Titre :

Methotrexate versus cyclosporine in adults with moderate-to-severe atopic dermatitis: a phase iii randomized noninferiority trial

Auteur(s) :

Goujon, Catherine [Auteur]
Service d'immunologie [Centre Hospitalier Lyon Sud - HCL]
Viguier, Manuelle [Auteur]
Immuno-Régulation dans les Maladies Auto-Immunes Inflammatoires et le Cancer - EA 7509 [IRMAIC]
Staumont, delphine [Auteur]
Récepteurs nucléaires, Maladies Cardiovasculaires et Diabète (EGID) - U1011
Bernier, Claire [Auteur]
Service de dermatologie [Nantes]
Guillet, Gerard [Auteur]
Laboratoire Inflammation, Tissus épithéliaux et Cytokines [LITEC [Poitiers]]
Lahfa, Morad [Auteur]
Service Dermatologie [CHU Toulouse]
Ferrier Le Bouedec, Marie-Christine [Auteur]
Service Dermatologie et Oncologie Cutanée [CHU Clermont-Ferrand]
Cambazard, Frederic [Auteur]
Service de Dermatologie - Allergologie - Oncodermatologie [CHU Saint-Etienne]
Bottigioli, David [Auteur]
Centre Hospitalier Lyon Sud [CHU - HCL] [CHLS]
Grande, Sophie [Auteur]
Service d'immunologie [Centre Hospitalier Lyon Sud - HCL]
Dahel, Karima [Auteur]
Centre Hospitalier Lyon Sud [CHU - HCL] [CHLS]
Berard, Frederic [Auteur]
Service d'immunologie [Centre Hospitalier Lyon Sud - HCL]
Rabilloud, Muriel [Auteur]
Biostatistiques santé [LBBE]
Mercier, Catherine [Auteur]
Biostatistiques santé [LBBE]
Nicolas, Jean-Francois [Auteur]
Centre Hospitalier Lyon Sud [CHU - HCL] [CHLS]

Titre de la revue :

The Journal of Allergy and Clinical Immunology: In Practice

Nom court de la revue :

J. Allergy Clin. Immunol.-Pract.

Numéro :

6

Pagination :

562-+

Date de publication :

2018-03

ISSN :

2213-2198

Mot(s)-clé(s) en anglais :

Cyclosporine
Atopic dermatitis
Methotrexate
Trial

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Methotrexate is currently used to treat atopic dermatitis but has never been assessed versus cyclosporine in adults. This study evaluated the efficacy and safety of methotrexate versus cyclosporine in patients with ...
Lire la suite >Methotrexate is currently used to treat atopic dermatitis but has never been assessed versus cyclosporine in adults. This study evaluated the efficacy and safety of methotrexate versus cyclosporine in patients with moderate-to-severe atopic dermatitis. Patients were randomized to receive either oral methotrexate (15 mg/wk) or cyclosporine (2.5 mg/kg/d) for 8 weeks. The primary end point was a patient achieving 50% improvement in the SCORing Atopic Dermatitis index (SCORAD 50) at week 8. When the primary end point was not achieved, methotrexate was increased to 25 mg and cyclosporine to 5 mg during the next 16 weeks. The secondary end points were a patient achieving a 50% reduction in the Eczema Area Severity Intensity index (EASI 50) and SCORAD 50 at each visit (ClinicalTrials.gov no. NCT00809172). A total of 97 patients received methotrexate 15 mg (n = 50) or cyclosporine 2.5 mg (n = 47). Regarding the primary end point at week 8, methotrexate was inferior to cyclosporine because the proportion of patients with SCORAD 50 was 8% (4 of 50) in the methotrexate arm versus 42% (18 of 43) in the cyclosporine arm. The difference in percentages for the 2 treatment groups (2-sided 90% CI) was -34% (-48% to -20%). At week 8, methotrexate and cyclosporine dosages were increased in 56% and 49% of the patients, respectively. Regarding EASI 50, the noninferiority end point was reached at week 20 in 92% (22 of 24) of patients in the methotrexate arm and 87% (26 of 30) of patients in the cyclosporine arm. The treatment-related adverse events were more frequent with cyclosporine (P < .0001). Methotrexate 15 mg/wk was inferior to cyclosporine 2.5 mg/kg/d at week 8. Increasing the doses of methotrexate to 25 mg/wk induced a significant improvement versus cyclosporine at week 20.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Collections :

• Récepteurs nucléaires, Maladies Cardiovasculaires et Diabète (RNMCD) - U1011

Date de dépôt :

2024-01-30T10:27:23Z
2024-04-09T14:29:25Z