At last June’s annual European Congress of Rheumatology conference, researchers presented, based on a phase III trial, on the efficacy of oral JAK inhibitor tofacitinib (Xeljanz) for psoriatic arthritis (PsA). “Many patients would like the option of having an oral option for treatment,” the lead author said at the time.
About half a year later, much has changed, reports Medpage. “After those data were presented at the EULAR meeting in Madrid, an FDA advisory committee voted to recommend approval (in August), another phase III trial named OPAL Beyond was published (in October), and FDA approval was granted (in December),” writes senior MedPage Today staff writer Nancy Walsh.
In fact, Walsh adds, the FDA advisory committee voted 10-1 in favor of the approval of tofacitinib, which reduces inflammation by decreasing the immune system’s effectiveness. The panel, however, indicated that the drug shouldn’t be labeled to suggest that it prevents psoriatic arthritis progression.
The mid-October study, which appeared in the New England Journal of Medicine, examined nearly 400 patients with active disease and insufficient response to tumor necrosis factor inhibitors (TNFi). For six months, the patients were randomly assigned as follows:
- 132 received 5 mg of tofacitinib twice daily.
- Another 132 received 10 mg of tofacitinib twice daily.
- 66 patients received placebo for three months; for the next three months, they received the same treatment as group one (5 mg of of tofacitinib twice daily).
- Another 65 patients received placebo for three months; for the next three, they had the same treatment as the second group (10 mg of tofacitinib twice daily).
At the midway point, patients in the first two groups had achieved ACR20 — meaning they had achieved at least a 20 percent improvement in disease — at rates of 50 percent (the 5 mg group) and 47 percent (the 10 mg group), while the placebo groups only experienced ACR20 at a rate of 24 percent. But the groups that started with tofacitinib also experienced “serious adverse events” at rates of 4 and 6 percent respectively over the course of the six months.
Those events, which those who received the drug for six months, included:
- Four serious infections.
- Three herpes zoster infections.
- One myocardial infraction.
- One ischemic stroke.
- Levels of liver enzymes that were more than three time the upper limit of normal ranges were more common in the groups that began with the drug than the placebo ones.
“Tofacitinib was more effective than placebo over three months in reducing disease activity,” the researchers wrote. “Adverse events were more frequent with tofacitinib than with placebo.”
On Dec. 14, Pfizer, which makes tofacitinib (Xeljanz), announced that the FDA had approved the drug for PsA. “Psoriatic arthritis is a complex and progressive disease with an unpredictable course,” Angela Hwang, Pfizer’s global president for inflammation and immunology, said in the news release. “The approval of XELJANZ is an important step forward for patients seeking new treatments and is a testament to Pfizer’s unwavering commitment to advancing patient care.”