Methotrexate is the most commonly prescribed drug for treating rheumatoid arthritis, reported the research team led by Eun Bong Lee, MD, of the Seoul National University College of Medicine in South Korea.
Patients (n=956) were randomly assigned to receive 5 mg or 10 mg of of tofacitinib twice daily or methotrexate at a dose that was incrementally increased to 20 mg per week over 8 weeks.
Mean changes in the van der Heijde modified total Sharp score from baseline to month six were significantly smaller in the tofacitinib groups versus the methotrexate group, but changes were modest in all three groups (P<0.001 for both tofacitinib doses versus methotrexate).
At six months, an American College of Rheumatology (ACR) 70 response was seen in 25.5% of the 5-mg tofacitinib group and 37.7% in the 10-mg group versus 12.0% in the methotrexate group (P<0.001 for both). In the tofacitinib group, herpes zoster developed in 4% of patients versus 1.1% in the methotrexate group.
Confirmed cancer developed in five patients who received tofacitinib and in one patient who received methotrexate. Tofacitinib was also associated with increases in creatinine levels and in low-density and high-density lipoprotein cholesterol levels.
“In patients who had not previously received methotrexate or therapeutic doses of methotrexate, tofacitinib monotherapy was superior to methotrexate in reducing signs and symptoms of rheumatoid arthritis and inhibiting the progression of structural joint damage,” concluded the researchers.
“The benefits of tofacitinib need to be considered in the context of the risks of adverse events.”
Disclosures: Several authors disclose financial ties to the pharmaceutical industry, including Pfizer, which funded the study.