title: Treatment of moderately to severely active systemic lupus erythematosus with adrenocorticotropic hormone: a single-site, open-label trial.
abstract: BACKGROUND
  Alternative therapeutic options are needed for patients with systemic lupus erythematosus (SLE) not adequately controlled with or intolerant to traditional treatments. This study evaluated the efficacy of Acthar® Gel (ACTH(1-39)) for reducing active SLE severity among patients receiving underlying conventional maintenance therapies.
  
  
  METHODS
  Ten females (mean age = 49 yrs, disease duration = 7 yrs, Systemic Lupus Erythematosus Disease Activity Index-2000 [SLEDAI-2 K] = 10) currently on maintenance self-administered ACTH(1-39) gel 1 mL (80 U/mL) for 7-15 days and were assessed weekly for 28 days. Outcome measures included Physician and Patient Global Assessments, SLEDAI-2 K, Lupus Quality of Life scale, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale, erythrocyte sedimentation rate, and C-reactive protein. Student's t-test compared data obtained at days 7, 14, and 28 with those from baseline.
  
  
  RESULTS
  The primary endpoint of SLEDAI-2 K improvement was reached at all observation times (p < 0.05) and statistically significant improvements were observed for most other parameters. No treatment-related serious or unexpected adverse events were observed.
  
  
  CONCLUSIONS
  The trial results reveal that among SLE patients in need of therapeutic alternatives, ACTH(1-39) gel may provide significant disease activity reduction.
authors.affiliation: Fiechtner Research, Lansing, MI, USA jjfiechtner@gmail.com.
authors.forename: J J
authors.initials: JJ
authors.lastname: Fiechtner
authors.affiliation: Fiechtner Research, Lansing, MI, USA.
authors.forename: T
authors.initials: T
authors.lastname: Montroy
mesh_terms: D000324:Adrenocorticotropic Hormone / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008875:Middle Aged; D012720:Severity of Illness Index
chemical_list: D000324:Adrenocorticotropic Hormone
keywords: Adrenocorticotropic hormone gel; SLEDAI-2 K; disease activity; systemic lupus erythematosus