Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs

Arthritis Research and Therapy

Volumn 17, Issue 1, 2015, Pages

  Strand, Vibeke ^a,e   Kremer, Joel ^b   Wallenstein, Gene ^c   Kanik, Keith S ^c   Connell, Carol ^c   Gruben, David ^c   Zwillich, Samuel H ^c   Fleischmann, Roy ^d  

^a Albany Medical College ^*  (United States)

^b ALBANY MEDICAL COLLEGE   (United States)

^c PFIZER INC   (United States)

^d METROPLEX CLINICAL RESEARCH CENTER   (United States)

^e STANFORD UNIVERSITY   (United States)

Author keywords

Autoimmunity; Patient perspective; Rheumatoid arthritis

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; INTERLEUKIN 6; JANUS KINASE 1; JANUS KINASE 2; JANUS KINASE 3; PLACEBO; TOFACITINIB; TUMOR NECROSIS FACTOR INHIBITOR; ANTIRHEUMATIC AGENT; PIPERIDINE DERIVATIVE; PYRIMIDINE DERIVATIVE; PYRROLE DERIVATIVE;

ADULT; ARTICLE; CONTROLLED STUDY; DISEASE ACTIVITY; FEMALE; FUNCTIONAL ASSESSMENT; GLOBAL ASSESSMENT OF FUNCTIONING; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; INTERACTIVE VOICE RESPONSE SYSTEM; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; PAIN ASSESSMENT; PHASE 3 CLINICAL TRIAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RHEUMATOID ARTHRITIS; SCORING SYSTEM; SHORT FORM 36; TREATMENT OUTCOME; TREATMENT RESPONSE; VISUAL ANALOG SCALE; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; MIDDLE AGED; MULTICENTER STUDY; QUESTIONNAIRE; SELF REPORT;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PIPERIDINES; PYRIMIDINES; PYRROLES; QUALITY OF LIFE; SELF REPORT; SURVEYS AND QUESTIONNAIRES; TREATMENT OUTCOME;

EID: 84946214701     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/s13075-015-0825-9     Document Type: Article

References (43)

1. Strand V, Singh JA. Newer biological agents in rheumatoid arthritis: impact on health-related quality of life and productivity. Drugs. 2010;70:121-45.
2. Strand V, Khanna D. The impact of rheumatoid arthritis and treatment on patients' lives. Clin Exp Rheumatol. 2010;28:S32-40.
3. Kirwan JR, Hewlett SE, Heiberg T, Hughes RA, Carr M, Hehir M, et al. Incorporating the patient perspective into outcome assessment in rheumatoid arthritis-progress at OMERACT 7. J Rheumatol. 2005;32:2250-6.
4. US Dept of Health, FDA, CDER C, CDRH. Guidance for Industry Patient-Reported Outcome Measures. In: Use in Medical Product Development to Support Labeling Claims. 2009. p. 1-39.
5. European Medicines Agency: Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products [ http://www.ispor.org/workpaper/emea-hrql-guidance.pdf ].
6. Bellamy N, Boers M, Felson D, Fries J, Furst D, Henry D, et al. Health status instruments/utilities. J Rheumatol. 1995;22:1203-7.
7. Kirwan JR, Minnock P, Adebajo A, Bresnihan B, Choy E, de Wit M, et al. Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis. J Rheumatol. 2007;34:1174-7.
8. Strand V, Boers M, Idzerda L, Kirwan JR, Kvien TK, Tugwell PS, et al. It's good to feel better but it's better to feel good and even better to feel good as soon as possible for as long as possible. Response criteria and the importance of change at OMERACT 10. J Rheumatol. 2011;38:1720-7.
9. Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, 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.
10. O'Dell JR. Therapeutic strategies for rheumatoid arthritis. N Engl J Med. 2004;350:2591-602.
11. Bathon JM, Cohen SB. The, American College of Rheumatology recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis: where the rubber meets the road. Arthritis Rheum. 2008;2008(59):757-9.
12. Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59:762-84.
13. Meyer DM, Jesson MI, Li X, Elrick MM, Funckes-Shippy CL, Warner JD, et al. Anti-inflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis. J Inflamm (Lond). 2010;7:41.
14. Kremer JM, Cohen S, Wilkinson BE, Connell CA, French JL, Gomez-Reino J, et al. A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone. Arthritis Rheum. 2012;64:970-81.
15. Kremer JM, Bloom BJ, Breedveld FC, Coombs JH, Fletcher MP, Gruben D, et al. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: results of a double-blind, placebo-controlled phase IIa trial of three dose levels of CP-690,550 versus placebo. Arthritis Rheum. 2009;60:1895-905.
16. Fleischmann R, Cutolo M, Genovese MC, Lee EB, Kanik KS, Sadis S, et al. Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. Arthritis Rheum. 2012;64:617-29.
17. Tanaka Y, Suzuki M, Nakamura H, Toyoizumi S, Zwillich SH. Phase II study of tofacitinib (CP-690,550) combined with methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate. Arthritis Care Res (Hoboken). 2011;63:1150-8.
18. Tanaka Y, Takeuchi T, Yamanaka H, Nakamura H, Toyoizumi S, Zwillich S. Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week randomized, phase 2 study. Mod Rehumatol. 2015;25:514-21.
19. Lee EB, Fleischmann R, Hall S, Wilkinson B, Bradley J, Gruben D, et al. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014;370:2377-86.
20. Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, 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.
21. Fleischmann R, Kremer J, Cush J, Schulze-Koops H, Connell CA, Bradley JD, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012;367:495-507.
22. van der Heijde D, Tanaka Y, Fleischmann R, Keystone E, Kremer J, Zerbini C, et al. Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: Twelve-month data from a twenty-four-month phase III randomized radiographic study. Arthritis Rheum. 2013;65:559-70.
23. van Vollenhoven RF, Fleischmann R, Cohen S, Lee EB, García Meijide JA, Wagner S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012;367:508-19.
24. Kremer J, Li ZG, Hall S, Fleischmann R, Genovese M, Martin-Mola E, et al. Tofacitinib in combination with nonbiologic DMARDs in patients with active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2013;159:253-61.
25. Wollenhaupt J, Silverfield J, Lee EB, Curtis JR, Wood SP, Soma K, et al. Safety and efficacy of tofacitinib, an oral Janus kinase Inhibitor, for the treatment of rheumatoid arthritis in open-label, long-term extension studies. J Rheumatol. 2014;41:837-52.
26. Wollenhaupt J, Silverfield J, Lee EN, Terry K, Kwok K, Lazariciu I, et al. Tofacitinib, an oral Janus kinase inhibitor, in the treatment of rheumatoid arthritis: safety and clinical and radiographic efficacy in open-label, long-term extension studies over 7 years. Arthritis Rheum. 2015;67(suppl 10):abs 1645.
27. Wells GA, Tugwell P, Kraag GR, Baker PR, Groh J, Redelmeier DA. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol. 1993;20:557-60.
28. Wells G, Li T, Maxwell L, Maclean R, Tugwell P. Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. J Rheumatol. 2007;34:280-9.
29. Farrar JT, Young Jr JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94:149-58.
30. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9:105-21.
31. Boyle MH, Furlong W, Feeny D, Torrance GW, Hatcher J. Reliability of the Health Utilities Index--Mark III used in the 1991cycle 6 Canadian General Social Survey Health Questionnaire. Qual Life Res. 1995;4:249-57.
32. Kosinski M, Zhao SZ, Dedhiya S, Osterhaus JT, Ware Jr JE. 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.
33. Strand V, Bombardier C, Maetzel A. Use of minimum clinically important differences [MCID] in evaluating patient responses to treatment of RA [abstract]. Arthritis Rheum. 2001;44:S187.
34. Strand V, Cannon G, Cohen S, Ware J. Correlation of HAQ with SF-36; comparison of leflunomide to methotrexate in patients with active RA [abstract]. Arthritis Rheum. 2001;44:S187.
35. Zhao SZ, Fiechtner JI, Tindall EA, Dedhiya SD, Zhao WW, Osterhaus JT, et al. Evaluation of health-related quality of life of rheumatoid arthritis patients treated with celecoxib. Arthritis Care Res. 2000;13:112-21.
36. Tugwell P, Wells G, Strand V, Maetzel A, Bombardier C, Crawford B, et al. Clinical improvement as reflected in measures of function and health-related quality of life following treatment with leflunomide compared with methotrexate in patients with rheumatoid arthritis: sensitivity and relative efficiency to detect a treatment effect in a twelve-month, placebo-controlled trial. Leflunomide Rheumatoid Arthritis Investigators Group. Arthritis Rheum. 2000;43:506-14.
37. Wells G, Li T, Maxwell L, Maclean R, Tugwell P. Responsiveness of patient reported outcomes including fatigue, sleep quality, activity limitation, and quality of life following treatment with abatacept for rheumatoid arthritis. Ann Rheum Dis. 2008;67:260-5.
38. Ware JE, Kosinski M, Dewey JE. How to score version two of the SF 36 Health Survey. Lincoln, RI: Quality Metric, Incorporate; 2000.
39. Strand V, Crawford B, Singh J, Choy E, Smolen JS, Khanna D. 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.
40. Pincus T. Are patient questionnaire scores as "scientific" as laboratory tests for rheumatology clinical care? Bull NYU Hosp Jt Dis. 2010;68:130-9.
41. Carr A, Hewlett S, Hughes R, Mitchell H, Ryan S, Carr M, et al. Rheumatology outcomes: the patient's perspective. J Rheumatol. 2003;30:880-3.
42. Dickens C, McGowan L, Clark-Carter D, Creed F. Depression in rheumatoid arthritis: a systematic review of the literature with meta-analysis. Psychosom Med. 2002;64:52-60.
43. Uguz F, Akman C, Kucuksarac S, Tufekci O. Anti-tumor necrosis factor-alpha therapy is associated with less frequent mood and anxiety disorders in patients with rheumatoid arthritis. Psychiatry Clin Neurosci. 2009;63:50-5.