AccentedTouch

“Up until now, most arthritis treatments have involved pills, injections, or surgery. But the Academic Medical Centre in Amsterdam is studying a whole new approach for treating rheumatoid that would involve implanting a pacemaker in the neck of the patient.” http://arthritis.about.com/b/2011/07/28/implanted-neck-device-may-be-future-treatment-for-rheumatoid-arthritis.htm

The new implanted device will work to inhibit the inflammation of the joint that was based on the theory of rheumatoid arthritis symptoms are results of the interactions between the nervous system as well as the immune system.

Several European countries have ten study participants which will participate to have the device implanted in their neck to stimulate one of the cranial nerves which is the vagus nerves.

Stimulation of vagus nerve is used to treat epilepsy and depression. The researchers recommend that by stimulating the vagus nerve for just one minute in a day would inhibit the inflammation and also slow the damage of the joints.

The Dutch Arthritis Association is allegedly “cautiously optimistic” as they wait for grades which the researchers expect to publish next year.

Biopharmaceutical company Scil Technology GmbH, with centre skill in protein drug development, formulation and analytics, announced that it has been awarded study funding by the German Federal Ministry of Education and Research (BMBF) under BMBF’s KMU-innovativ system. The EUR 0.9 million funding supports Scil Technology’s research program to discover the restorative possible of repellent proteins for the treatment of rheumatoid arthritis (RA).

According to Christian Nafe, CEO of Scil Technology, they are very pleased about the funding because the grant will enable them to explore an innovative, causal treatment for the incapacitating chronic disease with large unmet medical needs.

Dr. Carola Dony, CSO of Scil Technology said that the RA course is affected by the destructions of the cartilage tissue and the joint inflammation. Now, it has been published the repellent solution inhibits the fundamental processes related to the development of the disease. Hence, the protein class bears the potential that gives the first causative treatment of RA.

“The delivery of protein products in this indication is challenging,” said Christian Nafe. “However, we have long-standing experience with the controlled, sustained release of therapeutically active proteins for regenerative purposes, and we will now apply our know-how to optimize the product profile.” http://bulletin.sciencebusiness.net/news/75196/Scil-Technology-receives-public-research-grant-for-novel-rheumatoid-arthritis-treatments

“The results of this study, conducted in Germany, re-open the debate on whether it is ethical to conduct placebo-controlled studies where patients in the placebo-group are at a serious disadvantage compared to patients taking the new treatments. The study analysed current study designs, for new therapies such as abatacept (Orencia®), golimumab (Simponi®) or tocilizumab (Actemra®), and showed that patients in the placebo group experienced no change in medication, having to continue with their former, ineffective treatment plus placebo.” http://starglobaltribune.com/2011/rheumatoid-arthritis-negative-impact-of-placebo-treatment-to-rheumatoid-arthritis-patients-analyzed-9498

According to Helsinki-Declaration of the World Medical Association, Dr. Juche, Johanniter-Hospital, Treuenbrietzen, Germany, said that the placebo controlled study is designed is believed to be acceptable ethically when there is no treatment available. Nevertheless, the analysis verifies that the patient in the placebo group is on a disadvantage phase because they were given no change in their medication to decrease their active inflammatory condition or stop the progression of the disease. They recommend that the future clinical trials should have an active comparator group to make sure that the patients receive an effective treatment in order to improve the quality of life.

The researcher’s analysis shows that in the European Public Assessment Report (EPAR) of the EMA or European Medicine Agency for abatacept, golimumab and tocilizumab as samples. The chosen studies had to be in placebo controlled at the beginning and state clinical relevant outcome criteria.

According to the new hospital release, the hospital for the Special surgery rheumatologist currently conducted a study that showed the tumor necrosis factor which is the pro-inflammatory protein and can also suppress the feature and inflammation that may lead to a new treatment for rheumatoid arthritis.

“Many proteins have homeostatic functions, according to the release, and this is the first study that indicates TNF may have some suppressive functions. In the study, researchers designed experiments stimulating macrophages with lipopolysaccharide, which stimulates receptors for inflammation. The researchers treated human monocytes and macrophanges with TNF and then changed these cells with LPS.” http://beckersorthopedicandspine.com/news-analysis/4034-hospital-for-special-surgery-rheumatologists-find-possible-new-rheumatoid-arthritis-treatment

TNF suppressed the response of inflammation of the macrophages and monocytes. The ones that involves in the encoding of the A20 protein which is the protein GSK2 and the gene TNFAIP3 were involved in the inflammatory response to the TNF. The patients that produce the less A20 can be more susceptible in the inflammation or in the rheumatoid arthritis.

According to Lionel Ivanshkiv, MD, associate chief science officer and physician in the Arthritis and Tissue Degeneration program at HSS, who led the study, they think that it is relevant to rheumatoid arthritis, not only because the cells that they are studying are the same as the cells that get into the joints and make the cytokines involved in the rheumatoid arthritis but because it involves the A20. One of the best linked genes is the TNFAIP3 in the rheumatoid arthritis.

“The ACR hybrid score, a new measure of response to RA treatment recently developed by the American College of Rheumatology, demonstrated improved sensitivity compared to traditional ACR responses, according to recently published results in Arthritis Care & Research. Traditional ACR20/50/70 and DAS28 scores were compared to the ACR hybrid score in a post-hoc analysis of the RAPID 1 study, the first clinical trial data to be analyzed using the ACR hybrid score.” http://www.sacbee.com/2011/05/16/3630147/novel-acr-hybrid-score-in-rheumatoid.html

According to Dr. R.F. van Vollenhoven from the Karolinska Institute in Stockholm, Sweden and lead author of the publication, the ACR hybrid score wants to have a similar result to other standard outcome measures in which, certolizumab pegol treated patients had significantly have a higher improvement in the signs and symptoms of RA over placebo. He added that the results are of interests because the ACR hybrids score may show a more sensitive and good measure of the treatment in RA response compared to the recent accept standard and could be considered as a valuable primary end point in the future clinical trials.

ACR hybrid score use was evaluated virtual to other measures of response, that includes the ACR20/50/70 response rates and changes in DAS28 (disease activity score),as well as in the analyses differences between active treatment and placebo, elements that may be underestimated using ACR20/50/70 response criteria. By also including worsening disease activity, the ACR hybrid score may give a improved assessment of the treatment’s effect on overall change in disease activity.

Results from this post hoc analysis propose that certolizumab pegol plus MTX presented considerably better advantage than placebo plus MTX in spite of of measures according to ACR20 responder rates, ACR hybrid scores and mean alters from baseline in the DAS28. By all three measures, in some patients responses to certolizumab pegol plus MTX were considerably better by week 1, sustained to perk up through the first 12 weeks of treatment, and were constant to study at week 52. Of the certolizumab pegol plus MTX treated patients, 258 out of 392 (65.8%) and 172 out of 392 (43.9%) had ACR20 and ACR50 responses correspondingly.

“The data published were from the RAPID 1 study – the co-primary end points were ACR20 score at week 24 and change in mTSS (modified Total Sharp Score) at week 52. The post hoc analysis focused on patients who received MTX and either 200mg subcutaneously or placebo every 2 weeks for 52 weeks accounting for 393 patients in the ITT population (30 patients were excluded due to nonimputable data).” http://www.sacbee.com/2011/05/16/3630147/novel-acr-hybrid-score-in-rheumatoid.html