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A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Psoriasis
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A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

The purpose of this study is to assess the effectiveness and safety of guselkumab following a switch from ustekinumab or an ustekinumab biosimilar in participants with moderate to severe psoriasis, a chronic inflammatory skin disease characterized by erythematous, scaly plaques that may be associated with pain and pruritus, in routine clinical practice.

Primary outcome measures

  • Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) Score Less Than or Equal to (<=) 3 after Switching to Guselkumab at Week 28

Secondary outcome measures

  • Percentage of Participants Achieving a PASI Score <= 3 after Switching to Guselkumab at Weeks 12 and 52
  • Percentage of Participants Achieving a Greater Than or Equal to (>=) 90 Percent (%) Improvement in PASI Score (PASI 90) from Baseline at Weeks 12, 28 and 52
  • Percentage of Participants Achieving 100% Improvement in PASI Score (PASI 100) from Baseline at Weeks 12, 28 and 52
  • Number of Participants with Absolute PASI Course from Baseline to Week 52
  • Absolute Change from Baseline In PASI Scores at Week 52
  • Relative Change from Baseline In PASI Score at Week 52
  • Absolute Change from Baseline in Body Surface Area (BSA) Score at Week 52
  • Relative Change from Baseline in BSA Score at Week 52
  • Absolute Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 52
  • Relative Change from Baseline in DLQI Score at Week 52
  • Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 12, 28, and 52
  • Absolute Change from Baseline in World Health Organization-5 (WHO-5) Well-Being Index Questionnaire Score at Week 52
  • Relative Change from Baseline in WHO-5 Well-Being Index Questionnaire Score at Week 52
  • Absolute Change From Baseline in Worst Itch Numeric Rating Scores (WI-NRS) at Week 52
  • Relative Change from Baseline in WI-NRS at Week 52
  • Absolute Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI: PSO) Scores at Week 52
  • Relative Change from Baseline in WPAI:PSO Scores at Week 52
  • Absolute Change from Baseline in Anogenital Physician's Global Assessment (PGA) Score at Week 52
  • Percentage of Participants Achieving Anogenital PGA Score of 0 at Weeks 12, 28, and 52
  • Absolute Change from Baseline in Palmoplantar PGA Score at Week 52
  • Percentage of Participants Achieving Palmoplantar PGA Score of 0 at Weeks 12, 28, and 52
  • Absolute Change from Baseline in Scalp PGA Score at Week 52
  • Percentage of Participants Achieving Scalp PGA Score of 0 at Weeks 12, 28, and 52
  • Absolute Change from Baseline in Scalp Itch Numeric Rating Scales (NRS) at Week 52
  • Relative Change from Baseline in Scalp Itch NRS at Week 52
  • Relative Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 52
  • Percentage of Participants Achieving NAPSI Score of 0 at Weeks 12, 28, and 52
  • Demographic Characteristics: Age
  • Demographic Characteristics: Sex
  • Demographic Characteristics: Weight
  • Demographic Characteristics: Height
  • Clinical Characteristics: Time Since Psoriasis Diagnosis
  • Clinical Characteristics: Prior Treatments for Moderate to Severe Psoriasis
  • Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab
  • Treatment Patterns: Dose of the Treatment
  • Treatment Patterns: Frequency of the Treatment
  • Number of Participants with Specific Psoriatic Comorbidities
  • Number of Participants with Other Comorbidities
  • Number of Participants Receiving Concomitant Medications for Specific Psoriatic Comorbidities
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