Outcomes after rheumatoid arthritis patients complete their participation in a long-term observational study with tofacitinib combined with methotrexate: Practical and ethical implications in vulnerable populations after tofacitinib discontinuation
Rheumatology International Dec 29, 2017
Perez-Roman DI, et al. - Herein, rheumatoid arthritis (RA) patients who discontinued tofacitinib after completing their participation in a clinical trial, were assessed for disease activity and disability during the first year of follow-up. Findings revealed that early after tofacitinib discontinuation, a substantial proportion of RA patients deteriorated outcomes. In addition, with traditional DMARDS, some recovered baseline status.
Methods
- In the “Long term follow-up study with tofacitinib (and methotrexate) for RA treatment”, a total of 36 patients were enrolled from 2008 to 2016.
- Tofacitinib was discontinued at the termination of the study and patients were asked to enter an observational study; 35 agreed and had scheduled assessments at baseline, at 15 and 30 days of follow-up, at month 2 and 3, and thereafter every 3 months.
- DAS28-ESR and HAQ were used to assess disease activity and disability, respectively.
- During follow-up, treatment was treat-to-target oriented, only conventional DMARDs were indicated.
- Furthermore, researchers used descriptive statistics and nonparametric test.
Results
- Data demonstrated that in this IRB approved study, patients were primarily females (N = 34), had median (Q25–75) age of 52 years (45–58), and had received tofacitinib for a median of 7.9 years (6.3–8.3).
- Researchers found that from day 30 of follow-up, the proportion of patients with remission and low disease activity decreased and recovered after 270 days, meanwhile patients with high disease activity increased from 0% at baseline to 6.3% at 1 year.
- Remission/low disease activity was reported in 20 patients at study entry; during follow-up, 85% deteriorated after (median) 30 days; among them, 23.5% recovered their baseline status after a median of 172.5 days.
- In addition, findings showed a similar behavior displayed by the HAQ, but 66.7% recovered.
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