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In RA patients, tofacitinib has been found
to be clinically effective at different doses, notwithstanding the background
MTX dose.
Tofacitinib is a drug of the janus
kinase inhibitor class used for rheumatoid arthritis (RA) treatment. This is an
post hoc analysis which estimated the effect of methotrexate (MTX) dose on the
efficacy of tofacitinib in patients suffering from RA.
This ORAL Scan (NCT00847613) was a 2-year, randomized,
Phase 3 trial investigating tofacitinib in MTX-inadequate responder (IR)
patients with RA.
The patients were given tofacitinib 5 or 10 mg twice
daily (BID), or placebo, with low (≤12.5 mg/week), moderate (>12.5 to
<17.5 mg/week), or high (≥17.5 mg/week) firm background MTX.
At months 3 and 6, the efficacy
endpoints encompassed American College
of Rheumatology (ACR) 20/50/70 response rates, and mean change from baseline in
Clinical Disease Activity Index (CDAI), Disease Activity Score in 28 joints
(DAS28)–4(erythrocyte sedimentation rate [ESR]), Health Assessment
Questionnaire-Disability Index (HAQ-DI), and altered Total Sharp score.
A total of 797 patients were
included in this analysis with tofacitinib 5 mg BID (N = 321), tofacitinib 10 mg BID (N = 316), or placebo (N = 160). Low MTX doses were given to 242
patients, moderate MTX doses to 333 patients and high MTX doses to 222
patients.
Across all MTX doses,
ACR20/50/70 response rates were greater for both tofacitinib doses vs placebo
at months 3 and 6. The mean changes from baseline in CDAI and HAQ-DI were
notably greater for both tofacitinib doses vs placebo, irrespective of MTX
category at month 3. Stablity was observed in imrovements at month 6.
Across MTX doses at month 6,
both the tofacitinib doses revealed improvements in DAS28–4(ESR) and less
structural progression vs placebo.
Hence, regardless of MTX dose,
tofacitinib plus MTX portrayed greater clinical and radiographic efficacy than
placebo in MTX-IR patients with RA.
Clinical Rheumatology
Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by background methotrexate dose group
R Fleischmann et al.
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