“In essence, we re-educated the immune system T cells to be tolerant of the dnaJP1 amino acid sequence, which would usually contribute to inflammation in rheumatoid arthritis patients,” said Salvatore Albani, M.D., Ph.D, director of the Translational Research Unit of the Clinical Investigation Institute (CII) at the UCSD School of Medicine.
Oral ingestion of dnaJP1 is key, because the mucosal immune system found in the gut has the ability to “teach” the body to view a protein as one that isn’t dangerous or foreign. Much as food is ingested into the body and not rejected, the body tolerates dnaJP1.
DnaJP1 was found effective in a double-blind, placebo-controlled trial sponsored by the National Institutes of Health, which took place between 2000 and 2005 and involved 160 patients enrolled in centres nationwide. Patients received 25mg of dnaJP1 daily by mouth for six months, and the treatment was found to be safe and well-tolerated. When compared with a placebo, patients in the treatment group experienced lessening of symptoms such as swollen joints, tenderness, pain and decreased mobility.
Improvement was particularly significant at the follow up visits, indicating a lasting effect of the drug. Efficacy was quantified in data generated from physicians, patients and laboratories, measuring improvement according to standards set by the American College of Rheumatology (ACR) from the beginning to later points in the trial. For instance, “ACR 20” indicates a 20% improvement in standardized symptoms. ACR 20 response was in the 50-55% range; ACR 50 in the 30-40% range; and ACR 70 in the 15-20% range of patients completing the trial.
“Although the current available drugs pose risks to patients, the first two trials of dnaJP1 have not raised any significant safety concerns and offer an improved treatment option for patients with rheumatoid arthritis,” said Albani.
MEDICA.de; Source: University of California, San Diego