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 (United Kingdom)

Volumn 51, Issue 10, 2012, Pages 1860-1869

  Strand, Vibeke ^a   Burmester, Gerd R ^b   Ogale, Sarika ^c   Devenport, Jenny ^c   John, Ani ^c   Emery, Paul ^d  

^a STANFORD UNIVERSITY   (United States)

^b CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^c GENENTECH INC   (United States)

^d LEEDS TEACHING HOSPITALS NHS TRUST   (United Kingdom)

Author keywords

Health related quality of life; Patient reported outcomes; Randomized controlled trial; Rheumatoid arthritis; Tocilizumab

Indexed keywords

METHOTREXATE; PLACEBO; TOCILIZUMAB;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DISEASE ACTIVITY; DISEASE ACTIVITY SCORE 28; DRUG EFFECT; DRUG EFFICACY; FEMALE; FUNCTIONAL ASSESSMENT; FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY FATIGUE; HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX; HUMAN; MAJOR CLINICAL STUDY; MALE; PHYSICAL COMPONENT SUMMARY; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REMISSION; RHEUMATOID ARTHRITIS; SCORING SYSTEM; SHORT FORM 36; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DISABILITY EVALUATION; DRUG THERAPY, COMBINATION; FEMALE; HEALTH STATUS; HUMANS; MALE; METHOTREXATE; MIDDLE AGED; PAIN; PAIN MEASUREMENT; QUALITY OF LIFE; TREATMENT OUTCOME;

EID: 84867124231     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/kes131     Document Type: Article

References (34)

1. Lubeck DP. Health-related quality of life measurements and studies in rheumatoid arthritis. Am J Manag Care 2002;8:811-20.
2. Massarotti EM. Clinical and patient-reported outcomes in clinical trials of abatacept in the treatment of rheumatoid arthritis. Clin Ther 2008;30:429-42.
3. Khanna D, Tsevat J. Health-related quality of life-an introduction. Am J Manag Care 2007;13:S218-23.
4. Strand V, Singh JA. Newer biological agents in rheumatoid arthritis: impact on health-related quality of life and productivity. Drugs 2010;70:121-45.
5. Kirwan JR, Minnock P, Adebajo A et al. Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis. J Rheumatol 2007;34: 1174-7.
6. Emery P, Keystone E, Tony HP et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis 2008;67:1516-23.
7. Jones G, Sebba A, Gu J et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis 2010;69: 88-96.
8. Smolen JS, Beaulieu A, Rubbert-Roth A et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet 2008;371:987-97.
9. Genovese MC, McKay JD, Nasonov EL et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum 2008;58: 2968-80.
10. Kremer JM, Fleischmann RM, Halland AM et al. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with an inadequate response to methotrexate: the LITHE study. In: 71st Annual Meeting of the American College of Rheumatology, November 6-11, 2007, Boston, MA.
11. Nishimoto N, Hashimoto J, Miyasaka N et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis 2007;66:1162-7.
12. Kremer JL, Blanco R, Brzosko S et al. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum 2011;63:609-21.
13. Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol 2003;30:167-78.
14. Chandran V, Bhella S, Schentag C, Gladman DD. Functional assessment of chronic illness therapy-fatigue scale is valid in patients with psoriatic arthritis. Ann Rheum Dis 2007;66:936-9.
15. Strand V, Crawford B, Singh J et al. Use of 'spydergrams' to present and interpret SF-36 health-related quality of life data across rheumatic diseases. Ann Rheum Dis 2009;68: 1800-4.
16. Strand V, Singh JA. Health-related quality of life in rheumatoid arthritis. In: Hochberg MC et al., eds. Philadelphia: Elsevier Health Sciences, 2009:237-59.
17. Ara R, Brazier J. Predicting the short form-6D preference-based index using the eight mean short form-36 health dimension scores: estimating preference-based health-related utilities when patient level data are not available. Value Health 2008;12: 346-53.
18. Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 2005;14: 1523-32.
19. Wells GA, Tugwell P, Kraag GR et al. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol 1993;20:557-60.
20. Dworkin RH, Turk DC, Wyrwich KW et al. Interpreting the clinical importance of treatment outcomes in Chronic Pain Clinical Trials: IMMPACT recommendations. J Pain 2008; 9:105-121.
21. 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.
22. Kosinski M, Zhao SZ, Dedhiya S, Osterhaus JT, Ware JE Jr. 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.
23. Lubeck DP. Patient-reported outcomes and their role in the assessment of rheumatoid arthritis. Pharmacoeconomics 2004;22:27-38.
24. Hazes JM, Taylor P, Strand V et al. Physical function improvements and relief from fatigue and pain are associated with increased productivity at work and at home in rheumatoid arthritis patients treated with certolizumab pegol. Rheumatology 2010;49:1900-10.
25. Walker N, Michaud K, Wolfe F. Work limitations among working persons with rheumatoid arthritis: results, reliability, and validity of the work limitations questionnaire in 836 patients. J Rheumatol 2005;32:1006-12.
26. Osterhaus JT, Purcaru O, Richard L. Discriminant validity, responsiveness and reliability of the rheumatoid arthritis-specific Work Productivity Survey (WPS-RA). Arthritis Res Ther 2009;11:R73.
27. Wolfe F, Hawley DJ. The long-term outcomes of rheumatoid arthritis: work disability: a prospective 18 year study of 823 patients. J Rheumatol 1998;25:2108-17.
28. Singh JA, Nelson DB, Fink HA, Nichol KL. Health-related quality of life predicts future health care utilization and mortality in veterans with self-reported physiciandiagnosed arthritis: the veterans arthritis quality of life study. Semin Arthritis Rheum 2005;34:755-65.
29. Ethgen O, Kahler KH, Kong SX, Reginster JY, Wolfe F. The effect of health related quality of life on reported use of health care resources in patients with osteoarthritis and rheumatoid arthritis: a longitudinal analysis. J Rheumatol 2002;29:1147-55.
30. Yelin E, Wanke LA. An assessment of the annual and long-term direct costs of rheumatoid arthritis: the impact of poor function and functional decline. Arthritis Rheum 1999;42:1209-18.
31. 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.
32. 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 2006;45:1238-46.
33. 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.
34. van HD, Fransen J, Bleijenberg G, van RP. Physical and psychosocial correlates of severe fatigue in rheumatoid arthritis. Rheumatology 2010;49:1294-302. www.rheumatology.