title: Adalimumab treatment leads to reduction of tissue tumor necrosis factor-alpha correlated with venous leg ulcer improvement: a pilot study.
abstract: Venous leg ulcers (VLUs) have higher tumor necrosis factor-α (TNF-α) levels compared with normal skin. Refractory VLUs of long duration have higher TNF-α levels compared with VLUs of shorter duration. As up to 75% of VLUs fail to heal with standard care, we sought to evaluate the role of anti-TNF-α therapy for patients with refractory VLUs. Evaluable data were obtained in four of five subjects with recalcitrant VLUs treated with 80 mg of subcutaneous adalimumab at week 0 and with 40 mg at week 2 along with compression therapy and were followed-up for 6 weeks. Wound biopsies taken at weeks 0 and 4 were stained with anti-TNF-α antibodies. Average 4-week percent wound size reduction was 20.5% ± 6.4%. Two patients had wound size reduction more than 25%, and their percent wound size reduction correlated to percent TNF-α staining score reductions (P = 0.02, R(2) = 0.999). VLU TNF-α level decrease 4 weeks post-adalimumab treatment correlated with wound healing.
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.
authors.forename: Joshua D
authors.initials: JD
authors.lastname: Fox
authors.affiliation: Department of Medicine, Nassau University Medical Center, Nassau, NY, USA.
authors.forename: Katherine L
authors.initials: KL
authors.lastname: Baquerizo-Nole
authors.affiliation: Windsor Dermatology, East Windsor, NJ, USA.
authors.forename: Brian R
authors.initials: BR
authors.lastname: Keegan
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.
authors.forename: Flor
authors.initials: F
authors.lastname: Macquhae
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.
authors.forename: Julia
authors.initials: J
authors.lastname: Escandon
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.
authors.forename: Aliette
authors.initials: A
authors.lastname: Espinosa
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.
authors.forename: Carmen
authors.initials: C
authors.lastname: Perez
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.
authors.forename: Paolo
authors.initials: P
authors.lastname: Romanelli
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA. Rkirsner@miami.edu.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Kirsner
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000378:metabolism*; D014647:Varicose Ulcer / Q000188:drug therapy* / Q000378:metabolism* / Q000473:pathology; D014945:Wound Healing
chemical_list: D000893:Anti-Inflammatory Agents; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab
keywords: Adalimumab; Chronic wound; Immunohistochemistry; TNF-alpha; Venous leg ulcer