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Clinical Trial
. 2017 Apr;76(4):694-700.
doi: 10.1136/annrheumdis-2016-209821. Epub 2016 Oct 31.

Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)

Josef S Smolen  1 , Joel M Kremer  2 , Carol L Gaich  3 , Amy M DeLozier  3 , Douglas E Schlichting  3 , Li Xie  3 , Ivaylo Stoykov  3 , Terence Rooney  3 , Paul Bird  4 , Juan Miguel Sánchez Bursón  5 , Mark C Genovese  6 , Bernard Combe  7
Affiliations
Clinical Trial

Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)

Josef S Smolen et al. Ann Rheum Dis. 2017 Apr.

Abstract

Objectives: To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).

Methods: In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form-36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.

Results: 527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI <0.5; p≤0.001), reductions in fatigue (FACIT-F ≥3.56; p≤0.05), improvements in PtGA (p≤0.001) and pain (p≤0.001) and reductions in duration of MJS (p<0.01).

Conclusions: Baricitinib improved most PROs through 24 weeks compared with placebo in this study of treatment-refractory patients with previously inadequate responses to bDMARDs, including at least one TNFi. PRO results aligned with clinical efficacy data for baricitinib.

Trial registration number: NCT01721044; Results.

Keywords: DMARDs (biologic); DMARDs (synthetic); Outcomes research; Patient perspective; Rheumatoid Arthritis.

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Conflict of interest statement

Competing interests: JSS has received grants for his institution from Abbvie, Janssen, Eli Lilly and Company, MSD, Pfizer, Roche and has provided expert advice to and/or had speaking engagements for Abbvie, Amgen, Astra-Zeneca, Astro, Celgene, Celtrion, GSK, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Novo-Nordisk, Pfizer, Roche, Samsung, Sanofi, UCB. JMK has received research grant support and consultation honoraria from Eli Lilly and Company. He is an officer and stockholder in Corrona. He has received research grant support from Abbvie, Novartis, Amgen and Pfizer. He is on the speaker's bureau for Genentech. CLG, AMD, DES, LX, IS and TR are full-time employees of Eli Lilly and Company and DES, LX, IS and TR are minor shareholders of Eli Lilly and Company. PB has received grants and consulting fees from Abbvie, Pfizer, Novartis, Eli Lilly and Company, Roche, BMS and Jannsen. JMSB has received grants and consulting fees from Abbvie, Pfizer, UCB and Gebro. MCG has received grants and consulting fees from Abbvie, Astellas, Eli Lilly and Company, Galapagos, Gilead, Pfizer and Vertex. BC has received honorarium from Abbvie, BMS, Eli Lilly and Company, MSD, Pfizer, Roche-Chugai and UCB.

Figures

Figure 1
Figure 1
Percentage of patients reporting scores that met or exceeded the MCID. (A) SF-36 domains at week 12. (B) SF-36 domains at week 24. MCID, minimum clinically important difference; SF-36, Short Form-36.
Figure 2
Figure 2
Change from baseline for the (A) Physical Component Score and (B) Mental Component Score for the SF-36 and percentage of patients reporting scores that met or exceeded the MCID. LS, least squares; MCID, minimum clinically important difference; SF-36, Short Form-36.
Figure 3
Figure 3
Change in baseline over time for the (A) FACIT-F and (B) duration of morning joint stiffness. FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; LS, least squares; MCID, minimum clinically important difference.
See this image and copyright information in PMC

References

    1. Carr A, Hewlett S, Hughes R, et al. . Rheumatology outcomes: the patient's perspective. J Rheumatol 2003;30:880–3. - PubMed
    1. Strand V, Cohen S, Crawford B, et al. . Patient-reported outcomes better discriminate active treatment from placebo in randomized controlled trials in rheumatoid arthritis. Rheumatology (Oxford) 2004;43:640–7. 10.1093/rheumatology/keh140 - DOI - PubMed
    1. Klarenbeek NB, Güler-Yüksel M, van der Kooij SM, et al. . The impact of four dynamic, goal-steered treatment strategies on the 5-year outcomes of rheumatoid arthritis patients in the BeSt study. Ann Rheum Dis 2011;70:1039–46. 10.1136/ard.2010.141234 - DOI - PubMed
    1. Drossaers-Bakker KW, de Buck M, van Zeben D, et al. . Long-term course and outcome of functional capacity in rheumatoid arthritis: the effect of disease activity and radiologic damage over time. Arthritis Rheum 1999;42:1854–60. 10.1002/1529-0131(199909)42:9<1854::AID-ANR9>3.0.CO;2-F - DOI - PubMed
    1. Aletaha D, Smolen J, Ward MM. Measuring function in rheumatoid arthritis: Identifying reversible and irreversible components. Arthritis Rheum 2006;54:2784–92. 10.1002/art.22052 - DOI - PubMed

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