Rheumatoid arthritis

Sustained remission following the discontinuation of tofacitinib in patients with rheumatoid arthritis (XANADU study): an open-label randomised study

RMD OpenPublished Randomised controlled trial

Authors' conclusion

This study implies that a blanket cessation of tofacitinib may not be suitable for all patients, given that 58% of the participants experienced relapse. However, the withdrawal of tofacitinib is unlikely to result in the acquisition of treatment-resistance.

Study context

Population
Patients with RA with inadequate response to methotrexate (MTX) with or without bDMARDs48 in remission at week 52
Participants
113 patients
Comparison
Tofacitinib discontinuation vs MTX discontinuation after CDAI remission at week 52 on tofacitinib plus MTX
  • Tofacitinib discontinuationn = 24
  • MTX discontinuationn = 20reference
Primary endpoint
Proportion of patients who sustained clinical remission
Follow-up
Week 104
Methodological detailsopen-label
  • Open-label

Primary result

As reported in the abstract

Sustained remission

Further findings

Remission on tofacitinib resumption after relapse · patients who relapsed after tofacitinib discontinuation — Tofacitinib discontinuation
71.4%

Bio-naïve patients · week 52 and week 104

A greater proportion of bio-naïve patients achieved remission at week 52 and sustained low disease activity with tofacitinib discontinuation at week 104

Predictors of flare-free tofacitinib discontinuation · before discontinuation

Lower RF in patients discontinuing tofacitinib without flares
P = 0.04
Lower anti-CCP antibody in patients discontinuing tofacitinib without flares
P = 0.051

Safety

No severe adverse events after discontinuation of tofacitinib or MTX

Original publication

Sustained remission following the discontinuation of tofacitinib in patients with rheumatoid arthritis (XANADU study): an open-label randomised study. RMD Open. Published 25 April 2023. doi:10.1136/rmdopen-2023-003029

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