Chronic urticaria is defined by urticarial lesions persisting at 6 weeks. The cause is not found in about 75% of cases (chronic idiopathic urticaria). The gold standard treatment consists of anti-H1 molecules. In severe cases, refractory to anti-H1, few therapeutic alternatives exist. Methotrexate, which is not expensive and often prescribed by dermatologists, has been efficiently tried in an open study on severe chronic idiopathic urticaria, and also in few case reports.
Chronic urticaria, defined by its persistence beyond 6 weeks, is a common condition (0.1% to 3% of the general population), occurring at any age. The etiology is not found in nearly 75% of cases (chronic idiopathic urticaria). Chronic idiopathic urticaria may resolve over several months or years. The quality of life of patients is usually strongly spoiled. The gold standard treatment consist of anti-H1 molecules. In severe cases, which are refractory to anti-H1, few therapeutic alternatives exist. Two studies have shown a benefit when adding to anti-H1, montelukast, anti-leukotriene, or cyclosporine. Methotrexate, which is another immunosuppressive drug, cheap and commonly prescribed by dermatologists, has been efficient in severe chronic urticaria, in an open study and in few case reports. Methotrexate, an anti-metabolite drug which inhibits dihydrofolate reductase, is indicated in hematologic malignancies and in autoimmune diseases. It may be given by oral or parenteral administration, once a week, and requires regular monitoring of renal and hepatic function, and blood count.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
83
Methotrexate (Novatrex ®) tablets 2.5 mg methotrexate 0.2 mg/kg/week as a single dose, orally for 8 weeks. After 8 weeks, if the treatment is still not efficient, the dose will be increased to 0.25 mg/kg/week and continued until W18. For anti-H1 treatment, the same molecules with the same dosage than before the recruitment will be continued, and methotrexate will be added in this group.
Placebo: 0.2 mg / kg / week as a single dose, orally for 8 weeks. After eight weeks, if the patient is still very embarrassed, the dose is increased to 0.25 mg / kg / week in a weekly dose. For anti-H1 treatment, the same molecules with the same dosage than before the recruitment will be continued, and the placebo of methotrexate will be added in this group.
CHRU BREST Morvan
Brest, France
Chu Mondor
Créteil, France
Ch Le Mans
Le Mans, France
CHRU LILLE Huriez
Lille, France
Number of patients with complete remission of urticaria at 18 weeks
Number of patients with complete remission of urticaria at 18 weeks, defined as no urticarial lesion 30 days before W18
Time frame: at 18 weeks of treatment
Tolerance : clinical and biological safety
Number of patients with clinical adverse effects Number of patients with biological adverse effects
Time frame: 18 weeks
Efficacy of the treatment in improving symptoms : pruritus
Number of patients with : \- pruritus At 18 weeks and 26 weeks
Time frame: 18 weeks and 26 weeks
Persistency of the complete remission at 26 weeks
Number of patients with persistency of the complete remission, defined as no urticarial lesion from the withdrawal of treatment until W26
Time frame: 26 weeks
Efficacy of the treatment in improving symptoms : outbreaks by week
\- number of outbreaks by week/patient At 18 weeks and 26 weeks
Time frame: 18 weeks and 26 weeks
Efficacy of the treatment in improving symptoms : duration of lesions
\- mean +/- standard deviation duration of lesions At 18 weeks and 26 weeks
Time frame: 18 weeks and 26 weeks
Efficacy of the treatment in improving quality of life
Mean DLQI (quality of life) score : At 18 weeks and 26 weeks
Time frame: 18 weeks and 26 weeks
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CHRU NANCY Brabois
Nancy, France
Chru Nantes
Nantes, France
Hopital TENON
Paris, France
CHRU POITIERS La Miléterie
Poitiers, France
Chru Reims
Reims, France
CHRU RENNES Pontchaillou
Rennes, France
...and 1 more locations
Efficacy of the treatment in improving quality of sleep
Mean score of quality of sleep (from 0 to 100) At 18 weeks and 26 weeks
Time frame: 18 weeks and 26 weeks
Efficacy of the treatment in improving facial/cervical urticarial lesions
Number of patients with, either : * facial/cervical urticarial lesions * urticarial lesions on the body only * facial/cervical + body lesions Indeed, facial or cervical urticarial lesions are considered more disturbing. At W18 and W26
Time frame: 18 weeks and 26 weeks