To observe the clinical efficacy and safety of tacrolimus ointment combined with dupilumab injection in treatment of adult atopic dermatitis (AD).

Adult patients with AD in the Affiliated Hospital of Xuzhou Medical University were enrolled as study subjects. The control group was treated with tacrolimus ointment (external use, twice a day) + ebastine tablets (oral administration, 10 mg·times^-1·d^-1), and the observation group received tacrolimus ointment + ebastine tablets + dupilumab injection (subcutaneous injection, initial dose of 600 mg, followed by 300 mg·times^-1, once every two weeks). The clinical efficacy, skin barrier indicators, serum thymic stromal lymphopoietin (TSLP) and interleukin-31 (IL-31) were compared between the two groups, and the safety was assessed.

A total of 140 cases (80 cases in control group and 60 cases in observation group) were screened in this study. 48 pairs were successfully matched by the propensity matching score method according to the ratio of 1∶1. Finally, 48 cases in control group and 48 cases in observation group were included. After 4 weeks of treatment, the effective rate in observation group was 93.75% (45 cases/48 cases), which was significantly higher than 79.17% (38 cases /48 cases) in control group (P<0.05). the scoring atopic dermatitis (SCORAD) scores in observation and control groups were (15.56±3.33) and (21.50±3.51) points, and the investigator global assessment (IGA) scores were (1.98±0.57) and (2.25±0.44) points, and pruritus index (NRS) scores were (2.85±0.58) and (3.19±0.49) points, and dermatological life quality index (DLQI) scores were (10.04±1.03) and (10.88±1.16) points, and AD disease control (ADCT) scores were (7.00±0.29) and (7.17±0.43) points, respectively. The transdermal water loss (TEWL) values in observation group and control group were (13.17±2.37) g·m^-2·h^-1 and (15.35±3.21) g·m^-2·h^-1, and skin moisture contents were (26.46±4.68)% and (22.23±5.10)%, and sebum contents were (89.79±3.44) μg·cm^-2 and (80.31±3.73) μg·cm^-2, respectively. Serum TSLP levels in observation group and control group were (138.81±14.79) pg·mL^-1 and (148.30±16.23) pg·mL^-1, and serum IL-31 levels were (74.63±9.42) pg·mL^-1 and (85.34±10.18) pg·mL^-1, respectively, and the above indicators in observation group were statistically significantly different compared with those in control group (all P<0.05). During treatment, the adverse drug reactions in observation group were conjunctivitis, edema, diarrhea, swelling and pain at the injection site, and the adverse drug reactions in control group were nausea and edema, and there was no statistical significantly differences in the total incidence rate of adverse drug reactions between groups (P>0.05).

Combination of dupilumab injection on the basis of tacrolimus ointment and ebastine tablets has a significant clinical effect in the treatment of AD, and it can statically significantly improve the symptoms and skin barrier, and reduce the levels of serum TSLP and IL-31.