SESSION 1 / New systemic treatments
Yoko KATAOKA (Osaka, Japan)
Authors
Yoko KATAOKA, Rai FUJIMOTO, Sachiko SAKAMOTO, Hirohiko SHIRAI, Haruna HIROSE, Ayaki SHIGYO
Department of Dermatology,
Osaka Habikino Medical Center, Osaka, Japan
Overview
- Demographics
- Effect
- Clinical sign: EASI
- PRO : POEM, NRS, DLQI
- Biomarkers : IgE, TARC, LDH, EOS
- Adverse effect
- Analysis for different factors between High-responder and Low-responder
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Dupilumab:
Real world long term experience in a single center of Japan
Object and Method
- 110 cases treated by q2w dupilumab more than one year
- moderate to severe adult AD
- who have complete clinical (EASI and PRO) data
- With concomitant TCS and/ or TCI mostly proactive application
- Data were accumulated by every 4 months assessment
- Statistical analysis by SPSS ver.22
Patient Demographics
| Mix~Max | Median | |
|---|---|---|
| Age | 15~75 | 38 |
| Gender | M : F | 93 : 17 |
| Pre Cyclosporine | Yes : No | 47 : 63 |
| EASI | 5.6~65.4 | 19.9 |
| Total IgE (IU/ml) | 5~121,479 | 5586 |
| LDH (U/L) | 138~574 | 253 |
| Eos (/µl) | 0~2172 | 400 |
| TARC (pg/ml) | 100~15,413 | 1786 |
Patient history: AD severity in memory
Effect
① clinical sign: EASI
② Patient Reported Outcomes
③ Blood Biomarkers
Adverse effect
What is the difference between
High-responder and Low-responder?
12th M EASI 90 related factors: Biomarkers
12th M EASI 90 related factors: PRO
Five categories of POEM time course
① rapid-responder 31% (M:F=27:3)
④ Flat type 26% (M:F=25:3)
| pre | 1 M | 4 M | 5 M | |
|---|---|---|---|---|
| LDH | 357 | 286 | 264 | 269 |
| TARC | 1411 | 474 | 236 | 123 |
| Eo | 3.9 | 6.6 | 3.4 | 4.0 |
| totalIgE | 5047 | – | 1657 | 1004 |
⑤ V-shaped responder 20% (M:F=19:3)
Summary
- Dupilumab improves signs, symptoms and quality of life of moderate to severe adult AD for long term in the real world.
- EASI75:88.5%, EASI90:54.9% at 12th months are better than clinical trial. It might depend on the way of concomitant TCS or switching way from CyA.
- Conjunctivitis observed in 36%
- Response patterns are categorized into five types by POEM.
- High responders showed quick improvement of PRO.
- Low responders showed higher biomarkers, total IgE, TARC at 8th, 12th M.
- To maximize the effect, early prediction of low responders and intervention by concomitant treatment is needed.
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Conflict of interest :
Consultation fees – Stock ownership/profit – Patent fees – Manuscript fees – Scholarship fund – Affiliation with Endowed Department – Other remuneration such as gifts
- Remuneration for lecture: Sanofi, Sysmex
- Trust research/joint research funds: Pfizer, Maruho, Abbvie, Eli Lilly, Otsuka, Leo pharma, Sanofi