Table 1.
Treatments Considered in this Study
| Treatments | Targets | Dose Regimen (Highest Dose) | Reported Efficacies | No. of Patients in Placebo/Treatment Group (Phase) |
|---|---|---|---|---|
| ShA9 (Nakatsuji et al., 2021a) | Microbes | 2 g (to deliver 1 × 106 CFU/cm2) twice/day, topical, for 1 week (follow-up until 10 days) | Percentage-improved local EASI1 S. aureus |
17/35 (phase 1). Of 35 patients, 21 and 11 patients were colonized with S. aureus that is sensitive and resistant to ShA9 bacteriocin, respectively. The colonization status of the remaining three patients was not determined |
| Flucloxacillin (Ewing et al., 1998) | Microbes | 250 mg for four times/day, oral, for 4 weeks (follow-up until 12 weeks) | Surface area score2 Erythema score2 S. aureus |
25/25 (phase 2) |
| Dupilumab (anti‒IL-4 receptor subunit α antibody) (Callewaert et al., 2020; Blauvelt et al., 2017; Guttman-Yassky et al., 2019a) | IL-4 and IL-13 | 400 mg followed by 200 mg weekly, subcutaneous | EASI-75 Percentage-improved EASI S. aureus |
27/27 (phase 2) |
| 600 mg followed by 300 mg, weekly, subcutaneous, with concomitant use of topical corticosteroids | EASI-75, Percentage-improved EASI |
264/270 (phase 3) |
Abbreviations: CFU, colony-forming unit; EASI, Eczema Area and Severity Index; No., number; ShA9, Staphyloccocus hominis A9.
We used percentage-improved local EASI for percentage-improved EASI because ShA9 was applied on the ventral forearms locally.
We regarded percentage-improved score of a product of the surface area score and the erythema score as the percentage-improved EASI by assuming that the erythema represents the four signs (erythema, induration, excoriations, and lichenification) for the EASI score, which is calculated as a product of the area score and the severity score of the four signs. For dupilumab, we adopted S. aureus levels in phase 2 study and the percentage-improved EASI and EASI-75 in phase 3 study (“Selection of clinical studies for development of the quantitative systems pharmacology model” in Supplementary Materials and Methods).