Effect of filgotinib, a selective JAK 1 inhibitor, with and without methotrexate in patients with rheumatoid arthritis: Patient-reported outcomes

Arthritis Research and Therapy

Volumn 20, Issue 1, 2018, Pages

  Genovese, Mark ^a   Westhovens, Rene ^b   Meuleners, Luc ^c   Van der Aa, Annegret ^c   Harrison, Pille ^c   Tasset, Chantal ^c   Kavanaugh, Arthur ^d  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^c GALAPAGOS NV   (Belgium)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Filgotinib; JAK inhibitor; Patient Reported Outcome Measures; Rheumatoid Arthritis

Indexed keywords

FILGOTINIB; METHOTREXATE; PLACEBO; ANTIRHEUMATIC AGENT; JANUS KINASE 1; PROTEIN KINASE INHIBITOR; PYRIDINE DERIVATIVE; TRIAZOLE DERIVATIVE;

ADD ON THERAPY; ADULT; ARTICLE; CONTROLLED STUDY; DISEASE ACTIVITY; DISEASE SEVERITY; DRUG EFFECT; DRUG RESPONSE; FEMALE; FUNCTIONAL ASSESSMENT; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; PATIENT-REPORTED OUTCOME; PHASE 2 CLINICAL TRIAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; SHORT FORM 36; TREATMENT DURATION; TREATMENT RESPONSE; VISUAL ANALOG SCALE; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; METABOLISM; MIDDLE AGED; MULTICENTER STUDY; TREATMENT OUTCOME;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; JANUS KINASE 1; MALE; METHOTREXATE; MIDDLE AGED; PATIENT REPORTED OUTCOME MEASURES; PROTEIN KINASE INHIBITORS; PYRIDINES; TREATMENT OUTCOME; TRIAZOLES;

EID: 85044253176     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/s13075-018-1541-z     Document Type: Article

References (29)

1. American College of Rheumatology. Rheumatoid Arthritis. In: Disease & Conditions. American College of Rheumatology website; 2016. http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis. Accessed 2 Mar 2018.
2. Arshad A, Rashid R, Benjamin K. The effect of disease activity on fat-free mass and resting energy expenditure in patients with rheumatoid arthritis versus noninflammatory arthropathies/soft tissue rheumatism. Mod Rheumatol. 2007;17:470-5.
3. Gerhold K, Richter A, Schneider M, Bergerhausen HJ, Demary W, Liebhaber A, et al. Health-related quality of life in patients with long-standing rheumatoid arthritis in the era of biologics: data from the German biologics register RABBIT. Rheumatology (Oxford). 2015;54:1858-66.
4. Wang SL, Chang CH, Hu LY, Tsai SJ, Yang AC, You ZH. Risk of developing depressive disorders following rheumatoid arthritis: a nationwide population-based study. PLoS One. 2014;9:e107791.
5. Heinrich PC, Behrmann I, Muller-Newen G, Schaper F, Graeve L. Interleukin-6-type cytokine signalling through the gp130/Jak/STAT pathway. Biochem J. 1998;334(Pt 2):297-314.
6. Choy E. Understanding the dynamics: pathways involved in the pathogenesis of rheumatoid arthritis. Rheumatology (Oxford). 2012;51(Suppl 5):v3-11.
7. Dayer JM, Choy E. Therapeutic targets in rheumatoid arthritis: the interleukin-6 receptor. Rheumatology (Oxford). 2010;49:15-24.
8. Norman P. Selective JAK inhibitors in development for rheumatoid arthritis. Expert Opin Investig Drugs. 2014;23:1067-77.
9. Van Rompaey L, Galien R, van der Aar EM, Clement-Lacroix P, Nelles L, Smets B, et al. Preclinical characterization of GLPG0634, a selective inhibitor of JAK1, for the treatment of inflammatory diseases. J Immunol. 2013;191:3568-77.
10. Galien R, Brys R, Van der Aa A, Harrison P, Tasset C. Absence of Effects of Filgotinib on Erythrocytes, CD8+ and NK Cells in Rheumatoid Arthritis Patients Brings Further Evidence for the JAK1 Selectivity of Filgotinib [abstract]. Arthritis Rheumatol. 2015;67(suppl 10). http://acrabstracts.org/abstract/absence-of-effects-of-filgotinib-on-erythrocytes-cd8-and-nk-cells-in-rheumatoid-arthritis-patients-brings-further-evidence-for-the-jak1-selectivity-of-filgotinib/. Accessed 2 Mar 2018.
11. Westhovens R, Taylor PC, Alten R, Pavlova D, Enríquez-Sosa F, Mazur M, Greenwald M, Van der Aa A, Vanhoutte F, Tasset C, Harrison P. Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study. Ann Rheum Dis. 2016;76:998-1008.
12. Kavanaugh A, Kremer J, Ponce L, Cseuz R, Reshetko OV, Stanislavchuk M, Greenwald M, Van der Aa A, Vanhoutte F, Tasset C, Harrison P. Filgotinib (GLPG0634/GS-6034), an oral selective JAK1 inhibitor, is effective as monotherapy in patients with active rheumatoid arthritis: results from a randomised, dose-finding study. Ann Rheum Dis. 2017;76:1009-19.
13. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23:137-45.
14. Nikiphorou E, Radner H, Chatzidionysiou K, Desthieux C, Zabalan C, van Eijk-Hustings Y, et al. Patient global assessment in measuring disease activity in rheumatoid arthritis: a review of the literature. Arthritis Res Ther. 2016;18:251.
15. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473-83.
16. McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993;31:247-63.
17. Wolfe F, Michaud K, Strand V. Expanding the definition of clinical differences: from minimally clinically important differences to really important differences. Analyses in 8931 patients with rheumatoid arthritis. J Rheumatol. 2005;32:583-9.
18. 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.
19. Cella D, Yount S, Sorensen M, Chartash E, Sengupta N, Grober J. 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.
20. Wells GA, Boers M, Shea B, Brooks PM, Simon LS, Strand CV, et al. Minimal disease activity for rheumatoid arthritis: a preliminary definition. J Rheumatol. 2005;32:2016-24.
21. Cella D, Lai JS, Chang CH, Peterman A, Slavin M. Fatigue in cancer patients compared with fatigue in the general United States population. Cancer. 2002;94:528-38.
22. Maglinte GA, Hays RD, Kaplan RM. US general population norms for telephone administration of the SF-36v2. J Clin Epidemiol. 2012;65:497-502.
23. Maruish ME. (Ed.). User's manual for the SF-36v2 Health Survey (3rd ed.). Lincoln, RI: QualityMetric Incorporated. ISBN: 1-891810-28-6.
24. Strand V, Kosinski M, Chen CI, Joseph G, Rendas-Baum R, Graham NM, et al. Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial. Arthritis Res Ther. 2016;18:198.
25. Strand V, van Vollenhoven RF, Lee EB, Fleischmann R, Zwillich SH, Gruben D, et al. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis. Rheumatology (Oxford). 2016;55:1031-41.
26. Hazes JM, Taylor P, Strand V, Purcaru O, Coteur G, Mease P. 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 (Oxford). 2010;49:1900-10.
27. Genovese MC, Smolen JS, Weinblatt ME, Burmester GR, Meerwein S, Camp HS, et al. Efficacy and safety of ABT-494, a selective JAK-1 inhibitor, in a phase IIb study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Arthritis Rheumatol. 2016;68:2857-66.
28. Emery P, Blanco R, Maldonado Cocco J, Chen YC, Gaich CL, DeLozier AM, 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.
29. Wallenstein GV, Kanik KS, Wilkinson B, Cohen S, Cutolo M, Fleishmann R, et al. 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. Clin Exp Rheumatol. 2016;34:430-42.