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

• Published in: Rheumatology international Vol. 38; no. 4; pp. 599 - 606
• Main Authors: Pérez-Román, Diana I., Ortiz-Haro, Ana B., Ruiz-Medrano, Emmanuel, Contreras-Yáñez, Irazú, Pascual-Ramos, Virginia
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-04-2018; Springer Nature B.V
• Subjects: Adult; Aged; Antirheumatic Agents - adverse effects; Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - diagnosis; Arthritis, Rheumatoid - drug therapy; Disability Evaluation; Disease Progression; Drug Therapy, Combination; Ethics, Research; Female; Health risk assessment; Humans; Male; Medicine; Medicine & Public Health; Methotrexate - adverse effects; Methotrexate - therapeutic use; Middle Aged; Observational Research; Observational studies; Piperidines - adverse effects; Piperidines - therapeutic use; Protein Kinase Inhibitors - adverse effects; Protein Kinase Inhibitors - therapeutic use; Pyrimidines - adverse effects; Pyrimidines - therapeutic use; Pyrroles - adverse effects; Pyrroles - therapeutic use; Recurrence; Remission Induction; Research Design; Research Subjects; Rheumatoid arthritis; Rheumatology; Time Factors; Treatment Outcome; Vulnerable Populations; DMARDs; Rheumatoid arthritis; Tofacitinib cessation
• ISSN: 0172-8172; 1437-160X
• DOI: 10.1007/s00296-017-3910-3

To describe disease activity and disability during the first year of follow-up, from rheumatoid arthritis (RA) patients who discontinue tofacitinib after they end participation in a clinical trial. From 2008 to 2016, 36 patients were enrolled in the “Long term follow-up study with tofacitinib (and methotrexate) for RA treatment”. At the end of the study, tofacitinib was discontinued and patients were proposed to enter an observational study; 35 agree and had scheduled evaluations at baseline, at 15 and 30 days of follow-up, at month 2 and 3, and thereafter every 3 months. Disease activity was evaluated as per DAS28-ESR and disability as per HAQ. During follow-up, treatment was treat-to-target oriented, only conventional DMARDs were indicated. Descriptive statistics and nonparametric test were used. The study was approved by IRB. 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). The proportion of patients with remission and low disease activity decreased from day 30 of follow-up and recovered after 270 days, meanwhile patients with high disease activity increased from 0% at baseline to 6.3% at 1 year. At study entry, 20 patients had remission/low disease activity; during follow-up, 85% deteriorated after (median) 30 days; among them, 23.5% recovered their baseline status after a median of 172.5 days. The HAQ showed a similar behavior, but 66.7% recovered. A substantial proportion of RA patients deteriorated outcomes early after tofacitinib cessation; some patients recovered baseline status with traditional DMARDS.