Efficacy and Safety of Ixekizumab Treatment for Japanese Patients With Moderate to Severe Plaque Psoriasis, Erythrodermic Psoriasis and Generalized Pustular Psoriasis: Results From a 52-week, Open-Label, Phase 3 Study (UNCOVER-J)

J Dermatol. 2017 Apr;44(4):355-362. doi: 10.1111/1346-8138.13622. Epub 2016 Oct 11.

Abstract

Psoriasis, a chronic, immune-mediated skin disease characterized by red, scaly plaques, affects approximately 0.3% of the population in Japan. The aim of this open-label study was to evaluate the long-term efficacy and safety of ixekizumab, a humanized, anti-interleukin-17A monoclonal antibody, in Japanese patients with plaque psoriasis (n = 78, including 11 psoriatic arthritis), erythrodermic psoriasis (n = 8) and generalized pustular psoriasis (n = 5). Ixekizumab was administrated s.c. at baseline (week 0, 160 mg), from weeks 2 to 12 (80 mg every 2 weeks), and from weeks 16 to 52 (80 mg every 4 weeks). At week 52, 92.3% of patients with plaque psoriasis achieved Psoriasis Area and Severity Index (PASI) 75, 80.8% achieved PASI 90, 48.7% achieved PASI 100, and 52.6% had remission of plaques (by static Physician Global Assessment, sPGA [0]). Difficult to treat areas of psoriasis (nail or scalp) also responded to ixekizumab. All patients with psoriatic arthritis who were assessed (5/5) achieved an American College of Rheumatology 20 response. Most patients with erythrodermic psoriasis or generalized pustular psoriasis responded to ixekizumab and the clinical outcome was maintained over 52 weeks (75% and 60% of patients achieved sPGA [0, 1] at week 52, respectively). Mostly mild or moderate treatment-emergent adverse events were reported by 79 of 91 patients; the most common were nasopharyngitis, eczema, seborrheic dermatitis, urticaria and injection site reactions. In conclusion, 52-week ixekizumab treatment was efficacious and well tolerated in Japanese patients with plaque psoriasis. Efficacy was also observed in patients with erythrodermic psoriasis, generalized pustular psoriasis and psoriatic arthritis.

Keywords: Japan; erythrodermic psoriasis; generalized pustular psoriasis; ixekizumab; plaque psoriasis.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Arthritis, Psoriatic / drug therapy
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / therapeutic use*
  • Female
  • Humans
  • Injections, Subcutaneous
  • Interleukin-17 / antagonists & inhibitors*
  • Japan
  • Long Term Adverse Effects / chemically induced
  • Long Term Adverse Effects / epidemiology
  • Male
  • Middle Aged
  • Nails
  • Psoriasis / drug therapy*
  • Scalp
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • Dermatologic Agents
  • IL17A protein, human
  • Interleukin-17
  • ixekizumab