Profile of tofacitinib citrate and its potential in the treatment of moderate-to-severe chronic plaque psoriasis

Drug Design, Development and Therapy

Volumn 10, Issue , 2016, Pages 533-539

  Di Lernia, V ^a   Bardazzi, F ^b  

^a S MARIA NUOVA HOSPITAL   (Italy)

^b UNIVERSITY OF BOLOGNA   (Italy)

Author keywords

Alopecia; JAKs; Systemic; Therapy; Treatment; Vitiligo

Indexed keywords

ALANINE AMINOTRANSFERASE; CREATININE; ETANERCEPT; HEMOGLOBIN; JANUS KINASE; PLACEBO; PROTEIN KINASE; TOFACITINIB; JANUS KINASE 3; PIPERIDINE DERIVATIVE; PROTEIN KINASE INHIBITOR; PYRIMIDINE DERIVATIVE; PYRROLE DERIVATIVE;

ALOPECIA AREATA; CARDIOVASCULAR DISEASE; CLINICAL TRIAL (TOPIC); DISEASE SEVERITY; DRUG EFFICACY; DRUG MECHANISM; DRUG RESPONSE; DRUG TOLERABILITY; DYSLIPIDEMIA; HERPES ZOSTER; HUMAN; LYMPHOCYTE COUNT; NEOPLASM; NEUTROPHIL COUNT; OPPORTUNISTIC INFECTION; PSORIASIS VULGARIS; REVIEW; RHINOPHARYNGITIS; SINUSITIS; TREATMENT OUTCOME; TUBERCULOSIS; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VITILIGO; ANTAGONISTS AND INHIBITORS; CHRONIC DISEASE; PSORIASIS;

CHRONIC DISEASE; CLINICAL TRIALS AS TOPIC; HUMANS; JANUS KINASE 3; PIPERIDINES; PROTEIN KINASE INHIBITORS; PSORIASIS; PYRIMIDINES; PYRROLES;

EID: 84957596192     PISSN: None     EISSN: 11778881     Source Type: Journal    
DOI: 10.2147/DDDT.S82599     Document Type: Review

References (62)

1. Di Lernia V, Ficarelli E, Lallas A, Ricci C. Familial aggregation of moderate to severe plaque psoriasis. Clin Exp Dermatol. 2014;39:801–805.
2. Boehncke WH. Etiology and pathogenesis of psoriasis. Rheum Dis Clin North Am. 2015;41:665–675.
3. Di Lernia V, Ficarelli E. Current therapeutic approaches of psoriasis are affected by age at disease onset. J Dermatolog Treat. 2014;25:15–17.
4. Henseler T, Christophers E. Psoriasis of early and late onset: characterization of two types of psoriasis vulgaris. J Am Acad Dermatol. 1985;13:450–456.
5. Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(Suppl 2):ii14–ii17.
6. Gelfand JM, Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006;11;296:1735–1741.
7. Gisondi P, Dalle Vedove C, Girolomoni G. Patients with psoriasis have a higher prevalence of parental cardiovascular disease. Dermatology. 2011;222:330–335.
8. Gisondi P, Targher G, Bardazzi F, et al. Pharmacological treatment of moderate-severe psoriasis in patients with cardio-metabolic comorbidities. G Ital Dermatol Venereol. 2014;149(Suppl 2):7–11.
9. Gisondi P, Tessari G, Conti A, et al. Prevalence of metabolic syndrome in patients with psoriasis: a hospital-based case-control study. Br J Dermatol. 2007;157:68–73.
10. Ryan C, Kirby B. Psoriasis is a systemic disease with multiple cardiovascular and metabolic comorbidities. Dermatol Clin. 2015;33: 41–55.
11. Mrowietz U, Kragballe K, Reich K, et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011;303:1–10.
12. Girolomoni G, Altomare G, Ayala F, et al. Differential management of mild-to-severe psoriasis with biologic drugs: an Italian Delphi consensus expert panel. J Dermatolog Treat. 2015;26:128–133.
13. Weger W. Current status and new developments in the treatment of psoriasis and psoriatic arthritis with biological agents. Br J Pharmacol. 2010;160:810–820.
14. Dubois DS, Pouliot R. Promising new treatments for psoriasis. Scientific World J. 2013;2013:980419.
15. Gniadecki R, Kragballe K, Dam TN, Skov L. Comparison of drug survival rates for adalimumab, etanercept and infliximab in patients with psoriasis vulgaris. Br J Dermatol. 2011;164:1091–1096.
16. Yeung H, Wan J, Van Voorhees AS, et al. Patient-reported reasons for the discontinuation of commonly used treatments for moderate to severe psoriasis. J Am Acad Dermatol. 2013;68:64–72.
17. Di Lernia V, Ricci C, Lallas A, Ficarelli E. Clinical predictors of non-response to any tumor necrosis factor (TNF) blockers: a retrospective study. J Dermatolog Treat. 2014;25:73–74.
18. Di Lernia V, Tasin L, Pellicano R, et al. Impact of body mass index on retention rates of anti-TNF-alfa drugs in daily practice for psoriasis. J Dermatolog Treat. 2012;23:404–409.
19. De Simone C, Amerio P, Amoruso G, et al. Immunogenicity of anti-TNFα therapy in psoriasis: a clinical issue? Expert Opin Biol Ther. 2013;13:1673–1682.
20. Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the national psoriasis foundation surveys, 2003–2011. JAMA Dermatol. 2013;149:1180–1185.
21. Mansouri Y, Goldenberg G. New systemic therapies for psoriasis. Cutis. 2015;95:155–160.
22. Patterson H, Nibbs R, McInnes I, Siebert S. Protein kinase inhibitors in the treatment of inflammatory and autoimmune diseases. Clin Exp Immunol. 2014;176:1–10.
23. Murray PJ. The JAK-STAT signaling pathway: input and output integration. J Immunol. 2007;178:2623–2629.
24. Velazquez L, Fellous M, Stark GR, Pellegrini S. A protein tyrosine kinase in the interferon α/β signaling pathway. Cell. 1992;70:313–322.
25. Muller M, Briscoe J, Laxton C, et al. The protein tyrosine kinase JAK1 complements defects in interferon-alpha/beta and -gamma signal transduction. Nature. 1993;366:129–135.
26. Darnell JE Jr, Kerr IM, Stark GR. Jak–STAT pathways and transcriptional activation in response to IFNs and other extracellular signalling proteins. Science. 1994;264:1415–1421.
27. O’Shea JJ, Gadina M, Schreiber RD. Cytokine signaling in 2002: new surprises in the Jak/Stat pathway. Cell. 2002;109:121–131.
28. Leonard WJ, O’Shea JJ. Jaks and STATs: biological implications. Annu Rev Immunol. 1998;16:293–322.
29. Lindstrom TM, Robinson WH. A multitude of kinases – which are the best targets in treating rheumatoid arthritis? Rheum Dis Clin North Am. 2010;36:367–383.
30. Ghoreschi K, Gadina M. JAKpot! New small molecules in autoimmune and inflammatory. Exp Dermatol. 2014;23:7–11.
31. Borie DC, O’Shea JJ, Changelian PS. JAK3 inhibition, a viable new modality of immunosuppression for solid organ transplants. Trends Mol Med. 2004;10:532–541.
32. Macchi P, Villa A, Giliani S, et al. Mutations of Jak-3 gene in patients with autosomal severe combined immune deficiency (SCID). Nature. 1995;377:65–68.
33. Chiricozzi A, Faleri S, Saraceno R, et al. Tofacitinib for the treatment of moderate-to-severe psoriasis. Expert Rev Clin Immunol. 2015;11:443–455.
34. Kyttaris VC. Kinase inhibitors: a new class of antirheumatic drugs. Drug Des Devel Ther. 2012;6:245–250.
35. Chang BY, Zhao F, He X, et al. JAK3 inhibition significantly attenuates psoriasiform skin inflammation in CD18 mutant PL/J mice. J Immunol. 2009;183:2183–2192.
36. 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.
37. Fridman JS, Scherle PA, Collins R, et al. Selective inhibition of JAK1 and JAK2 is efficacious in rodent models of arthritis: preclinical characterization of INCB028050. J Immunol. 2010;184:5298–5307.
38. Boy MG, Wang C, Wilkinson BE, et al. Double-blind, placebo-controlled, dose-escalation study to evaluate the pharmacologic effect of CP-690,550 in patients with psoriasis. J Invest Dermatol. 2009;129:2299–2302.
39. 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;73:2192–2198.
40. Ghoreschi K, Laurence A, O’Shea JJ. Janus kinases in immune cell signalling. Immunol Rev. 2009;228:273–287.
41. Hsu L, Armstrong AW. JAK inhibitors: treatment efficacy and safety profile in patients with psoriasis. J Immunol Res. 2014;2014:283617.
42. Pesu M, Laurence A, Kishore N, Zwillich SH, Chan G, O’Shea JJ. Therapeutic targeting of Janus kinases. Immunol Rev. 2008;223:132–142.
43. Papp KA, Menter MA, Abe M, et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015;173:949–961.
44. Bachelez H, van de Kerkhof PC, Strohal R, et al. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial. Lancet. 2015;386:552–561.
45. Bissonnette R, Iversen L, Sofen H, et al. Tofacitinib withdrawal and retreatment in moderate-to-severe chronic plaque psoriasis: a randomized controlled trial. Br J Dermatol. 2015;172:1395–1406.
46. Meyer DM, Jesson MI, Li X, et al. 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.
47. Winthrop KL, Park SH, Gul A, et al. Tuberculosis and other opportunistic infections in tofacitinib-treated patients with rheumatoid arthritis. Ann Rheum Dis. Epub 2015 Aug 28. doi:10.1136/annrheumdis-2015-207319.
48. Wollenhaupt J, Silverfield J, Lee EB, et al. Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open-label, long term extension studies. J Rheumatol. 2014;41:837–852.
49. Strand V, Ahadieh S, French J, et al. Systematic review and meta-analysis of serious infections with tofacitinib and biologic disease-modifying antirheumatic drug treatment in rheumatoid arthritis clinical trials. Arthritis Res Ther. 2015;17:362.
50. ® (tofacitinib) tablets [prescribing information]. New York: Pfizer Labs. 2012. Available from:http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203214s000lbl.pdf. Accessed 19 January, 2016.
51. Gupta P, Alvey C, Wang R, et al. Lack of effect of tofacitinib (CP-690,550) on the pharmacokinetics of the CYP3A4 substrate midazolam in healthy volunteers: confirmation of in vitro data. Br J Clin Pharmacol. 2012;74:109–115.
52. Ports WC, Khan S, Lan S, et al. A randomized phase 2a efficacy and safety trial of the topical Janus kinase inhibitor tofacitinib in the treatment of chronic plaque psoriasis. Br J Dermatol. 2013;169:137–145.
53. Ports WC, Feldman SR, Gupta P, et al. Randomized pilot clinical trial of tofacitinib solution for plaque psoriasis: challenges of the intra-subject study design. J Drugs Dermatol. 2015;14:777–784.
54. Lee EB, Fleischmann R, Hall S, et al. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014;370:2377–2386.
55. van Vollenhoven RF, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012;367:508–519.
56. Vivar N, Van Vollenhoven RF. Advances in the treatment of rheumatoid arthritis. F1000Prime Rep. 2014;6:31.
57. Brittany G, Craiglow, King BA. Killing two birds with one stone: oral tofacitinib reverses alopecia universalis in a patient with plaque psoriasis. J Invest Dermatol. 2014;134:2988–2990.
58. Craiglow BG, King BA. Tofacitinib citrate for the treatment of vitiligo: a pathogenesis-directed therapy. JAMA Dermatol. 2015;151:1110–1112.
59. Xing L, Dai Z, Jabbari A, et al. Alopecia areata is driven by cytotoxic T lymphocytes and is reversed by JAK inhibition. Nat Med. 2014;20:1043–1049.
60. Harel S, Higgins CA, Cerise JE, et al. Pharmacologic inhibition of JAK-STAT signaling promotes hair growth. Sci Adv. 2015;23;1:e1500973.
61. Rashighi M, Agarwal P, Richmond JM, et al. CXCL10 is critical for the progression and maintenance of depigmentation in a mouse model of vitiligo. Sci Transl Med. 2014;6:223.
62. Levy LL, Urban J, King BA. Treatment of recalcitrant atopic dermatitis with the oral Janus kinase inhibitor tofacitinib citrate. J Am Acad Dermatol. 2015;73:395–399.