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Methotrexate Versus Cyclosporine in Adults with Moderate-to-Severe Atopic Dermatitis: A Phase III Randomized Noninferiority Trial

Catherine Goujon 1 Manuelle Viguier 2 Delphine Staumont-Sallé 3 Claire Bernier 4 Gérard Guillet 5 Morad Lahfa 6 Marie-Christine Ferrier Le Bouedec 7 Frédéric Cambazard 8 David Bottigioli 9 Sophie Grande 1 Karima Dahel 9 Frédéric Bérard 10 Muriel Rabilloud 11 Catherine Mercier 11 Jean-François Nicolas 12
1 Service d'immunologie [Centre Hospitalier Lyon Sud - HCL]
2 Service de Dermatologie [AP-HP Hôpital Saint-Louis]
3 Service de Dermatologie
4 Service de dermatologie [Nantes]
5 LITEC - Laboratoire Inflammation, Tissus épithéliaux et Cytokines
6 Service de dermatologie (CHU de Toulouse)
7 CHU Clermont-Ferrand
8 University Hospital of St-Etienne, Department of Dermatology
9 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]
10 Département de Dermatologie [CH Lyon-Sud, Pierre-Bénite]
11 Biostatistiques santé
Département biostatistiques et modélisation pour la santé et l'environnement [LBBE]
12 Immunologie de l'allergie cutanée et vaccination – Immunology of skin allergy and vaccination
CIRI - Centre International de Recherche en Infectiologie - UMR
Abstract : BACKGROUND: Methotrexate is currently used to treat atopic dermatitis but has never been assessed versus cyclosporine in adults. OBJECTIVE: This study evaluated the efficacy and safety of methotrexate versus cyclosporine in patients with moderate-to-severe atopic dermatitis. METHODS: 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). RESULTS: 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 \textless .0001). CONCLUSIONS: 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.
Keywords : Trial Methotrexate Cyclosporine Atopic dermatitis
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Journal articles
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https://hal.archives-ouvertes.fr/hal-01911515
Contributor : Laure-Hélène Davoine Connect in order to contact the contributor
Submitted on : Friday, November 2, 2018 - 7:33:49 PM
Last modification on : Thursday, January 20, 2022 - 11:44:02 AM

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CNRS | UNIV-LYON1 | CIRI | ENS-LYON | UDL | UNIV-POITIERS | HCL | CHLS | BIOENVIS | LITEC | UNIV-NANTES | CIRI-M-VOCANSON-EIA | INRIA

Citation

Catherine Goujon, Manuelle Viguier, Delphine Staumont-Sallé, Claire Bernier, Gérard Guillet, et al.. Methotrexate Versus Cyclosporine in Adults with Moderate-to-Severe Atopic Dermatitis: A Phase III Randomized Noninferiority Trial. Journal of Allergy and Clinical Immunology: In Practice, Elsevier, 2018, 6 (2), pp.562-569.e3. ⟨10.1016/j.jaip.2017.07.007⟩. ⟨hal-01911515⟩

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