Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: Results of two Phase 2 randomised controlled trials

Clinical and Experimental Rheumatology

Volumn 34, Issue 3, 2016, Pages 430-442

  Wallenstein, Gene V ^a   Kanik, Keith S ^a   Wilkinson, Bethanie ^a   Cohen, Stanley ^b   Cutolo, Maurizio ^c   Fleischmann, Roy ^b   Genovese, Mark C ^d   Gomez Reino, Juan ^e   Gruben, David ^a   Kremer, Joel ^f   Krishnaswami, Sriram ^a   Lee, Eun Bong ^g   Pascual Ramos, Virginia ^h   Strand, Vibeke ^d   Zwillich, Samuel H ^a  

^a PFIZER INC   (United States)

^b METROPLEX CLINICAL RESEARCH CENTER   (United States)

^c UNIVERSITY OF GENOA   (Italy)

^d STANFORD UNIVERSITY   (United States)

^e University Hospital of Santiago de Compostela   (Spain)

^f ALBANY MEDICAL COLLEGE   (United States)

^g Seoul National University College of Medicine   (South Korea)

^h INSTITUTO NACIONAL DE CIENCIAS MÉDICAS Y NUTRICIÓN SALVADOR ZUBIRÁN   (Mexico)

Author keywords

Janus kinases; Pain; Quality of life; Rheumatoid arthritis; Tofacitinib

Indexed keywords

ADALIMUMAB; C REACTIVE PROTEIN; GLUCOCORTICOID; METHOTREXATE; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; TOFACITINIB; TUMOR NECROSIS FACTOR INHIBITOR; ANTIRHEUMATIC AGENT; JANUS KINASE; PIPERIDINE DERIVATIVE; PYRIMIDINE DERIVATIVE; PYRROLE DERIVATIVE;

ADAPTIVE IMMUNITY; ADULT; ARTICLE; CLINICAL ASSESSMENT; CLINICAL ASSESSMENT TOOL; CONTROLLED STUDY; DAS28; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; ERYTHROCYTE SEDIMENTATION RATE; FATIGUE; FEMALE; FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY FATIGUE; HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX; HUMAN; INNATE IMMUNITY; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NUMBERS NEEDED TO TREAT; PAIN; PATIENT ASSESSMENT OF ARTHRITIS PAIN; PATIENT ASSESSMENT OF DISEASE ACTIVITY; PATIENT GLOBAL ASSESSMENT OF ARTHRITIS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; SHORT FORM 36; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; VISUAL ANALOG SCALE; AGED; ANTAGONISTS AND INHIBITORS; ARTHRALGIA; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; DISEASE RESISTANCE; DRUG ADMINISTRATION; DRUG MONITORING; IMMUNOLOGY; MIDDLE AGED; MULTICENTER STUDY; PAIN MEASUREMENT; PATHOPHYSIOLOGY; PROCEDURES; PSYCHOLOGY;

ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRALGIA; ARTHRITIS, RHEUMATOID; DISEASE RESISTANCE; DRUG ADMINISTRATION SCHEDULE; DRUG MONITORING; FEMALE; HUMANS; JANUS KINASES; MALE; MIDDLE AGED; PAIN MEASUREMENT; PIPERIDINES; PYRIMIDINES; PYRROLES; QUALITY OF LIFE; TREATMENT OUTCOME;

EID: 84982815543     PISSN: 0392856X     EISSN: 1593098X     Source Type: Journal    
DOI: None     Document Type: Article

References (45)

1. GRON KL, ORNBJERG LM, HETLAND ML, et al.: The association of fatigue, comorbidity burden, disease activity, disability and gross domestic product in patients with rheumatoid arthritis. Results from 34 countries participating in the Quest-RA program. Clin Exp Rheumatol 2014; 32: 869-77.
2. KOSINSKI M, KUJAWSKI SC, MARTIN R, et al.: Health-related quality of life in early rheumatoid arthritis: impact of disease and treatment response. Am J Manag Care 2002; 8: 231-40.
3. STRAND V, SINGH JA: Newer biological agents in rheumatoid arthritis: impact on health-related quality of life and productivity. Drugs 2010; 70: 121-45.
4. JANTTI J, AHO K, KAARELA K, KAUTIAINEN H: Work disability in an inception cohort of patients with seropositive rheumatoid arthritis: a 20 year study. Rheumatology (Oxford) 1999; 38: 1138-41.
5. WOLFE F, MICHAUD K, LI T: Sleep disturbance in patients with rheumatoid arthritis: evaluation by medical outcomes study and visual analog sleep scales. J Rheumatol 2006; 33: 1942-51.
6. 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.
7. MAINI RN, BREEDVELD FC, KALDEN JR, et al.: Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum 2004; 50: 1051-65.
8. van RIEL PL, FREUNDLICH B, MacPEEK D, et al.: Patient-reported health outcomes in a trial of etanercept monotherapy versus combination therapy with etanercept and methotrexate for rheumatoid arthritis: the ADORE trial. Ann Rheum Dis 2007; 67: 1104-10.
9. 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.
10. BAUMGARTNER SW, FLEISCHMANN RM, MORELAND LW, et al.: Etanercept (Enbrel) in patients with rheumatoid arthritis with recent onset versus established disease: improvement in disability. J Rheumatol 2004; 31: 1532-7.
11. BREEDVELD FC, WEISMAN MH, KAVANAUGH AF, et al.: The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 2006; 54: 26-37.
12. KLARESKOG L, van der HEIJDE D, de JAGER JP, et al.: Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 2004; 363: 675-81.
13. 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.
14. ASKLING J, BONGARTZ T: Malignancy and biologic therapy in rheumatoid arthritis. Curr Opin Rheumatol 2008; 20: 334-9.
15. KHRAISHI M: Comparative overview of safety of the biologics in rheumatoid arthritis. J Rheumatol 2009; 82 (Suppl.): 25-32.
16. MARTIN-MOLA E, BALSA A: Infectious complications of biologic agents. Rheum Dis Clin North Am 2009; 35: 183-99.
17. WOLFE F, MICHAUD K: Biologic treatment of rheumatoid arthritis and the risk of malignancy: analyses from a large US observational study. Arthritis Rheum 2007; 56: 2886-95.
18. GHORESCHI K, LAURENCE A, O'SHEA JJ: Janus kinases in immune cell signaling. Immunol Rev 2009; 228: 273-87.
19. MEYER DM, JESSON MI, LI X, et al.: Antiinflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis. J Inflamm (Lond) 2010; 7: 41.
20. LI X, JESSON M, LEE J, et al.: Characterization of a potent inhibitor of JAK kinases, CP- 690,550, and inhibition of specific JAK/STAT pathways at efficacious exposures in a rodent model of arthritis. Abstract presented at the 15th International Inflammation Research Association Conference, Chantilly, Virginia, 21-24 September, 2008.
21. KREMER JM, BLOOM BJ, BREEDVELD FC, 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 dosage levels of CP- 690,550 versus placebo. Arthritis Rheum 2009; 60: 1895-905.
22. COOMBS JH, BLOOM BJ, BREEDVELD FC, et al.: Improved pain, physical functioning and health status in patients with rheumatoid arthritis treated with CP-690,550, an orally active Janus kinase (JAK) inhibitor: results from a randomised, double-blind, placebocontrolled trial. Ann Rheum Dis 2010; 69: 413-6.
23. FLEISCHMANN R, CUTOLO M, GENOVESE MC, 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.
24. KREMER JM, COHEN S, WILKINSON BE, 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.
25. FLEISCHMANN R, KREMER J, CUSH J, et al.: Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med 2012; 367: 495-507.
26. van VOLLENHOVEN RF, FLEISCHMANN R, COHEN S, et al.: Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med 2012; 367: 508-19.
27. LEE EB, FLEISCHMANN R, HALL S, et al.: Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med 2014; 370: 2377- 86.
28. BURMESTER GR, BLANCO R, CHARLESSCHOEMAN 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.
29. van der HEIJDE D, TANAKA Y, FLEISCHMANN R, et al.: Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twentyfour- month phase III randomized radiographic study. Arthritis Rheum 2013; 65: 559-70.
30. KREMER J, LI ZG, HALL S, et al.: Tofacitinib in combination with nonbiologic DMARDs in patients with active rheumatoid arthritis: a randomized trial. Ann Intern Med 2013; 159: 253-61.
31. ARNETT FC, EDWORTHY SM, BLOCH DA, et al.: The American Rheumatism Association revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988; 31: 315-24.
32. BRUCE B, FRIES JF: The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol 2003; 30: 167-78.
33. 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.
34. 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.
35. STRAND V, SCOTT DL, EMERY P, et al.: Physical function and health related quality of life: analysis of 2-year data from randomized, controlled studies of leflunomide, sulfasalazine, or methotrexate in patients with active rheumatoid arthritis. J Rheumatol 2005; 32: 590-601.
36. CHRISTENSEN PM, KRISTIANSEN IS: Number-needed-to-treat (NNT)-needs treatment with care. Basic Clin Pharmacol Toxicol 2006; 99: 12-6.
37. STRAND V, KANIK K, CONNELL CA, et al.: The effects of the oral JAK inhibitor CP- 690,550 on patient reported outcomes in a phase 3 study of active rheumatoid arthritis. Ann Rheum Dis 2011; 70: 88.
38. STRAND V, KREMER J, LI ZG, et al.: Tofacitinib (CP-690,550) in combination with traditional disease-modifying anti-rheumatic drugs: patient- reported outcomes from a Phase 3 study in patients with active rheumatoid arthritis and an inadequate response to disease-modifying anti-rheumatic drugs. Arthritis Rheum 2011; 63: S1032-S1033.
39. BURMESTER G, van der HEIJDE D, STRAND V, et al.: Effects of tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis receiving stable dose methotrexate: results of two phase 3 studies. Arthritis Rheum 2012; 64 (Suppl. 10): 549.
40. van VOLLENHOVEN RF, WALLENSTEIN G, LEE EB, et al.: Effects of tofacitinib (CP- 690,550), an oral Janus kinase inhibitor, or adalimumab on patient reported outcomes in a phase 3 study of active rheumatoid arthritis. Ann Rheum Dis 2012; 71: 206.
41. STRAND V, FLEISCHMANN R, ALTEN R, et al.: Oral START: Effects of the oral JAK inhibitor tofacitinib monotherapy versus methotrexate on patient reported outcomes in the phase 3 oral START trial of active rheumatoid arthritis. Ann Rheum Dis 2013; 72: 252.
42. STRAND V, BURMESTER GR, ZERBINI CA, et al.: Tofacitinib with methotrexate in thirdline treatment of patients with active rheumatoid arthritis: Patient-reported outcomes from a Phase 3 trial. Arthritis Care Res (Hoboken) 2014; 67: 475-83.
43. POLLARD LC, CHOY EH, GONZALEZ J, KHOSHABA B, SCOTT DL: Fatigue in rheumatoid arthritis reflects pain, not disease activity. Rheumatology (Oxford) 2006; 45: 885-9.
44. COHEN SB, STRAND V, AGUILAR D, OFMAN JJ: Patient- versus physician-reported outcomes in rheumatoid arthritis patients treated with recombinant interleukin-1 receptor antagonist (anakinra) therapy. Rheumatology (Oxford) 2004; 43: 704-11.
45. TUGWELL P, WELLS G, STRAND V, 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 twelvemonth, placebo-controlled trial. Leflunomide Rheumatoid Arthritis Investigators Group. Arthritis Rheum 2000; 43: 506-14.