Baricitinib for the treatment of rheumatoid arthritis and systemic lupus erythematosus: a 2019 update

References

• Smolen JS, Aletaha D, Bijlsma JW, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010;69(4):631–637.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Breedveld FC, Burmester GR, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Ann Rheum Dis. 2016;75(1):3–15.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Landewe R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76(6):960–977.
   PubMed Web of Science ®Google Scholar
• O‘Shea JJ, Plenge R. JAK and STAT signaling molecules in immunoregulation and immune-mediated disease. Immunity. 2012;36(4):542–550.
   PubMed Web of Science ®Google Scholar
• Kubo S, Yamaoka K, Maeshima K, et al. The possible mode of action of Tofacitinib, a JAK inhibitor. Inflamm Regen. 2014;34(3):129–133.
   Google Scholar
• Karaman MW, Herrgard S, Treiber DK, et al. A quantitative analysis of kinase inhibitor selectivity. Nat Biotechnol. 2008;26(1):127–132.
   PubMed Web of Science ®Google Scholar
• Ghoreschi K, Jesson MI, Li X, et al. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J Immunol. 2011;186:4234–4243.
   PubMed Web of Science ®Google Scholar
• Fridman J, Scherle P, Collins R, et al. Selective inhibition of JAK1 and JAK2 is efficacious in rodent models of arthritis: preclinical characterization of INCB028050. J Immunol. 2010;184(9):5298–5307.
   PubMed Web of Science ®Google Scholar
• Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2017;376(7):652–662.
   PubMed Web of Science ®Google Scholar
• Darnell JE Jr., Kerr IM, Stark GR. Jak-STAT pathways and transcriptional activation in response to IFNs and other extracellular signaling proteins. Science. 1994;264(5164):1415–1421.
   PubMed Web of Science ®Google Scholar
• Nakayamada S, Kubo S, Iwata S, et al. Recent progress in JAK inhibitors for the treatment of rheumatoid arthritis. BioDrugs. 2016;30(5):407–419.
   PubMed Web of Science ®Google Scholar
• Nakayamada S, Kubo S, Iwata S, et al. Chemical JAK inhibitors for the treatment of rheumatoid arthritis. Expert Opin Pharmacother. 2016;17:2215–2225.
   PubMed Web of Science ®Google Scholar
• Maeshima K, Yamaoka K, Kubo S, et al. The JAK inhibitor tofacitinib regulates synovitis through inhibition of interferon-gamma and interleukin-17 production by human CD4+ T cells. Arthritis Rheum. 2012;64(6):1790–1798.
   PubMed Web of Science ®Google Scholar
• Wang SP, Iwata S, Nakayamada S, et al. Tofacitinib, a JAK inhibitor, inhibits human B cell activation in vitro. Ann Rheum Dis. 2014;73(12):2213–2215.
   PubMed Web of Science ®Google Scholar
• Kubo S, Yamaoka K, Kondo M, et al. The JAK inhibitor, tofacitinib, reduces the T cell stimulatory capacity of human monocyte-derived dendritic cells. Ann Rheum Dis. 2014;73(12):2192–2198.
   PubMed Web of Science ®Google Scholar
• Kubo S, Nakayamada S, Tanaka Y. Baricitinib for the treatment of rheumatoid arthritis. Expert Rev Clin Immunol. 2016;12(9):911–919.
   PubMed Web of Science ®Google Scholar
• Shi JG, Chen X, Lee F, et al. The pharmacokinetics, pharmacodynamics, and safety of baricitinib, an oral JAK 1/2 inhibitor, in healthy volunteers. J Clin Pharmacol. 2014;54(12):1354–1361.
   PubMed Web of Science ®Google Scholar
• McInnes I, Higgs R, Lee J et al. Ex vivo comparison of baricitinib, upadacitinib, filgotinib, and tofacitinib for cytokine signaling in human leukocyte subpopulations. ACR/ARHP Annual Meeting. ABSTRACT NUMBER: 2870. 2017 Nov 7, San Diego
   Google Scholar
• Eli Lilly C Lilly FDA advisory committee meeting NDA 207924 briefing document. [cited 2019 Apr 03]. Available from: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM605062.pdf.
   Google Scholar
• Kubo S, Nakayamada S, Sakata K, et al. Janus kinase inhibitor baricitinib modulates human innate and adaptive immune system. Front Immunol. 2018;9:1510.
   PubMed Web of Science ®Google Scholar
• Yoneyama M, Suhara W, Fukuhara Y, et al. Direct triggering of the type I interferon system by virus infection: activation of a transcription factor complex containing IRF-3 and CBP/p300. Embo J. 1998;17(4):1087–1095.
   PubMed Web of Science ®Google Scholar
• Sato M, Tanaka N, Hata N, et al. Involvement of the IRF family transcription factor IRF-3 in virus-induced activation of the IFN-beta gene. FEBS Lett. 1998;425(1):112–116.
   PubMed Web of Science ®Google Scholar
• Sato M, Hata N, Asagiri M, et al. Positive feedback regulation of type I IFN genes by the IFN-inducible transcription factor IRF-7. FEBS Lett. 1998;441(1):106–110.
   PubMed Web of Science ®Google Scholar
• Honda K, Yanai H, Negishi H, et al. IRF-7 is the master regulator of type-I interferon-dependent immune responses. Nature. 2005;434(7034):772–777.
   PubMed Web of Science ®Google Scholar
• Honda K, Taniguchi T. IRFs: master regulators of signalling by Toll-like receptors and cytosolic pattern-recognition receptors. Nat Rev Immunol. 2006;6(9):644–658.
   PubMed Web of Science ®Google Scholar
• Mitchell TS, Moots RJ, Wright HL. Janus kinase inhibitors prevent migration of rheumatoid arthritis neutrophils towards interleukin-8, but do not inhibit priming of the respiratory burst or reactive oxygen species production. Clin Exp Immunol. 2017;189(2):250–258.
   PubMed Web of Science ®Google Scholar
• Karonitsch T, Beckmann D, Dalwigk K, et al. Targeted inhibition of Janus kinases abates interfon gamma-induced invasive behaviour of fibroblast-like synoviocytes. Rheumatology (Oxford). 2018;57(3):572–577.
   PubMed Web of Science ®Google Scholar
• Li P, Li M, Lindberg MR, et al. PAD4 is essential for antibacterial innate immunity mediated by neutrophil extracellular traps. J Exp Med. 2010;207(9):1853–1862.
   PubMed Web of Science ®Google Scholar
• Kubo S, Nakayamada S, Yoshikawa M, et al. peripheral immunophenotyping identifies three subgroups based on T Cell heterogeneity in lupus patients. Arthritis Rheumatol. 2017;69(10):2029–2037.
   PubMed Web of Science ®Google Scholar
• Fleischmann R, Schiff M, van der Heijde D, et al. Baricitinib, methotrexate, or combination in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Rheumatol. 2017;69(3):506–517.
   PubMed Web of Science ®Google Scholar
• Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017;76(1):88–95.
   PubMed Web of Science ®Google Scholar
• Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374(13):1243–1252.
   PubMed Web of Science ®Google Scholar
• Keystone EC, Taylor PC, Tanaka Y, et al. Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study. Ann Rheum Dis. 2017;76(11):1853–1861.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Kremer JM, Gaich CL, et al. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). Ann Rheum Dis. 2017;76(4):694–700.
   Google Scholar
• Ummarino D. Rheumatoid arthritis: RA-BEACON illuminates baricitinib. Nat Rev Rheumatol. 2016;12:313.
   Google Scholar
• Genovese MC, Kremer JM, Kartman CE, et al. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. Rheumatology (Oxford). 2018;57(5):900–908.
   PubMed Web of Science ®Google Scholar
• van der Heijde D, Durez P, Schett G, et al. Structural damage progression in patients with early rheumatoid arthritis treated with methotrexate, baricitinib, or baricitinib plus methotrexate based on clinical response in the phase 3 RA-BEGIN study. Clin Rheumatol. 2018;37(9):2381–2390.
   PubMed Web of Science ®Google Scholar
• van der Heijde D, Dougados M, Chen YC, et al. Effects of baricitinib on radiographic progression of structural joint damage at 1 year in patients with rheumatoid arthritis and an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open. 2018;4(1):e000662.
   PubMedGoogle Scholar
• Hetland ML, Jensen DV, Krogh NS. Monitoring patients with rheumatoid arthritis in routine care: experiences from a treat-to-target strategy using the DANBIO registry. Clin Exp Rheumatol. 2014;32(5 Suppl 85):S-141–146.
   Web of Science ®Google Scholar
• Takeuchi T, Genovese MC, Haraoui B, et al. Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study. Ann Rheum Dis. 2019;78(2):171–178.
   Google Scholar
• Winthrop KL. The emerging safety profile of JAK inhibitors in rheumatic disease. Nat Rev Rheumatol. 2017;13(4):234–243.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Genovese MC, Takeuchi T, et al. Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment. J Rheumatol. 2019;46(1):7–18.
   PubMed Web of Science ®Google Scholar
• Tanaka Y, Ishii T, Cai Z, et al. Efficacy and safety of baricitinib in Japanese patients with active rheumatoid arthritis: A 52-week, randomized, single-blind, extension study. Mod Rheumatol. 2018;28(1):20–29.
   PubMed Web of Science ®Google Scholar
• Tanaka Y, Atsumi T, Amano K, et al. Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis: subgroup analyses of four multinational phase 3 randomized trials. Mod Rheumatol. 2018;28(4):583–591.
   PubMed Web of Science ®Google Scholar
• Tanaka Y, McInnes IB, Taylor PC, et al. Characterization and changes of lymphocyte subsets in baricitinib-treated patients with rheumatoid arthritis: an integrated analysis. Arthritis Rheumatol. 2018;70:1923–1932.
   Web of Science ®Google Scholar
• Hahn B. Systemic Lupus Erythematosus. In: Jameson J, Fauci A, Kasper D, et al., editors. Harrison‘s principles of internal medicine. New York City: McGraw-Hill Education; 2018. p. 2515–2526.
   Google Scholar
• van Vollenhoven RF, Mosca M, Bertsias G, et al. Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. Ann Rheum Dis. 2014;73(6):958–967.
   PubMed Web of Science ®Google Scholar
• Bertsias G, Ioannidis JP, Boletis J, et al. EULAR recommendations for the management of systemic lupus erythematosus. Report of a task force of the EULAR standing committee for international clinical studies including therapeutics. Ann Rheum Dis. 2008;67(2):195–205.
   PubMed Web of Science ®Google Scholar
• Tanaka Y, Kubo S, Iwata S, et al. B cell phenotypes, signaling and their roles in secretion of antibodies in systemic lupus erythematosus. Clin Immunol. 2018;186:21–25.
   PubMed Web of Science ®Google Scholar
• Navarra SV, Guzman RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721–731.
   PubMed Web of Science ®Google Scholar
• Zhang F, Bae SC, Bass D, et al. A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea. Ann Rheum Dis. 2018;77(3):355–363.
   PubMed Web of Science ®Google Scholar
• Wallace DJ, Furie RA, Tanaka Y, et al. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2018;392(10143):222–231.
   PubMed Web of Science ®Google Scholar
• Okada Y, Wu D, Trynka G, et al. Genetics of rheumatoid arthritis contributes to biology and drug discovery. Nature. 2014;506(7488):376–381.
   PubMed Web of Science ®Google Scholar
• Haendel MA, Chute CG, Robinson PN. Classification, ontology, and precision medicine. N Engl J Med. 2018;379(15):1452–1462.
   PubMed Web of Science ®Google Scholar
• Nakayamada S, Kubo S, Yoshikawa M, et al. Differential effects of biological DMARDs on peripheral immune cell phenotypes in patients with rheumatoid arthritis. Rheumatology (Oxford). 2018;57(1):164–174.
   PubMed Web of Science ®Google Scholar