Methotrexate shows longer efficacy in pediatric atopic dermatitis than cyclosporine
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Key takeaways:
- Both methotrexate and cyclosporin showed efficacy in the treatment of atopic dermatitis in children.
- While cyclosporine’s efficacy was faster acting, those treated with methotrexate experienced longer sustained efficacy.
Both methotrexate and cyclosporin are efficacious in the treatment of severe pediatric atopic dermatitis, but methotrexate showed higher rates of sustained treatment response, according to a study.
“Although a bit slower in onset of action (12 weeks follow-up point), methotrexate is more efficacious than cyclosporin in the long run,” Carsten Flohr, MD, chair of dermatology and population health sciences at King’s College London and the study’s lead author, told Healio.
“Disease control was also better in the Methotrexate arm after stopping treatment and is significantly cheaper, making it an excellent first choice medication in this patient group, especially in low-income settings,” Flohr continued.
In the multicenter, parallel group, assessor-blinded TREAT trial, Flohr and colleagues included 103 pediatric patients aged 2 to 16 years in the United Kingdom and Ireland who had severe recalcitrant atopic eczema.
Patients were randomly assigned to receive oral cyclosporin (CyA; Neoral, Novartis Pharmaceuticals) or methotrexate (MTX). CyA was dosed at 4 mg/kg per day, with the option of doses increasing to a maximum of 5 mg/kg or decreasing at 12 weeks. Oral MTX was dosed at 0.1 mg/kg at week 0 and then 0.4 mg/kg per week, with a maximum dose of 25 mg per week, through week 36. Those in the MTX group also were prescribed once-daily oral folic acid 1 mg.
At week 12, those in the CyA group had a statistically significant improvement over the MTX group, with a mean change in baseline of –5.69 (97.5% CI, –10.81 to –0.57), using the Objective Severity Scoring of Atopic Dermatitis (o-SCORAD) assessment. In the CyA group, more patients reached o-SCORAD-50 at week 12 (OR = 2.6; 95% CI, 1.23-5.49). However, at week 60, those in the MTX group had a superior rate of efficacy in reaching and maintaining o-SCORAD-50 (OR = 0.33; 95% CI, 0.13-0.85).
Participant-reported flares after the trial were significantly higher in the CyA group (9.41) compared with the MTX group (9.41 vs. 6.19; OR = 3.22; 95% CI, 0.42-6.01).
Quality of life assessments showed both treatment options significantly improved the patient’s quality of life with no significant differences between the two.
Topical anti-inflammatory treatments were reportedly used more often in the CyA group than in the MTX group throughout the trial, with the total number of days in topical corticosteroids being 94.5 in the CyA group and 78.72 in the MTX group. Further, the mean time on topical calcineurin inhibitors was 51.16 days in the CyA group and 26.09 days in the MTX group.
Adverse events were reported in 94.1% of the CyA arm and 92.2% of the MTX group. Serious adverse events were reported in five (10%) of the CyA group and seven (14%) of the MTX group, with two in each group considered possibly or probably related to the drug.
“Both drugs were adequately tolerated and appear safe in children and young people with AD,” Flohr told Healio.
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