A randomized trial of methotrexate versus azathioprine for severe atopic eczema

• Published in: Journal of allergy and clinical immunology Vol. 128; no. 2; pp. 353 - 359
• Main Authors: Schram, Mandy Elvira, MD, Roekevisch, Evelien, MD, Leeflang, Mariska Maria Geertruida, PhD, Bos, Jan Dositheus, MD, PhD, FRCP, Schmitt, Jochen, MD, Spuls, Phyllis Ira, MD, PhD
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01-08-2011; Elsevier; Elsevier Limited
• Subjects: Adult; Allergic diseases; Allergy and Immunology; atopic dermatitis; Atopic eczema; azathioprine; Azathioprine - administration & dosage; Azathioprine - adverse effects; Azathioprine - therapeutic use; Biological and medical sciences; Children & youth; Clinical medicine; Clinical trials; Dermatitis, Atopic - drug therapy; Dermatitis, Atopic - physiopathology; Disease; Drug dosages; Drug therapy; Eczema; Enzymes; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Humans; Immunopathology; Immunosuppressive Agents - administration & dosage; Immunosuppressive Agents - adverse effects; Immunosuppressive Agents - therapeutic use; Male; Medical sciences; methotrexate; Methotrexate - administration & dosage; Methotrexate - adverse effects; Methotrexate - therapeutic use; Middle Aged; off-label; Quality of Life; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Severity of Illness Index; Skin allergic diseases. Stinging insect allergies; Studies; Treatment Outcome; trial; SCORAD; IGA; POEM; Severity scoring of atopic dermatitis; Eczema area and intensity index; TPMT; Patient global assessment; atopic dermatitis; azathioprine; methotrexate; VAS; Thymus and activation-regulated chemokine; PGA; Atopic eczema; trial; Thiopurine methyltransferase; Visual analog scale; EASI; Patient-oriented eczema measurement; Investigator global assessment; TARC; off-label; Antineoplastic agent; Allergy; Immunopathology; Skin disease; Thiopurine derivatives; Atopy; Antifolate; Randomization; Immunology; Antimetabolic; Atopic dermatitis; Eczema; Clinical trial; Azathioprine; Methotrexate; Comparative study
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/j.jaci.2011.03.024

Background Patients with severe atopic eczema frequently require systemic treatment to control their disease. Methotrexate and azathioprine are proposed as off-label treatment options, but direct comparisons are lacking. Objectives We sought to compare the efficacy and safety of methotrexate versus azathioprine in adults with severe atopic eczema. Methods Patients with severe atopic eczema were randomly assigned in a 1:1 ratio to receive either methotrexate (dosage, 10-22.5 mg/wk) or azathioprine (dosage, 1.5-2.5 mg/kg/d) for 12 weeks, followed by a 12-week follow-up period. Primary outcome was the mean change in the severity scoring of atopic dermatitis index after 12 weeks. Efficacy assessors blinded for allocation of treatment were used to perform clinical outcome assessment. Analyses were done on an intention-to-treat basis. Results Of the 45 patients screened, 42 were included. At week 12, patients in the methotrexate group had a mean relative reduction in the severity scoring of atopic dermatitis index of 42% (SD, 18%) compared with 39% (SD, 25%) in the azathioprine group ( P  = .52). Proportions of patients achieving at least mild disease and reductions on impact of quality of life, symptoms, and levels of thymus and activation-regulated chemokine were similar in both groups at weeks 12 and 24. No statistically significant differences were found in the number and severity of adverse events. Abnormalities in blood count were more common in the azathioprine group. No serious adverse events occurred. Conclusion Both treatments achieved clinically relevant improvement and were safe in the short term. Methotrexate and azathioprine are appropriate options for the treatment of severe atopic eczema.