medac announced today that the 1-year results of the METOP trial on subcutaneous methotrexate had been published in The Lancet. Methotrexate has been used in plaque-type psoriasis as an effective systemic treatment for more than 50 years. But so far there have not been any high-quality clinical trials with subcutaneous methotrexate in long-term therapy. Now, however, the new data published in The Lancet show a favourable benefit-risk profile for subcutaneous methotrexate administered for 52 weeks in patients with psoriasis.1
The METOP (Methotrexate Optimized treatment schedule in patients with Psoriasis) trial has been evaluating the efficacy and safety of self-administered subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis using an optimised dosing regimen2. In this international trial, 120 trial subjects received a weekly methotrexate starting dose subcutaneously using a pre-filled syringe. The dose was increased if, by week 8, there had not been at least a 50 % improvement in the Psoriasis Area and Severity Index (PASI) score. The placebo group also switched to methotrexate after week 16. The treatment was continued up until week 52.
A substudy investigated the molecular mechanism of action of subcutaneous methotrexate in psoriasis. Skin samples were taken for this at the start of the trial and after 16 weeks of treatment.
The results of the METOP trial show a favourable benefit-risk profile for subcutaneous methotrexate administered for 52 weeks in patients with psoriasis. Furthermore, a reduction in specific cytokines and a significant decrease in important inflammatory cells were demonstrated in the substudy.
1 Warren, RB et al., An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;389:528-537
2 ClinicalTrials.gov: Trial in Patients With Psoriasis Treated With Methotrexate Using an Optimized Treatment Schedule (METOP). clinicaltrials.gov/ct2/show/NCT02902861 (06.03.2017)
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