Effect of Ixekizumab on Patient Reported Outcomes and Quality of Life in Patients With Moderate-to-Severe Plaque Psoriasis: 5-Year Results from the UNCOVER-1 and -2 Studies

J Drugs Dermatol. 2021 Apr 1;20(4):394-401. doi: 10.36849/JDD.2021.5821.

Abstract

Objective: We describe patient-reported outcomes and quality of life through 5 years of treatment in patients with moderate-to-severe plaque psoriasis in the UNCOVER-1 and -2 studies.

Methods: This analysis included patients who were randomized to ixekizumab every 2 weeks then received ixekizumab every 4 weeks during the maintenance period, and who achieved static physician global assessment (0,1) at week 12, completed week 60, and entered the long-term extension period (weeks 60–264). Outcomes measures included responses in itch numeric rating scale (NRS), skin pain visual analog scale (VAS), and dermatology life quality index (DLQI) (0,1), and mean change from baseline in short form health survey (SF-36) mental (MCS) and physical component summaries (PCS), psoriasis skin appearance bothersomeness (PSAB), and work productivity activity impairment (WPAI).

Results: At week 264 in UNCOVER-1 and -2, the observed itch NRS ≥4 responses were 82.4% and 93.1%, respectively, the itch NRS=0 responses were 51.7% and 58.5%, respectively, the skin pain VAS=0 responses were 59.3% and 63.1%, respectively, and the DLQI (0,1) responses were 75.0% and 88.1%, respectively. The observed mean changes from baseline at week 264 in UNCOVER-1 and UNCOVER-2 were 3.4 and 6.5, respectively, for SF-36 MCS, 4.4 and 4.8, respectively, for SF-36 PCS, and -21.3 and -22.0, respectively, for PSAB. WPAI psoriasis item scores improved from baseline in both UNCOVER-1 and -2.

Conclusion: Ixekizumab provided clinically meaningful and sustained improvements in itch, skin pain, DLQI, PSAB, SF-36 PCS, SF-36 MCS, and WPAI through 5 years of treatment in patients with moderate-to-severe plaque psoriasis. J Drugs Dermatol. 20(4):394-401. doi:10.36849/JDD.5821Visit the JDD Psoriasis Resource Center for more.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Clinical Trials, Phase III as Topic
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects
  • Etanercept / administration & dosage
  • Etanercept / adverse effects
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Pain / diagnosis
  • Pain / drug therapy*
  • Pain / etiology
  • Pain / psychology
  • Pain Measurement / statistics & numerical data
  • Patient Reported Outcome Measures
  • Psoriasis / complications
  • Psoriasis / diagnosis
  • Psoriasis / drug therapy*
  • Psoriasis / psychology
  • Quality of Life*
  • Randomized Controlled Trials as Topic
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • Dermatologic Agents
  • ixekizumab
  • Etanercept