Infection rates were also higher among subjects taking tofacitinib compared with those on placebo. Dr. Lapteva also noted 12 cases of tuberculosis (TB) in the clinical development program. Six of these cases were observed in the randomized Phase III trials, and all six occurred in the 10-mg groups.
Changes in hematological parameters, liver function tests, and lipids were observed in patients treated with tofacitinib.
To monitor for safety, patients should be evaluated and tested for TB before they’re given the drug and monitored for signs and symptoms throughout treatment. Also, blood counts should be taken at baseline, at four to eight weeks, then every three months. Routine monitoring of liver enzymes should be done, and lipid parameters should be checked every four to eight weeks.
These recommendations are included in the prescribing information for tofacitinib.
Although they provide the general basis for the product’s safe use, she said, “We all need to decide on the best approach to therapy for each individual patient, taking into consideration their disease activity and comorbid conditions.”
Thomas Collins is a freelance medical journalist based in Florida.
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