In a nutshell
This study investigated the safety and effectiveness of peficitinib (Smyraf) in patients with unresponsive rheumatoid arthritis (RA).
They found that this treatment reduced RA symptoms and was well tolerated in these patients.
Some background
Rheumatoid arthritis (RA) is caused by painful swelling and inflammation in the joints. RA is a chronic (long-term) condition. Patients are treated with disease-modifying anti-rheumatic drugs (DMARDs). DMARDs are drugs that reduce inflammation. Methotrexate (MTX) is a synthetic DMARD (csDMARD) used as a first-line treatment in RA. Patients may not respond to MTX. In this case, a biological DMARD (bDMARD) may be prescribed to improve RA management.
Janus kinase (JAK) inhibitors are bDMARDs. Blocking JAK enzymes prevents the release of inflammatory chemicals. Peficitinib (PFC) is a new JAK inhibitor. It is unclear if PFC is safe and effective in the treatment of unresponsive RA.
Methods & findings
This study included 507 patients with RA. Patients were randomly assigned to either PFC, placebo or etanercept (Enbrel; ETN) treatment. PFC-treated patients were given either 100 mg or 150 mg PFC daily. Treatment lasted 52 weeks. ETN (a bDMARD) was used as a reference group for safety. Placebo patients switched to PFC (100 mg or 150 mg) at 12 weeks. The main outcome was a 20% reduction in RA symptoms (ACR20 score). Treatment-related adverse events (TRAEs; side effects) were also assessed.
At week 12, ACR20 was significantly higher in PFC-treated patients compared to placebo. ACR20 rates were 57.7% (100 mg) and 74.5% (150 mg). This compared to 83.5% (ETN) and 30.7% (placebo). This was maintained until week 52. In patients treated initially with placebo, responses improved when they were switched to PFC.
TRAE rates were similar in both groups. Most TRAEs were mild to moderate. PFC was associated with higher rates of serious infection. This included herpes zoster-related disease.
The bottom line
The authors concluded that PFC reduced RA symptoms and was well tolerated.
The fine print
This study compared PFC to placebo over a relatively short period (12 weeks). More investigation is needed to determine if PFC is as effective as other bDMARDs.
Peficitinib has received in March 2019 marketing approval in Japan for the treatment of RA.
What’s next?
If you have any concerns regarding RA please consult with your physician.
Published By :
Annals of the rheumatic diseases
Date :
Jul 26, 2019
