A review of clinical trials of biologic agents and small molecules for psoriasis in Asian subjects

Giornale Italiano di Dermatologia e Venereologia

Volumn 151, Issue 4, 2016, Pages 412-431

  Tsai, Ya Chu ^a   Tsai, Tsen Fang ^b  

^a FAR EASTERN MEMORIAL HOSPITAL   (Taiwan)

^b NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

Author keywords

Adalimumab; Asia; Etanercept; Inliximab; Psoriasis; Ustekinumab

Indexed keywords

ADALIMUMAB; ANTIPSORIASIS AGENT; APREMILAST; BIOSIMILAR AGENT; BRODALUMAB; ETANERCEPT; GUSELKUMAB; INFLIXIMAB; IXEKIZUMAB; SECUKINUMAB; TOFACITINIB; USTEKINUMAB; BIOLOGICAL FACTOR; DERMATOLOGICAL AGENT; IMMUNOLOGIC FACTOR;

ASIAN; CLINICAL TRIAL (TOPIC); CONTROLLED CLINICAL TRIAL (TOPIC); DISEASE DURATION; DRUG EFFICACY; DRUG SAFETY; DRUG SYNTHESIS; HUMAN; IMMUNOGENICITY; MEDLINE; MULTICENTER STUDY (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PSORIASIS; PSORIATIC ARTHRITIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW (TOPIC); ASIAN CONTINENTAL ANCESTRY GROUP; BODY WEIGHT; PATHOLOGY; SEVERITY OF ILLNESS INDEX;

ARTHRITIS, PSORIATIC; ASIAN CONTINENTAL ANCESTRY GROUP; BIOLOGICAL FACTORS; BODY WEIGHT; DERMATOLOGIC AGENTS; HUMANS; IMMUNOLOGIC FACTORS; PSORIASIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEVERITY OF ILLNESS INDEX;

EID: 84977263565     PISSN: 03920488     EISSN: 18271820     Source Type: Journal    
DOI: None     Document Type: Review

References (75)

1. Leonardi CL, Powers JL, Matheson RT, Goffe BS, Zitnik R, Wang A, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med 2003; 349: 2014-22.
2. Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, et al. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ 2010; 340: C147.
3. Tsai TF, Youn J, Foley P. PRESTA: Asia-Pacific subanalysis. Unpub-lished data presented at the Asian Academy of Dermatology and Ve-nereology; 2009 Nov 6-7, Hanoi, Vietnam.
4. Strohal R, Puig L, Chouela E, Tsai TF, Melin J, Freundlich B, et al. The eficacy and safety of etanercept when used with as-needed ad-junctive topical therapy in a randomised, double-blind study in sub-jects with moderate-To-severe psoriasis (the PRISTINE trial). J Der-matolog Treat 2013; 24: 169-78.
5. Youn JI, Lee JH, Kim TY. A multicenter, randomized, open pilot trial assessing the eficacy and safety of etanercept 50 mg twice week-ly followed by etanercept 25 mg twice weekly, the combination of etanercept 25 mg twice weekly and acitretin and acitretin alone in patients with moderate to severe psoriasis. The 16th annual meeting in the Korean society for psoriasis; 2012 Sep 15th, Seoul, Korea.
6. Clark L, Lebwohl M. The effect of weight on the efficacy of biologic therapy in patients with psoriasis. J Am Acad Dermatol 2008; 58: 443-46.
7. Edson-Heredia E, Sterling KL, Alatorre CI, Cuyun Carter G, Pacz-kowski R, Zarotsky V, et al. Heterogeneity of response to biologic treatment: Perspective for psoriasis. J Invest Dermatol 2014; 134: 18-23.
8. Shah SK, Arthur A, Yang YC, Stevens S, Alexis AF. A retrospective study to investigate racial and ethnic variations in the treatment of psoriasis with etanercept. J Drugs Dermatol 2011; 10: 866-72.
9. ClinicalTrials.gov http://ClinicalTrials.gov
10. Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate; [Internet]. Available from: Https://clini-caltrials.gov/ct2/show/NCT02313922?term=nct02313922& rank=1 [cited 2016, Mar 23]
11. ClinicalTrials.gov. Safety and Eficacy of Etanercept in Patients with Psoriasis; [Internet]. Available from: Https://clinicaltrials.gov/ct2/show/NCT02258282?term=NCT02258282&rank=1 [cited 2016, Mar 23]
12. Hsu L, Snodgrass BT, Armstrong AW. Antidrug antibodies in psoriasis: A systematic review. Br J Dermatol 2014; 170: 261-73
13. Huang Q, Yang QP, Fang X, Han L, Zheng ZZ, FU WW, et al. Treat-ment of psoriasis vulgaris with a recombinant human tumor necrosis factor receptor: Fc fusion protein: A multicentre, randomized, double blind trial. Chinese Journal of Dermatology 2007; 40: 655-8.
14. Saurat JH, Stingl G, Dubertret L, Papp K, Langley RG, Ortonne JP, et al. Efficacy and safety results from the randomized controlled com-parative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol 2008; 158: 558-66.
15. 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: 106-15.
16. Menter A, Gordon KB, Leonardi CL, Gu Y, Goldblum OM. Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis. J Am Acad Dermatol 2010; 63: 448-56.
17. Asahina A, Nakagawa H, Etoh T, Ohtsuki M. Adalimumab in Japa-nese patients with moderate to severe chronic plaque psoriasis: Ef-icacy and safety results from a Phase II/III randomized controlled study. J Dermatol 2010; 37: 299-310.
18. Zhang JH, Gu J, Zheng J, Zheng M, Wang G, Gu Y, et al. Eficacy and safety of adalimumab in Chinese patients with moderate to severe plaque psoriasis: Results from a phase 3, randomized, placebo-con-Trolled, double-blind study. The 73rd annual meeting of the American Academy of Dermatology; 2015 March 20-24; San Francisco, Cali-fornia.
19. Menter A, Gordon KB, Leonardi CL, Gu Y, Goldblum OM. Eficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis. J Am Acad Dermatol 2010; 63: 448-56
20. Asahina A, Ohtsuki M, Etoh T, Gu Y, Okun MM, Teixeira HD, et al. Adalimumab treatment optimization for psoriasis: Results of a long-Term phase 2/3 Japanese study. J Dermatol 2015; 42: 1042-52.
21. Revicki D, Willian MK, Saurat JH, Papp KA, Ortonne JP, Sexton C, et al. Impact of adalimumab treatment on health-related quality of life and other patient-reported outcomes: Results from a 16-week ran-domized controlled trial in patients with moderate to severe plaque psoriasis. Br J Dermatol 2008; 158: 549-57.
22. Study to compare efficacy and safety of ABP 501 and adalimumab (HumiraR) in adults with moderate to severe plaque psoriasis; [Internet]. Available from: Https: //clinicaltrials.gov/ct2/resu lts?term=nct01970488& Search=Search [cited 2016, Mar 30].
23. ClinicalTrials.gov. Study to demonstrate equivalent eficacy and to compare safety of biosimilar adalimumab (GP2017) and humira (ADACCESS); [Internet]. Available from: Https: //clinicaltrials.gov/ ct2/show/NCT02016105?term=nct02016105& rank=1 [cited 2016, Mar 30].
24. Reich K, Nestle FO, Papp K, Ortonne JP, Evans R, Guzzo C, et al. Infliximab induction and maintenance therapy for moderate-To-severe psoriasis: A phase III, multicentre, double-blind trial. Lancet 2005; 366: 1367-74.
25. Torii H, Nakagawa H. Inliximab monotherapy in Japanese patients with moderate-To-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial. J Dermatol Sci 2010; 59: 40-9.
26. Menter A, Feldman SR, Weinstein GD, Papp K, Evans R, Guzzo C, et al. A randomized comparison of continuous vs. intermittent inlixi-mab maintenance regimens over 1 year in the treatment of moderate-To-severe plaque psoriasis. J Am Acad Dermatol 2007; 56: E31-15.
27. Edson-Heredia E, Sterling KL, Alatorre CI, Cuyun Carter G, Pacz-kowski R, Zarotsky V, et al. Heterogeneity of response to biologic treatment: Perspective for psoriasis. J Invest Dermatol 2014; 134: 18-23.
28. Torii H, Nakagawa H. Long-Term study of infliximab in Japanese pa-Tients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. J Dermatol 2011; 38: 321-34.
29. Yang HZ, Wang K, Jin HZ, Gao TW, Xiao SX, Xu JH, et al. Inf-liximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: A randomized, double-blind, placebo-controlled multicenter trial. Chin Med J (Engl) 2013; 125: 1845-51.
30. 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: 1665-74.
31. Papp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, Yeild-ing N, et al. Eficacy and safety of ustekinumab, a human inter-leukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet 2008; 371: 1675-84.
32. Tsai TF, Ho JC, Song M, Szapary P, Guzzo C, Shen YK, et al. Effica-cy and safety of ustekinumab for the treatment of moderate-To-severe psoriasis: A phase III, randomized, placebo-controlled trial in Taiwan-ese and Korean patients (PEARL). J Dermatol Sci 2011; 63: 154-63.
33. Igarashi A, Kato T, Kato M, Song M, Nakagawa H. Eficacy and safety of ustekinumab in Japanese patients with moderate-To-severe plaque-Type psoriasis: Long-Term results from a phase 2/3 clinical trial. J Dermatol 2012; 39: 242-52.
34. Zhu X, Zheng M, Song M, Shen YK, Chan D, Szapary PO, et al. Ef-icacy and safety of ustekinumab in Chinese patients with moderate to severe plaque-Type psoriasis: Results from a phase 3 clinical trial (LOTUS). J Drugs Dermatol 2013; 12: 166-74.
35. Lebwohl M, Papp K, Han C, Schenkel B, Yeilding N, Wang Y, et al. Ustekinumab improves health-related quality of life in patients with moderate-To-severe psoriasis: Results from the PHOENIX 1 trial. Br J Dermatol 2010; 162: 137-46.
36. Tsai TF, Song M, Shen YK, Schenkel B, Choe YB, Kim NI, et al. Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to -evere psoriasis: Results from the PEARL trial. J Drugs Dermatol 2012; 11: 943-9.
37. Tsai TF, Ho V, Song M, Szapary P, Kato T, Wasfi Y, et al. The safety of ustekinumab treatment in patients with moderate-To-severe psoria-sis and latent tuberculosis infection. Br J Dermatol 2012; 167: 1145-52.
38. Chiu HY, Chu TW, Cheng YP, Tsai TF. The Association between Clinical Response to Ustekinumab and Immunogenicity to Ustekinu-mab and Prior Adalimumab. PLoS One 2015; 10): E0142930.
39. Gordon KB, Duffin KC, Bissonnette R, Prinz JC, Wasfi Y, Li S, et al. A Phase 2 Trial of Guselkumab vs. Adalimumab for Plaque Psoriasis. N Engl J Med 2015; 373: 136-44.
40. ClinicalTrials.gov. A study of guselkumab in the treatment of partici-pants with moderate to severe plaque-Type psoriasis (VOYAGE 1); [Internet]. Available from: Https: //clinicaltrials.gov/ct2/show/NCT02 https://clinicaltrials.gov/ct2/show/NCT02207231?term=nct02207231& rank=1 [cited 2016, Mar 23]
41. ClinicalTrials.gov. A study of guselkumab in the treatment of partici-pants with moderate to severe plaque-Type psoriasis with randomized withdrawal and retreatment (VOYAGE 2); [Internet]. Available from: Https: //clinicaltrials.gov/ct2/show/NCT02207244?term=nct02207244& rank=1 [cited 2016, Mar 23]
42. ClinicalTrials.gov. A study of guselkumab in participants with mod-erate to severe plaque-Type psoriasis and an inadequate response to ustekinumab (NAVIGATE); [Internet]. Available from: Https://clini-caltrials.gov/ct2/show/NCT02203032?term=NCT02203032& rank=1 [cited 2016, Mar 23]
43. ClinicalTrials.gov. An efficacy and safety study of CNTO1959 (guselkumab) in the treatment of participants with generalized pus-Tular psoriasis or erythrodermic psoriasis; [Internet]. Available from: Https: //clinicaltrials.gov/ct2/show/NCT02343744?term=NCT02343744& rank=1 [cited 2016, Mar 23]
44. Langley RG, Elewski BE, Lebwohl M, Reich K, Grifiths CE, Papp K, et al. Secukinumab in plaque psoriasis-results of two phase 3 tri-Als. N Engl J Med 2014; 371: 326-38.
45. Lee JH, Tsai TF, Morita A, Zheng E, Ko L, Fox T, et al. Secukinumab efficacy and safety in Asian subjects with moderate to severe plaque psoriasis: Pooled analysis from the FIXTURE and ERASURE phase 3 clinical studies. The 73 rd annual meeting of the American Academy of Dermatology; 2015 March 20-24; San Francisco, California.
46. Ohtsuki M, Morita A, Abe M, Takahashi H, Seko N, Karpov A, et al. Secukinumab eficacy and safety in Japanese patients with moder-Ate-To-severe plaque psoriasis: Subanalysis from ERASURE, a rand-omized, placebo-controlled, phase 3 study. J Dermatol 2014; 41: 1039-46.
47. Mrowietz U, Leonardi CL, Girolomoni G, Toth D, Morita A, Bal-ki SA, et al. Secukinumab retreatment-As-needed vs. ixed-interval maintenance regimen for moderate to severe plaque psoriasis: A ran-domized, double-blind, noninferiority trial (SCULPTURE). J Am Acad Dermatol 2015; 73: 27-36 e21.
48. Thaci D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized con-Trolled trial. J Am Acad Dermatol 2015; 73: 400-9.
49. Psoriasis management and comorbidities. The 30th annual meeting of the Japanese Society for Psoriasis Research; 2015 Sep 4-5; Nagoya, Japan
50. Tsai TF, Blauvelt A, Gong Y, Huang J, Fox T. Secukinumab Treat-ment Shows No Evidence for Reactivation of Previous or Latent TB Infection in Subjects with Psoriasis: A Pooled Phase 3 Safety Analy-sis. The 73rd annual meeting of the American Academy of Dermatol-ogy; 2015 March 20-24; San Francisco, California.
51. Tsai T, Blauvelt A, Karpov A. Evaluation of infections with secukinu-mab in a pooled analysis of 10 clinical studies of moderate-To-severe plaque psoriasis. J Invest Dermatol 2014; 134: S33.
52. Sanford M, McKeage K. Secukinumab: Irst global approval. Drugs 2015; 75: 329-38.
53. Griffiths CE, Reich K, Lebwohl M, van de Kerkhof P, Paul C, Menter A, et al. Comparison of ixekizumab with etanercept or placebo in moderate-To-severe psoriasis (UNCOVER-2 and UNCOVER-3): Re-sults from two phase 3 randomised trials. Lancet 2015; 386: 541-51.
54. Saeki H, Nakagawa H, Ishii T, Morisaki Y, Aoki T, Berclaz PY, et al. Eficacy and safety of open-label ixekizumab treatment in Japanese patients with moderate-To-severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis. J Eur Acad Dermatol Ve-nereol 2015; 29: 1148-55.
55. ClinicalTrials.gov. A study comparing different dosing regimens of ixekizumab (LY2439821) in participants with moderate to severe plaque psoriasis (IXORA-P); [Internet]. Available from: Https: //clini-caltrials.gov/ct2/show/NCT02513550?term=NCT02513550& rank=1 [cited 2016, Mar 23].
56. Papp K, Reich K, Leonardi C, Paul C, Blauvelt A, Baran W, et al. Eficacy and safety of brodalumab in patients with moderate to se-vere plaque psoriasis: Results of aMAGINE-1, a Phase 3, randomized, double-Blind, placebo-controlled study through week 12. The 73rd annual meeting of the American Academy of Dermatology; 2015 March 20-24; San Francisco, California.
57. Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med 2015; 373: 1318-28.
58. Nakagawa H, Niiro H, Ootaki K. Brodalumab, a human anti-inter-leukin-17-receptor antibody in the treatment of Japanese patients with moderate-To-severe plaque psoriasis: Eficacy and safety results from a phase II randomized controlled study. J Dermatol Sci 2016; 81: 44-52.
59. Papp K, Menter A, Strober B, Kricorian G, Thompson EH, Milmont CE, et al. Eficacy and safety of brodalumab in subpopulations of patients with dificult-To-Treat moderate-To-severe plaque psoriasis. J Am Acad Dermatol 2015; 72: 436-439 e431.
60. Yamasaki K, Nakagawa H. Clinical eficacy and safety of broda-lumab (KHK4827), a fully human anti-interleukin-17-receptor a monoclonal antibody, in Japanese patients with generalized pustular psoriasis and psoriatic erythroderma: A phase 3, open-label, long-Term study. The 73rd Annual Meeting of the American Academy of Dermatology 2015 March 20-24; San Francisco, California.
61. Gordon KB, Kimball AB, Chau D, Viswanathan HN, Li J, Revicki DA, et al. Impact of brodalumab treatment on psoriasis symptoms and health-related quality of life: Use of a novel patient-reported outcome measure, the Psoriasis Symptom Inventory. Br J Dermatol 2014; 170: 705-15.
62. Papp K, Reich K, Leonardi CL, Kircik L, Chimenti S, Langley RG, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Eficacy and Safety Trial Evaluat-ing the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol 2015; 73: 37-49.
63. Paul C, Cather J, Gooderham M, Poulin Y, Mrowietz U, Ferrandiz C, et al. Eficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate-To-severe plaque psoriasis over 52 weeks: A phase III, randomized controlled trial (ESTEEM 2). Br J Dermatol 2015; 173: 1387-99.
64. ClinicalTrials.gov. Efficacy and safety study of two doses of apremi-last (CC-10004) in Japanese subjects with moderate-To-severe plaque-Type psoriasis; [Internet]. Available from: Https: //clinicaltrials. gov/ct2/show/NCT01988103?term=NCT01988103& rank=1 [cited 2016, Mar 23]
65. Papp KA, Menter A, Strober B, Langley RG, Buonanno M, Wolk R, et al. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: A Phase 2b randomized placebo-control-led dose-ranging study. Br J Dermatol 2012; 167: 668-77.
66. Papp KA, Menter MA, Abe M, Elewski B, Feldman SR, Gottlieb AB, et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Results from two randomized, placebo-con-Trolled, phase III trials. Br J Dermatol 2015; 173: 949-61.
67. Bissonnette R, Iversen L, Sofen H, Grifiths CE, Foley P, Romiti R, et al. Tofacitinib withdrawal and retreatment in moderate-To-severe chronic plaque psoriasis: A randomized controlled trial. Br J Dermatol 2015; 172: 1395-406.
68. ClinicalTrials.gov. A long term study to evaluate the safety and toler-Ability of CP-690,550 for patients with moderate to severe chronic plaque psoriasis; [Internet]. Available from: Https: //clinicaltrials.gov/ https://clinicaltrials.gov/ct2/show/NCT01163253?term=nct+01163253& rank=1 [cited 2016, Mar 23]
69. Menter A, Papp KA, Cather J, Leonardi C, Pariser DM, Krueger JM, et al. Eficacy of tofacitinib in moderate-To-severe psoriasis: Sub-group analysis of patients stratiied by baseline characteristics. The 23rd World Congress of Dermatology (WCD); 2015 Jun 8-13; Van-couver, Canada.
70. Bachelez H, van de Kerkhof PC, Strohal R, Kubanov A, Valenzuela F, Lee JH, et al. Tofacitinib vs. etanercept or placebo in moderate-To-severe chronic plaque psoriasis: A phase 3 randomised non-inferiority trial. Lancet 2015; 386: 552-61.
71. Asahina A, Ohtsuki M, Shibasaki Y, Toyoizumi S, Nagaoka M. Ef-icacy, safety and tolerability of oral tofacitinib for the treatment of moderate to severe plaque psoriasis and/or psoriatic arthritis: Results of a 52-week, Phase 3 randomized study with variable dosing of ac-Tive treatment. The 24th European Academy of Dermatology and Venereology (EADV) Congress; 2015 Oct 7-11; COPENHAGEN, DENMARK.
72. ClinicalTrials.gov. A study evaluating the efficacy and safety of CP-690,550 in Asian subjects with moderate to severe plaque psoriasis; [Internet]. Available from: Https: //clinicaltrials.gov/ct2/show/record/ https://clinicaltrials.gov/ct2/show/record/NCT01815424?term=NCT01815424& rank=1 [cited 2016, Mar 23]
73. Winthrop KL, Yamanaka H, Valdez H, Mortensen E, Chew R, Krish-naswami S, et al. Herpes zoster and tofacitinib therapy in patients with rheumatoid arthritis. Arthritis Rheumatol 2014; 66: 2675-84.
74. Huang PH, Liao YH, Wei CC, Tseng YH, Ho JC, Tsai TF. Clinical effectiveness and safety experience with alefacept in the treatment of patients with moderate-To-severe chronic plaque psoriasis in Taiwan: Results of an open-label, single-Arm, multicentre pilot study. J Eur Acad Dermatol Venereol 2008; 22: 923-30.
75. Tsai TF, Liu MT, Liao YH, Licu D. Clinical effectiveness and safety experience with efalizumab in the treatment of patients with mod-erate-To-severe plaque psoriasis in Taiwan: Results of an open-label, single-Arm pilot study. J Eur Acad Dermatol Venereol 2008; 22: 345-52.