Many arthritis patients are anxious to know how the clinical trials are progressing for Pfizer’s oral biologic drug, tofacitinib, which is being developed as a treatment for Rheumatoid arthritis. New data released this month revealed that tofacitinib was as effective as Abbott’s self-injectable drug Adalimumab (Humira). However, more patients experienced serious side effects. Sounds like mixed results, right?
Actually, the incidence of overall adverse events was considered similar for tofacitinib and Humira — although the proportion of patients who developed serious side effects was numerically higher for tofacitinib. But it’s important to note, while the number was higher, the number was still considered small. These findings were derived from a 12-month trial comparing tofacitinib and Humira, called ORAL Standard. The trial involved 717 patients with moderate to severe rheumatoid arthritis who continued taking methotrexate. The patients were divided into four treatment groups: 5 mg tofacitinib twice daily, 10 mg tofacitinib twice daily, Humira injections every two weeks, or placebo.
While more study details will be released at the American College of Rheumatology in November, it looks like Pfizer will seek FDA approval by the end of this year for tofacitinib (possibly for both doses). While effectiveness seems not to be in question, safety will get some scrutiny. Also released were results from a pooled analysis of late-stage tofacitinib trials, altogether involving 6,200 patients. Pfizer concluded that mortality rates were consistent with what is typically associated with standard treatments given to slow progression of arthritis symptoms. Stay tuned.