Comparable Clinical Efficacy Observed Between Tofacitinib Once-Daily, Twice-Daily Dose in RA

older paerson holding their hand in pain
older paerson holding their hand in pain
Tofacitinib extended release has comparable clinical efficacy to tofacitinib administered twice daily.

The following article is part of conference coverage from the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, Illinois. Rheumatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from ACR/ARHP 2018 .

CHICAGO — Tofacitinib 11 mg once daily had comparable clinical efficacy to tofacitinib 5 mg twice daily in reducing disease activity for patients with rheumatoid arthritis (RA), according to study data presented at the 2018 ACR/ARHP Annual Meeting, held October 19-24, 2018, in Chicago, Illinois.

From the Corrona US RA Registry, investigators abstracted data on patients initiating tofacitinib 5 mg twice daily or 11 mg once daily between February 2016 and March 2018. As a primary outcome measure, patients were assessed for achievement of the minimum clinically important difference in Clinical Disease Activity Index (CDAI) improvement from baseline to 6±3 months follow-up. Additional outcome measures included changes in CDAI from baseline to follow-up, patient-reported pain, patient-reported fatigue, Health Assessment Questionnaire scores, and achievement of low disease activity or remission at 6 months.

Of 791 patients who initiated tofacitinib (11 mg once daily: n=460; 5 mg twice daily: n=234), a total of 334 (11 mg once daily: n=196; 5 mg twice daily: n=138) had CDAI data at 6 months after initiation. Following adjustments for prior use of anti-inflammatory RA medications, no significant between-formulation differences in CDAI improvements were observed. Additionally, there were no significant differences in the odds of achieving low disease activity or remission between study groups. Similar proportions also achieved Health Assessment Questionnaire scores ≥0.22, and each group experienced comparable improvements in patient-reported pain and fatigue. Similar proportions of patients in each group remained on their dose at 6 months of follow-up (11 mg once daily: 61.2%; 5 mg twice daily: 67.4%; P =.43). A total of 135 patients switched from 5 mg twice daily to 11 mg once daily during the course of the study; their outcomes at 6 months were similar to those observed at the time of switch.

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These data suggest that the extended-release formulation of tofacitinib has comparable efficacy to tofacitinib administered twice daily. No unexpected safety risks were observed during the course of the study.

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Cohen S, Litman HJ, Chen C, et al. Clinical effectiveness of tofacitinib 11mg once daily (QD) versus tofacitinib 5mg twice daily (BID) in the Corrona US RA Registry. Presented at: 2018 ACR/ARHP Annual Meeting; October 19-24, 2018; Chicago, IL. Abstract 580.

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