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DOI 10.1080/09546634.2022.2138691

Медицинская библиотека · The Journal of dermatological treatment · 2022

Anti-IL-17A blockade did not significantly reduce inflammatory lesions in a placebo-controlled pilot study in adult patients with moderate to severe acne.

Thiboutot Diane M, Craft Noah, Rissmann Robert, Gatlik Ewa, Souquières Malika, Jones Julie, Loesche Christian

Рандомизированное исследованиеСтатьяПеревод пока не подготовлен

Аннотация

BACKGROUND

CJM112 is a potent anti-IL-17A monoclonal antibody, whose clinical efficacy in psoriasis was recently documented. This study aimed to assess the effect of IL-17A blockade, using CJM112, in patients with moderate to severe acne.

METHODS

A randomized, placebo-controlled, double-blind, parallel-group, proof-of-concept study was conducted on patients with moderate to severe acne. Patients received CJM112 300 mg, 75 mg, or placebo subcutaneously during Treatment Period 1 (0-12 weeks). Patients receiving placebo were re-randomized to receive CJM112 300 mg or 75 mg during Treatment Period 2 (12-24 weeks). The primary endpoint was the number of inflammatory facial lesions at Week 12.

RESULTS

As the futility criterion was met during the interim analysis, only 52/75 (69.3%) patients were recruited. In total, 48/52 (92.3%) and 26/41 (63.4%) completed Treatment Periods 1 and 2, respectively. All groups exhibited a reduction in facial inflammatory lesions, with no difference observed between CJM112 and placebo (CJM112 300 mg 27.6 ± 20.7; CJM112 75 mg 30.4 ± 34.8; placebo 23.6 ± 13.6; primary endpoint). Additionally, no differences were observed between groups in other secondary and exploratory endpoints at Week 12.

CONCLUSIONS

Anti-IL-17A therapy was not significantly different compared to the placebo in reducing inflammatory lesions in patients with moderate to severe acne.

Для цитирования: Thiboutot Diane M, Craft Noah, Rissmann Robert, Gatlik Ewa, Souquières Malika, Jones Julie, Loesche Christian. Anti-IL-17A blockade did not significantly reduce inflammatory lesions in a placebo-controlled pilot study in adult patients with moderate to severe acne.. The Journal of dermatological treatment. 2022. DOI: 10.1080/09546634.2022.2138691.

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