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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

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Abstract

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.

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Authors and Affiliations

  1. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Avenida Vasco de Quiroga n° 15, Colonia Belisario Domínguez Sección XVI, 14080, Ciudad de México, Mexico

    Diana I. Pérez-Román, Ana B. Ortiz-Haro, Emmanuel Ruiz-Medrano, Irazú Contreras-Yáñez & Virginia Pascual-Ramos

  2. Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Avenida Vasco de Quiroga n° 15, Colonia Belisario Domínguez Sección XVI, 04500, Ciudad de México, Mexico

    Virginia Pascual-Ramos

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  1. Diana I. Pérez-Román
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  2. Ana B. Ortiz-Haro
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  3. Emmanuel Ruiz-Medrano
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  4. Irazú Contreras-Yáñez
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  5. Virginia Pascual-Ramos
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Contributions

DIPR: She participated in the conception and design of the study. She performed patient’s clinical evaluations. ABOH: She participated in the conception and design of the study. She performed patient’s clinical evaluations. ERM: He participated in the conception and design of the study. He performed patient’s clinical evaluations. ICY: She participated in the conception and design of the study; she performed the statistical analysis. She is in charge of databases integrity. VPR: She participated in the conception and design of the study; performed the statistical analysis and drafted the manuscript. She performed patient’s clinical evaluations.

Corresponding author

Correspondence to Virginia Pascual-Ramos.

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This study was not funded.

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All authors declare that they have no conflict of interest.

Ethical approval

All procedures performed this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Pérez-Román, D.I., Ortiz-Haro, A.B., Ruiz-Medrano, E. et al. 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. Rheumatol Int 38, 599–606 (2018). https://doi.org/10.1007/s00296-017-3910-3

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