The promising results for the drug baricitinib emerged from a large clinical trial (phase 3), randomized, double “blind” with the use of virtual done within oecd (placebo), which was held in 178 medical centers in 24 countries and lasted 24 weeks. Of the 527 patients that have tried the new drug, in pill form, suffering from rheumatoid arthritis for 14 years on average.
The scientists, led by professor of immunology and rheumatology Mark Genovese at the University Medical Center Stanford, California, made the relevant publication in the american medical magazine “The New England Journal of Medicine”.
“It is the first drug showing visible clinical benefit for patients who have failed every other brand drug for rheumatoid arthritis,” said Genovese.
It is an inflammatory autoimmune condition, which suffers approximately 1.5% of the population in developed countries. Usually manifests itself at the age of 30 to 60 years old, causing pain, stiffness, swelling and eventually destruction of the joints, particularly on the edges. Approximately three out of four patients are women, for reasons unknown.
Although in the past, the diagnosis of the disease was equivalent with ominous prognosis, after the mid-90’s, there have been several advances in the treatment, with the development of new medicines.
However, it has been observed that more and more patients drugs have a lower effectiveness or cause unwanted side effects. It is estimated that 15% to 20% of patients do not respond to treatment – and the percentage tends to increase over time.
The new drug focuses exactly on these patients, with moderate to severe rheumatoid arthritis, which has affected at least six joints. The patients in the clinical trial, split into three groups: one taking 4 milligrams of baricitinib once a day, the second half of the dose, and the third a placebo.
55% of the patients of the first group of high dosage showed a decrease of at least 20% in the number of affected joints, a rate that was 49% in the second group of lower dosage, and 26% in the case of the placebo effect. Also, regardless of the dose, patients who had taken the drug, experienced a reduction of markers of inflammation and improved functionality of the joints.
The side effects were mainly more frequent mild infections of the upper respiratory tract. Severe were the side effects at 4% (low dose) to 10% (high dose) of patients. 1% to 4%, respectively, experienced herpes zoster, while it recorded an increase of “good” and “bad” cholesterol.
The drug produced by the pharmaceutical Eli Lilly, which has already filed an application for approval for circulation to the competent supervisory authority of the united states, the Food and Drug administration (FDA).
Clinical trials of new drug offer hope for rheumatoid arthritis
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