BIOLOGIC ARMAMENTARIUM IN PSORIASIS

  • Ganesh Pai Medical Director, Derma-Care ‘The Trade Centre’, Bunts Hostel Road, Mangalore -575 003. Karnataka, India.
  • Nithin Sashidharan Clinical Pharmacologist, Bangalore, Karnataka, India

Abstract

Psoriasis is an autoimmune disease and further classed as a chronic inflammatory skin condition serving as global burden. Moderate to severe psoriasis can be treated with conventional therapies. Less efficacy, poor patient compliance and toxicity issues were the major problems associated with conventional therapies. The introduction of biologic therapy has great impression on psoriatic treatment duration and enhanced quality of life in psoriasis patients. The new biologic therapies are tailor made medications with goal of more specific and effective treatment; less toxicity. The biologic therapy is aimed to target antigen presentation and co-stimulation, T-cell activation and leukocyte adhesion; and pro-inflammatory cascade. They act as effective and safer substitute to traditional therapy. Secukinumab, certolizumab, itolizumab, golimumab, ustekinumab, adalimumab, infliximab etanercept, alefacept etc. are the approved biologic with global market. This review briefs about psoriasis pathogenesis, traditional treatments and biologic therapies potential.

References

1. Khandpur S, Bhari N. Newer targeted therapies in psoriasis. Indian J
Dermatol Venereol Leprol 2013;79 Suppl 7:S47-52.
2. Available from: http://www.psoriasis.org/about-psoriasis/treatments/
severity. [Last accessed on 2015 Feb 11].
3. Sivamani RK, Correa G, Ono Y, Bowen MP, Raychaudhuri SP,
Maverakis E. Biological therapy of psoriasis. Indian J Dermatol
2010;55(2):161-70.
4. Sanchez AP. Immunopathogenesis of psoriasis. An Bras Dermatol
2010;85(5):747-9.
5. Rahman M, Alam K, Ahmad MZ, Gupta G, Afzal M, Akhter S, et al.
Classical to current approach for treatment of psoriasis: A review.
Endocr Metab Immune Disord Drug Targets 2012;12(3):287-302.
6. Available from: http://www.the-dermatologist.com/content/
immunopathogenesis-psoriasis-and-mechanism-biologics. [Last
accessed on 2015 Feb 11].
7. Das RP, Jain AK, Ramesh V. Current concepts in the pathogenesis of
psoriasis. Indian J Dermatol 2009;54(1):7-12.
8. Panchal MR, Coope H, McKenna DJ, Alexandroff AB. Long-term
safety of biologics in the treatment of psoriasis. Psoriasis Targets Ther
2014;4:1-9.
9. Di Nuzzo S, Feliciani C, Cortelazzi C, Fabrizi G, Pagliarello C.
Immunopathogenesis of psoriasis: Emphasis on the role of Th17 Cells.
Int Trends Immun 2014;2(3):111-5.
10. Zheng Y, Danilenko DM, Valdez P, Kasman I, Eastham-Anderson J,
Wu J, et al. Interleukin-22, a T(H)17 cytokine, mediates IL-23-induced
dermal inflammation and acanthosis. Nature 2007;445(7128):648-51.
11. Available from: http://www.psoriasis.org/document.doc?id=354. [Last
downloaded on 2015 Feb 11].
12. Alshobaili HA, Shahzad M, Al-Marshood A, Khalil A, Settin A,
Barrimah I. Genetic background of psoriasis. Int J Health Sci (Qassim)
2010;4(1):23-9.
13. Heller MM, Lee ES, Koo JY. Stress as an influencing factor in psoriasis.
Skin Therapy Lett 2011;16(5):1-4.
14. Asokan N, Prathap P, Rejani P. Severity of psoriasis among adult males
is associated with smoking, not with alcohol use. Indian J Dermatol
2014;59:237-40.
15. Dogra S, Yadav S. Psoriasis in India: Prevalence and pattern. Indian J
Dermatol Venereol Leprol 2010;76(6):595-601.
16. Dogra A, Sachdeva S. Biologic therapy in psoriasis. Indian J Dermatol
Venereol Leprol 2006;72(4):256-64.
17. Parrish JA. Treatments for severe psoriasis. Pharmcol Ther
1981;15(2):313-20.
18. Lebwohl M, Ting PT, Koo JY. Psoriasis treatment: Traditional therapy.
Ann Rheum Dis 2005;64 Suppl 2:ii83-6.
19. Li K, Armstrong AW. A review of health outcomes in patients with
psoriasis. Dermatol Clin 2012;30(1):61-72, viii.
20. Uva L, Miguel D, Pinheiro C, Antunes J, Cruz D, Ferreira J, et al.
Mechanisms of action of topical corticosteroids in psoriasis. Int J
Endocrinol 2012;2012:561018.
21. Kim GK. The rationale behind topical vitamin d analogs in the treatment
of psoriasis: Where does topical calcitriol fit in? J Clin Aesthet Dermatol
2010;3(8):46-53.
22. Fluhr JW, Cavallotti C, Berardesca E. Emollients, moisturizers, and
keratolytic agents in psoriasis. Clin Dermatol 2008;26(4):380-6.
23. Reynolds NJ, Al-Daraji WI. Calcineurin inhibitors and sirolimus:
Mechanisms of action and applications in dermatology. Clin Exp
Dermatol 2002;27(7):555-61.
24. Norris DA, Mechanisms of action of topical therapies and the rationale for
combination therapy. J Am Acad Dermatol 2005;53 1 Suppl 1:S17-25.
25. McGill A, Frank A, Emmett N, Turnbull DM, Birch-Machin MA,
Reynolds NJ. The anti-psoriatic drug anthralin accumulates in
keratinocyte mitochondria, dissipates mitochondrial membrane potential, and induces apoptosis through a pathway dependent on
respiratory competent mitochondria. FASEB J 2005;19(8):1012-4.
26. Kostovic K, Pasic A. Phototherapy of psoriasis: Review and update.
Acta Dermatovenerol Croat 2004;12(1):42-50.
27. Adachi Y, Uchida N, Matsuo T, Horio T. Clinical effect of vitamin D3
analogues is not inactivated by subsequent UV exposure. Photodermatol
Photoimmunol Photomed 2008;24(1):16-8.
28. Lebwohl M, Quijije J, Gilliard J, Rollin T, Watts O. Topical calcitriol is
degraded by ultraviolet light. J Invest Dermatol 2003;121(3):594-5.
29. Guidelines for the Management of Psoriasis. Available from: http://
www.dermnetnz.org/doctors/guidelines/psoriasis-guidelines.html.
30. Cooper KD, Voorhees JJ, Fisher GJ, Chan LS, Gupta AK, Baadsgaard
O. Effects of cyclosporine on immunologic mechanisms in psoriasis.
J Am Acad Dermatol 1990;23:1318-26.
31. Roll A, Reich K, Boer A. Use of fumaric acid esters in psoriasis. Indian
J Dermatol Venereol Leprol 2007;73(2):133-7.
32. Mydlarski PR. Mycophenolate mofetil: A dermatologic perspective.
Skin Therapy Lett 2005;10(3):1-6.
33. Yamauchi PS, Rizk D, Kormeili T, Patnaik R, Lowe NJ. Current
systemic therapies for psoriasis: Where are we now? J Am Acad
Dermatol 2003;49 2 Suppl: S66-77.
34. Sanford M, McKeage K. Secukinumab: First global approval. Drugs
2015;75(3):329-38.
35. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/DermatologicandOphthalmic
DrugsAdvisoryCommittee/UCM419023.pdf.
36. Girolomoni G, Mrowietz U, Paul C. Psoriasis: Rationale for targeting
interleukin-17. Br J Dermatol 2012;167:717-24.
37. Qu N, Xu M, Mizoguchi I, Furusawa J, Kaneko K, Watanabe K, et al.
Pivotal roles of T-helper 17-related cytokines, IL-17, IL-22, and IL-23,
in inflammatory diseases. Clin Dev Immunol 2013;2013:968549.
38. Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K,
et al. Secukinumab in plaque psoriasis 7esults of two phase 3 trials.
N Engl J Med 2014;371(4):326-38.
39. Ohtsuki M, Morita A, Abe M, Takahashi H, Seko N, Karpov A, et al.
Secukinumab efficacy and safety in Japanese patients with moderateto-severe
plaque
psoriasis:
Subanalysis
from
ERASURE,
a randomized,

placebo-controlled,
phase 3 study.
J
Dermatol
2014;41(12):1039-46.
40. Blauvelt A, Prinz JC, Gottlieb AB, Kingo K, Sofen H, Ruer-Mulard M,
et al. Secukinumab administration by pre-filled syringe: Efficacy, safety
and usability results from a randomized controlled trial in psoriasis
(FEATURE). Br J Dermatol 2015;172(2):484-93.
41. Paul C, Lacour JP, Tedremets L, Kreutzer K, Jazayeri S, Adams S,
et al. Efficacy, safety and usability of secukinumab administration
by autoinjector/pen in psoriasis: A randomized, controlled trial
(JUNCTURE). J Eur Acad Dermatol Venereol 2015;29(6):1082-90.
42. Mrowietz U, Leonardi C, Girolomoni G, Toth D, Morita A, Balki S,
et al. Secukinumab ‘‘fixed-interval’’ vs. ‘‘retreatment-as-needed’’
regimen for moderate-to severe plaque psoriasis: A study comparing
secukinumab use in long-term psoriasis maintenance therapy
(SCULPTURE). Oral Presentation at: 22
Annual Congress of the
European Academy of Dermatology and Venereology; October 2-6,
2013; Istanbul, Turkey.
nd
43. Gisondi P, Dalle Vedove C, Girolomoni G. Efficacy and safety of
secukinumab in chronic plaque psoriasis and psoriatic arthritis therapy.
Dermatol Ther (Heidelb) 2014;4(1):1-9.
44. Available from: http://www.fda.gov/downloads/advisorycommittees/
committeesmeetingmaterials/drugs/arthritisadvisorycommittee/
ucm361565.pdf. [Last accessed on 2015 Feb 12].
45. Available from: http://www.ukmi.nhs.uk/applications/ndo/record_
view_open.asp?newDrugID=5013. [Last accessed on 2015 Feb 12].
46. Cimzia® EU Summary of Product Characteristics. Available from:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_
Product_Info. [Last accessed on 2015 Feb 12].
47. Hansen RB, Kavanaugh A. Certolizumab pegol for the treatment of
psoriatic arthritis. Expert Rev Clin Immunol 2015;11:307-18.
48. Chimenti MS, Saraceno R, Chiricozzi A, Giunta A, Chimenti S,
Perricone R. Profile of certolizumab and its potential in the treatment of
psoriatic arthritis. Drug Des Devel Ther 2013;7:339-48.
49. Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, et al.
Successful treatment of moderate to severe plaque psoriasis with the
PEGylated Fab’ certolizumab pegol: Results of a phase II randomized,
placebo-controlled trial with a re-treatment extension. Br J Dermatol
2012;167(1):180-90.
50. Mease PJ, Fleischmann R, Deodhar AA, Wollenhaupt J, Khraishi M,
Kielar D, et al. Effect of certolizumab pegol on signs and symptoms in
patients with psoriatic arthritis: 24-week results of a Phase 3 double-
blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum
Dis 2014;73(1):48-55.
51. Gladman D, Fleischmann R, Coteur G, Woltering F, Mease PJ. Effect of
certolizumab pegol on multiple facets of psoriatic arthritis as reported
by patients: 24-week patient-reported outcome results of a phase III,
multicenter study. Arthritis Care Res (Hoboken) 2014;66(7):1085-92.
52. Ferrante M, Vermeire S, Rutgeerts PJ. Drug safety evaluation of
certolizumab pegol. Expert Opin Drug Saf 2014;13(2):255-66.
53. Prescribing Information of CIMZIA. Available from: http://www.
cimzia.com/assets/pdf/Prescribing_Information.pdf. [Last accessed on
2015 Feb 12].
54. Budamakuntla L, Madaiah M, Sarvajnamurthy S, Kapanigowda S.
Itolizumab provides sustained remission in plaque psoriasis: A 5-year
follow-up experience. Clin Exp Dermatol 2015;40(2):152-5.
55. Le Dantec C, Alonso R, Fali T, Montero E, Devauchelle V, Saraux A,
et al. Rationale for treating primary Sjögren’s syndrome patients
with an anti-CD6 monoclonal antibody (Itolizumab). Immunol Res
2013;56(2-3):341-7.
56. Dubel S, Reichert JM. Itolizumab (Alzumab®), mogamulizumab
(Poteligeo®), and tositumomab (Bexxar®). In: Handbook of
Therapeutic Antibodies. 2
ed. Weinheim, Germany: Wiley-Blackwell
Press; 2014. p. 2113-214.
nd
57. Reichert JM. Antibodies to watch in 2013: Mid-year update. MAbs
2013;5(4):513-7.
58. Precribing Information of Alzumab. Available from: http://www.
biocon.com/docs/prescribing_information/immunotherapy/alzumab_
pi.pdf.
59. Krupashankar DS, Dogra S, Kura M, Saraswat A, Budamakuntla L,
Sumathy TK, et al. Efficacy and safety of itolizumab, a novel antiCD6
monoclonal antibody,
in patients
with
moderate
to
severe
chronic

plaque
psoriasis:
Results of
a double-blind,
randomized,
placebocontrolled,
phase-III study.
J
Am
Acad
Dermatol 2014;71(3):484-92.
60. FDA Approval History for Stelara. Available from: http://www.drugs.
com/history/stelara.html.
61. Benson J, Orlovsky Y, Luo J, Wu SJ, Lacy E, Li J. Ustekinumab
neutralizes human IL-12 and IL-23 mediated Th1 and Th17 cell
function and provides clinical benefit to patients with plaque psoriasis.
FASEB J 2008;22:664.14.
62. Koutruba N, Emer J, Lebwohl M. Review of ustekinumab, an
interleukin-12 and interleukin-23 inhibitor used for the treatment of
plaque psoriasis. Ther Clin Risk Manag 2010;6:123-41.
63. Harrington LE, Hatton RD, Mangan PR, Turner H, Murphy TL,
Murphy KM, et al. Interleukin 17-producing CD4 effector T cells
develop via a lineage distinct from the T helper type 1 and 2 lineages.
Nat Immunol 2005;6(11):1123-32.
64. Leonardi CL, Kimball AB, Papp KA, Yeilding N, Guzzo C, Wang Y,
et al. Efficacy and safety of ustekinumab, a human interleukin-12/23
monoclonal antibody, in patients with psoriasis: 76-week results from
a randomised, double-blind, placebo-controlled trial (PHOENIX 1).
Lancet 2008;371(9625):1665-74.
65. Papp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, Yeilding N,
et al. Efficacy and safety of ustekinumab, a human interleukin-12/23
monoclonal antibody, in patients with psoriasis: 52-week results from
a randomised, double-blind, placebo-controlled trial (PHOENIX 2).
Lancet 2008;371(9625):1675-84.
66. Griffiths CE, Strober B, Fidelus-Gort R, Menter A. A phase 3,
multicenter, randomized study comparing ustekinumab and etanercept
for the treatment of moderate to severe plaque psoriasis. P3318. AAD
Meeting, San Francisco; 2009.
67. McInnes IB, Kavanaugh A, Gottlieb AB, Puig L, Rahman P, Ritchlin C,
et al. Efficacy and safety of ustekinumab in patients with active psoriatic
arthritis: 1 year results of the phase 3, multicentre, double-blind,
placebo-controlled PSUMMIT 1 trial. Lancet 2013;382(9894):780-9.
68. The Drug Bank Database. Available from: http://www.drugbank.ca/
drugs/DB00051.
69. FDA Approves Humira for Rheumatoid Arthritis. Available from:
http://www.drugs.com/newdrugs/fda-approves-humira-rheumatoidarthritis-77.html.
70. Summary Product Characteristics of Humira. Available
from: http://www.ec.europa.eu/health/documents/community
register/2003/200309086865/anx_6865_en.pdf.
71. Vena GA, Cassano N. Drug focus: Adalimumab in the treatment of
moderate to severe psoriasis. Biologics 2007;1(2):93-103.
72. Gordon KB, Langley RG, Leonardi C, Toth D, Menter MA, Kang S, et al.
Clinical response to adalimumab treatment in patients with moderate to
severe psoriasis: Double-blind, randomized controlled trial and openlabel
extension study.
J
Am
Acad
Dermatol 2006;55(4):598-606.
73. Saurat JH, Stingl G, Dubertret L, Papp K, Langley RG, Ortonne JP, et al.
Efficacy and safety results from the randomized controlled comparative
study of adalimumab vs. methotrexate vs. placebo in patients with
psoriasis (CHAMPION). Br J Dermatol 2008;158(3):558-66.
74. Alwawi EA, Mehlis SL, Gordon KB. Treating psoriasis with
adalimumab. Ther Clin Risk Manag 2008;4(2):345-51.
75. Saurat JH, Langley RG, Reich K, Unnebrink K, Sasso EH,
Kampman W. Relationship between methotrexate dosing and clinical
response in patients with moderate to severe psoriasis: Subanalysis of
the CHAMPION study. Br J Dermatol 2011;165(2):399-406.
76. Menter A, Tyring SK, Gordon K, Kimball AB, Leonardi CL,
Langley RG, et al. Adalimumab therapy for moderate to severe
psoriasis: A randomized, controlled phase III trial. J Am Acad Dermatol
2008;58(1):106-15.
77. Nicolazzo D, Kerdel F, Kerdel F. Critical appraisal of adalimumab
in the treatment of chronic plaque psoriasis. Psoriasis Targets Ther
2014;4:11-8.
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How to Cite
Pai, G., and N. Sashidharan. “BIOLOGIC ARMAMENTARIUM IN PSORIASIS”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 9, no. 1, Jan. 2016, pp. 65-72, https://innovareacademics.in/journals/index.php/ajpcr/article/view/7949.
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