메뉴 건너뛰기




Volumn 55, Issue 9, 2015, Pages 1051-1060

Effect of ceralifimod (ONO-4641) on lymphocytes and cardiac function: Randomized, double-blind, placebo-controlled trial with an open-label fingolimod arm

Author keywords

heart rate; lymphocyte count; pharmacodynamics; sphingosine 1 phosphate

Indexed keywords

CERALIFIMOD; FINGOLIMOD; PLACEBO; AZETIDINE DERIVATIVE; IMMUNOSUPPRESSIVE AGENT; NAPHTHALENE DERIVATIVE;

EID: 84937727626     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.513     Document Type: Article
Times cited : (28)

References (26)
  • 1
    • 84870459692 scopus 로고    scopus 로고
    • Efficacy and immunomodulatory actions of ONO-4641, a novel selective agonist for sphingosine 1-phosphate receptors 1 and 5, in preclinical models of multiple sclerosis
    • Komiya T, Sato K, Shioya H, et al., Efficacy and immunomodulatory actions of ONO-4641, a novel selective agonist for sphingosine 1-phosphate receptors 1 and 5, in preclinical models of multiple sclerosis. Clin Exp Immunol. 2013; 171: 54-62.
    • (2013) Clin Exp Immunol. , vol.171 , pp. 54-62
    • Komiya, T.1    Sato, K.2    Shioya, H.3
  • 2
    • 84862327950 scopus 로고    scopus 로고
    • Sphingosine 1-phosphate receptor 5 mediates the immune quiescence of the human brain endothelial barrier
    • van Doorn, R, Lopes, Pinheiro, MA, Kooij, G, et al., Sphingosine 1-phosphate receptor 5 mediates the immune quiescence of the human brain endothelial barrier. J Neuroinflammation. 2012; 9: 133.
    • (2012) J Neuroinflammation. , vol.9 , pp. 133
    • Van Doorn, R.1    Pinheiro, M.A.2    Kooij, G.3
  • 3
    • 84894272443 scopus 로고    scopus 로고
    • Relapse rates in patients with multiple sclerosis receiving ONO-4641, a sphingosine-1-phosphate receptor agonist: Interim results from an extension of the DreaMS study
    • on behalf of the DreaMS study investigators. (Suppl 1).
    • Zipp F, Vollmer T, Bar-Or A, et al., on behalf of the DreaMS study investigators. Relapse rates in patients with multiple sclerosis receiving ONO-4641, a sphingosine-1-phosphate receptor agonist: interim results from an extension of the DreaMS study. Mult Scler J. 2013; 19 (Suppl 1): 454-455.
    • (2013) Mult Scler J. , vol.19 , pp. 454-455
    • Zipp, F.1    Vollmer, T.2    Bar-Or, A.3
  • 4
    • 84937727436 scopus 로고    scopus 로고
    • Magnetic resonance imaging measures of efficacy in patients with multiple sclerosis receiving ONO-4641, a sphingosine-1-phosphate receptor-1 and -5 agonist: Interim results from an extension of the DreaMS study
    • on behalf of the DreaMS study investigators. (Suppl 1).
    • Vollmer T, Zipp F, Bar-Or A, Due B, Thangavelu K, Fischer TZ, on behalf of the DreaMS study investigators. Magnetic resonance imaging measures of efficacy in patients with multiple sclerosis receiving ONO-4641, a sphingosine-1-phosphate receptor-1 and -5 agonist: interim results from an extension of the DreaMS study. Mult Scler J. 2013; 19 (Suppl 1): 226-227.
    • (2013) Mult Scler J. , vol.19 , pp. 226-227
    • Vollmer, T.1    Zipp, F.2    Bar-Or, A.3    Due, B.4    Thangavelu, K.5    Fischer, T.Z.6
  • 5
    • 79960855026 scopus 로고    scopus 로고
    • A review of its use in the management of relapsing-remitting multiple sclerosis
    • Scott LJ. Fingolimod:, a review of its use in the management of relapsing-remitting multiple sclerosis. CNS Drugs. 2011; 25: 673-698.
    • (2011) CNS Drugs. , vol.25 , pp. 673-698
    • Scott, L.J.1
  • 6
    • 79955455801 scopus 로고    scopus 로고
    • Mechanisms of fingolimod's efficacy and adverse effects in multiple sclerosis
    • Cohen JA, Chun J., Mechanisms of fingolimod's efficacy and adverse effects in multiple sclerosis. Ann Neurol. 2011; 69: 759-777.
    • (2011) Ann Neurol. , vol.69 , pp. 759-777
    • Cohen, J.A.1    Chun, J.2
  • 7
    • 84937732417 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research. Medical review; Fingolimod, Application Number 22-527; Washington, DC
    • Center for Drug Evaluation and Research. Medical review; Fingolimod, Application Number 22-527; Washington, DC; 2010.
    • (2010)
  • 8
    • 84875443952 scopus 로고    scopus 로고
    • The evaluation and management of drug effects on cardiac conduction (PR and QRS intervals) in clinical development
    • Nada A, Gintant GA, Kleiman R, et al., The evaluation and management of drug effects on cardiac conduction (PR and QRS intervals) in clinical development. Am Heart J. 2013; 165: 489-500.
    • (2013) Am Heart J. , vol.165 , pp. 489-500
    • Nada, A.1    Gintant, G.A.2    Kleiman, R.3
  • 9
    • 84860284278 scopus 로고    scopus 로고
    • Placebo-controlled study of the effects of fingolimod on cardiac rate and rhythm and pulmonary function in healthy volunteers
    • Schmouder R, Hariry S, David OJ., Placebo-controlled study of the effects of fingolimod on cardiac rate and rhythm and pulmonary function in healthy volunteers. Eur J Clin Pharmacol. 2012; 68: 355-362.
    • (2012) Eur J Clin Pharmacol. , vol.68 , pp. 355-362
    • Schmouder, R.1    Hariry, S.2    David, O.J.3
  • 10
    • 33745927144 scopus 로고    scopus 로고
    • FT Y720: Placebo-controlled study of the effect on cardiac rate and rhythm in healthy subjects
    • Schmouder R, Serra, D, Wang, Y, Kovarik, JM, DiMarco, J, Hunt, TL, Bastien, MC., FT Y720: placebo-controlled study of the effect on cardiac rate and rhythm in healthy subjects. J Clin Pharmacol. 2006; 46: 895-904.
    • (2006) J Clin Pharmacol. , vol.46 , pp. 895-904
    • Serra, S.R.1    Wang, D.2    Kovarik, Y.3    DiMarco, J.M.4    Hunt, J.5    Bastien, T.L.6
  • 11
    • 2342634478 scopus 로고    scopus 로고
    • Single-dose FTY720 pharmacokinetics, food effect, and pharmacological responses in healthy subjects
    • Kovarik JM, Schmouder R, Barilla D, Wang Y, Kraus G,. Single-dose FTY720 pharmacokinetics, food effect, and pharmacological responses in healthy subjects. Br J Clin Pharmacol. 2004; 57: 586-591.
    • (2004) Br J Clin Pharmacol. , vol.57 , pp. 586-591
    • Kovarik, J.M.1    Schmouder, R.2    Barilla, D.3    Wang, Y.4    Kraus, G.5
  • 12
    • 84937726700 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research. Cross discipline team leader review; Fingolimod, Application Number 22-527, Washington, DC
    • Center for Drug Evaluation and Research. Cross discipline team leader review; Fingolimod, Application Number 22-527, Washington, DC; 2010.
    • (2010)
  • 13
    • 33947376484 scopus 로고    scopus 로고
    • Oral-intravenous crossover study of fingolimod pharmacokinetics, lymphocyte responses and cardiac effects
    • Kovarik JM, Hartmann S, Bartlett M, et al., Oral-intravenous crossover study of fingolimod pharmacokinetics, lymphocyte responses and cardiac effects. Biopharm Drug Dispos. 2007; 28: 97-104.
    • (2007) Biopharm Drug Dispos. , vol.28 , pp. 97-104
    • Kovarik, J.M.1    Hartmann, S.2    Bartlett, M.3
  • 14
    • 84883324473 scopus 로고    scopus 로고
    • Use of a biomarker in exposure-response analysis to support dose selection for fingolimod
    • Lee JY, Wang Y., Use of a biomarker in exposure-response analysis to support dose selection for fingolimod. CPT Pharmacometrics Syst Pharmacol. 2013; 2: e67.
    • (2013) CPT Pharmacometrics Syst Pharmacol. , vol.2 , pp. e67
    • Lee, J.Y.1    Wang, Y.2
  • 15
    • 84937728298 scopus 로고    scopus 로고
    • ONO-4641, potent and selective sphingosine 1 phosphate receptor-1 and -5 agonist, requires less lymphopenia than fingolimod to be effective in a preclinical model of multiple sclerosis
    • (Suppl 1).
    • Savinainen A, El Bawab S, Crandall T, Chang R, Boschert U, Dellovade T,. ONO-4641, potent and selective sphingosine 1 phosphate receptor-1 and -5 agonist, requires less lymphopenia than fingolimod to be effective in a preclinical model of multiple sclerosis. Mult Scler J. 2013; 19 (Suppl 1): 235-236.
    • (2013) Mult Scler J. , vol.19 , pp. 235-236
    • Savinainen, A.1    El Bawab, S.2    Crandall, T.3    Chang, R.4    Boschert, U.5    Dellovade, T.6
  • 16
    • 33751085414 scopus 로고    scopus 로고
    • Rituximab reduces B cells and T cells in cerebrospinal fluid of multiple sclerosis patients
    • Cross AH, Stark JL, Lauber J, Ramsbottom MJ, Lyons JA., Rituximab reduces B cells and T cells in cerebrospinal fluid of multiple sclerosis patients. J Neuroimmunol. 2006; 180: 63-70.
    • (2006) J Neuroimmunol. , vol.180 , pp. 63-70
    • Cross, A.H.1    Stark, J.L.2    Lauber, J.3    Ramsbottom, M.J.4    Lyons, J.A.5
  • 17
    • 17644396349 scopus 로고    scopus 로고
    • Immunology of multiple sclerosis
    • Sospedra M, Martin R., Immunology of multiple sclerosis. Annu Rev Immunol. 2005; 23: 683-747.
    • (2005) Annu Rev Immunol. , vol.23 , pp. 683-747
    • Sospedra, M.1    Martin, R.2
  • 18
    • 84879288884 scopus 로고    scopus 로고
    • Targeting B cells in the treatment of multiple sclerosis: Recent advances and remaining challenges
    • Lehmann-Horn K, Kronsbein HC, Weber MS., Targeting B cells in the treatment of multiple sclerosis: recent advances and remaining challenges. Ther Adv Neurol Disord. 2013; 6: 161-173.
    • (2013) Ther Adv Neurol Disord. , vol.6 , pp. 161-173
    • Lehmann-Horn, K.1    Kronsbein, H.C.2    Weber, M.S.3
  • 19
    • 80855156707 scopus 로고    scopus 로고
    • Sequential desensitization of CXCR4 and S1P5 controls natural killer cell trafficking
    • Mayol K, Biajoux V, Marvel J, Balabanian K, Walzer T., Sequential desensitization of CXCR4 and S1P5 controls natural killer cell trafficking. Blood. 2011; 118: 4863-4871.
    • (2011) Blood. , vol.118 , pp. 4863-4871
    • Mayol, K.1    Biajoux, V.2    Marvel, J.3    Balabanian, K.4    Walzer, T.5
  • 20
    • 84897560960 scopus 로고    scopus 로고
    • Comprehensive immunophenotyping of cerebrospinal fluid cells in patients with neuroimmunological diseases
    • Han S, Lin YC, Wu T, et al., Comprehensive immunophenotyping of cerebrospinal fluid cells in patients with neuroimmunological diseases. J Immunol. 2014; 192: 2551-2563.
    • (2014) J Immunol. , vol.192 , pp. 2551-2563
    • Han, S.1    Lin, Y.C.2    Wu, T.3
  • 21
    • 0020625382 scopus 로고
    • Diurnal variation of lymphocyte subsets identified by monoclonal antibodies
    • Bertouch JV, Roberts-Thomson PJ, Bradley J., Diurnal variation of lymphocyte subsets identified by monoclonal antibodies. Br Med J (Clin Res Ed). 1983; 286: 1171-1172.
    • (1983) Br Med J (Clin Res Ed). , vol.286 , pp. 1171-1172
    • Bertouch, J.V.1    Roberts-Thomson, P.J.2    Bradley, J.3
  • 22
    • 84883062704 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of ponesimod, a selective S1P1 receptor modulator, in the first-in-human study
    • Brossard P, Derendorf, H, Xu, J, Maatouk, H, Halabi, A, Dingemanse, J., Pharmacokinetics and pharmacodynamics of ponesimod, a selective S1P1 receptor modulator, in the first-in-human study. Br J Clin Pharmacol. 2013; 76: 888-896.
    • (2013) Br J Clin Pharmacol. , vol.76 , pp. 888-896
    • Brossard P1    Derendorf, H.2    Xu, J.3    Maatouk, H.4    Halabi, A.5    Dingemanse, J.6
  • 23
    • 84895738813 scopus 로고    scopus 로고
    • Multiple-dose tolerability, pharmacokinetics, and pharmacodynamics of ponesimod, an S1P receptor modulator: Favorable impact of dose up-titration
    • Brossard P, Scherz M, Halabi A, Maatouk H, Krause A, Dingemanse J., Multiple-dose tolerability, pharmacokinetics, and pharmacodynamics of ponesimod, an S1P receptor modulator: favorable impact of dose up-titration. J Clin Pharmacol. 2014; 54: 179-188.
    • (2014) J Clin Pharmacol. , vol.54 , pp. 179-188
    • Brossard, P.1    Scherz, M.2    Halabi, A.3    Maatouk, H.4    Krause, A.5    Dingemanse, J.6
  • 24
    • 84880327078 scopus 로고    scopus 로고
    • Siponimod for patients with relapsing-remitting multiple sclerosis (BOLD): An adaptive, dose-ranging, randomised, phase 2 study
    • Selmaj K, Li DK, Hartung HP, et al., Siponimod for patients with relapsing-remitting multiple sclerosis (BOLD): an adaptive, dose-ranging, randomised, phase 2 study. Lancet Neurol. 2013; 12: 756-767.
    • (2013) Lancet Neurol. , vol.12 , pp. 756-767
    • Selmaj, K.1    Li, D.K.2    Hartung, H.P.3
  • 25
    • 84867319781 scopus 로고    scopus 로고
    • The selective sphingosine 1-phosphate receptor modulator BAF312 redirects lymphocyte distribution and has species-specific effects on heart rate
    • Gergely P, Nuesslein-Hildesheim B, Guerini D, et al., The selective sphingosine 1-phosphate receptor modulator BAF312 redirects lymphocyte distribution and has species-specific effects on heart rate. Br J Pharmacol. 2012; 167: 1035-47.
    • (2012) Br J Pharmacol. , vol.167 , pp. 1035-1047
    • Gergely, P.1    Nuesslein-Hildesheim, B.2    Guerini, D.3
  • 26
    • 84937733511 scopus 로고    scopus 로고
    • US Food and Drug Administration. Prescribing information (fingolimod). Washington, DC
    • US Food and Drug Administration. Prescribing information (fingolimod). Washington, DC; 2012.
    • (2012)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.