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Clinical Trial
. 2017 Sep 18;19(1):208.
doi: 10.1186/s13075-017-1410-1.

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

Michael Schiff  1 , Tsutomu Takeuchi  2 , Roy Fleischmann  3 , Carol L Gaich  4 , Amy M DeLozier  4 , Douglas Schlichting  4 , Wen-Ling Kuo  4 , Ji-Eon Won  5 , Tara Carmack  4 , Terence Rooney  4 , Patrick Durez  6   7 , Saeed Shaikh  8 , Rodolfo Pardo Hidalgo  9 , Ronald van Vollenhoven  10 , Cristiano A F Zerbini  11
Affiliations
Clinical Trial

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

Michael Schiff et al. Arthritis Res Ther. .

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.

Keywords: Baricitinib; HAQ-DI; Health-related quality of life; JAK inhibitor; PRO; RA; Rheumatoid; health status indicators; tsDMARD.

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Conflict of interest statement

Ethics approval and consent to participate

The study was conducted in accordance with ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines and was approved by each center’s institutional review board or ethics committee. All patients provided written informed consent.

Consent for publication

Not applicable.

Competing interests

Financial Support and Disclosures: MS has received consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Johnson & Johnson, Novartis, Roche, and UCB (< US$10,000 each) and speaking fees from AbbVie and Bristol-Myers Squibb (> US$10,000). TT has received consulting fees from Pfizer Japan Inc., Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Daiichi Sankyo Co., Ltd., Nipponkayaku Co., Ltd, Janssen Pharmaceutical K.K., Merck Serono Co., Ltd., Takeda Pharmaceutical Co., Ltd. (< US$10,000 each), and from Mitsubishi Tanabe Pharma Co., Astellas Pharma Inc, AbbVie GK, Bristol–Myers K.K. Asahi Kasei Medical K.K (> US$10,000 each), and speaking fees from Celtrion, Nipponkayaku Co., Ltd, Pfizer Japan Inc., UCB Japan, Diaichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., (< US$10,000 each) and from Chugai Pharmaceutical Co,. Ltd., AbbVie GK., Bristol–Myers K.K., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Janssen Pharmaceutical K.K., and Astellas Pharma Inc., (> US$10,000 each). RF has received consulting fees from AbbVie, Amgen, Bristol–Myers Squibb, Janssen, Eli Lilly and Company, and Sanofi-Aventis (< US$10,000 each), and consulting fees from Pfizer and UCB (> US$10,000 each). CG, AD, DS, W-LK, J-EW, TC, and TR are employees of Eli Lilly and Company and all, except TC and AD are shareholders. PD has received consulting fees from Eli Lilly and Company. SS has received consulting fees from Abbvie, Eli Lilly, Roche, and UCB. RPH has no conflicts of interest related to this manuscript. RvV has received consulting fees from AbbVie, Biotest, BMS, Celgene, Crescendo, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, UCB, and Vertex and research grants from AbbVie, Amgen, BMS, GSK, Pfizer, Roche, and UCB. CAFZ has received consulting fees from Merck, Pfizer, Sanofi, and Eli Lilly and Company (< US$10,000 each).

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Figures

Fig. 1
Fig. 1
Change from baseline over time for the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (a), morning joint stiffness duration (b), worst joint pain (c), and worst tiredness (d). The dashed line represents the minimum clinically important difference (MCID) in the FACIT-F (≥ 3.56 points). The question asked for morning joint stiffness duration was “Please indicate how long your morning joint stiffness lasted yesterday (duration in minutes).” The question for worst joint pain was “Please rate your joint pain by selecting the one number that describes your joint pain at its WORST in the last 24 hours (0 = no pain; 10 = pain as bad as you can imagine).” The question for worst tiredness was “Please rate your tiredness by selecting the one number that describes your WORST level of tiredness during the past 24 hours (0 = no tiredness; 10 = as bad as you can imagine)”. MTX methotrexate
Fig. 2
Fig. 2
Change from baseline over time in the Physical Component Score (PCS) (a) and Mental Component Score (MCS) (b) of the Short Form-36 (SF-36). The dashed line represents the minimum clinically important difference (MCID) in the SF-36 PCS (≥ 5 points) and SF-36 MCS (≥ 5 points). MTX methotrexate
See this image and copyright information in PMC

References

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