Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis

Vibeke Strand, Ronald F van Vollenhoven, Eun Bong Lee, Roy Fleischmann, Samuel H. Zwillich, David Gruben, Tamas Koncz, Bethanie Wilkinson, Gene Wallenstein

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

OBJECTIVE: To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX.

METHODS: In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep).

RESULTS: At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P < 0.05). Changes from baseline at month 3 with tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab.

CONCLUSION: Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo.

Original languageEnglish
Pages (from-to)1031-41
Number of pages11
JournalRheumatology
Volume55
Issue number6
DOIs
Publication statusPublished - Jun 2016

Cite this

Strand, Vibeke ; van Vollenhoven, Ronald F ; Lee, Eun Bong ; Fleischmann, Roy ; Zwillich, Samuel H. ; Gruben, David ; Koncz, Tamas ; Wilkinson, Bethanie ; Wallenstein, Gene. / Tofacitinib or adalimumab versus placebo : patient-reported outcomes from a phase 3 study of active rheumatoid arthritis. In: Rheumatology. 2016 ; Vol. 55, No. 6. pp. 1031-41.
@article{6eeac47aa33a43568da3116734a186ed,
title = "Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis",
abstract = "OBJECTIVE: To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX.METHODS: In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep).RESULTS: At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P < 0.05). Changes from baseline at month 3 with tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab.CONCLUSION: Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo.",
keywords = "Journal Article",
author = "Vibeke Strand and {van Vollenhoven}, {Ronald F} and Lee, {Eun Bong} and Roy Fleischmann and Zwillich, {Samuel H.} and David Gruben and Tamas Koncz and Bethanie Wilkinson and Gene Wallenstein",
note = "{\circledC} The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.",
year = "2016",
month = "6",
doi = "10.1093/rheumatology/kev442",
language = "English",
volume = "55",
pages = "1031--41",
journal = "Rheumatology",
issn = "1462-0324",
publisher = "Oxford University Press",
number = "6",

}

Strand, V, van Vollenhoven, RF, Lee, EB, Fleischmann, R, Zwillich, SH, Gruben, D, Koncz, T, Wilkinson, B & Wallenstein, G 2016, 'Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis' Rheumatology, vol. 55, no. 6, pp. 1031-41. https://doi.org/10.1093/rheumatology/kev442

Tofacitinib or adalimumab versus placebo : patient-reported outcomes from a phase 3 study of active rheumatoid arthritis. / Strand, Vibeke; van Vollenhoven, Ronald F; Lee, Eun Bong; Fleischmann, Roy; Zwillich, Samuel H.; Gruben, David; Koncz, Tamas; Wilkinson, Bethanie; Wallenstein, Gene.

In: Rheumatology, Vol. 55, No. 6, 06.2016, p. 1031-41.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Tofacitinib or adalimumab versus placebo

T2 - patient-reported outcomes from a phase 3 study of active rheumatoid arthritis

AU - Strand, Vibeke

AU - van Vollenhoven, Ronald F

AU - Lee, Eun Bong

AU - Fleischmann, Roy

AU - Zwillich, Samuel H.

AU - Gruben, David

AU - Koncz, Tamas

AU - Wilkinson, Bethanie

AU - Wallenstein, Gene

N1 - © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.

PY - 2016/6

Y1 - 2016/6

N2 - OBJECTIVE: To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX.METHODS: In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep).RESULTS: At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P < 0.05). Changes from baseline at month 3 with tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab.CONCLUSION: Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo.

AB - OBJECTIVE: To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX.METHODS: In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep).RESULTS: At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P < 0.05). Changes from baseline at month 3 with tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab.CONCLUSION: Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo.

KW - Journal Article

U2 - 10.1093/rheumatology/kev442

DO - 10.1093/rheumatology/kev442

M3 - Article

VL - 55

SP - 1031

EP - 1041

JO - Rheumatology

JF - Rheumatology

SN - 1462-0324

IS - 6

ER -