Eun Bong Lee, MD, from Seoul National University College of Medicine in South Korea, and colleagues randomly assigned 956 patients to receive 5mg or 10mg of tofacitinib twice daily or methotrexate at a dose that was incrementally increased to 20mg per week over 8 weeks.
The researchers found that mean changes in the van der Heijde modified total Sharp score from baseline to month six were significantly smaller in the tofacitinib groups vs. the methotrexate group, but changes were modest in all three groups (P<0.001 for both tofacitinib doses vs. methotrexate). At 6 months, an American College of Rheumatology (ACR) 70 response was seen in 25.5% of the 5mg tofacitinib group and 37.7% in the 10mg group vs. 12.0% in the methotrexate group (P<0.001 for both). In the tofacitinib group, herpes zoster developed in 4% of patients vs. 1.1% in the methotrexate group. Confirmed cancer developed in 5 patients who received tofacitinib and in 1 patient who received methotrexate. Tofacitinib was also associated with increases in creatinine levels and in low-density and high-density lipoprotein cholesterol levels.
“The benefits of tofacitinib need to be considered in the context of the risks ofadverse events,” the authors write.
Several authors disclose financial ties to the pharmaceutical industry, including Pfizer, which funded the study.