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Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6
Author(s) -
Vollenhoven Ronald F.,
Lee Eun Bong,
Fallon Lara,
Zwillich Samuel H.,
Wilkinson Bethanie,
Chapman Douglass,
DeMasi Ryan,
Keystone Edward
Publication year - 2019
Publication title -
arthritis care and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.032
H-Index - 163
eISSN - 2151-4658
pISSN - 2151-464X
DOI - 10.1002/acr.23585
Subject(s) - tofacitinib , medicine , rheumatoid arthritis , placebo , methotrexate , erythrocyte sedimentation rate , janus kinase inhibitor , post hoc analysis , clinical trial , adalimumab , randomized controlled trial , gastroenterology , surgery , pathology , alternative medicine
Objective Optimal targeted treatment in rheumatoid arthritis requires early identification of failure to respond. This post hoc analysis explored the relationship between early disease activity changes and the achievement of low disease activity ( LDA ) and remission targets with tofacitinib. Methods Data were from 2 randomized, double‐blind, phase III studies. In the ORAL Start trial, methotrexate ( MTX )–naive patients received tofacitinib 5 or 10 mg twice daily, or MTX , for 24 months. In the placebo‐controlled ORAL Standard trial, MTX inadequate responder patients received tofacitinib 5 or 10 mg twice daily or adalimumab 40 mg every 2 weeks, with MTX , for 12 months. Probabilities of achieving LDA (using a Clinical Disease Activity Index [ CDAI ] score ≤10 or the 4‐component Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [ DAS 28‐ ESR ] ≤3.2) at months 6 and 12 were calculated, given failure to achieve threshold improvement from baseline (change in CDAI ≥6 or DAS 28‐ ESR ≥1.2) at month 1 or 3. Results In ORAL Start, 7.2% and 5.4% of patients receiving tofacitinib 5 and 10 mg twice daily, respectively, failed to show improvement in the CDAI ≥6 at month 3; of those who failed, 3.8% and 28.6%, respectively, achieved month 6 CDAI ‐defined LDA . In ORAL Standard, 18.8% and 17.5% of patients receiving tofacitinib 5 and 10 mg twice daily, respectively, failed to improve CDAI ≥6 at month 3; of those who failed, 0% and 2.9%, respectively, achieved month 6 CDAI ‐defined LDA . Findings were similar when considering improvements at month 1 or DAS 28‐ ESR thresholds. Conclusion In patients with an inadequate response to MTX , lack of response to tofacitinib after 1 or 3 months predicted a low probability of achieving LDA at month 6. Lack of an early response may be considered when deciding whether to continue treatment with tofacitinib.