Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: Secondary analyses from the RA-BEAM study

Annals of the Rheumatic Diseases

Volumn 76, Issue 11, 2017, Pages 1853-1861

  Keystone, Edward C ^a   Taylor, Peter C ^b   Tanaka, Yoshiya ^c   Gaich, Carol ^d   Delozier, Amy M ^d   Dudek, Anna ^e   Zamora, Jorge Velasco ^f   Cobos, Jose Arturo Covarrubias ^g   Rooney, Terence ^d   Bono, Stephanie De ^d   Arora, Vipin ^d   Linetzky, Bruno ^d   Weinblatt, Michael E ^h  

^a MOUNT SINAI HOSPITAL   (Canada)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^d ELI LILLY AND COMPANY   (United States)

^e Medica Pro Familia   (Poland)

^f CER Instituto Medico   (Argentina)

^g Unidad Reumatologica Las Americas S C P Médico   (United States)

^h BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

outcomes research; patient perspective; rheumatoid arthritis

Indexed keywords

ADALIMUMAB; BARICITINIB; PLACEBO; ANTIRHEUMATIC AGENT; AZETIDINE DERIVATIVE; SULFONAMIDE;

ADULT; ARTHRALGIA; ARTICLE; CLINICAL ASSESSMENT TOOL; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; EUROQOL 5 D; FEMALE; FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY FATIGUE; HEALTH ASSESSMENT QUESTIONNAIRE; HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX; HUMAN; JOINT STIFFNESS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PATIENT-REPORTED OUTCOME; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRODUCTIVITY; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; SHORT FORM 36; TREATMENT OUTCOME; VISUAL ANALOG SCALE; WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT QUESTIONNAIRE RHEUMATOID ARTHRITIS; ANALYSIS OF VARIANCE; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; COMPLICATION; FATIGUE; MIDDLE AGED; PAIN MEASUREMENT; SEVERITY OF ILLNESS INDEX; STATISTICAL MODEL;

ADALIMUMAB; ADULT; ANALYSIS OF VARIANCE; ANTIRHEUMATIC AGENTS; ARTHRALGIA; ARTHRITIS, RHEUMATOID; AZETIDINES; DOUBLE-BLIND METHOD; FATIGUE; FEMALE; HUMANS; LOGISTIC MODELS; MALE; MIDDLE AGED; PAIN MEASUREMENT; PATIENT REPORTED OUTCOME MEASURES; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; SULFONAMIDES; SURVEYS AND QUESTIONNAIRES; TREATMENT OUTCOME;

EID: 85030999408     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2017-211259     Document Type: Article

References (37)

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 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. D rossaers-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. Kekow J, Moots RJ, Emery P, et al. Patient-reported outcomes improve with etanercept plus methotrexate in active early rheumatoid arthritis and the improvement is strongly associated with remission: The COMET trial. Ann Rheum Dis 2010;69:222-5.
8. Gossec L, Dougados M, Dixon W. Patient-reported outcomes as end points in clinical trials in rheumatoid arthritis. RMD Open 2015;1:e000019.
9. Guidance for industry: patient-reported outcome measures: use in Medical Product Development to support labeling claims. Secondary Guidance for Industry: Patient-Reported Outcome Measures Use in Medical Product Development to Support Labeling Claims. 2009 http://www. fda. gov/downloads/Drugs/./Guidances/UCM193282. pdf (accessed 17 Apr 2017).
10. Fries JF, Spitz P, Kraines RG, et al. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45.
11. Sokka T. Morning stiffness and other patient-reported outcomes of rheumatoid arthritis in clinical practice. Scand J Rheumatol Suppl 2011;125:23-7.
12. Smolen JS, Landewe R, Bijlsma J, et al. EULAR recommendations for themanagement of rheumatoid arthritis with synthetic and biologicaldisease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 2017:1-18.
13. Keystone EC, Taylor PC, Drescher E, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Ann Rheum Dis 2015;74:333-40.
14. T anaka Y, Emoto K, Cai Z, et al. Efficacy and safety of Baricitinib in Japanese patients with active rheumatoid Arthritis Receiving Background Methotrexate therapy: A 12-week, Double-blind, randomized Placebo-controlled study. J Rheumatol 2016;43:504-11.
15. Fleischmann R, Schiff M, van der Heijde D, et al. Baricitinib, Methotrexate, or combination in patients with Rheumatoid Arthritis and no or Limited Prior Disease-Modifying Antirheumatic Drug Treatment. Arthritis Rheumatol 2017;69:506-17.
16. D ougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis 2017;76:88-95.
17. Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid Arthritis. N Engl J Med 2016;374:1243-52.
18. T aylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med 2017;376:652-62.
19. Bruce B, Fries JF. The Health Assessment Questionnaire (HAQ). Clin Exp Rheumatol 2005;23(Suppl 39):S14-18.
20. R amey D, Fries J, Singh G. The Health Assessment Questionnaire 1995: status and review. Spiker B, ed. Quality of life and pharmacoeconomics in clinical trials. 2nd ed. Philadelphia: Lippincott-Raven, 1996:227-37.
21. 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.
22. N avarro-Compán V, Smolen JS, Huizinga TW, et al. Quality indicators in rheumatoid arthritis: results from the METEOR database. Rheumatology 2015;54:1630-9.
23. 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;32:811-9.
24. 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 2015;67:475-83.
25. 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 antitumor necrosis factor therapy. Arthritis Rheum 2008;59:785-93.
26. 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.
27. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.
28. 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.
29. Strand V, Singh JA. Newer biological agents in rheumatoid arthritis: impact on healthrelated quality of life and productivity. Drugs 2010;70:121-45.
30. EuroQol Group. EQ-5D-5L User Guide. Version 1.0. 2011. http://www. euroqol. org/fileadmin/user- upload/Documenten/PDF/Folders- Flyers/UserGuide- EQ-5D-5L. pdf (accessed 1 Jul 2012)
31. http://www.euroqol.org/fileadmin/user-upload/Documenten/PDF/Folders-Flyers/EQ-5D-5L-UserGuide-2015.pdf (accessed 17 Apr 2017)
32. Brooks R. EuroQol: The current state of play. Health Policy 1996;37:53-72.
33. 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.
34. R eilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4:353-65.
35. Smolen JS, Kremer JM, Gaich CL, et al. 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). Ann Rheum Dis 2017;76:694-700.
36. Schiff M, Takeuchi T, Gaich C, et al. THU0623 P atient-Reported Outcomes from A Phase 3 Study of Baricitinib in Patients with Early Rheumatoid Arthritis Who Had Received Limited or No Treatment with Disease-Modifying anti-Rheumatic Drugs: Table 1. Ann Rheum Dis 2016;75263:419.1-419.
37. Emery P, Blanco R, Maldonado Cocco J, et al. Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis. RMD Open 2017;3:e000410.