MONOCLONAL ANTIBODIES IN THE TREATMENT OF PSORIASIS AND PSORIATIC ARTHRITIS


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

The article presents clinical data on the possibility of use in the treatment of psoriasis and psoriatic arthritis monoclonal antibodies (MA): their structure, mechanism of action, dosages and routes of administration. Drugs are divided into groups according to the results of the certification. Data from international studies on the efficacy and tolerability of MA in different nosological entities, as well as the results of own author’s clinical observations are analyzed. Practical recommendations on the use of MA in psoriasis and psoriatic arthritis are presented.

Full Text

Restricted Access

About the authors

M. I Kurdina

CG "MEDSI"

Email: m.i.kurdina@gmail.com
MD, Prof., Chief Specialist in Dermatology and cosmetology Moscow

References

  1. Schein feld N. Adalimumab (HUMIRA): A review. J. Drugs Dermatol. 2003;2:375-77.
  2. Mease P.J., Ory P., Sharp J.T., Ritchlin C.T., Van den Bosch F., Wellborne F., Birbara C., Thomson G.T., Perdok R.J., Medich J., Wong R.L., Gladman D.D. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the adalimumab effectiveness in psoriatic arthritis trial (ADEPT). Ann. Rheum. Dis. 2009;68(5):702-9.
  3. Menter A., Tyring S.K., Gordon K., Kimball A.B., Leonardi C.L, Langley R.G., Strober B.E., Kaul M., Gu Y., Okun M., Papp K. Adalimumab therapy for moderate to severe psoriasis: a randomfeed, controlled phase III trial. J. Am. Acad. Dermatol. 2008;58( 1): 106-15.
  4. Gordon K., Papp K., Poulin Y., Gu Y., Rozo S., Sasso E.H. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J. Am. Acad. Dermatol. 2012;66(2):241-51.
  5. Hutas G. Golimumab: a fully human monoclonal antibody against TNF alpha. Curr. Opin. Mol. Ther. 2008;10:393-406.
  6. Kavanaugh A., McInnes I., Mease P., Krueger G.G., Gladman D., Gomez-Reino J., Papp K., Zrubek J., Mudivarthy S., Mack M., Visvanathan S., Beutler A. Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum. 2009;60(4):976-86.
  7. Lee W.K, Kim G.W., Cho H.H. Erythrodermic Psoriasis Treated with Golimumab: A Case Report. Ann. Dermatol. 2015;27(4):446-49.
  8. REMICADE® (infliximab). Prescribing information. Janssen Biotech, Inc.
  9. Reich K., Nestle F.O., Papp K., Ortonne J.P., Evans R., Guzzo C.A. EXPRESS study investigators. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet. 2005;366:1367-74.
  10. Gottlieb A.B., Evans R., Li S., Dooley L.T., Guz-zo C.A., Baker D., Bala M., Marano S.W., Menter A. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J. Am. Acad. Dermatol. 2004;51(4):534-42.
  11. Antoni C., Krueger G.G., de Vlam K., Birbara C., Beutler A., Guzzo C.A., Zhou B., Dooley L.T., Kavanaugh A. Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Ann. Rheum. Dis. 2005;64(8): 1150-57.
  12. Antoni C., Kavanaugh A., van der Heijde D., Beutler A., Keenan G., Zhou B., Kirkham B.W., Tutuncu Z., Burmester G.R., Schneider U., Furst D., Molitor J., Keystone E., Gladman D.D., Manger B., Wassenberg S., Weier R., Wallace D.J., Weisman M.H., Kalden J.R., Smolen J.S. Two-year efficacy and safety of infliximab treatment in patients with active psoriatic arthritis: findings of the infliximab multinational psoriatic arthritis controlled trial (IMPACT). J. Rheumatol. 2008;35:869-76.
  13. Leonardi C.L., Kimball A.B., Papp K.A., Yeilding N., Guzzo C., Wang Y., Li S., Dooley L.T., Gordon K.B. 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). Lancet. 2008;371:1665-74.
  14. Papp K.A., Langley R.G., Lebwohl M.N., Krueger G.G., Szapary P., Yeilding N., Guzzo C., Hsu M.C., Wang Y., Li S., Dooley L.T., Reich K. 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). Lancet. 2008;371:1675-84.
  15. Gottlieb A., Narang K. Ustekinumab in the treatment of psoriatic arthritis: latest findings and clinical potential. Ther. Adv. Musculoskelet. Dis. 2013;5(5):277-85.
  16. Palfreeman A.C., McNamee K.E., McCann F.E. New developments in the management of psoriasis and psoriatic arthritis: a focus on apremilast. Drug Des. Devel. Ther. 2013;7:201-10.
  17. Schafer P.H., Parton A., Capone L., Cedzik D., Brady H., Evans J.F., Man H.W., Muller G.W., Stirling D.I., Chopra R. Apremilast is a selective PDE4 inhibitor with regulatory effects on innate immunity. Cell Signal. 2014;26:2016-29.
  18. Kavanaugh A., Mease P.J., Gomez-Reino J.J., Adebajo A.O., Wollenhaupt J., Gladman D.D., Lespessailles E., Hall S., Hochfeld M., Hu C., Hough D., Stevens R.M., Schett G. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann. Rheum. Dis. 2014;73(6): 102 0-2 6.
  19. Clinical Trials.gov. Study to evaluate safety and effectiveness of oral apremilast (CC- 10004) in patients with moderate to severe plaque psoriasis (ESTEEM 1). http://clinicaltrials.gov/ct2/show/ NCT01194219.
  20. ClinicalTrials.gov. Study to evaluate safety and effectiveness of oral apremilast (CC- 10004) in patients with moderate to severe plaque psoriasis. (ESTEEM 2). http://clinical trials.gov/ct2/show/ NCT01232283?term=apr emilast&rank= 10.
  21. ClinicalTrials.gov. Efficacy and safety study of apremilast to treat active psoriatic arthritis (PALACE 1 ). http://clinicaltrials.gov/ct2/show/ NCT01172938?term=apremilast&r ank= 1.
  22. ClinicalTrials.gov. Efficacy and safety study of apremilast to treat active psoriatic arthritis (PALACE 2). http://clinicaltrials.gov/ct2/show/ NCT01212757?term=apremilast&r ank=2.
  23. ClinicalTrials.gov. PALACE 3: efficacy and safety study of apremilast to treat active psoriatic arthritis. http://clinicaltrials.gov/ct2/show/ NCT01212770?term=apremilast&r ank=3.
  24. Langley R.G., Elewski B.E., Lebwohl M., Reich K., Griffiths C.E., Papp K., Puig L., Nakagawa H., Spelman L., Sigurgeirsson B., Rivas E., Tsai T.F., Wasel N., Tyring S., Salko T., Hampele I., Notter M., Karpov A., Helou S., Papavassilis C. Secukinumab in plaque psoriasis - results of two phase 3 trials. N. Engl. J. Med. 2014;371:326-38.
  25. McInnes I.B., Sieper J., Braun J., Emery P., van der Heijde D., Isaacs J.D., Dahmen G., Wollenhaupt J., Schulze-Koops H., Kogan J., Ma S., Schumacher M.M., Bertolino A.P., Hueber W., Tak P.P. Efficacy and safety of secukinumab, a fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriatic arthritis: a 24-week, randomised, double-blind, placebo-controlled, phase II proof-of-concept trial. Ann. Rheum. Dis. 2014;73(2):349-56.
  26. Melmed G.Y., Targan S.R., Yasothan U., Hanicq D., Kirkpatrick P. Certolizumab pegol. Nat. Rev. Drug Discov. 2008;7:641-42.
  27. Mease P.J., Fleischmann R., Deodhar A.A., Wollenhaupt J., Khraishi M., Kielar D., Woltering F., Stach C., Hoepken B., Arledge T., van der Heijde D. 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.
  28. Reich K., Ortonne J.P., Gottlieb A.B., Terpstra I.J., Coteur G., Tasset C., Mease P. 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.
  29. Owen C.M., Harrison P.V. Successful treatment of severe psoriasis with basiliximab, an interleukin-2 receptor monoclonal antibody. Clin. Exp. Dermatol. 2000;25:195-97.
  30. Salim A, Emerson R.M., Dalziel K.L. Successful treatment of severe generalized pustular psoriasis with basiliximab (interleukin-2 receptor blocker). Br J Dermatol. 2000;143:1121-22.
  31. ClinicalTrials.gov. NCT01708590 Study of efficacy, safety, and withdrawal and retreatment with brodalumab in moderate to severe plaque psoriasis subjects (AMAGINE-1).
  32. ClinicalTrials.gov. NCT01708629 Study of efficacy and safety of brodalumab compared with placebo and ustekinumab in moderate to severe plaque psoriasis subjects (AMAGINE-3).
  33. Mease P.J., Genovese M.C., Greenwald M.W., Ritchlin C.T., Beaulieu A.D., Deodhar A., Newmark R., Feng J, Erondu N., Nirula A. Brodalumab, an Anti-IL17RA monoclonal antibody, in psoriatic arthritis. N. Engl. J. Med. 2014;370:2295-306.
  34. Bhat S., Czuczman M.S. Galiximab: a review. Expert Opin. Biol. Ther. 2010;10(3):451-58. Smith S., Schöder H., Johnson J., Jung S.H., Bartlett N.L, Cheson B.D.; Alliance for Clinical Trials in Oncology. The anti-CD80 primatized monoclonal antibody, galiximab, is well-tolerated but has limited activity in relapsed Hodgkin lymphoma: Cancer and Leukemia Group B 50602 (Alliance). Leuk. Lymphoma. 2013;54(7): 1405-10.
  35. Gottlieb A.B., Kang S., Linden K.G., Lebwohl M., Menter A., Abdulghani A.A., Goldfarb M., Chieffo N, Totoritis M.C. Evaluation of safety and clinical activity of multiple doses of the anti-CD80 monoclonal antibody, galiximab, in patients with moderate to severe plaque psoriasis. Clin. Immunol. 2004;111(1):28-37.
  36. Callis-Duffin K., Gordon K., Wasfi Y., Shen Y.K. A phase 2 multicenter, randomized, placebo-and active-comparator-controlled, dose-ranging trial to evaluate guselkumab for the treatment of patients with moderate to severe plaque-type psoriasis (X-PLORE). J. Am. Acad. Dermatol. 2014;70(5) Suppl 1:AB162. 3 7. Giovannoni G., Radue E. W., Havrdova E., Riester K., Greenberg S., Mehta L., Elkins J. Effect of daclizumab high-yield process in patients with highly active relapsing-remitting multiple sclerosis. J. Neurol. 2014;261:316-23.
  37. Krueger J.G., Walters I.B., Miyazawa M., Gilleaudeau P., Hakimi J., Light S., Sherr A., Gottlieb A.B. Successful in vivo blockade of CD25 (high-affinity interleukin 2 receptor) on T cells by administration of humanized anti-Tac antibody to patients with psoriasis. J Am Acad Dermatol. 2000;43(4):448-58.
  38. Wohlrab J., Fischer M., Taube K.M., Marsch W.C. Treatment of recalcitrant psoriasis with daclizumab. Br. J. Dermatol. 2001; 144:209-10.
  39. Dichmann S., Mrowietz U., Schopf E., Norgauer J. Humanized monoclonal anti-CD25 antibody as a novel therapeutic option in HIV-associated psoriatic erythroderma. J. Am. Acad. Dermatol. 2002;47:635-36.
  40. Lilly's ixekizumab superior to etanercept and placebo in phase 3 psoriasis studies. INDIANAPOLIS, Aug. 21, 2014/PRNewswire/.
  41. http://clinicaltrials.gov/ct2/show/ NCT01729754?term=SCH-900222&phase=2&fund=2&rank= 1.
  42. http://clinicaltrials.gov/ct2/show/ NCT01722331?term=SCH-900222&phase=2 & fund=2 &rank=2.
  43. Tofacitinib. Drugs RD. 2010;10(4):271-84.
  44. Ghoreschi K., Jesson M.I., Li X., Lee J.L., Ghosh S., Alsup J.W., Warner J.D., Tanaka M., Steward-Tharp S.M., Gadina M., Thomas C.J., Minnerly J.C., Storer C.E., LaBranche T.P., Radi Z.A., Dowty M.E., Head R.D., Meyer D.M., Kishore N., O'Shea J.J. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J. Immunol. 2011;186(7):4234-43.
  45. Papp K.A., Menter A., Strober B, Langley R.G., Buonanno M., Wolk R., Gupta P., Krishnaswami S., Tan H., Harness J.A. Efficacy and safety of tofaci tinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a phase 2b randomized placebocontrolled dose-ranging study. Br. J. Dermatol. 2012;167(3):668-77.
  46. Craiglow B.G., King B.A. Killing two birds with one stone: oral tofacitinib reverses alopecia universalis in a patient with plaque psoriasis. J. Invest. Dermatol. 2014;134(12):2988-90.
  47. Bissonnette R., Langley R.G., Papp K., Matheson R., Toth D., Hultquist M., Geba G.P., White B. Humanized anti-CD2 monoclonal antibody treatment of plaque psoriasis: efficacy and pharmacodynamic results of two randomized, double-blind, placebo-controlled studies of intravenous and subcutaneous siplizumab. Arch. Dermatol. Res. 2009;301(6):429-42.
  48. Krueger G., Lohner M., Roskos L., et al. Clinical trials results: a fully human anti-IL-8 antibody in patients with moderate to severe psoriasis. Poster presented at annual meeting of the American Academy of Dermatology; March 2, 2001; Washington, DC.
  49. Bachelez H., Flageul B., Dubertret L., Fraitag S., Grossman R., Brousse N., Poisson D., Knowles R.W., Wacholtz M.C., Haverty T.P., Chatenoud L., Bach J.F. Treatment of recalcitrant plaque psoriasis with a humanized non-depleting antibody to CD4. J. Autoimmun. 1998;11:53-62.
  50. Gottlieb A.B., Lebwohl M., Shirin S., Sherr A., Gilleaudeau P., Singer G., Solodkina G., Grossman R., Gisoldi E., Phillips S., Neisler H.M., Krueger J.G. Anti-CD4 monoclonal antibody treatment of moderate to severe psoriasis vulgaris: results of a pilot, multicenter, multiple-dose, placebo-controlled study. J. Am. Acad. Dermatol. 2000; 43(4):595-604.
  51. Leonardi C.L. Current concepts and review of efalizumab in the treatment of psoriasis. Dermatol. Clin. 2004;22:427-35.
  52. Kothary N., Diak I.L., Brinker A., Bezabeh S., Avigan M., Dal Pan G. Progressive multifocal leukoencephalopathy associated with efalizumab use in psoriasis patients. J. Am. Acad. Dermatol. 2011;65(3):546-51.

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies