Clinical trial NCT03414086 - References

Dermatomyositis — Predictor of Clinical Response to Acthar in Myositis

Citation(s)

•   Acosta-Rodriguez EV, Napolitani G, Lanzavecchia A, Sallusto F
  Interleukins 1beta and 6 but not transforming growth factor-beta are essential for the differentiation of interleukin 17-producing human T helper cells. Nat Immunol. 2007 Sep;8(9):942-9. Epub 2007 Aug 5.
•   aggarwal r oc, bandos a, goudeau d, koontz d, zenbia q, reed am, ascherman dp, levesque mc
  effect of b cell depletion therapy with rituximab on myositis associated antibody levels in idiopathic inflammatory myopathy. arthritis and research. 2012;64(10(suppl)):s325.
•   aggarwal r oc, Wilkerson er, koontz d, metes id, reed am, ascherman dp, levesque mc
  peripheral blood memory b cell numbers predit clinical response following rituximab treatment of adult and childhood myositis. arthritis and research. 2013;65(10(suppl)):s755-66.
•   Aggarwal R, Bandos A, Reed AM, Ascherman DP, Barohn RJ, Feldman BM, Miller FW, Rider LG, Harris-Love MO, Levesque MC; RIM Study Group, Oddis CV
  Predictors of clinical improvement in rituximab-treated refractory adult and juvenile dermatomyositis and adult polymyositis. Arthritis Rheumatol. 2014 Mar;66(3):740-9. doi: 10.1002/art.38270.
•   Aggarwal R, Cassidy E, Fertig N, Koontz DC, Lucas M, Ascherman DP, Oddis CV
  Patients with non-Jo-1 anti-tRNA-synthetase autoantibodies have worse survival than Jo-1 positive patients. Ann Rheum Dis. 2014 Jan;73(1):227-32. doi: 10.1136/annrheumdis-2012-201800. Epub 2013 Feb 19.
•   Aggarwal R, Lucas M, Fertig N, Oddis CV, Medsger TA Jr
  Anti-U3 RNP autoantibodies in systemic sclerosis. Arthritis Rheum. 2009 Apr;60(4):1112-8. doi: 10.1002/art.24409.
•   Aggarwal R, Oddis CV, Goudeau D, Fertig N, Metes I, Stephens C, Qi Z, Koontz D, Levesque MC
  Anti-signal recognition particle autoantibody ELISA validation and clinical associations. Rheumatology (Oxford). 2015 Jul;54(7):1194-9. doi: 10.1093/rheumatology/keu436. Epub 2014 Dec 17.
•   Baechler EC, Bilgic H, Reed AM
  Type I interferon pathway in adult and juvenile dermatomyositis. Arthritis Res Ther. 2011;13(6):249. doi: 10.1186/ar3531. Epub 2011 Dec 22. Review.
•   Baram TZ, Mitchell WG, Tournay A, Snead OC, Hanson RA, Horton EJ
  High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study. Pediatrics. 1996 Mar;97(3):375-9.
•   Bernstein RM, Morgan SH, Chapman J, Bunn CC, Mathews MB, Turner-Warwick M, Hughes GR
  Anti-Jo-1 antibody: a marker for myositis with interstitial lung disease. Br Med J (Clin Res Ed). 1984 Jul 21;289(6438):151-2.
•   Bilgic H, Ytterberg SR, Amin S, McNallan KT, Wilson JC, Koeuth T, Ellingson S, Newman B, Bauer JW, Peterson EJ, Baechler EC, Reed AM
  Interleukin-6 and type I interferon-regulated genes and chemokines mark disease activity in dermatomyositis. Arthritis Rheum. 2009 Nov;60(11):3436-46. doi: 10.1002/art.24936.
•   Biswas PS, Aggarwal R, Levesque MC, Maers K, Ramani K
  Type I interferon and T helper 17 cells co-exist and co-regulate disease pathogenesis in lupus patients. Int J Rheum Dis. 2015 Jul;18(6):646-53. doi: 10.1111/1756-185X.12636. Epub 2015 May 11.
•   Bomback AS, Tumlin JA, Baranski J, Bourdeau JE, Besarab A, Appel AS, Radhakrishnan J, Appel GB
  Treatment of nephrotic syndrome with adrenocorticotropic hormone (ACTH) gel. Drug Des Devel Ther. 2011 Mar 14;5:147-53. doi: 10.2147/DDDT.S17521.
•   Carbone G, Wilson A, Diehl SA, Bunn J, Cooper SM, Rincon M
  Interleukin-6 receptor blockade selectively reduces IL-21 production by CD4 T cells and IgG4 autoantibodies in rheumatoid arthritis. Int J Biol Sci. 2013;9(3):279-88. doi: 10.7150/ijbs.5996. Epub 2013 Mar 7.
•   Catania A, Gatti S, Colombo G, Lipton JM
  Targeting melanocortin receptors as a novel strategy to control inflammation. Pharmacol Rev. 2004 Mar;56(1):1-29. Review.
•   Catania A, Lonati C, Sordi A, Carlin A, Leonardi P, Gatti S
  The melanocortin system in control of inflammation. ScientificWorldJournal. 2010 Sep 14;10:1840-53. doi: 10.1100/tsw.2010.173. Review.
•   Chevrel G, Page G, Granet C, Streichenberger N, Varennes A, Miossec P
  Interleukin-17 increases the effects of IL-1 beta on muscle cells: arguments for the role of T cells in the pathogenesis of myositis. J Neuroimmunol. 2003 Apr;137(1-2):125-33.
•   Diehl SA, Schmidlin H, Nagasawa M, Blom B, Spits H
  IL-6 triggers IL-21 production by human CD4+ T cells to drive STAT3-dependent plasma cell differentiation in B cells. Immunol Cell Biol. 2012 Sep;90(8):802-11. doi: 10.1038/icb.2012.17. Epub 2012 Apr 10.
•   Dienz O, Eaton SM, Bond JP, Neveu W, Moquin D, Noubade R, Briso EM, Charland C, Leonard WJ, Ciliberto G, Teuscher C, Haynes L, Rincon M
  The induction of antibody production by IL-6 is indirectly mediated by IL-21 produced by CD4+ T cells. J Exp Med. 2009 Jan 16;206(1):69-78. doi: 10.1084/jem.20081571. Epub 2009 Jan 12.
•   Greenberg SA, Bradshaw EM, Pinkus JL, Pinkus GS, Burleson T, Due B, Bregoli L, O'Connor KC, Amato AA
  Plasma cells in muscle in inclusion body myositis and polymyositis. Neurology. 2005 Dec 13;65(11):1782-7. Erratum in: Neurology. 2006 Feb 28;66(4):493. Bregoli, L S [corrected to Bregoli, L].
•   Grogan JL, Ouyang W
  A role for Th17 cells in the regulation of tertiary lymphoid follicles. Eur J Immunol. 2012 Sep;42(9):2255-62. doi: 10.1002/eji.201242656. Review.
•   Gunawardena H, Betteridge ZE, McHugh NJ
  Myositis-specific autoantibodies: their clinical and pathogenic significance in disease expression. Rheumatology (Oxford). 2009 Jun;48(6):607-12. doi: 10.1093/rheumatology/kep078. Review.
•   Karnowski A, Chevrier S, Belz GT, Mount A, Emslie D, D'Costa K, Tarlinton DM, Kallies A, Corcoran LM
  B and T cells collaborate in antiviral responses via IL-6, IL-21, and transcriptional activator and coactivator, Oct2 and OBF-1. J Exp Med. 2012 Oct 22;209(11):2049-64. doi: 10.1084/jem.20111504. Epub 2012 Oct 8.
•   Khanna S, Reed AM
  Immunopathogenesis of juvenile dermatomyositis. Muscle Nerve. 2010 May;41(5):581-92. doi: 10.1002/mus.21669. Review.
•   Kimura A, Kishimoto T
  IL-6: regulator of Treg/Th17 balance. Eur J Immunol. 2010 Jul;40(7):1830-5. doi: 10.1002/eji.201040391. Review.
•   Kishimoto T
  Interleukin-6: discovery of a pleiotropic cytokine. Arthritis Res Ther. 2006;8 Suppl 2:S2. Epub 2006 Jul 28. Review.
•   Levine T
  Treating refractory dermatomyositis or polymyositis with adrenocorticotropic hormone gel: a retrospective case series. Drug Des Devel Ther. 2012;6:133-9. doi: 10.2147/DDDT.S33110. Epub 2012 Jun 11. Erratum in: Drug Des Devel Ther. 2012;6:163.
•   Ma CS, Deenick EK, Batten M, Tangye SG
  The origins, function, and regulation of T follicular helper cells. J Exp Med. 2012 Jul 2;209(7):1241-53. doi: 10.1084/jem.20120994. Review.
•   Ma CS, Deenick EK
  Human T follicular helper (Tfh) cells and disease. Immunol Cell Biol. 2014 Jan;92(1):64-71. doi: 10.1038/icb.2013.55. Epub 2013 Oct 22. Review.
•   McGeachy MJ, Cua DJ
  The link between IL-23 and Th17 cell-mediated immune pathologies. Semin Immunol. 2007 Dec;19(6):372-6. doi: 10.1016/j.smim.2007.10.012. Epub 2007 Dec 3. Review.
•   Morita R, Schmitt N, Bentebibel SE, Ranganathan R, Bourdery L, Zurawski G, Foucat E, Dullaers M, Oh S, Sabzghabaei N, Lavecchio EM, Punaro M, Pascual V, Banchereau J, Ueno H
  Human blood CXCR5(+)CD4(+) T cells are counterparts of T follicular cells and contain specific subsets that differentially support antibody secretion. Immunity. 2011 Jan 28;34(1):108-21. doi: 10.1016/j.immuni.2010.12.012. Epub 2011 Jan 6. Erratum in: Immunity. 2011 Jan 28;34(1):135.
•   Narazaki M, Hagihara K, Shima Y, Ogata A, Kishimoto T, Tanaka T
  Therapeutic effect of tocilizumab on two patients with polymyositis. Rheumatology (Oxford). 2011 Jul;50(7):1344-6. doi: 10.1093/rheumatology/ker152. Epub 2011 Apr 22.
•   Oddis CV, Reed AM, Aggarwal R, Rider LG, Ascherman DP, Levesque MC, Barohn RJ, Feldman BM, Harris-Love MO, Koontz DC, Fertig N, Kelley SS, Pryber SL, Miller FW, Rockette HE; RIM Study Group
  Rituximab in the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis: a randomized, placebo-phase trial. Arthritis Rheum. 2013 Feb;65(2):314-24. doi: 10.1002/art.37754.
•   Okiyama N, Sugihara T, Iwakura Y, Yokozeki H, Miyasaka N, Kohsaka H
  Therapeutic effects of interleukin-6 blockade in a murine model of polymyositis that does not require interleukin-17A. Arthritis Rheum. 2009 Aug;60(8):2505-12. doi: 10.1002/art.24689.
•   Page G, Chevrel G, Miossec P
  Anatomic localization of immature and mature dendritic cell subsets in dermatomyositis and polymyositis: Interaction with chemokines and Th1 cytokine-producing cells. Arthritis Rheum. 2004 Jan;50(1):199-208.
•   Patakas A, Benson RA, Withers DR, Conigliaro P, McInnes IB, Brewer JM, Garside P
  Th17 effector cells support B cell responses outside of germinal centres. PLoS One. 2012;7(11):e49715. doi: 10.1371/journal.pone.0049715. Epub 2012 Nov 16.
•   Rider LG, Lachenbruch PA, Monroe JB, Ravelli A, Cabalar I, Feldman BM, Villalba ML, Myones BL, Pachman LM, Rennebohm RM, Reed AM, Miller FW; IMACS Group
  Damage extent and predictors in adult and juvenile dermatomyositis and polymyositis as determined with the myositis damage index. Arthritis Rheum. 2009 Nov;60(11):3425-35. doi: 10.1002/art.24904.
•   Rider LG, Werth VP, Huber AM, Alexanderson H, Rao AP, Ruperto N, Herbelin L, Barohn R, Isenberg D, Miller FW
  Measures of adult and juvenile dermatomyositis, polymyositis, and inclusion body myositis: Physician and Patient/Parent Global Activity, Manual Muscle Testing (MMT), Health Assessment Questionnaire (HAQ)/Childhood Health Assessment Questionnaire (C-HAQ), Childhood Myositis Assessment Scale (CMAS), Myositis Disease Activity Assessment Tool (MDAAT), Disease Activity Score (DAS), Short Form 36 (SF-36), Child Health Questionnaire (CHQ), physician global damage, Myositis Damage Index (MDI), Quantitative Muscle Testing (QMT), Myositis Functional Index-2 (FI-2), Myositis Activities Profile (MAP), Inclusion Body Myositis Functional Rating Scale (IBMFRS), Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), Cutaneous Assessment Tool (CAT), Dermatomyositis Skin Severity Index (DSSI), Skindex, and Dermatology Life Quality Index (DLQI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S118-57. doi: 10.1002/acr.20532. Review.
•   rohit aggarwal cvo, andriy bandos, Danielle goudeau, diane koontz, qi zenbiao, ann m
  reed. dan p ascherman, and marc c levesque. . effect of b cell depletion therapy with rituximab on myositis associated antibody levels in idiopathic inflammatory myopathy. arthritis and research. 2012;64(10(suppl.)):s325.
•   Scuderi F, Mannella F, Marino M, Provenzano C, Bartoccioni E
  IL-6-deficient mice show impaired inflammatory response in a model of myosin-induced experimental myositis. J Neuroimmunol. 2006 Jul;176(1-2):9-15. Epub 2006 May 24.
•   Simsarian JP, Saunders C, Smith DM
  Five-day regimen of intramuscular or subcutaneous self-administered adrenocorticotropic hormone gel for acute exacerbations of multiple sclerosis: a prospective, randomized, open-label pilot trial. Drug Des Devel Ther. 2011;5:381-9. doi: 10.2147/DDDT.S19331. Epub 2011 Jul 11.
•   Sweeney CM, Lonergan R, Basdeo SA, Kinsella K, Dungan LS, Higgins SC, Kelly PJ, Costelloe L, Tubridy N, Mills KH, Fletcher JM
  IL-27 mediates the response to IFN-ß therapy in multiple sclerosis patients by inhibiting Th17 cells. Brain Behav Immun. 2011 Aug;25(6):1170-81. doi: 10.1016/j.bbi.2011.03.007. Epub 2011 Mar 21.
•   Sweet RA, Lee SK, Vinuesa CG
  Developing connections amongst key cytokines and dysregulated germinal centers in autoimmunity. Curr Opin Immunol. 2012 Dec;24(6):658-64. doi: 10.1016/j.coi.2012.10.003. Epub 2012 Nov 1. Review.
•   Tournadre A, Lenief V, Eljaafari A, Miossec P
  Immature muscle precursors are a source of interferon-ß in myositis: role of Toll-like receptor 3 activation and contribution to HLA class I up-regulation. Arthritis Rheum. 2012 Feb;64(2):533-41. doi: 10.1002/art.33350.
•   Tournadre A, Lenief V, Miossec P
  Expression of Toll-like receptor 3 and Toll-like receptor 7 in muscle is characteristic of inflammatory myopathy and is differentially regulated by Th1 and Th17 cytokines. Arthritis Rheum. 2010 Jul;62(7):2144-51. doi: 10.1002/art.27465.
•   Tournadre A, Porcherot M, Chérin P, Marie I, Hachulla E, Miossec P
  Th1 and Th17 balance in inflammatory myopathies: interaction with dendritic cells and possible link with response to high-dose immunoglobulins. Cytokine. 2009 Jun;46(3):297-301. doi: 10.1016/j.cyto.2009.02.013. Epub 2009 Mar 19.

Predictor of Clinical Response to Acthar in Myositis: Phase II of Acthar Clinical Trial

Details for clinical trial NCT03414086