Efficacy and safety of baricitinib in Japanese patients with active rheumatoid arthritis receiving background methotrexate therapy: A 12-week, double-blind, randomized placebo-controlled study

Journal of Rheumatology

Volumn 43, Issue 3, 2016, Pages 504-511

  Tanaka, Yoshiya ^a   Emoto, Kahaku ^b   Cai, Zhihong ^b   Aoki, Takehiro ^b   Schlichting, Douglas ^b   Rooney, Terence ^b   Macias, William ^b  

^a UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^b ELI LILLY AND COMPANY   (United States)

Author keywords

Baricitinib; Japan; Rheumatoid arthritis

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BARICITINIB; CREATINE KINASE; CREATININE; HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METHOTREXATE; PLACEBO; ANTIRHEUMATIC AGENT; AZETIDINE DERIVATIVE; SULFONAMIDE;

ADULT; AGED; ARTICLE; CATARACT; CHOLECYSTITIS; CONTROLLED STUDY; DISEASE ACTIVITY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HUMAN; HUMAN CELL; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; JAPANESE (PEOPLE); LABORATORY TEST; LIVER DYSFUNCTION; LIVER FUNCTION TEST; LYMPHOCYTE; LYMPHOCYTOPENIA; MALE; MULTICENTER STUDY; NEUTROPHIL; PANCREATITIS; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PHYSICAL ACTIVITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DOSE RESPONSE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; SYMPTOM ASSESSMENT;

ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; AZETIDINES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; METHOTREXATE; MIDDLE AGED; REMISSION INDUCTION; SEVERITY OF ILLNESS INDEX; SULFONAMIDES; SYMPTOM ASSESSMENT; TREATMENT OUTCOME;

EID: 84959860761     PISSN: 0315162X     EISSN: 14992752     Source Type: Journal    
DOI: 10.3899/jrheum.150613     Document Type: Article

References (27)

1. McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med 2011;365:2205-19.
2. Gordon RA, Grigoriev G, Lee A, Kalliolias GD, Ivashkiv LB. The interferon signature and STAT1 expression in rheumatoid arthritis synovial fluid macrophages are induced by tumor necrosis factor α and counter-regulated by the synovial fluid microenvironment. Arthritis Rheum 2012;64:3119-28.
3. O'Shea JJ, Kontzias A, Yamaoka K, Tanaka Y, Laurence A. Janus kinase inhibitors in autoimmune diseases. Ann Rheum Dis 2013;72 Suppl 2:ii111-5.
4. Leonard WJ, O'Shea JJ. Jaks and STATs: biological implications. Annu Rev Immunol 1998;16:293-322.
5. Kubo S, Yamaoka K, Kondo M, Yamagata K, Zhao J, Iwata S, et al. The JAK inhibitor, tofacitinib, reduces the T cell stimulatory capacity of human monocyte-derived dendritic cells. Ann Rheum Dis 2014;73:2192-8.
6. Fridman JS, Scherle PA, Collins R, Burn TC, Li Y, Li J, et al. Selective inhibition of JAK1 and JAK2 is efficacious in rodent models of arthritis: preclinical characterization of INCB028050. J Immunol 2010;184:5298-307.
7. 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.
8. Norman P. Selective JAK inhibitors in development for rheumatoid arthritis. Expert Opin Investig Drugs 2014;23:1067-77.
9. Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Ann Rheum Dis 2015;74:333-40.
10. Keystone EC, Taylor PC, Genovese MC, Schlichting DE, De La Torre I, Beattie SD, et al. Safety and efficacy of baricitinib through 128 weeks in an open-label, long-term extension study in patients with rheumatoid arthritis. [Internet. Accessed November 27, 2015.] Available from: acrabstracts.org/abstract/safety-and-efficacy-ofbaricitinib-through-128-weeks-in-an-open-label-long-termextension-study-in-patients-with-rheumatoid-arthritis
11. Taylor P, Genovese MC, Keystone E, Schlichting D, Beattie S, Macias W. Baricitinib, an oral Janus kinase inhibitor, in the treatment of rheumatoid arthritis: safety and efficacy in open-label, long-term extension study. Ann Rheum Dis 2013;72 Suppl 3:65.
12. Kochi Y, Suzuki A, Yamada R, Yamamoto K. Ethnogenetic heterogeneity of rheumatoid arthritis-implications for pathogenesis. Nat Rev Rheumatol 2010;6:290-5.
13. Alamanos Y, Drosos AA. Epidemiology of adult rheumatoid arthritis. Autoimmun Rev 2005;4:130-6.
14. Ogasawara M, Tamura N, Onuma S, Kusaoi M, Sekiya F, Matsudaira R, et al. Observational cross-sectional study revealing less aggressive treatment in Japanese elderly than nonelderly patients with rheumatoid arthritis. J Clin Rheumatol 2010;16:370-4.
15. Yamanaka H, Tanaka Y, Inoue E, Hoshi D, Momohara S, Hanami K, et al. Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan: results from a retrospective study (REACTION study). Mod Rheumatol 2011;21:122-33.
16. Harrold LR, Harrington JT, Curtis JR, Furst DE, Bentley MJ, Shan Y, et al. Prescribing practices in a US cohort of rheumatoid arthritis patients before and after publication of the American College of Rheumatology treatment recommendations. Arthritis Rheum 2012;64:630-8.
17. Hochberg MC, Chang RW, Dwosh I, Lindsey S, Pincus T, Wolfe F. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 1992;35:498-502.
18. Aletaha D, Landewe R, Karonitsch T, Bathon J, Boers M, Bombardier C, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Rheum 2008;59:1371-7.
19. Smolen JS, Breedveld FC, Eberl G, Jones I, Leeming M, Wylie GL, et al. Validity and reliability of the twenty-eight-joint count for the assessment of rheumatoid arthritis activity. Arthritis Rheum 1995;38:38-43.
20. Villaverde V, Balsa A, Cantalejo M, Fernandez-Prada M, Madero MR, Munoz-Fernandez S, et al. Activity indices in rheumatoid arthritis. J Rheumatol 2000;27:2576-81.
21. Greenwald MW, Fidelus-Gort R, Levy R, Liang J, Vaddi K, Williams WV, et al. A randomized dose-ranging, placebo-controlled study of INCB028050, a selective JAK1 and JAK2 inhibitor in subjects with active rheumatoid arthritis. Arthritis Rheum 2010;62 Suppl 10:2172.
22. 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.
23. O'Shea JJ, Schwartz DM, Villarino AV, Gadina M, McInnes IB, Laurence A. The JAK-STAT pathway: impact on human disease and therapeutic intervention. Ann Rev Med 2015;66:311-28.
24. 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 dosage levels of CP-690,550 versus placebo. Arthritis Rheum 2009;60:1895-905.
25. Kawashiri SY, Kawakami A, Yamasaki S, Imazato T, Iwamoto N, Fujikawa K, et al. Effects of the anti-interleukin-6 receptor antibody, tocilizumab, on serum lipid levels in patients with rheumatoid arthritis. Rheumatol Int 2011;31:451-6.
26. Nishimoto N, Yoshizaki K, Maeda K, Kuritani T, Deguchi H, Sato B, et al. Toxicity, pharmacokinetics, and dose-finding study of repetitive treatment with the humanized anti-interleukin 6 receptor antibody MRA in rheumatoid arthritis. Phase I/II clinical study. J Rheumatol 2003;30:1426-35.
27. Souto A, Salgado E, Maneiro JR, Mera A, Carmona L, Gomez-Reino JJ. Lipid profile changes in patients with chronic inflammatory arthritis treated with biologic agents and tofacitinib in randomized clinical trials: a systematic review and meta-analysis. Arthritis Rheumatol 2015;67:117-27.