A phase 3 randomized, multicenter, double-blind study to evaluate the safety of upadacitinib in combination with topical corticosteroids in adolescent and adult patients with moderate-to-severe atopic dermatitis in Japan (Rising Up): An interim 24-week analysis
| Autor: | Norito Katoh, Yukihiro Ohya, Hiroyuki Murota, Masanori Ikeda, Xiaofei Hu, Kimitoshi Ikeda, John Liu, Takuya Sasaki, Alvina D. Chu, Henrique D. Teixeira, Hidehisa Saeki |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
safety
Janus kinase inhibitors SAE serious adverse event vIGA-AD validated Investigator's Global Assessment for Atopic Dermatitis atopic dermatitis EASI Eczema Area and Severity Index EASI 90 ≥90% improvement in Eczema Area and Severity Index fungi TCS topical corticosteroid clinical trial Dermatology AD atopic dermatitis topical corticosteroids upadacitinib CPK creatine phosphokinase RL1-803 EASI 50 ≥50% improvement in eczema area and severity index EASI 75 ≥75% improvement in Eczema Area and Severity Index AESI adverse event of special interest Original Article eczema JAK Janus kinase AE adverse event TEAE treatment-emergent adverse event |
| Zdroj: | JAAD International JAAD International, Vol 6, Iss, Pp 27-36 (2022) |
| ISSN: | 2666-3287 |
| Popis: | Background: Systemic atopic dermatitis treatments that have acceptable safety are needed. Objective: To evaluate the safety of the oral Janus kinase inhibitor upadacitinib in combination with topical corticosteroids (TCSs) for the treatment of atopic dermatitis. Methods: In this phase 3, double-blind study (Rising Up), Japanese patients (12-75 years) with moderate-to-severe atopic dermatitis were randomized in a 1:1:1 ratio to receive 15 mg of upadacitinib + TCS, 30 mg of upadacitinib + TCS, or a placebo + TCS (rerandomized in a 1:1 ratio to receive either 15 or 30 mg of upadacitinib + TCS at week 16). Adverse events and laboratory data were assessed for safety. Results: In 272 treated patients, the serious adverse event rates were similar for 15- and 30-mg upadacitinib + TCS at week 24 (15 mg, 56%; 30 mg, 64%) but greater than those for placebo + TCS (42%). Acne (all mild or moderate; none leading to discontinuation) occurred more frequently with upadacitinib + TCS (15 mg, 13.2%; 30 mg, 19.8%) than with placebo + TCS (5.6%). Furthermore, herpes zoster infection (4.4% vs 0%), anemia (1.1% vs 0%), neutropenia (4.4% vs 1.1%), and creatine phosphokinase elevations (2.2% vs 1.1%) occurred more frequently with 30-mg upadacitinib + TCS than with 15-mg upadacitinib + TCS; none of these events were reported with placebo + TCS. No thromboembolic events, malignancies, gastrointestinal perforations, active tuberculosis, or deaths occurred. Limitations: The limitations included a small sample size and short observation period as well as nongeneralizability of the results beyond Japanese populations. Conclusions: The results were generally consistent with those of previous reports; no new safety risks were detected. |
| Databáze: | OpenAIRE |
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