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)

Annals of the Rheumatic Diseases

Volumn 76, Issue 4, 2017, Pages 694-700

  Smolen, Josef S ^a   Kremer, Joel M ^b   Gaich, Carol L ^c   Delozier, Amy M ^c   Schlichting, Douglas E ^c   Xie, Li ^c   Stoykov, Ivaylo ^c   Rooney, Terence ^c   Bird, Paul ^d   Sánchez Bursón, Juan Miguel ^e   Genovese, Mark C ^f   Combe, Bernard ^g  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b ALBANY MEDICAL COLLEGE   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d UNIVERSITY OF NEW SOUTH WALES   (Australia)

^e HOSPITAL UNIVERSITARIO DE VALME   (Spain)

^f STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^g UNIV MONTPELLIER   (France)

Author keywords

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

Indexed keywords

BARICITINIB; DISEASE MODIFYING ANTIRHEUMATIC DRUG; PLACEBO; TUMOR NECROSIS FACTOR INHIBITOR; AZETIDINE DERIVATIVE; PROTEIN KINASE INHIBITOR; SULFONAMIDE;

ADULT; ANALYSIS OF COVARIANCE; ARTICLE; CONTROLLED STUDY; DISEASE ASSESSMENT; DISEASE DURATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG RESPONSE; EUROQOL 5 D; FATIGUE; FEMALE; FUNCTIONAL ASSESSMENT; FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY FATIGUE; HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX; HUMAN; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; MORNING STIFFNESS; MULTICENTER STUDY; PAIN ASSESSMENT; PATIENT GLOBAL ASSESSMENT OF DISEASE ACTIVITY; PATIENT-REPORTED OUTCOME; PHASE 3 CLINICAL TRIAL; PRODUCTIVITY; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; SHORT FORM 36; WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT QUESTIONNAIRE RHEUMATOID ARTHRITIS; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; COMPLICATION; PAIN MEASUREMENT; PRESENTEEISM; QUALITY OF LIFE; QUESTIONNAIRE; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

ADULT; ARTHRITIS, RHEUMATOID; AZETIDINES; DOUBLE-BLIND METHOD; EFFICIENCY; HUMANS; PAIN MEASUREMENT; PATIENT REPORTED OUTCOME MEASURES; PRESENTEEISM; PROTEIN KINASE INHIBITORS; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; SULFONAMIDES; SURVEYS AND QUESTIONNAIRES; YOUNG ADULT;

EID: 84994904843     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2016-209821     Document Type: Article

References (41)

1. Carr A, Hewlett S, Hughes R, et al. Rheumatology outcomes: The patients perspective. J Rheumatol 2003;30:880-3.
2. 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.
3. Klarenbeek NB, Göler-Yöksel 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.
4. 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.
5. Aletaha D, Smolen J, Ward MM. Measuring function in rheumatoid arthritis: Identifying reversible and irreversible components. Arthritis Rheum 2006;54:2784-92.
6. Smolen JS, Aletaha D, Grisar JC, et al. Estimation of a numerical value for joint damage-related physical disability in rheumatoid arthritis clinical trials. Ann Rheum Dis 2010;69:1058-64.
7. Aletaha D, Strand V, Smolen JS, et al. Treatment-related improvement in physical function varies with duration of rheumatoid arthritis: A pooled analysis of clinical trial results. Ann Rheum Dis 2008;67:238-43.
8. Aletaha D, Ward MM. Duration of rheumatoid arthritis influences the degree of functional improvement in clinical trials. Ann Rheum Dis 2006;65:227-33.
9. Smolen JS, Aletaha D. Rheumatoid arthritis therapy reappraisal: strategies, opportunities and challenges. Nat Rev Rheumatol 2015;11:276-89.
10. Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014;73:492-509.
11. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol 2016;68:1-26.
12. Sanderson T, Morris M, Calnan M, et al. What outcomes from pharmacologic treatments are important to people with rheumatoid arthritis? Creating the basis of a patient core set. Arthritis Care Res (Hoboken) 2010;62:640-6.
13. Gossec L, Dougados M, Dixon W. Patient-reported outcomes as end points in clinical trials in rheumatoid arthritis. RMD Open 2015;1:e000019.
14. Aletaha D, Landewe R, Karonitsch T, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Rheum 2008;59:1371-7.
15. OShea JJ, Holland SM, Staudt LM. JAKs and STATs in immunity, immunodeficiency, and cancer. N Engl J Med 2013;368:161-70.
16. Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med 2016;374:1243-52.
17. Brazier JE, Harper R, Jones NM, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ 1992;305:160-4.
18. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical care 1992;30:473-83.
19. Strand V, Singh JA. Newer biological agents in rheumatoid arthritis: impact on health-related quality of life and productivity. Drugs 2010;70:121-45.
20. Kosinski M, Zhao SZ, Dedhiya S, et al. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum 2000;43:1478-87.
21. EuroQol Group. EuroQol-A new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208.
22. Brooks R. EuroQol: The current state of play. Health Policy 1996;37:53-72.
23. EuroQol Group. EQ-5D-5L User Guide. Version 1.0. April 2011. Originally accessed at: http://www.euroqol.org/fileadmin/user-upload/Documenten/PDF/Folders-Flyers/UserGuide-EQ-5D-5L.pdf (accessed 1 Jul 2012).
24. Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20: 1727-36.
25. Cella D, Yount S, Sorensen M, et al. Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol 2005;32:811-19.
26. Strand V, Burmester GR, Zerbini CA, et al. Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial. Arthritis Care Res (Hoboken) 2015;67:475-83.
27. Keystone E, Burmester GR, Furie R, et al. Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-Tumor necrosis factor therapy. Arthritis Rheum 2008;59:785-93.
28. Bruce B, Fries JF. The Health Assessment Questionnaire (HAQ). Clin Exp Rheumatol 2005;23(Suppl 39):S14-18.
29. Ramey DR, Fries JF, Singh G. The Health Assessment Questionnaire 1995: status and review. In: Spiker B, ed. Quality of life and pharmacoeconomics in clinical trials. 2nd edn. Philadelphia: Lippincott-Raven, 1996:227-37.
30. Wells GA, Tugwell P, Kraag GR, et al. Minimum important difference between patients with rheumatoid arthritis: The patients perspective. J Rheumatol 1993;20:557-60.
31. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4:353-65.
32. Navarro-Compán V, Smolen JS, Huizinga TWJ, et al. Quality indicators in rheumatoid arthritis: results from the METEOR database. Rheumatology 2015;54:1630-9.
33. Felson DT, Anderson JJ, Boers M, et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. Arthritis Rheum 1993;36:729-40.
34. Strand V, Burmester GR, Ogale S, et al. Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study. Rheumatology (Oxford) 2012;51:1860-9.
35. Westhovens R, Cole JC, Li T, et al. Improved health-related quality of life for rheumatoid arthritis patients treated with abatacept who have inadequate response to anti-TNF therapy in a double-blind, placebo-controlled, multicentre randomized clinical trial. Rheumatology (Oxford) 2006;45:1238-46.
36. Smolen JS, Kay J, Doyle MK, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): A multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet 2009;374:210-21.
37. Strand V, Smolen JS, van Vollenhoven RF, et al. Certolizumab pegol plus methotrexate provides broad relief from the burden of rheumatoid arthritis: Analysis of patient-reported outcomes from the RAPID 2 trial. Ann Rheum Dis 2011;70:996-1002.
38. Keystone EC, Genovese MC, Klareskog L, et al. Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: The GO-FORWARD Study. Ann Rheum Dis 2009;68:789-96.
39. Burmester GR, Blanco R, Charles-Schoeman C, et al. Tofacitinib (CP-690, 550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: A randomised phase 3 trial. Lancet 2013;381:451-60.
40. Keystone EC, van der Heijde D, Kavanaugh A, et al. Clinical, functional, and radiographic benefits of longterm adalimumab plus methotrexate: final 10-year data in longstanding rheumatoid arthritis. J Rheumatol 2013;40:1487-97.
41. Genovese MC, Schiff M, Luggen M, et al. Longterm safety, efficacy of abatacept through 5 years of treatment in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor inhibitor therapy. J Rheumatol 2012;39:1546-54.