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Study: Humira provides faster clinical disease response vs. methotrexate for treatment of psoriasis

Humira provided faster and more complete clinical disease responses compared with methotrexate as treatment for plaque psoriasis, according to recently published study results.

Researchers conducted an assessor-blind clinical trial of 30 patients between the ages of 18 years and 85 years with chronic plaque-type psoriasis who were treated at the outpatient dermatology center of Tufts Medical Center, Boston, from Aug. 18, 2009, to Oct. 11, 2011. Patients were randomly assigned to receive a 16-week course of subcutaneous Humira (adalimumab, AbbVie), in which patients received 40 mg every 2 weeks after a loading dose, or oral methotrexate given as a dosage of 7.5 mg/week and increased based on published protocols up to 25 mg/week. Treatment response was evaluated by masked assessors, who assigned a histologic grade to skin biopsy specimens obtained at baseline and weeks 1, 2, 4 and 16. Genomic, immunohistochemical and messenger RNA (mRNA) profiles were primary outcomes of the study.

At week 16, 67% of patients in the adalimumab cohort achieved a 75% reduction in the Psoriasis Area and Severity Index (PASI 75) compared with 27% of the methotrexate-treated patients.

Significant downregulation of helper T-cell related (T_H1, T_H17 and T_H22) mRNA expression was experienced by the methotrexate responders compared with the compared with methotrexate nonresponders. There was only one nonresponder in the adalimumab-treated patients, limiting comparisons in that cohort, according to the researchers.

No significant difference in gene expression was found between adalimumab and methotrexate responders at any study point. Early downregulation of chemokine (C-C motif) ligand 20 (CCL20) mRNA was demonstrated by adalimumab responders, compared with late regulation in responders to methotrexate. Additionally, interleukin 22 (IL22) mRNA showed similar differences between the cohorts.

According to the researchers, only CCL20 and IL22 mRNA demonstrated any significance in an analysis of variance findings for key mRNA and immunohistochemical marker expression comparing adalimumab and methotrexate responders.

“Clinical response to adalimumab in psoriasis is faster, more complete and characterized by faster downregulation of CCL20 and IL22 compared with methotrexate,” the researchers concluded. “Therefore, IL22- and CCL20-related signaling pathways are candidates for further investigation to understand disease mechanisms and drug development in psoriasis.” – by Bruce Thiel

Disclosures: Goldminz reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.