Rheumatoid Arthritis: Sirukumab Presents Safety Issues

In a report that was published on July 31st, 2017, the U.S. Food and Drug Administration (FDA) publicly stated the results of patients taking the rheumatoid arthritis (RA) drug, sirukumab, and patients taking a placebo. There were ultimately more fatalities in those patients who took sirukumab than in those who took the placebo. Johnson and Johnson, located in Irvine, California, is the creator of this experimental RA drug.

In a report published on July 31st, 2017, the FDA released the results of a study featuring a group of patients who were taking a drug for rheumatoid arthritis known as sirukumab, and another group of patients who were on a placebo. It showed there was a greater number of fatalities in the patients who consumed sirukumab than in those who were on a placebo. The creator of this experimental RA medicine is Johnson and Johnson. This report was published just a few days before a committee of outside advisors planned to meet in order to discuss sirukumab and whether or not it should be approved. One of the most common causes of death among those who consumed sirukumab was infection, along with certain major heart-related issues. The report also stated that, whereas there were other, similar safety concerns about some of the other drugs in the same class, the majority of instances of death were isolated only to those who took sirukumab. A spokesman for Johnson and Johnson, Brian Kenney, stated how serious RA is and that, since patients are often forced to cycle through various kinds of therapies before finding the one that is the most effective in the treatment of their disease, sirukumab would be worth the risk.

After the approval, sirukumab would be named Plivensia. It is essentially a human monoclonal blood protein that is known to be produced in response to a specific kind of antigen. This antibody specifically blocks interleukin 6 (IL-6), which is a specific cytokine present in the body. IL-6 is known to be one of the main contributors of RA inflammation. Sirukumab is intended to act as an alternative drug therapy for RA patients who are unable to find any other drugs that can treat their disease or those who are unable to tolerate the other drug options. Studies carried out at 50mg as well as 100mg doses every two to four weeks have found sirukumab to be successful in effectively treating RA symptoms. Sirukumab was observed to improve all the signs and symptoms caused by RA. Sirukumab was also noted to bring about an improvement in the life of the patient, as has been reported in the patient-reported outcome, which includes a few other factors, such as quality of life, pain, fatigue, and physical kinds of function.

The study’s data have also revealed that some of the most common contrary events in the clinical development phases of sirukumab were known to include upper respiratory tract infections, colds, and laboratory abnormalities. Some of the other common adverse events which are involved are the injection of the drug as well as swelling, redness, and pain caused at the site of injection. There were also reports of malignancies, heart-related issues, and, in serious cases, death, as per the clinical studies of sirukumab. But there is still hope that the FDA will understand the drug’s benefits in the third phase, and then it may recommend to start sirukumab as a new treatment option for RA patients.