In a nutshell
The study looked at the safety of multiple treatments of ofatumumab (Arzerra) in patients with rheumatoid arthritis. The authors concluded that there were no additional risks to patients after multiple treatments with ofatumumab.
Some background
In rheumatoid arthritis (RA), the immune system attacks the healthy joints the way it would a virus or bacteria. Ofatumumab is a biological drug under investigation for the treatment of RA. This drug works by blocking the activity of cells that are known to contribute to the over-activation of the immune system.
Some patients have a good response to these types of drugs, but others may need more than one course of treatment to reduce disease activity. Biological drugs can weaken the immune system of RA patients. Negative side effects associated with multiple treatments need to be monitored. Some of the most common side effects experienced are serious infections and reaction to the injection of the drug.
Methods & findings
483 patients with RA in three clinical trials received up to 7 courses of treatment with ofatumumab. The drug was delivered by intravenous injection (injection of the drug into the bloodstream).
The majority of patients experienced at least one side effect during the course of treatments.
The most common side effects were reactions to the injection of the drug. These included rash, throat irritation, cough, hives and itching. These were most often experienced during the first infusion and decreased significantly by the second infusion.
Between 32% and 53% of patients experienced infections during their treatment. Non-serious infections included respiratory tract infections, urinary tract infections and bronchitis.
Between 1% and 5% of patients experienced serious infections. These included serious respiratory tract infections, cellulitis (bacterial skin infection), gastroenteritis (inflammation of the stomach and intestines) and herpes infections.
The bottom line
The authors concluded that ofatumumab was well tolerated in patients with RA. Serious infections were not common and did not increase with multiple treatments.
The fine print
These clinical trials were concluded early. It was found that low doses of subcutaneous (injection under the skin) injections were highly effective. Subcutaneous injections are less invasive than intravenous injections.
What’s next?
Consult with your physician regarding the treatment options available for rheumatoid arthritis.
Published By :
PLOS ONE
Date :
Jun 23, 2016
