Tofacitinib in Rheumatoid Arthritis Treatment

Positioning of Tofacitinib in Treatment Algorithm

Tofacitinib is a JAK inhibitor classified as a targeted synthetic DMARD (tsDMARD), not a conventional synthetic DMARD (csDMARD) or biological DMARD (bDMARD) 1
The European League Against Rheumatism (EULAR) guidelines specifically recommend that tofacitinib should be considered only after biological treatment has failed 2, 4
Despite approval in some countries for use after failure of csDMARDs, safety concerns have led to recommendations against first-line use 3, 5

Limited long-term safety data is available compared to established csDMARDs and bDMARDs 4, 5
Clinical trials have revealed a numerical increase in serious infection rates compared with controls 3
Herpes zoster infections appear to be more common with tofacitinib than with TNF inhibitors 3
Several cases of tuberculosis and non-TB opportunistic infections have been reported 4
Hematologic abnormalities including lymphocytopenia and anemia have been observed 3

First-line therapy should involve conventional synthetic DMARDs, particularly methotrexate 1
If treatment targets are not reached with csDMARDs, biological DMARDs should be considered before tofacitinib 2, 6
After failure of biological DMARDs, tofacitinib may be considered as a treatment option 4, 5

The annual cost of tofacitinib (approximately US$25,000) is similar to biological agents 4
The availability of biosimilars at potentially lower costs may influence treatment sequencing decisions 7

If tofacitinib is used (after biological treatment failure), close monitoring for infections, particularly herpes zoster, is essential 3
Regular monitoring of complete blood counts is necessary due to potential hematologic abnormalities 3
Patients should be screened for tuberculosis before initiating therapy 4