In a nutshell
The study looked at the safety and effectiveness of a new treatment for rheumatoid arthritis called sarilumab used in combination with methotrexate (Rheumatrex). The authors concluded that the combination of these two treatments can reduce symptoms of rheumatoid arthritis compared to methotrexate alone.
Some background
In rheumatoid arthritis (RA), the immune system attacks healthy joints, which can lead to pain and swelling. Methotrexate is often the first treatment prescribed to RA patients. However, methotrexate is not effective for all patients. In these cases, patients may be switched to a different type of treatment called a biological drug such as tofacitinib (Xeljanz). These drugs work in different ways and may be prescribed in combination with methotrexate. Sarilumab is a new biological drug currently being developed treat RA. This drug works by blocking the activity of a protein that is known to contribute to the inflammation and joint damage in RA.
Methods & findings
Data was collected from two phases in a study to assess the effects of sarilumab. In the first phase, 136 RA patients were randomly assigned to receive either placebo (control drug with no active effect) or sarilumab at different doses plus methotrexate over 12 weeks. In the second phase, 259 RA patients were randomly assigned to receive either placebo or one of two doses of sarilumab plus methotrexate over 52 weeks. All patients had previously received methotrexate but had not responded to this treatment on its own.
Overall, sarilumab was more effective at higher doses.
Signs of tissue destruction were reduced by 61.4% in the first phase of the study. This was significantly greater compared to placebo (4.1%). Sarilumab reduced signs of tissue destruction by 60.3% in the second phase of the study. This was also significantly greater compared to placebo (8.1%).
Signs of inflammation were reduced by 34.9% in the first phase of the study and by 31.5% in the second phase. These improvements were significantly greater compared to placebo. Sarilumab also significantly reduced signs of bone degradation.
Side effects associated with sarilumab included infection, low white blood cell count, and pain at the injection site.
The bottom line
The authors concluded that a combination of sarilumab and methotrexate can reduce a number of RA symptoms more than methotrexate alone.
The fine print
Some of the authors are affiliated with the companies that produce sarilumab.
Published By :
Arthritis Research & Therapy
Date :
Oct 06, 2016