Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study

(e.g., date of diagnosis, severity, comorbidities)

(e.g., month and year of birth (where allowed) or age, gender, race (if allowed), ethnicity (if allowed), Fitzpatrick skin type)

The WI-NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the intensity of their worst pruritus (itch) using the 0 to 10 WI-NRS. Scores range from 0 to 10, with higher scores indicating greater itch intensity.

The WI-NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the intensity of their worst pruritus (itch) using the 0 to 10 WI-NRS. Scores range from 0 to 10, with higher scores indicating greater itch intensity.

The Skin Pain NRS is a single-item Patient-Reported Outcomes (PRO). Patients indicate the intensity of their worst skin pain over the past 24 hours by selecting a number on the scale that ranges from 0 ("No pain") to 10 ("Worst pain imaginable"). Scores range from 0 to10, with higher scores indicating greater pain intensity.

The Skin Pain NRS is a single-item Patient-Reported Outcomes (PRO). Patients indicate the intensity of their worst skin pain over the past 24 hours by selecting a number on the scale that ranges from 0 ("No pain") to 10 ("Worst pain imaginable"). Scores range from 0 to10, with higher scores indicating greater pain intensity.

The Sleep Disturbance NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the severity of their sleep disturbance using a 0 to 10 NRS. Scores range from 0 to10, with higher scores indicating worse sleep quality.

The Sleep Disturbance NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the severity of their sleep disturbance using a 0 to 10 NRS. Scores range from 0 to10, with higher scores indicating worse sleep quality.

The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.

The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.

The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.

The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.

The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.

The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.

The DLQI is designed to measure the health-related quality of life of adults with a skin disease. The DLQI consists of 10 questions related to the effect of skin disease over the past week. Overall scoring ranges from 0 to 30, with a high score indicative of a poorer Health-Related Quality of Life (HRQoL)

The modified PAS is a clinical-reported measure that evaluates the pruritic lesions. The modified questionnaire consists of five items: the type (visible lesions: item 1a; predominant lesions: item1b), estimated number (item 2), distribution (item 3), the representative body area and exact number of lesions (item 4), and the activity in terms of percentage of pruriginous lesions with excoriations/crusts on top (reflecting active scratching; item 5a) and the percentage of healed pruriginous lesions (reflecting healing of chronic prurigo; item 5b). The modified PAS will be completed based on the standard of care clinical assessment.

The IGA-CPG Activity is an instrument used to assess the overall activity of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.

The IGA-CPG Activity is an instrument used to assess the overall activity of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.

The IGA-CPG Stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.

The IGA-CPG Stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.

The EQ-5D-5L comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The HADS is a Patient-Reported Outcomes (PRO) instrument for screening anxiety and depression in non-psychiatric populations. The HADS consists of 14 items, 7 each for anxiety and depression symptoms. Patients select a response from 0 to 3 for each item, based on how they have been feeling in the past week. Scores range from 0 to 21 for each subscale. HADS anxiety (HADS-A) and HADS depression (HADS-D) scores ≤ 7 indicate no clinically relevant symptoms (normal), 8 to 10 borderline abnormal (borderline case), and 11 to 21 abnormal (maximum 21) indicating more severe symptoms.

The Work Productivity and Activity Impairment General Health (WPAI-GH) is a 6-item Patient-Reported Outcomes (PRO) instrument that measures the effect of a condition on productivity during work and regular activities in the seven days prior to completion. The instrument comprises 4 domains: absenteeism, presenteeism, overall work impairment, and activity impairment due to health. WPAI-GH outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.