.
The idea behind is a suppression of immune responses by helminths like Trichuris suis in order to modulate inflammation in rheumatoid arthritis and other diseases.
What do we have? An abandoned study? I don’t know what stopped the study. EU Clinical Trials Register tells us that the study has been prematurely ended. No reasons given. I’ve tried to contact the person mentioned in the study for scientific enquiries, but I didn’t receive an answer so far.
M.A. Pineda and colleagues published a study last year: “From the worm to the pill, the parasitic worm product ES-62 raises new horizons in the treatment of rheumatoid arthritis.” “ES-62 is a secreted glycoprotein of the filarial nematode Acanthocheilonema viteae.” ES-62 inhibits Th17-cell dependent IL-17 production, but doesn’t affect NK and NK T cell IL-17 production, and therefore the authors think, ES-62 might make a particularly attractive therapeutic for RA. I have my concerns of IL-17 being a target in RA, but that’s another story. Link: http://www.ncbi.nlm.nih.gov/pubmed/25801883
As other scientific groups continue to look for clues in which helminthes may be helpful in fighting RA and other inflammatory diseases, I hope that we’ll get more information on what happened to TSORA.
I have enough space here to add any news!
The idea behind is a suppression of immune responses by helminths like Trichuris suis in order to modulate inflammation in rheumatoid arthritis and other diseases.
What do we have? An abandoned study? I don’t know what stopped the study. EU Clinical Trials Register tells us that the study has been prematurely ended. No reasons given. I’ve tried to contact the person mentioned in the study for scientific enquiries, but I didn’t receive an answer so far.
M.A. Pineda and colleagues published a study last year: “From the worm to the pill, the parasitic worm product ES-62 raises new horizons in the treatment of rheumatoid arthritis.” “ES-62 is a secreted glycoprotein of the filarial nematode Acanthocheilonema viteae.” ES-62 inhibits Th17-cell dependent IL-17 production, but doesn’t affect NK and NK T cell IL-17 production, and therefore the authors think, ES-62 might make a particularly attractive therapeutic for RA. I have my concerns of IL-17 being a target in RA, but that’s another story. Link: http://www.ncbi.nlm.nih.gov/pubmed/25801883
As other scientific groups continue to look for clues in which helminthes may be helpful in fighting RA and other inflammatory diseases, I hope that we’ll get more information on what happened to TSORA.
I have enough space here to add any news!
03.11.2016:
I've
just received an email by one of the investigators, who had been in maternity
protection and therefore could not answer earlier. The study is incomplete
because of insolvency of the sponsor. But she assured that the data, which had
been accumulated, will be published. I'll look
forward to discuss the results here.
20.01.2017:
Last weekend
I’ve met one of the principal investigators of TSORA. He told me that working
on the statistics had just started, but that there’ll be a publication later
this year.
.
Dr. Kirsch, have you had any update on the results of this study (TSORA)? I have been searching and haven't found anything - that's how I found your blog. I am very interested if there have been any positive results from any of the nonpharmaceutical interventions for RA. Thanks!
ReplyDeleteI'll be attending the Annual Meeting of the German Society for Rheumatology (like the ACR in the US) in Stuttgart early next month. Either I see a poster on the study or I'll ask again. Thanks for asking. I hope to bring back some information on TSORA.
DeleteI've seen the principal investigator, who told me, that statistics are under way and results are expected by the end of this year. I'll keep you informed.
Delete