A review of tofacitinib efficacy in rheumatoid arthritis patients who have had an inadequate response or intolerance to methotrexate

Expert Opinion on Pharmacotherapy

Volumn 18, Issue 14, 2017, Pages 1525-1533

  Fleischmann, Roy ^a  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

Author keywords

clinical trials; kinase inhibition; monotherapy; rheumatoid arthritis; Tofacitinib

Indexed keywords

JANUS KINASE; METHOTREXATE; TOFACITINIB; ANTIRHEUMATIC AGENT; JANUS KINASE INHIBITOR; PIPERIDINE DERIVATIVE; PYRIMIDINE DERIVATIVE; PYRROLE DERIVATIVE;

DIGESTIVE SYSTEM PERFORATION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; HERPES ZOSTER; HUMAN; INFECTION; MONOTHERAPY; NON MELANOMA SKIN CANCER; OPPORTUNISTIC INFECTION; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RHEUMATOID ARTHRITIS; TUBERCULOSIS; COMBINATION DRUG THERAPY; TREATMENT OUTCOME;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DRUG THERAPY, COMBINATION; HUMANS; JANUS KINASE INHIBITORS; METHOTREXATE; PIPERIDINES; PYRIMIDINES; PYRROLES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 85028522696     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1080/14656566.2017.1370453     Document Type: Review

References (52)

1. Olsen NJ, Stein CM., New drugs for rheumatoid arthritis. N Engl J Med. 2004;350(21):2167–2179.
2. Strand V, Singh JA., Improved health-related quality of life with effective disease-modifying antirheumatic drugs: evidence from randomized controlled trials. Am J Manag Care. 2007;13(Suppl 9):S237- S251.
3. 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.
4. Singh JA, Saag KG, Bridges SL, Jr., et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2016;68(1):1–26.
5. 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.
6. 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.
7. Klareskog L, Van Der Heijde D, De Jager J, 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(9410):675–681.
8. Emery P, Fleischmann RM, Moreland L, et al. Golimumab, a human anti-TNF-ɑ monoclonal antibody, injected subcutaneously every 4 weeks in MTX-naive patients with active rheumatoid arthritis: 24-week results of a phase 3, multicenter, randomized, double-blind, placebo-controlled study (GO-BEFORE study). Arthritis Rheum. 2009;60(8):2272–2283.
9. Emery P, Burmester G, Bykerk V, et al. Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period. Ann Rheum Dis. 2015;74(1):19–26.
10. Burmester G, Rigby W, Van Vollenhoven R, et al. Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial. Ann Rheum Dis. 2017;76(7):1279–1284.
11. Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006;54(5):1390–1400.
12. Hodge J, Kawabata T, Krishnaswami S, et al. The mechanism of action of tofacitinib–an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2016;34:318–328.
13. McInnes I, Liew F. Cytokine networks - towards new therapies for rheumatoid arthritis. Nat Clin Pract Rheumatol. 2005;1:31–39.
14. O’Shea J. Targeting the JAK/STAT pathway for immunosuppression. Ann Rheum Dis. 2004;63(Suppl. 2):ii67–ii71.
15. Mavers M, Ruderman E, Perlman H. Intracellular signal pathways: potential for therapies. Curr Rheumatol Rep. 2009;11:378–385.
16. O’Sullivan L, Liongue C, Lewis R, et al. Ward A: cytokine receptor signaling through the JAK-STAT-SOCS pathway in disease. Mol Immunol. 2007;44:2497–2506.
17. McInnes I, Schett G. Cytokines in the pathogenesis of rheumatoid arthritis. Nat Rev Immunol. 2007;7:429–442.
18. Lubberts E. Th17 cytokines and arthritis. Semin Immunopathol. 2010;32:43–53.
19. Ghoreschi K, Laurence A, O’Shea JJ. Janus kinases in immune cell signaling. Immunol Rev. 2009;228:273–287.
20. West K. CP-690550, a JAK3 inhibitor as an immunosuppressant for the treatment of rheumatoid arthritis, transplant rejection, psoriasis and other immune-mediated disorders. Curr Opin Investig Drugs. 2009;10:491–504.
21. 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.
22. Dougados M, Van Der Heijde D, Chen Y, 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.
23. Genovese M, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374(13):1243–1252.
24. Taylor P, Keystone E, Van Der Heijde D, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2017;376(7):642–652.
25. Felson D, Anderson J, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38(6):727–735.
26. ClinicalTrials.gov Identifier:NCT01885078
27. Westhovens R, Taylor P, Alten R, et al. 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 (DARWIN 1). Ann Rheum Dis. 2017;76(6):998–1008.
28. Kavanaugh A, Kremer J, Ponce L, et al. 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 (DARWIN 2). Ann Rheum Dis. 2017;76(6):1009–1019.
29. Genovese M, Smolen J, Weinblatt M, 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(12):2857–2866.
30. Kremer J, Emery P, Camp H, et al. A phase IIb study of ABT-494, a selective JAK-1 inhibitor, in patients with rheumatoid arthritis and an inadequate response to anti-tumor necrosis factor therapy. Arthritis Rheumatol. 2016;68(12):2867–2877.
31. Takeuchi T, Tanaka Y, Iwasaki M, et al. Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study. Ann Rheum Dis. 2016;75(6):1057–1064.
32. Genovese M, Greenwald M, Codding C, et al. Peficitinib, a JAK inhibitor, in combination with limited conventional synthetic disease-modifying antirheumatic drugs in the treatment of moderate-to-severe rheumatoid arthritis. Arthritis Rheumatol. 2017;69(5):932–942.
33. Kivitz A, Gutierrez-Urena S, Poiley J, et al. Peficitinib, a JAK inhibitor, in the treatment of moderate-to-severe rheumatoid arthritis in patients with an inadequate response to methotrexate. Arthritis Rheumatol. 2017;69(4):709–719.
34. Fleischmann R, Damjanov N, Kivitz A, et al. A randomized, double-blind, placebo-controlled, twelve-week, dose-ranging study of decernotinib, an oral selective JAK-3 inhibitor, as monotherapy in patients with active rheumatoid arthritis. Arthritis Rheumatol. 2015;67(2):334–343.
35. Karaman M, Herrgard S, Treiber D, et al. A quantitative analysis of kinase inhibitor selectivity. Nat Biotechnol. 2008;26:127–132.
36. Meyer D, Jesson M. 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.
37. Murray PJ. The JAK-STAT signaling pathway: input and output integration. J Immunol. 2007;178(5):2623–2629.
38. O’Sullivan L, Liongue C, Lewis R, et al. Cytokine receptor signaling through the JAK-STAT-SOCS pathway in disease. Mol Immunol. 2007;44(10):2497–2506.
39. Jiang J, Ghoreschi K, Deflorian F, et al. Examining the chirality, conformation and selective kinase inhibition of 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d] pyrimidin-4-yl) amino) piperidin-1-y l)-3-oxopropanenitrile (CP-690,550). J Med Chem. 2008;51(24):8012–8018.
40. Yamaoka K. Benefit and risk of tofacitinib in the treatment of rheumatoid arthritis: a focus on herpes zoster. Drug Saf. 2016;39(9):823–840.
41. Van Vollenhoven R, Choy E, Lee E, et al. Tofacitinib, an oral Janus kinase inhibitor, in the treatment of rheumatoid arthritis: changes in lymphocytes and lymphocyte subset counts and reversibility after up to 8 years of tofacitinib treatment. Ann Rheum Dis. 2016;75(Supplement 2):258. EULAR 2016 Abstract THU0199.
42. Nakayamada S, Kubo S, Iwata S, et al. Chemical JAK inhibitors for the treatment of rheumatoid arthritis. Expert Opin Pharmacother. 2016;17:2215–2225.
43. Fleischmann R, Cutolo M, Genovese, 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(3):617–629.
44. Fleischmann R, Kremer J, Cush J, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012;367(6):495–507.
45. Lee EB, Fleischmann R, Hall S, et al. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014;370:2377–2386.
46. Fleischmann R, Mysler E, Hall S, et al. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Lancet. 2017;390(10093),457–468.
47. Cohen SB, Tanaka Y, Mariette X, et al. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017;76:1253–1262.
48. Curtis J, Xie F, Yun H, et al. Real-world comparative risks of herpes virus infections in tofacitinib and biologic-treated patients with rheumatoid arthritis. Ann RheumDis. 2016;75(10):1843–1847.
49. Federal drug administration prescribing information for tofacitinib. Accessed on August 21, 2017 at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203214Orig1s000TOC.cfm
50. European Commission prescribing (EC) for tofacitinib. Accessed on August 20, 2017 at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004214/human_med_001662.jsp
51. Japanese Ministry of Health, Labor and Welfare (MHLW) prescribing information for tofacitinib. Accessed on August 20, 2017 at http://press.pfizer.com/press-release/xeljanz-tofacitinib-citrate-approved-japan-treatment-adults-rheumatoid-arthritis-ra
52. Fleischmann R, Huizinga T, Kavanaugh A, et al. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open.2016;2(2):e000262.