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


Journal

The Journal of dermatological treatment
ISSN: 1471-1753
Titre abrégé: J Dermatolog Treat
Pays: England
ID NLM: 8918133

Informations de publication

Date de publication:
Dec 2023
Historique:
pubmed: 29 10 2022
medline: 7 2 2023
entrez: 28 10 2022
Statut: ppublish

Résumé

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

Sections du résumé

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

Identifiants

pubmed: 36305633
doi: 10.1080/09546634.2022.2138691
doi:

Substances chimiques

Antibodies, Monoclonal 0

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2138691

Auteurs

Diane M Thiboutot (DM)

Department of Dermatology, Pennsylvania State University College of Medicine, Hershey, PA, USA.

Noah Craft (N)

Department of Dermatology, Good Dermatology, Torrance, CA, USA.
Department of Dermatology, People Science, Venice, CA, USA.

Robert Rissmann (R)

Department of Dermatology, Centre for Human Drug Research, Leiden, The Netherlands.
Department of Biotherapeutics, Leiden Academic Center for Drug Research, Leiden University, Leiden, The Netherlands.

Ewa Gatlik (E)

Novartis Institute for Biomedical Research, Basel, Switzerland.

Malika Souquières (M)

Novartis Institute for Biomedical Research, Basel, Switzerland.
Priothera SAS, Saint-Louis, France.

Julie Jones (J)

Biostatistical Sciences and Pharmacometrics, Novartis Pharma AG, Basel, Switzerland.

Christian Loesche (C)

Novartis Institute for Biomedical Research, Basel, Switzerland.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH