VANCOUVER, B.C. – In the first head-to-head trial in atopic dermatitis, cyclosporine was about five times more effective in terms of SCORAD 50 but was associated with more adverse events, Dr. Catherine Goujon-Henry reported at the World Congress of Dermatology.
Based on the findings, dermatologists should consider treating AD patients with a relatively high dose of methotrexate, such as 15 mg weekly, or first stabilize flaring patients with cyclosporine and then switch them to methotrexate for long-term disease control, said Dr. Goujon-Henry, who is with the Clinical Research Unit in Immunology at Lyon-Sud Hospital in Lyon, France.
Methotrexate is recommended in atopic dermatitis but has never been directly compared with cyclosporine, Dr. Goujon-Henry noted. For the study, she and her colleagues randomized 97 adults with moderate to severe AD to 8 weeks of treatment with either methotrexate at 15 mg per week or cyclosporine at 2.5 mg per kg per day. Patients only were allowed to use topical glucocorticoids or tacrolimus during the first month of the trial.
Only 8% of the methotrexate group achieved SCORAD 50 by week 8, compared with 42% of cyclosporine patients, Dr. Goujon-Henry reported. Furthermore, only 35% of the methotrexate group achieved EASI 50 compared with 68% of the cyclosporine group, she said. In addition, Dermatology Life Quality Index (DLQI) scores were 5 or less for only 37% of methotrexate patients, compared with 56% of cyclosporine patients, she reported.
The protocol called for increasing the methotrexate dose to 25 mg per week and the cyclosporine dose to 5 mg per kg per day for patients who did not achieve SCORAD 50 by week 8. Dose increases were performed for 74% of the methotrexate group and for 58% of the cyclosporine group, Dr. Goujon-Henry said. At week 12, 15 of the 50 methotrexate patients were considered non-responders and went off study, as did three cyclosporine patients. At this point, 43% of the methotrexate patients who remained on study had achieved SCORAD 50, as had 62% of cyclosporine patients.
Also at week 16, two-thirds of methotrexate patients and 79% of cyclosporine patients had achieved EASI 50, and 61% of methotrexate patients and 77% of cyclosporine patients scored 5 or less on the DLQI, Dr. Goujon-Henry reported. However, about 53% of cyclosporine patients experienced drug-related adverse events, compared with 40% of the methotrexate group, she said. Serious adverse events that led to treatment discontinuation included arterial hypertension and hypertrichosis for the cyclosporine group, and lymphopenia and hepatitis for the methotrexate group, she reported.
Taken together, the findings support using methotrexate as first-line therapy for moderate to severe atopic dermatitis, but patients need to expect a slower treatment response in exchange for the better safety profile, Dr. Goujon-Henry said.
She disclosed no relevant conflicts of interest.