Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment

Michael Schiff, Tsutomu Takeuchi, Roy Fleischmann, Carol L. Gaich, Amy M. DeLozier, Douglas Schlichting, Wen Ling Kuo, Ji Eon Won, Tara Carmack, Terence Rooney, Patrick Durez, Saeed Shaikh, Rodolfo Pardo Hidalgo, Ronald van Vollenhoven, Cristiano A.F. Zerbini

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: This study evaluates patient-reported outcomes (PROs) in a double-blind, phase III study of baricitinib as monotherapy or combined with methotrexate (MTX) in patients with active rheumatoid arthritis (RA) with no or minimal prior conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and naïve to biological DMARDs. Methods: Patients were randomized 4:3:4 to MTX administered once weekly (N = 210), baricitinib monotherapy (4 mg once daily (QD), N = 159), or combination of baricitinib (4 mg QD) and MTX (baricitinib + MTX, N = 215). PROs included the Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration of morning joint stiffness (MJS), worst joint pain, worst tiredness, Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA), Short Form 36 version 2, Acute (SF-36); and EuroQol 5-Dimensions (EQ-5D) Health State Profile. Comparisons were assessed with analysis of covariance (ANCOVA) and logistic regression models. Results: Compared to MTX, patients in both baricitinib groups reported greater improvement (p ≤ 0.01) in HAQ-DI, PtGA, pain, fatigue, worst join pain, SF-36 physical component score, and EQ-5D at weeks 24 and 52. For the SF-36 mental component score, patients in both baricitinib groups reported statistically significant improvements (p ≤ 0.01) at week 52 compared to MTX-treated patients. Statistically significant improvements (p ≤ 0.05) were observed with the WPAI-RA for the baricitinib groups vs. MTX at week 24 and for the WPAI-RA daily activity and work productivity measures for baricitinib + MTX at week 52. Conclusions: In this study, baricitinib alone or in combination with MTX, when used as initial therapy, resulted in significant improvement compared to MTX in the majority of the pre-specified PRO measures. Trial Registration: ClinicalTrials.gov, NCT01711359. Registered on 18 October 2012.

Original languageEnglish
Article number208
JournalArthritis Research and Therapy
Volume19
Issue number1
DOIs
Publication statusPublished - 2017 Sep 18

Fingerprint

Antirheumatic Agents
Methotrexate
Rheumatoid Arthritis
Therapeutics
Fatigue
Health
Logistic Models
baricitinib
Patient Reported Outcome Measures
Pain
Arthralgia
Pain Measurement
Chronic Disease
Joints

Keywords

  • Baricitinib
  • HAQ-DI
  • Health status indicators
  • Health-related quality of life
  • JAK inhibitor
  • PRO
  • RA
  • Rheumatoid
  • TsDMARD

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

Cite this

Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. / Schiff, Michael; Takeuchi, Tsutomu; Fleischmann, Roy; Gaich, Carol L.; DeLozier, Amy M.; Schlichting, Douglas; Kuo, Wen Ling; Won, Ji Eon; Carmack, Tara; Rooney, Terence; Durez, Patrick; Shaikh, Saeed; Hidalgo, Rodolfo Pardo; van Vollenhoven, Ronald; Zerbini, Cristiano A.F.

In: Arthritis Research and Therapy, Vol. 19, No. 1, 208, 18.09.2017.

Research output: Contribution to journalArticle

Schiff, M, Takeuchi, T, Fleischmann, R, Gaich, CL, DeLozier, AM, Schlichting, D, Kuo, WL, Won, JE, Carmack, T, Rooney, T, Durez, P, Shaikh, S, Hidalgo, RP, van Vollenhoven, R & Zerbini, CAF 2017, 'Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment', Arthritis Research and Therapy, vol. 19, no. 1, 208. https://doi.org/10.1186/s13075-017-1410-1
Schiff, Michael ; Takeuchi, Tsutomu ; Fleischmann, Roy ; Gaich, Carol L. ; DeLozier, Amy M. ; Schlichting, Douglas ; Kuo, Wen Ling ; Won, Ji Eon ; Carmack, Tara ; Rooney, Terence ; Durez, Patrick ; Shaikh, Saeed ; Hidalgo, Rodolfo Pardo ; van Vollenhoven, Ronald ; Zerbini, Cristiano A.F. / Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. In: Arthritis Research and Therapy. 2017 ; Vol. 19, No. 1.
@article{e00612579371429494edfdb420cd1a69,
title = "Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment",
abstract = "Background: This study evaluates patient-reported outcomes (PROs) in a double-blind, phase III study of baricitinib as monotherapy or combined with methotrexate (MTX) in patients with active rheumatoid arthritis (RA) with no or minimal prior conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and na{\"i}ve to biological DMARDs. Methods: Patients were randomized 4:3:4 to MTX administered once weekly (N = 210), baricitinib monotherapy (4 mg once daily (QD), N = 159), or combination of baricitinib (4 mg QD) and MTX (baricitinib + MTX, N = 215). PROs included the Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration of morning joint stiffness (MJS), worst joint pain, worst tiredness, Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA), Short Form 36 version 2, Acute (SF-36); and EuroQol 5-Dimensions (EQ-5D) Health State Profile. Comparisons were assessed with analysis of covariance (ANCOVA) and logistic regression models. Results: Compared to MTX, patients in both baricitinib groups reported greater improvement (p ≤ 0.01) in HAQ-DI, PtGA, pain, fatigue, worst join pain, SF-36 physical component score, and EQ-5D at weeks 24 and 52. For the SF-36 mental component score, patients in both baricitinib groups reported statistically significant improvements (p ≤ 0.01) at week 52 compared to MTX-treated patients. Statistically significant improvements (p ≤ 0.05) were observed with the WPAI-RA for the baricitinib groups vs. MTX at week 24 and for the WPAI-RA daily activity and work productivity measures for baricitinib + MTX at week 52. Conclusions: In this study, baricitinib alone or in combination with MTX, when used as initial therapy, resulted in significant improvement compared to MTX in the majority of the pre-specified PRO measures. Trial Registration: ClinicalTrials.gov, NCT01711359. Registered on 18 October 2012.",
keywords = "Baricitinib, HAQ-DI, Health status indicators, Health-related quality of life, JAK inhibitor, PRO, RA, Rheumatoid, TsDMARD",
author = "Michael Schiff and Tsutomu Takeuchi and Roy Fleischmann and Gaich, {Carol L.} and DeLozier, {Amy M.} and Douglas Schlichting and Kuo, {Wen Ling} and Won, {Ji Eon} and Tara Carmack and Terence Rooney and Patrick Durez and Saeed Shaikh and Hidalgo, {Rodolfo Pardo} and {van Vollenhoven}, Ronald and Zerbini, {Cristiano A.F.}",
year = "2017",
month = "9",
day = "18",
doi = "10.1186/s13075-017-1410-1",
language = "English",
volume = "19",
journal = "Arthritis Research and Therapy",
issn = "1478-6354",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment

AU - Schiff, Michael

AU - Takeuchi, Tsutomu

AU - Fleischmann, Roy

AU - Gaich, Carol L.

AU - DeLozier, Amy M.

AU - Schlichting, Douglas

AU - Kuo, Wen Ling

AU - Won, Ji Eon

AU - Carmack, Tara

AU - Rooney, Terence

AU - Durez, Patrick

AU - Shaikh, Saeed

AU - Hidalgo, Rodolfo Pardo

AU - van Vollenhoven, Ronald

AU - Zerbini, Cristiano A.F.

PY - 2017/9/18

Y1 - 2017/9/18

N2 - Background: This study evaluates patient-reported outcomes (PROs) in a double-blind, phase III study of baricitinib as monotherapy or combined with methotrexate (MTX) in patients with active rheumatoid arthritis (RA) with no or minimal prior conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and naïve to biological DMARDs. Methods: Patients were randomized 4:3:4 to MTX administered once weekly (N = 210), baricitinib monotherapy (4 mg once daily (QD), N = 159), or combination of baricitinib (4 mg QD) and MTX (baricitinib + MTX, N = 215). PROs included the Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration of morning joint stiffness (MJS), worst joint pain, worst tiredness, Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA), Short Form 36 version 2, Acute (SF-36); and EuroQol 5-Dimensions (EQ-5D) Health State Profile. Comparisons were assessed with analysis of covariance (ANCOVA) and logistic regression models. Results: Compared to MTX, patients in both baricitinib groups reported greater improvement (p ≤ 0.01) in HAQ-DI, PtGA, pain, fatigue, worst join pain, SF-36 physical component score, and EQ-5D at weeks 24 and 52. For the SF-36 mental component score, patients in both baricitinib groups reported statistically significant improvements (p ≤ 0.01) at week 52 compared to MTX-treated patients. Statistically significant improvements (p ≤ 0.05) were observed with the WPAI-RA for the baricitinib groups vs. MTX at week 24 and for the WPAI-RA daily activity and work productivity measures for baricitinib + MTX at week 52. Conclusions: In this study, baricitinib alone or in combination with MTX, when used as initial therapy, resulted in significant improvement compared to MTX in the majority of the pre-specified PRO measures. Trial Registration: ClinicalTrials.gov, NCT01711359. Registered on 18 October 2012.

AB - Background: This study evaluates patient-reported outcomes (PROs) in a double-blind, phase III study of baricitinib as monotherapy or combined with methotrexate (MTX) in patients with active rheumatoid arthritis (RA) with no or minimal prior conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and naïve to biological DMARDs. Methods: Patients were randomized 4:3:4 to MTX administered once weekly (N = 210), baricitinib monotherapy (4 mg once daily (QD), N = 159), or combination of baricitinib (4 mg QD) and MTX (baricitinib + MTX, N = 215). PROs included the Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration of morning joint stiffness (MJS), worst joint pain, worst tiredness, Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA), Short Form 36 version 2, Acute (SF-36); and EuroQol 5-Dimensions (EQ-5D) Health State Profile. Comparisons were assessed with analysis of covariance (ANCOVA) and logistic regression models. Results: Compared to MTX, patients in both baricitinib groups reported greater improvement (p ≤ 0.01) in HAQ-DI, PtGA, pain, fatigue, worst join pain, SF-36 physical component score, and EQ-5D at weeks 24 and 52. For the SF-36 mental component score, patients in both baricitinib groups reported statistically significant improvements (p ≤ 0.01) at week 52 compared to MTX-treated patients. Statistically significant improvements (p ≤ 0.05) were observed with the WPAI-RA for the baricitinib groups vs. MTX at week 24 and for the WPAI-RA daily activity and work productivity measures for baricitinib + MTX at week 52. Conclusions: In this study, baricitinib alone or in combination with MTX, when used as initial therapy, resulted in significant improvement compared to MTX in the majority of the pre-specified PRO measures. Trial Registration: ClinicalTrials.gov, NCT01711359. Registered on 18 October 2012.

KW - Baricitinib

KW - HAQ-DI

KW - Health status indicators

KW - Health-related quality of life

KW - JAK inhibitor

KW - PRO

KW - RA

KW - Rheumatoid

KW - TsDMARD

UR - http://www.scopus.com/inward/record.url?scp=85029652284&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85029652284&partnerID=8YFLogxK

U2 - 10.1186/s13075-017-1410-1

DO - 10.1186/s13075-017-1410-1

M3 - Article

C2 - 28923098

AN - SCOPUS:85029652284

VL - 19

JO - Arthritis Research and Therapy

JF - Arthritis Research and Therapy

SN - 1478-6354

IS - 1

M1 - 208

ER -