“That’s one of the reasons why I like monotherapy tofacitinib; there’s less LFT [liver function test] elevation with the monotherapy than there is with combination, and LFT elevation concerns me when methotrexate is on board,” he said.
What This Means
Dr. Fleischmann said the results validate what is common treatment practice.
“[If] I have a patient who’s on methotrexate, [and] they have an incomplete response to methotrexate, I add tofacitinib. I don’t switch. I add,” he said. “And if the patient has a good response, a really good response, then I discontinue methotrexate. And what I see in practice is that about two-thirds or three-quarters of patients do well with tofacitinib monotherapy; there are, however, some patients who do better with combination of tofacitinib plus methotrexate.”
Dr. Fleischmann was asked how he would reconcile these results with findings, published earlier this year, that monotherapy with baricitinib, another JAK inhibitor, was superior to adalimumab plus MTX, even though tofacitinib was not found to be superior to adalimumab plus MTX in this trial.2
He said this trial should not call into question the baricitinib findings. “There would have to be a head-to-head trial of tofacitinib vs. baricitinib,” he said. “You can’t compare one trial with another in different study populations.”
RA Medication Study
In an 810-patient study, researchers found that those started on a higher dose of MTX, 15 mg or higher, were more likely to have a good response according to EULAR criteria than those started on a lower dose, 7.5 mg or lower.
It was an effort to get at the appropriate starting dose of the drug, a subject that is open to question, sometimes leading to varying treating patterns.
In the study, which used data from the U.K.’s 35-center Rheumatoid Arthritis Medication Study (RAMS), 171 patients were in the low-dose group and 639 in the high-dose group.3 Patients in the high-dose group had significantly lower Visual Analogue Scores (VAS) than the low-dose group (P=.0001) at baseline and were significantly less likely to be given concomitant non-biological disease-modifying drugs (P=.003), said Rebecca Davies, a research assistant at the University of Manchester, who presented the findings.
Those in the high-dose group were significantly more likely to have achieved a good EULAR response after six months, with a relative risk ratio of 2.65 (P=.004). She noted that the study looked only at the starting dose and didn’t take into account any escalations.
Dr. Fleischmann said the chosen “high” dose of 15 mg is actually fairly low and that 20 mg is a dose more commonly considered high, although a session moderator pointed out that some studies have found that, given orally, there is not much of an increase in the bioavailability of the drug at doses higher than 15 mg.
