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Neurology

The CLARION study design and status update: a long-term, registry-based study evaluating adverse events of special interest in patients with relapsing multiple sclerosis newly started on cladribine tablets

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Pages 1167-1176 | Received 07 Jan 2022, Accepted 28 Mar 2022, Published online: 28 Apr 2022

References

  • Dirks P, Zingler V, Leemhuis J, et al. Design of a non-interventional post-marketing study to assess the long-term safety and effectiveness of ocrelizumab in German real world multiple sclerosis cohorts - the CONFIDENCE study protocol. BMC Neurol. 2020;20(1):95.
  • Butzkueven H, Kappos L, Wiendl H, et al. Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP). J Neurol Neurosurg Psychiatry. 2020;91(6):660–668.
  • Chisari CG, Toscano S, D’Amico E, et al. An update on the safety of treating relapsing-remitting multiple sclerosis. Expert Opin Drug Saf. 2019;18(10):925–948.
  • European Medicines Agency. Use of disease registries for benefit-risk evaluation of medicines: a regulatory perspective 2018. Available from: www.ema.europa.eu/en/documents/presentation/presentation-registry-initiative-april-2018_en.pdf.
  • Hillert J, Trojano M, Vukusic S, et al. Big multiple sclerosis data – a registry basis for post authorization safety studies (PASS) for multiple sclerosis [P1381]. Mult Scler. 2019;25(2 suppl):761–762.
  • Baker D, Pryce G, Herrod SS, et al. Potential mechanisms of action related to the efficacy and safety of cladribine. Mult Scler Relat Disord. 2019;30:176–186.
  • Comi G, Cook S, Giovannoni G, et al. Effect of cladribine tablets on lymphocyte reduction and repopulation dynamics in patients with relapsing multiple sclerosis. Mult Scler Relat Disord. 2019;29:168–174.
  • Stuve O, Soelberg Soerensen P, Leist T, et al. Effects of cladribine tablets on lymphocyte subsets in patients with multiple sclerosis: an extended analysis of surface markers. Ther Adv Neurol Disord. 2019;12:1756286419854986.
  • Cook S, Leist T, Comi G, et al. Safety of cladribine tablets in the treatment of patients with multiple sclerosis: an integrated analysis. Mult Scler Relat Disord. 2019;29:157–167.
  • Leist T, Cook S, Comi G, et al. Long-term safety data from the cladribine tablets clinical development program in multiple sclerosis. Mult Scler Relat Disord. 2020;46:102572.
  • European Medicines Agency. Guideline on Risk Management Systems for Medicinal Products for Human Use [EMEA/CHMP/96268/2005] 2005. [Feb 2021]. Available from: https://www.pharmacoepi.org/pub/?id=1c2a4382-2354-d714-51bd-b9fdecdb3d0c.
  • European Network of Centres for Pharmacoepidemiology and Pharmacovigilance registration number, EUPAS24484 Available from: www.encepp.eu/encepp/viewResource.htm?id=28797.
  • Hillert J, Butzkueven B, Soilu-Hänninen M, et al. Incidence of infections and severe lymphopenia in patients newly initiating cladribine tablets or fingolimod for treatment of multiple sclerosis: CLARION study [P742]. Mult Scler. 2021;27(2 suppl):622–623.
  • Wormser D, Evershed J, Ferreira G, et al. VERISMO: a post-marketing safety study to determine the incidence of all malignancies and breast cancer in patients with multiple sclerosis treated with ocrelizumab (P4.2-043). Neurology. 2019;92(15 Supplement):P4.2–043.
  • Flachenecker P, Buckow K, Pugliatti M, et al. Multiple sclerosis registries in Europe - results of a systematic survey. Mult Scler. 2014;20(11):1523–1532.
  • Myhr KM, Grytten N, Torkildsen Ø, et al. The Norwegian Multiple Sclerosis Registry and Biobank. Acta Neurol Scand. 2015;132(199):24–28.
  • Hillert J, Stawiarz L. The Swedish MS registry – clinical support tool and scientific resource. Acta Neurol Scand. 2015;132(199):11–19.
  • Persson R, Lee S, Yood MU, et al. Multi-database study of multiple sclerosis: Identification, validation and description of MS patients in two countries. J Neurol. 2019;266(5):1095–1106.
  • Pukkala E, Engholm G, Højsgaard Schmidt LK, et al. Nordic cancer registries - an overview of their procedures and data comparability. Acta Oncol. 2018;57(4):440–455.
  • Leinonen MK, Miettinen J, Heikkinen S, et al. Quality measures of the population-based Finnish Cancer Registry indicate sound data quality for solid malignant tumours. Eur J Cancer. 2017;77:31–39.
  • Maret-Ouda J, Tao W, Wahlin K, et al. Nordic registry-based cohort studies: possibilities and pitfalls when combining Nordic registry data. Scand J Public Health. 2017;45(17_suppl):14–19.
  • Magyari M, Moore N, Wergeland S, et al. Novel use of harmonized data quality indicators in long-term safety studies using multiple sclerosis registries: approach in CLARION study. ICPE. 2021; 23–25 August.
  • Giovannoni G, Comi G, Cook S, et al. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):416–426.
  • Leist TP, Comi G, Cree BA, et al. Effect of oral cladribine on time to conversion to clinically definite multiple sclerosis in patients with a first demyelinating event (ORACLE MS): a phase 3 randomised trial. Lancet Neurol. 2014;13(3):257–267.
  • Freedman MS, Leist TP, Comi G, et al. The efficacy of cladribine tablets in CIS patients retrospectively assigned the diagnosis of MS using modern criteria: Results from the ORACLE-MS study. Mult Scler J Exp Transl Clin. 2017;3(4):2055217317732802.
  • Montalban X, Leist TP, Cohen BA, et al. Cladribine tablets added to IFN-beta in active relapsing MS: the ONWARD study. Neurol Neuroimmunol Neuroinflamm. 2018;5(5):e477.
  • Giovannoni G, Soelberg Sorensen P, Cook S, et al. Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study. Mult Scler. 2018;24(12):1594–1604.
  • Moccia M, Lanzillo R, Petruzzo M, et al. Single-center 8-years clinical follow-up of cladribine-treated patients from phase 2 and 3 trials. Front Neurol. 2020;11:489.
  • Disanto G, Moccia M, Sacco R, et al. Monitoring of safety and effectiveness of cladribine in multiple sclerosis patients over 50 years. Mult Scler Relat Disord. 2022;58:103490.
  • Walton C, King R, Rechtman L, et al. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler. 2020;26(14):1816–1821.
  • Strom BL, editor. Pharmacoepidemiology. 4th ed. Chichester (UK): John Wiley & Sons Ltd; 2006.