FDA Approves Pfizer’s Drug to Treat Adult Patients With AS

FDA recently approved Pfizer’s Xeljanz (tofacitinib) to treat adults with active ankylosing spondylitis (AS).

The agency approved the drug specifically for individuals who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Tofacitinib is the first and only oral JAK inhibitor approved in the US for five indications.

“We are proud to offer Xeljanz, a treatment option for ankylosing spondylitis that does not require an injection or an infusion, to treat this debilitating and chronic immuno-inflammatory disease,” Mike Gladstone, global president of inflammation & immunology at Pfizer, said in the announcement.

“This regulatory approval affirms the clinical value and versatility of Xeljanz, the first and only Janus kinase (JAK) inhibitor approved for five indications in the United States for the treatment of patients with certain immuno-inflammatory conditions,” Gladstone continued.

FDA based its approval of tofacitinib on results from a Phase 3 clinical trial. The trial enrolled 269 patients living with AS to receive Xeljanz five milligram twice daily or a placebo.

The trial met its primary endpoint. At week 16, the percentage of patients achieving an Assessment in SpondyloArthritis international Society (ASAS) 20 response was notably greater with tofacitinib (56.4 percent) versus placebo (29.4 percent).

Overall, the percentage of patients achieving ASAS40 response with tofacitinib was 40.6 percent, compared to 12.5 percent with placebo.

The safety profile observed in patients with AS treated with tofacitinib was consistent with that observed in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients.

Researchers have studied tofacitinib in over 50 clinical trials globally, including more than 20 trials in RA patients and studies in coronavirus patients.

In June 2021, tofacitinib elicited a lower cumulative incidence of death or respiratory failure through Day 28 than a placebo in COVID-19 patients hospitalized with pneumonia.

The trial data, published by the New England Journal of Medicine, found that 18.1 percent of patients who received tofacitinib experienced low cumulative incidence of death or respiratory failure, compared to 29 percent of patients who received a placebo.