Dupilumab De-escalation in Pediatric Atopic Dermatitis

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• Dermatitis, Atopic 1,419

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's planned enrollment of 30 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Study arms

• Experimental
  Dupilumab - discontinuation

  Participants will discontinue their dupilumab treatment for atopic dermatitis.

  Drug: Dupilumab - Discontinuation

• Experimental
  Dupilumab - dose reduction

  Participants whose standard dupilumab dosing for atopic dermatitis is 200 mg or 300 mg every 2 weeks will decrease drug administration to every 4 weeks, and participants whose standard dupilumab dosing is 200 mg or 300 mg every 4 weeks will decrease administration to every 8 weeks.

  Drug: Dupilumab - Dose Reduction

• Experimental
  Dupilumab - standard dosing

  Participants will continue to receive standard maintenance dupilumab dosing for atopic dermatitis according to FDA labeling, as indicated below. Infants ≥6 months and Children \<6 years: 5 to \<15 kg: 200 mg every 4 weeks. 15 to \<30 kg: 300 mg every 4 weeks Children ≥6 years and Adolescents ≤17 years: 15 to \<30 kg: 300 mg every 4 weeks 30 to \<60 kg: 200 mg every other week ≥60 kg: 300 mg every other week

  Drug: Dupilumab - Standard Dose

Interventions

• DrugDupilumab - Discontinuation

  Drug injections are discontinued.

  Also known as: Dupixent

• DrugDupilumab - Dose Reduction

  The drug is given as a subcutaneous injection.

  Also known as: Dupixent

• DrugDupilumab - Standard Dose

  The drug is given as a subcutaneous injection.

  Also known as: Dupixent

Primary outcomes

1. Percentage of Participants with Successful Dose Reduction of Dupilumab

   Successful de-escalation is defined as maintaining a reduced dose (i.e., less frequent administration) of dupilumab after initial de-escalation on week 0. Patients who require re-escalating the dose of dupilumab to standard dosing or adding other systemic treatments for their AD will be regarded as treatment failure.

   Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

2. Percentage of Participants with Successful Discontinuation of Dupilumab

   Successful discontinuation is defined as maintaining discontinuation of dupilumab after initial discontinuation on week 0. Patients who require resumption of dupilumab or beginning other systemic treatments for their AD will be regarded as treatment failure.

   Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

Secondary outcomes

1. Change in Investigator's Global Assessment (IGA) Scores

   IGA is a global clinical assessment scale to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on the degree of erythema and papulation/infiltration. The IGA score ranges from 0 to 4. Higher scores indicate greater severity of AD.

   Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

2. Change in Eczema Area and Severity Index (EASI) Scores

   The EASI score is used to evaluate severity of AD based on AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. The total EASI score ranges from 0 to 72. Higher scores indicate greater severity of AD.

   Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

3. Change in Patient Oriented Eczema Measure (POEM) Scores

   The POEM is a 7-item questionnaire to assess disease symptoms in children and adults with AD. It is composed of 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The total POEM score ranges from 0 to 28. Higher scores indicate more severe disease and poor quality of life.

   Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

4. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score

   The PROMIS Itch questionnaire measures the extent to which patients experience problems with itchiness over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Almost Always). Higher scores reflect greater severity of experienced itch symptoms.

   Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

5. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score

   The PROMIS Sleep Problem questionnaire measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Almost always; and 5 = Always). The sleep problems contain sleep disturbances (sleep quality, sleep onset, sleep continuity) and sleep-related impairment (perceptions of sleepiness during usual awake hours and reported impairments during the day associated with sleep problems or daytime sleepiness). Higher scores reflect greater severity of sleep problems.

   Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

6. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire score

   The PROMIS Anxiety questionnaire measures the extent to which patients experience problems with anxiety over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Often; and 5 = Almost Always). The questionnaire includes fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), social/separation anxiety (fear or distress when separating from caregivers), and somatic symptoms related to arousal (racing heart, dizziness). Higher scores reflect greater severity of experienced anxiety symptoms.

   Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

7. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire score

   The PROMIS Depressive Symptoms questionnaire measures the extent to which patients experience problems with depression over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Almost Always; and 5 = Always). The depressive symptoms include negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation); decreased positive affect, anhedonia (loss of interest, inability to engage in play), and engagement. Higher scores reflect greater severity of experienced depressive symptoms.

   Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

8. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function questionnaire score

   The PROMIS Cognitive Function questionnaire measures the extent to which patients experience problems with cognitive function over the past 4 weeks using a 5-point Likert scale (1 = All of the time; 2 = Most of the time; 3 = Some of the time; 4 = A little of the time; and 5 = None of the time). The questionnaire includes difficulties in cognitive abilities (e.g., memory, attention, and decision making), and difficulties in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering, and learning). Lower scores reflect greater impact on cognitive function.

   Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

9. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire score

   The PROMIS Global Health questionnaire measures the extent to which patients experience problems with global health in general using a 5-point Likert scale (1 = Poor; 2 = Fair; 3 = Good; 4 = Fair; and 5 = Excellent). The questionnaire includes an overall evaluation of physical, mental health, and social health. Higher scores reflect a lower quality of global health.

   Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

10. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity questionnaire score

    The PROMIS Pain Intensity questionnaire measures the intensity of patients' pain due to their AD over the past 7 days using a 10 point scale, with 0 indicating "No Pain" and 10 indicating "the worst pain possible." Higher raw scores reflect greater severity of experienced pain due to AD.

    Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

11. Change in Children's Dermatology Life Quality Index (CDLQI) score

    CDLQI is a 10-item questionnaire to assess the impact of skin problems on the quality of life of children between the ages of 4-16 years old over the last one week. Each question is evaluated on a 4-point scale: Not at all = 0, A Little = 1, Quite A Lot = 2, Very Much = 3. Higher scores indicate worse child-reported quality of life. CDLQI scores indicate the degree of severity burden on the quality of life: No effect = 0-1; Small effect = 2-6; Moderate effect = 7-12; Very large effect = 13-18; and Extremely large effect = 19-30.

    Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

12. Change in Family Dermatology Life Quality Index (FDLQI) score

    FDLQI is a 10-item questionnaire to assess the impact of skin problems on the quality of life of families over the last one month. Each question is evaluated on a 4-point scale: Not at all = 0, A Little = 1, Quite A Lot = 2, Very Much = 3. Higher scores indicate worse quality of life. FDLQI scores indicate the degree of severity burden on the quality of life: No effect = 0-1; Small effect = 2-6; Moderate effect = 7-12; Very large effect = 13-18; and Extremely large effect = 19-30.

    Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

13. Changes in Utilization of Topical Medications for Atopic Dermatitis

    Participants will provide a self-report of their daily utilization of topical medications (medication name, dose and frequency) using a paper-form Daily Diary.

    Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

14. Adverse Events After Dupilumab Dose-reduction or Discontinuation

    The number of participants who experience adverse events ≥ Grade 2 is based on the Common Terminology Criteria for Adverse Events (CTCAE). The CTCAE is generally graded as follows: Grade 1 - mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not needed; Grade 2 - moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living; Grade 3 - severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self care activities of daily living; Grade 4 - life-threatening consequences; urgent intervention indicated; Grade 5 - death related to adverse event.

    Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

Publications

• Drucker AM, Wang AR, Li WQ, Sevetson E, Block JK, Qureshi AA. The Burden of Atopic Dermatitis: Summary of a Report for the National Eczema Association. J Invest Dermatol. 2017 Jan;137(1):26-30. doi: 10.1016/j.jid.2016.07.012. Epub 2016 Sep 8. PubMed 27616422 ↗
• Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020 Aug 1;396(10247):345-360. doi: 10.1016/S0140-6736(20)31286-1. PubMed 32738956 ↗