Atopic dermatitis Atopic Dermatitis
Conditions
Interventions
None listed
Sponsors
Kabashima Kenji
Miyaji Yoshiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for participation in this study, a patient must meet all of the following criteria: 1)Patients with atopic dermatitis who meet one of the following criteria: (1)Patients for whom nemolizumab administration has been decided (prospective cohort). (2)Patients who are currently receiving nemolizumab (retrospective cohort). 2)Patients aged 6 years or older at the initiation of nemolizumab therapy. 3)Patients who met the eligibility criteria for nemolizumab therapy according to the applicable clinical practice guidelines at the time of treatment initiation. 4)Patients with documented information in their medical records pertaining to the eligibility criteria specified in the applicable clinical practice guidelines at the time of nemolizumab treatment initiation, including pruritus VAS scores, NRS scores, or itch scores, and EASI scores. 5)Patients who have provided written informed consent, or whose legal guardians have provided written informed consent, for participation in this study. 6)Patients who initiated nemolizumab therapy on or after March 1, 2023.
Exclusion criteria
Exclusion criteria: 1)Patients with diseases that may confound the evaluation of skin rash and pruritus in atopic dermatitis, including but not limited to: Urticaria, Photosensitivity, Psoriasis, Seborrheic dermatitis, Cutaneous lymphoma, Chronic pruritus of other etiologies, Other pruritic dermatoses 2)Patients currently participating in any other interventional clinical trial. 3)Patients who are unable to commit to clinic visits for at least 6 months following informed consent. 4)Patients enrolled in a post-marketing surveillance study of nemolizumab. 5)Patients whom the investigators deem unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of nemolizumab, as assessed by the incidence of generalized skin rash during early and intermediate stages of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Safety of nemolizumab within the first 16 weeks of initial administration. 2)Detailed exploration of skin symptom exacerbations following nemolizumab administration and identification of exacerbating factors. 3)Proportion of patients achieving a 4-point or greater improvement in pruritus NRS or a pruritus NRS score of 0 or 1 during the observation period. 4)Proportion of patients achieving a 75% improvement in EASI or an EASI score of 7 or lower during the observation period. 5)Proportion of patients achieving a 90% improvement in EASI or an EASI score of 3 or lower during the observation period. 6)Changes over time in pruritus NRS, EASI, and PRO (Patient-Reported Outcome) assessments during the observation period. 7)The duration (in weeks) between nemolizumab discontinuation and restart. 8)Changes over time in pruritus NRS, EASI, and PRO assessments from resumption to interruption of nemolizumab administration. | — |
Contacts
Public ContactMotohiro Honda
EBC&M LLC
Outcome results
None listed