title: Oral ACTH (H.P. Acthar(®)Gel) inhibits IL-1 and IL-17 secretion in humans.
abstract: OBJECTIVE
  We have shown that oral corticotropin hormone (ACTH) decreased clinical score, inflammatory foci and T(eff) IL-17 in fed and adoptive transferred recipient mice with experimental autoimmune encephalomyelitis (EAE). Therefore, we determined whether oral administration of ACTH had immunological and endocrinological effects and was safe in humans.
  
  
  METHODS
  Three groups of three healthy adult volunteers were assayed for total serum ACTH, cortisol and a set of pro-inflammatory and counter-regulatory cytokines after ingested dose(s) of ACTH 4 IU (n=3), 41 IU (n=3), or 123 IU (n=3) over 5 days.
  
  
  RESULTS
  There were no safety issues during the trial. There was no increase in total ACTH levels after day 1 or day 5. There was no significant increase in total cortisol among the groups comparing day 1 to day 5. There were significant decreases in the inflammatory cytokine IL-1 and IL-17 secretion at day 6 compared to baseline with the 123 IU dose but not after the 4 IU and 41 IU doses.
  
  
  CONCLUSIONS
  These data provide evidence for the safety and an immunological effect of oral ACTH in humans. It is unknown if the change in IL-1 and IL-17 reflects a local GI-mediated effect or effects following systemic absorption of ACTH.
authors.affiliation: Department of Neurology, University of Texas-Houston, Health Science Center (UT-Health), P.O. Box 20708, 6431 Fannin Street, Houston, TX 77030, United States. staley.a.brod@uth.tmc.edu
authors.forename: Staley A
authors.initials: SA
authors.lastname: Brod
authors.forename: Victoria
authors.initials: V
authors.lastname: Bauer
authors.forename: Zachary
authors.initials: Z
authors.lastname: Hood
mesh_terms: D000284:Administration, Oral; D000324:Adrenocorticotropic Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000328:Adult; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D005782:Gels; D006728:Hormones / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D007375:Interleukin-1 / Q000037:antagonists & inhibitors* / Q000378:metabolism; D020381:Interleukin-17 / Q000037:antagonists & inhibitors* / Q000378:metabolism; D008297:Male; D011446:Prospective Studies; D013997:Time Factors
chemical_list: D005782:Gels; D006728:Hormones; D007375:Interleukin-1; D020381:Interleukin-17; D000324:Adrenocorticotropic Hormone