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

Baseline Characteristics: PN-related medical history

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

Time frame: At baseline

Baseline Characteristics: Socio-demographics of PN patients

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

Time frame: At baseline

Baseline Characteristics: Type of PN therapies received prior to initiation of dupilumab treatment

Time frame: At baseline

Proportion of patients using concomitant medication

Time frame: At baseline

Proportion of patients with a ≥ four-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS)

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.

Time frame: From baseline up to month 18

Mean change in WI-NRS

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.

Time frame: From baseline up to month 18

Proportion of patients with a ≥ four-point improvement (reduction) in Skin Pain Numeric Rating Scale (NRS)

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.

Time frame: From baseline up to month 18

Mean change in Skin Pain NRS

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.

Time frame: From baseline up to month 18

Proportion of patients with a ≥ two-point improvement (reduction) in Sleep Disturbance Numeric Rating Scale (NRS)

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.

Time frame: From baseline up to month 18

Mean change in Sleep Disturbance NRS

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.

Time frame: From baseline up to month 18

Proportion of patients with Patient Global Impression of Change of PN Disease (PGIC) score of "Very much better (improved)"

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.

Time frame: From baseline up to month 18

Proportion of patients with PGIC score of "Very much better (improved)" or "Moderately better (improved)"

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.

Time frame: From baseline up to month 18

Mean change in PGIC

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.

Time frame: From baseline up to month 18

Proportion of patients with Patient Global Impression of Severity of PN Disease (PGIS) score of "None"

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.

Time frame: From baseline up to month 18

Proportion of patients with PGIS score of "None" or "Mild"

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.

Time frame: From baseline up to month 18

Mean change in PGIS

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.

Time frame: From baseline up to month 18

Mean change in Dermatology Life Quality Index (DLQI)

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)

Time frame: From baseline up to month 18

Mean change in Pruritus Activity Score (PAS)

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.

Time frame: From baseline up to month 18

Proportion of patients with Investigator's Global Assessment-chronic prurigo Activity (IGA-CPG Activity) score of 0 or 1

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.

Time frame: From baseline up to month 18

Mean change in IGA-CPG Activity

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.

Time frame: From baseline up to month 18

Proportion of patients with Investigator's Global Assessment-chronic prurigo Stage (IGA-CPG Stage) score of 0 or 1

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.

Time frame: From baseline up to month 18

Mean change in IGA-CPG Stage

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.

Time frame: From baseline up to month 18

Mean change in EQ-5D-5L

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.

Time frame: From baseline up to month 18

Mean change in Hospital Anxiety and Depression Scale (HADS) total score

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.

Time frame: From baseline up to month 18

Proportion of patients reported working, absenteeism score, presenteeism score, and overall impairment working score using the Work Productivity and Activity Impairment (WPAI) questionnaire

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.

Time frame: From baseline up to month 18

Percentage of patients experiencing AEs and SAEs

Time frame: From baseline up to month 18