In a nutshell
This study examined the effectiveness of peficitinib in patients with moderate to severe rheumatoid arthritis. The results showed that this new drug was safe and effective.
Some background
Rheumatoid arthritis (RA) is a chronic autoimmune disease (when the immune system attacks healthy tissue) that causes pain, stiffness, swelling, and restricted movement in the joints. The first treatment for many patients in methotrexate (Trexall). However, many patients continue to progress despite treatment, therefore, new types of treatments are needed.
Peficitinib (PEF) is a new drug from a group of drugs called janus kinase (JAK) inhibitors. JAK inhibitors block enzymes that lead to inflammation and immune responses. They are thought to be promising in the treatment of RA.
Methods & findings
The current study examined the safety and effectiveness of PEF in moderate to severe RA patients.
A total of 232 Japanese patients with moderate to severe RA completed the study. They were randomized into five groups: placebo (substance with no effect on the body) group, PEF 25 mg, PEF 50 mg, PEF 100 mg, and PEF 150 mg. PEF was given to the patients orally, once daily.
Each of the PEF groups showed a significantly better outcome than the placebo group. A decrease in disease activity was seen in 10.7% of the placebo group, and from 23.6% to 65.5% of the PEF groups. Increasing dosages led to improved response.
The levels of adverse events were similar across all groups (64.3% in the placebo group and 52% to 71% across the PEF groups). The most common adverse events in the PEF groups were head colds, increase in an enzyme (creatine phosphokinase) that indicates there is tissue damage in certain organs and muscles, and diarrhea. No serious infections were noted.
The bottom line
The study concluded that treatment with PEF in patients with moderate to severe RA was effective and safe.
The fine print
The authors note that PEF is a drug that suppresses the immune system, and further studies should carefully evaluate PEFs safety and assess adverse events such as infections.
This study was funded by Astellas Pharma, the manufacturers of PEF.
Published By :
Annals of the rheumatic diseases
Date :
Dec 15, 2015
