5,082
Views
5
CrossRef citations to date
0
Altmetric
Editorial

Costimulatory pathway targets for autoimmune and inflammatory conditions: clinical successes, failures, and hope for the future

ORCID Icon &
Pages 99-106 | Received 09 May 2018, Accepted 05 Dec 2018, Published online: 11 Jan 2019

References

  • Esposito P, Grosjean F, Rampino T, et al. Costimulatory pathways in kidney transplantation: pathogenetic role, clinical significance and new therapeutic opportunities. Int Rev Immunol. 2014;33(3):212–233.
  • van Berkel M, Oosterwegel M. CD28 and ICOS: similar or separate costimulators of T cells? Immunol Lett. 2006;105(2):115–122.
  • Kälble F, Schaier M, Schäfer S, et al. An update on chemical pharmacotherapy options for the prevention of kidney transplant rejection with a focus on costimulation blockade. Expert Opin Pharmacother. 2017;18(8):799–807.
  • Vanhove B, Poirier N, Fakhouri F, et al. Antagonist anti-CD28 therapeutics for the treatment of autoimmune disorders. Antibodies. 2017;6(4):19.
  • Trialtrove® database [Internet]. Informa Pharma Intelligence, Citeline; [cited 2018 Nov 30]. Available from: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/trialtrove . Access to Trialtrove® is provided via company-specific URLs, and users are granted access via IP recognition.
  • Suntharalingam G, Perry MR, Ward S, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med. 2006;355(10):1018–1028.
  • TheraMAB: New mechanism of action for treatment of autoimmune diseases [Internet]. [cited 2018 Nov 30]. Available from: http://www.theramab.ru/TheraMAB_NAture.pdf
  • Merrill JT, Shevell DE, Duchesne D, et al. An anti-CD28 domain antibody, lulizumab, in systemic lupus erythematosus: results of a phase II study. Arthritis Rheumatol. 2018;70(S9):1–3553. Abstract Number: 972.
  • Poirier N, Blancho G, Hiance M, et al. First-in-human study in healthy subjects with FR104, a PEGylated monoclonal antibody fragment antagonist of CD28. J Immunol. 2016;197(12):4593–4602.
  • OSE Immunotherapeutics reports first-half 2018 results and provides a corporate update [Internet]. OSE Immunotherapeutics [updated 2018 Sep 6; cited 2018 Nov 30]. Available from: https://ose-immuno.com/wp-content/uploads/2018/09/EN_180906_Semester-results_v0509.pdf
  • Bulger EM, Maier RV, Sperry J, et al. A novel drug for treatment of necrotizing soft-tissue infections: a randomized clinical trial. JAMA Surg. 2014;149(6):528–536.
  • Pharmaprojects® database [Internet]. Informa Pharma Intelligence, Citeline. [cited 2018 Nov 30] Available from: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/pharmaprojects . Access to Pharmaprojects® is provided via company-specific URLs, and users are granted access via IP recognition.
  • Cornec D, Devauchelle-Pensec V, Tobón GJ, et al. B cells in Sjögren’s syndrome: from pathophysiology to diagnosis and treatment. J Autoimmun. 2012;39(3):161–167.
  • Sullivan BA, Tsuji W, Kivitz A, et al. Inducible T-cell co-stimulator ligand (ICOSL) blockade leads to selective inhibition of anti-KLH IgG responses in subjects with systemic lupus erythematosus. Lupus Sci Med. 2016;3(1):e000146.
  • Cheng LE, Amoura Z, Cheah B, et al. A randomized, double-blind, parallel-group, placebo-controlled, multiple-dose study to evaluate AMG 557 in patients with systemic lupus erythematosus and active lupus arthritis. Arthritis Rheumatol. 2018;70(7):1071–1076.
  • Amgen and Astrazeneca announce collaboration to jointly develop and commercialize clinical-stage inflammation portfolio [Internet]. Amgen; [updated 2012 Apr 2; cited 2018 Nov 30]. Available from: http://investors.amgen.com/phoenix.zhtml?c=61656&p=irol-newsArticle&ID=1679295
  • Amgen Pipeline [Internet]. Amgen; [cited 2018 Nov 30]. Available from: https://www.amgenpipeline.com/pipeline/
  • Law C, Grewal I. Therapeutic interventions targeting CD40L (CD154) and CD40: the opportunities and challenges. Adv Exp Med Biol. 2009;647:8–36.
  • Bhat P, Radhakrishnan J. B lymphocytes and lupus nephritis: new insights into pathogenesis and targeted therapies. Kidney Int. 2008;73(3):261–268.
  • Chamberlain C, Colman PJ, Ranger AM, et al. Repeated administration of dapirolizumab pegol in a randomised phase I study is well tolerated and accompanied by improvements in several composite measures of systemic lupus erythematosus disease activity and changes in whole blood transcriptomic profiles. Ann Rheum Dis. 2017;76(11):1837–1844.
  • Kim SC, Wakwe W, Higginbotham LB, et al. Fc-silent anti-CD154 domain antibody effectively prevents nonhuman primate renal allograft rejection. Am J Transplant. 2017;17(5):1182–1192.
  • Boumpas DT, Furie R, Manzi S, et al. BG9588 Lupus Nephritis Trial Group. A short course of BG9588 (anti-CD40 ligand antibody) improves serologic activity and decreases hematuria in patients with proliferative lupus glomerulonephritis. Arthritis Rheum. 2003;48(3):719–727.
  • IDEC pharmaceuticals corporation 10-K for the fiscal year ended December 31, 2002 [Internet]. United States Securities and Exchange Commission; [ updated 2003 Mar 31; cited 2018 Nov 30]. Available from: https://www.sec.gov/Archives/edgar/data/875045/000104746903011017/a2106647z10-k.htm
  • Albulescu M, Bush J, Almazedi F, et al. Safety, tolerability, and dose-dependent inhibition of T-cell-dependent antibody response with MEDI4920, a novel, engineered CD40L Antagonist: results of a single-ascending dose study in healthy volunteers. Arthritis Rheumatol. 2016;68(S10):1–4550. Abstract Number: 1610.
  • Biomedtracker database [Internet]. Informa Pharma Intelligence [cited 2018 Nov 30] Available from https://www.biomedtracker.com. Access to Biomedtracker is provided via company-specific URLs, and users are granted access via IP recognition.
  • Anil Kumar MS, Papp K, Tainaka R, et al. Randomized, controlled study of bleselumab (ASKP1240) pharmacokinetics and safety in patients with moderate-to-severe plaque psoriasis. Biopharm Drug Dispos. 2018;39(5):245–255.
  • Harland R, Klintmalm G, Yang H, et al. ASKP1240 in de novo kidney transplant recipients. Am J Transplant. 2015;15(S3):517. Abstract Number: 517.
  • Fisher B, Zeher M, Ng WF, et al. The novel anti-CD40 monoclonal antibody CFZ533 shows beneficial effects in patients with primary sjogren’s syndrome: a phase IIa double-blind, placebo-controlled randomized trial. Arthritis Rheumatol. 2017;69(S10):1–4426. Abstract Number: 1784.
  • Nashan B, Tedesco H, van Den Hoogen M, et al. CFZ533, a new anti-CD40 mAB demonstrates comparable efficacy and better renal function versus tacrolimus in de-novo CNI-free kidney transplantation. Am J Transplant. 2018;18(S4):1–1029. Abstract Number: 400.
  • Novartis pharmaceuticals clinical trial results for CCFZ533X2101 [Internet]. Novartis AG; [cited 2018 Sep 27]. Available from: https://www.novctrd.com/CtrdWeb/displaypdf.nov?trialresultid=17078
  • Daniluk S, Ptaszynski R, Mueller-Ladner U, et al. Safety and efficacy of BI 655064, an antagonistic anti-CD40 antibody in rheumatoid arthritis (RA) patients. Ann Rheum Dis. 2016;75(S2):718. Abstract Number: SAT0147.
  • AbbVie and Boehringer Ingelheim announce global collaboration on promising immunology compounds [Internet]. Boehringer Ingelheim; [ updated 2016 Mar 7; cited 2018 Nov 30]. Available from: https://www.boehringer-ingelheim.com/press-release/abbvie-boehringer-ingelheim-immunology-compounds?
  • AbbVie Pipeline: ABBV-323 [Internet]. AbbVie; [cited 2018 Nov 30]. Available from: https://www.abbvie.com/our-science/pipeline/abbv-323.html
  • Seshasayee D, Lee WP, Zhou M, et al. In vivo blockade of OX40 ligand inhibits thymic stromal lymphopoietin driven atopic inflammation. J Clin Invest. 2007;117(12):3868–3878.
  • Guttman-Yassky E, Pavel AB, Estrada Y, et al. GBR 830 induces progressive and sustained changes in atopic dermatitis biomarkers in patient skin lesions. J Invest Dermatol. 2018;138(5):S77. Abstract Number: 453.
  • Glenmark’s management discussion and analysis for the fourth quarter of FY 2017 – 18 [Internet]. Glenmark Pharmaceuticals; [ updated 2018 May 29; cited 2018 Nov 30]. Available from: http://www.glenmarkpharma.com/sites/default/files/MDA_Q4FY18_0.pdf
  • Kyowa Hakko Kirin Co., Ltd. Pipeline: KHK4083 [Internet]. Kyowa Hakko Kirin Co., Ltd.; [cited 2018 Nov 30]. Available from: https://www.kyowa-kirin.com/research_and_development/pipeline/index.html#
  • Mease P, McInnes I, Strand V, et al. SAT0468 Presence of poor prognostic factors may predict response to abatacept in patients with active psoriatic arthritis: results from a post hoc analysis from a phase III study. Arthritis Rheumatol. 2017;69(S10):872–873. Abstract Number: 608.
  • Ahmad H, Baker J, Østergaard M, et al. OP0284 evaluation of the impact of baseline levels of MRI-detected inflammation on treatment response in early, seropositive, MTX-naïve RA: data from the AVERT trial. Ann Rheum Dis. 2017;76(S2):1–1659. Abstract Number: OP0284.
  • FDA approved drug products label: ORENCIA [Internet]. United States Food and Drug Administration; [ updated 2017 Jun 30; cited 2018 Nov 30]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s209lbl.pdf
  • Sandborn WJ, Colombel JF, Sands BE, et al. Abatacept for Crohn’s disease and ulcerative colitis. Gastroenterology. 2012;143(1):62–69.
  • Khanna D, Spino C, Bush E, et al. Abatacept Vs. placebo in early diffuse cutaneous systemic sclerosis-results of a phase 2 investigator initiated, double-blind, placebo-controlled, multicenter, randomized controlled trial study. Arthritis Rheumatol. 2018;70(S9):1–3584. Abstract Number: 900.
  • Dooley M, Appel G, Furie R, et al. A phase III randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of abatacept or placebo on standard of care in patients with active class III or IV lupus nephritis. Arthritis Rheumatol. 2018;70(S9):1–3584. Abstract Number: 971.
  • Parulekar AD, Boomer JS, Patterson BM, et al. A randomized controlled trial to evaluate inhibition of T-cell costimulation in allergen-induced airway inflammation. Am J Respir Crit Care Med. 2013;187(5):494–501.
  • Song IH, Heldmann F, Rudwaleit M, et al. Treatment of active ankylosing spondylitis with abatacept: an open-label, 24-week pilot study. Ann Rheum Dis. 2011;70(6):1108–1110.
  • Khoury SJ, Rochon J, Ding L, et al. ACCLAIM: a randomized trial of abatacept (CTLA4-Ig) for relapsing-remitting multiple sclerosis. Mult Scler. 2017;23(5):686–695.
  • Tiwari D, Horan J, Langston A, et al. A first-in-disease trial of in vivo costimulation blockade for GVHD prevention: the addition of abatacept to standard GVHD prophylaxis controls early CD4+ T cell proliferation and is associated with low rates of severe acute GVHD. Biol Blood Marrow Transplant. 2013;19(2):S327–8.
  • FDA Approved Drug Products Label: NULOJIX [Internet]. United States Food and Drug Administration; [ updated 2011 Jun 15; cited 2018 Nov 30]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125288s0000lbl.pdf
  • Klintmalm FB, Feng S, Lake JR, et al. Belatacept‐based immunosuppression in de novo liver transplant recipients: 1‐year experience from a phase II randomized study. Am J Transplant. 2014;14(8):1817–1827.
  • Interim report for the 6 months ended June 30, 2011 [Internet]. Genmab; [cited 2018 Nov 30]. Available from: https://ir.genmab.com/static-files/7bc0d3ba-202e-499c-9af5-82e14b49f9cf
  • FF pharmaceuticals closes series A financing round [Internet]. FF Pharmaceuticals BV; [updated 2013 Jan 23; cited 2018 Nov 30] Available from: http://www.ffpharma.com/2014/uploads/news/id4/FFP_Press_release_EN_130123.pdf