Developing a Construct to Evaluate Flares in Rheumatoid Arthritis: A Conceptual Report of the OMERACT RA Flare Definition Working Group

REFERENCES

1. 1.↵
   1. Bingham CO,
   2. Pohl C,
   3. Woodworth TE,
   4. Hewlett SE,
   5. May JE,
   6. Rahman MU,
   7. et al.

   Developing a standardized definition for disease “Flare” in rheumatoid arthritis. OMERACT 9 Special Interest Group. J Rheumatol 2009;36:2335–41.

   OpenUrlAbstract/FREE Full Text
2. 2.↵
   1. Barton JL,
   2. Imboden J,
   3. Graf J,
   4. Glidden D,
   5. Yelin EH,
   6. Schillinger D

   . Patient-physician discordance in assessments of global disease severity in rheumatoid arthritis. Arthritis Care Res 2010;62:857–64.

   OpenUrl
3. 3.↵
   1. Petersson IF,
   2. Rader T,
   3. Tugwell P

   . OMERACT 10 — Domains session: Domains selection for patient reported outcomes — what to measure? OMERACT 10. (Unpublished pre-conference paper.)
4. 4.↵
   1. Bingham CO,
   2. Pohl C,
   3. Alten R,
   4. Christensen R,
   5. Choy E,
   6. Hewlett S,
   7. et al.

   “Flare” and disease worsening in rheumatoid arthritis: time for definition. Int J Adv Rheumatol 2009;7:85–91.

   OpenUrl
5. 5.↵
   1. Bingham CO III.,
   2. Alten R,
   3. Bartlett SJ,
   4. Bykerk VP,
   5. Brooks PM,
   6. Choy E,
   7. et al;
   8. for the OMERACT RA Flare Definition Working Group

   . Identifying preliminary domains to detect and measure rheumatoid arthritis flares: Report of the OMERACT 10 RA Flare Workshop. J Rheumatol 2011;38:1751–8.

   OpenUrlAbstract/FREE Full Text
6. 6.↵
   1. Bell MJ,
   2. Tavares R,
   3. Guillemin F,
   4. Bykerk VP,
   5. Tugwell P,
   6. Wells GA

   . Development of a self-administered early inflammatory arthritis detection tool. BMC Musculoskel Disord 2010;11:50.

   OpenUrlCrossRef
7. 7.↵
   1. Bykerk VP,
   2. Solomon D,
   3. Bingham CO,
   4. Frits M,
   5. Iannaccone C,
   6. Weinblatt M

   . The role of objective measures vs. patient reported outcomes (PROs) as a reflection of flares in patients with RA: Results from the Brigham RA Sequential Study (BRASS) [abstract 2636]. Arthritis Rheum, ACR 2010).
8. 8.↵
   1. Woodworth T,
   2. Furst DE,
   3. Alten R,
   4. Bingham CO,
   5. Yocum D,
   6. Sloan V,
   7. et al.

   Standardizing assessment and reporting of adverse effects in rheumatology clinical trials. II: the Rheumatology Common Toxicity Criteria v.2.0. J Rheumatol 2007;34:1401–14.

   OpenUrlAbstract/FREE Full Text
9. 9.↵
   1. Smolen J,
   2. Landewé R,
   3. Breedveld FC,
   4. Dougados M,
   5. Emery P,
   6. Gaujoux-Viala C,
   7. et al.

   EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010;69:964–75.

   OpenUrlAbstract/FREE Full Text
10. 10.↵
    1. Yazici Y,
    2. Erkan D,
    3. Kulman I,
    4. Belostocki K,
    5. Harrison MJ

    . Decreased flares of rheumatoid arthritis during the first year of etanercept treatment: further evidence of clinical effectiveness in the “real world”. Ann Rheum Dis 2002;61:638–40.

    OpenUrlAbstract/FREE Full Text
11. 11.↵
    1. Van Vollenhoven RF,
    2. Brannemark S,
    3. Klareskog L

    . Dose escalation of infliximab in clinical practice: improvements seen may be explained by a regression-like effect. Ann Rheum Dis 2004;63:426–30.

    OpenUrlAbstract/FREE Full Text
12. 12.↵
    1. Smolen JS,
    2. Keystone EC,
    3. Emery P,
    4. Breedveld FC,
    5. Betteridge N,
    6. Burmester G,
    7. et al.

    Consensus statement on the use of rituximab in patients with rheumatoid arthritis. Ann Rheum Dis 2007;66:143–50.

    OpenUrlAbstract/FREE Full Text
13. 13.↵
    1. Mease PJ,
    2. Cohen S,
    3. Gaylis NB,
    4. Chubick A,
    5. Kael AT,
    6. Greenwald M,
    7. et al.

    Efficacy and safety of retreatment in patients with rheumatoid arthritis with previous inadequate response to tumor necrosis factor inhibitors: results from the SUNRISE trial. J Rheumatol 2010;37:917–27.

    OpenUrlAbstract/FREE Full Text
14. 14.↵
    1. Lovell DJ,
    2. Giannini EH,
    3. Reiff A,
    4. Cawkwell GD,
    5. Silverman ED,
    6. Nocton JJ,
    7. et al.

    Etanercept in children with polyarticular juvenile rheumatoid arthritis. N Engl J Med 2000;342:763–9.

    OpenUrlCrossRefPubMed
15. 15.↵
    1. Thurlings RM,
    2. Vos K,
    3. Gerlag DM,
    4. Tak PP

    . Disease activity-guided rituximab therapy in rheumatoid arthritis: the effects of re-treatment in initial nonresponders versus initial responders. Arthritis Rheum 2008;58:3657–64.

    OpenUrlCrossRefPubMed
16. 16.↵
    1. Van Vollenhoven RF,
    2. Boumpas D,
    3. Westhovens R,
    4. Brzosko M,
    5. Svensson K,
    6. Bjorneboe O,
    7. et al.

    Response, remission and flare during early treatment of rheumatoid arthritis with infliximab: The REMARK Study [abstract]. Ann Rheum Dis 2010;69 Suppl 3:535.

    OpenUrl
17. 17.↵
    1. Fleischmann RM,
    2. Cohen SB,
    3. Moreland LW,
    4. Schiff M,
    5. Mease PJ,
    6. Smith DB,
    7. et al.

    Methotrexate dosage reduction in patients with rheumatoid arthritis beginning therapy with infliximab: the Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) trial. Curr Med Res Opin 2005;21:1181–90.

    OpenUrlCrossRefPubMed
18. 18.↵
    1. Westhovens R,
    2. Yocum D,
    3. Han J,
    4. Berman A,
    5. Strusberg I,
    6. Geusens P,
    7. et al.

    The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: a large, randomized, placebo-controlled trial. Arthritis Rheum 2006;54:1075–86.

    OpenUrlCrossRefPubMed
19. 19.↵
    1. Hewlett S,
    2. Sanderson T,
    3. May J,
    4. Alten R,
    5. Bingham CO III.,
    6. Cross M,
    7. et al.

    “I’m hurting, I want to kill myself”: Rheumatoid arthritis flare is more than a high joint count — an international patient perspective on flare where medical help is sought. Rheumatology 2011; May 12 (Epub ahead of print).
20. 20.↵
    1. Sanderson T,
    2. Morris M,
    3. Calnan M,
    4. Richards P,
    5. Hewlett S

    . Patient perspective of measuring treatment efficacy: The rheumatoid arthritis patient priorities for pharmacologic interventions outcomes. Arthritis Care Res 2010;62:647–56.

    OpenUrlCrossRef
21. 21.↵
    1. Furst D,
    2. Chang H,
    3. Ranganath V,
    4. Khanna D,
    5. Kremer JM,
    6. Greenberg J

    . Defining change in disease activity parameters associated with loss of response over time in RA patients [abstract 1817]. Arthritis Rheum 2007;56 Suppl:S709.

    OpenUrl
22. 22.↵
    1. Kirwan JR,
    2. Minnock P,
    3. Adebajo A,
    4. Bresnihan B,
    5. Choy E,
    6. de Wit M,
    7. et al.

    Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis. J Rheumatol 2007;34:1174–7.

    OpenUrlAbstract/FREE Full Text
23. 23.↵
    1. Kvien TK,
    2. Heiberg T,
    3. Hagen KB

    . Minimal clinically important improvement/difference (MCII/MCID) and patient acceptable symptom state (PASS): what do these concepts mean? Ann Rheum Dis 2007;66 Suppl III:iii40–iii41.

    OpenUrlAbstract/FREE Full Text
24. 24.↵
    1. Dougados M

    . It’s good to feel better but it’s better to feel good... and even better to feel good as soon as possible and for as long as possible [editorial]. J Rheumatol 2005;32:1–2.

    OpenUrlFREE Full Text
25. 25.↵
    1. Strand V,
    2. Singh J

    . Newer biologic agents improve health related quality of life and productivity in rheumatoid arthritis. Drugs 2010;70:121–45.

    OpenUrlCrossRefPubMed
26. 26.↵
    1. Aletaha D,
    2. Landewé R,
    3. Karonitsch T,
    4. Bathon J,
    5. Boers M,
    6. Bombardier C,
    7. et al.

    Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Rheum 2008;59:1371–7.

    OpenUrlCrossRefPubMed
27. 27.↵
    1. Gossec L,
    2. Paternotte S,
    3. Aanerud GJ,
    4. Balanescu A,
    5. Boumpas DT,
    6. Carmona L,
    7. et al.

    Finalisation and validation of the Rheumatoid Arthritis Impact of Disease (RAID) score, a patient-derived composite measure of impact of rheumatoid arthritis. A EULAR initiative. Ann Rheum Dis 2011; [in press].
28. 28.↵
    Guidance for industry: Patient-reported outcome measures: use in medical product development to support labeling claims. December 2009. [Internet. Accessed April 6, 2011.] US Department of Health and Human Services, FDA. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf
29. 29.↵
    1. van Tuyl LHD,
    2. Vlad SC,
    3. Felson DT,
    4. Wells G,
    5. Boers M

    . Defining remission in rheumatoid arthritis: results of an initial American College of Rheumatology/European League Against Rheumatism consensus conference. Arthritis Rheum 2009;61:704–10.

    OpenUrlCrossRefPubMed