Safety and efficacy of guselkumab in Japanese patients with moderate-to-severe plaque psoriasis: a randomized, placebo-controlled, ascending-dose study

British Journal of Dermatology

Volumn 178, Issue 3, 2018, Pages 689-696

  Nemoto, O ^a   Hirose, K ^b   Shibata, S ^b   Li, K ^c   Kubo, H ^b  

^a Sapporo Skin Clinic   (Japan)

^b Janssen Pharmaceutical KK   (Japan)

^c JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

GUSELKUMAB; INTERLEUKIN 17; INTERLEUKIN 17F; DERMATOLOGICAL AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BODY SURFACE; BODY WEIGHT; CLINICAL ARTICLE; CLINICAL EVALUATION; COHORT ANALYSIS; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECZEMA; EFFICACY PARAMETERS; ELECTROCARDIOGRAM; FEMALE; FOLLICULITIS; HEAT RASH; HUMAN; HUMAN CELL; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; JAPANESE (PEOPLE); MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; PHASE 1 CLINICAL TRIAL; PHYSICAL EXAMINATION; PRIORITY JOURNAL; PRURITUS; PSORIASIS AREA AND SEVERITY INDEX; PSORIASIS VULGARIS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SINGLE DRUG DOSE; SKIN DISEASE; SKIN INFECTION; TREATMENT RESPONSE; URTICARIA; YOUNG ADULT; CLINICAL TRIAL; DOSE RESPONSE; PSORIASIS; SEVERITY OF ILLNESS INDEX; SUBCUTANEOUS DRUG ADMINISTRATION; TREATMENT OUTCOME;

ADULT; AGED; ANTIBODIES, MONOCLONAL; DERMATOLOGIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; PSORIASIS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85040725015     PISSN: 00070963     EISSN: 13652133     Source Type: Journal    
DOI: 10.1111/bjd.16236     Document Type: Article

References (28)

1. Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med 2009; 361:496–509.
2. Griffiths CE, Reich K, Lebwohl M et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet 2015; 386:541–51.
3. Langley RG, Elewski BE, Lebwohl M et al. Secukinumab in plaque psoriasis — results of two phase 3 trials. N Engl J Med 2014; 371:326–38.
4. Lebwohl M, Strober B, Menter A et al. Phase 3 Studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med 2015; 373:1318–28.
5. World Health Organization Executive Board. Psoriasis: report by the secretariat. Available at: http://apps.who.int/gb/ebwha/pdf_files/EB133/B133_5-en.pdf (last accessed 14 December 2017).
6. Kopp T, Riedl E, Bangert C et al. Clinical improvement in psoriasis with specific targeting of interleukin-23. Nature 2015; 521:222–6.
7. Sofen H, Smith S, Matheson RT et al. Guselkumab (an IL-23-specific mAb) demonstrates clinical and molecular response in patients with moderate-to-severe psoriasis. J Allergy Clin Immunol 2014; 133:1032–40.
8. Gordon KB, Duffin KC, Bissonnette R et al. A phase 2 Trial of guselkumab versus adalimumab for plaque psoriasis. N Engl J Med 2015; 373:136–44.
9. Krueger JG, Ferris LK, Menter A et al. Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol 2015; 136(116–24):e7.
10. Papp K, Thaci D, Reich K et al. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol 2015; 173:930–9.
11. Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature 2007; 445:866–73.
12. Yawalkar N, Tscharner GG, Hunger RE et al. Increased expression of IL-12p70 and IL-23 by multiple dendritic cell and macrophage subsets in plaque psoriasis. J Dermatol Sci 2009; 54:99–105.
13. Mease PJ. Inhibition of interleukin-17, interleukin-23 and the TH17 cell pathway in the treatment of psoriatic arthritis and psoriasis. Curr Opin Rheumatol 2015; 27:127–33.
14. Stritesky GL, Yeh N, Kaplan MH. IL-23 promotes maintenance but not commitment to the Th17 lineage. J Immunol 2008; 181:5948–55.
15. Zhuang Y, Calderon C, Marciniak SJ, Jr. et al. First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis. Eur J Clin Pharmacol 2016; 72:1303–10.
16. Kubota K, Kamijima Y, Sato T et al. Epidemiology of psoriasis and palmoplantar pustulosis: a nationwide study using the Japanese national claims database. BMJ Open 2015; 5:e006450.
17. Fredriksson T, Pettersson U. Severe psoriasis – oral therapy with a new retinoid. Dermatologica 1978; 157:238–44.
18. Blauvelt A, Papp KA, Griffiths CE et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol 2017; 76:405–17.
19. Reich K, Armstrong AW, Foley P et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol 2017; 76:418–31.
20. Aggarwal S, Ghilardi N, Xie MH et al. Interleukin-23 promotes a distinct CD4 T cell activation state characterized by the production of interleukin-17. J Biol Chem 2003; 278:1910–4.
21. Wilson NJ, Boniface K, Chan JR et al. Development, cytokine profile and function of human interleukin 17-producing helper T cells. Nat Immunol 2007; 8:950–7.
22. Ness-Schwickerath KJ, Jin C, Morita CT. Cytokine requirements for the differentiation and expansion of IL-17A- and IL-22-producing human Vγ2Vδ2 T cells. J Immunol 2010; 184:7268–80.
23. Villanova F, Flutter B, Tosi I et al. Characterization of innate lymphoid cells in human skin and blood demonstrates increase of NKp44+ ILC3 in psoriasis. J Invest Dermatol 2014; 134:984–91.
24. Ward NL, Umetsu DT. A new player on the psoriasis block: IL-17A- and IL-22-producing innate lymphoid cells. J Invest Dermatol 2014; 134:2305–7.
25. Laggner U, Di Meglio P, Perera GK et al. Identification of a novel proinflammatory human skin-homing Vg9Vd2 T cell subset with a potential role in psoriasis. J Immunol 2011; 187:2783–93.
26. Cai Y, Shen X, Ding C et al. Pivotal role of dermal IL-17-producing gammadelta T cells in skin inflammation. Immunity 2011; 35:596–610.
27. Pantelyushin S, Haak S, Ingold B et al. Rorgammat+ innate lymphocytes and gammadelta T cells initiate psoriasiform plaque formation in mice. J Clin Invest 2012; 122:2252–6.
28. Teunissen MB, Munneke JM, Bernink JH et al. Composition of innate lymphoid cell subsets in the human skin: enrichment of NCR(+) ILC3 in lesional skin and blood of psoriasis patients. J Invest Dermatol 2014; 134:2351–60.