Real-world treatment patterns and effectiveness of cladribine tablets in patients with relapsing forms of multiple sclerosis in the United States

Mult Scler Relat Disord. 2023 Nov:79:105052. doi: 10.1016/j.msard.2023.105052. Epub 2023 Oct 6.

Abstract

Background: Real-world evidence on the use of cladribine tablets (CladT) for relapsing forms of multiple sclerosis (RMS) in the United States is emerging. The objective of this study was to assess the real-world treatment patterns and effectiveness of CladT in RMS.

Methods: Adults with RMS initiating CladT were selected from the Symphony Integrated Dataverse. Baseline and follow-up periods were the 12 months before and 24 months after CladT initiation (index date). Switching to another disease-modifying therapy (DMT) and number of CladT courses were described during follow-up. Annualized relapse rate (ARR), MS disease severity, Expanded Disability Status Scale-Derived Disability Indicators (EDSS-DDI), corticosteroid use, and healthcare resource utilization (HRU) were described during Years 1 and 2 of follow-up and compared with baseline.

Results: A total of 539 CladT-treated patients were included (mean age: 49.9 years; 77.6 % female). Over the 2-year follow-up, 91 % and 59 % of patients had one and two CladT courses, respectively, and 7 % of patients had evidence of switching to another DMT. ARR, MS disease severity score, and corticosteroid use decreased significantly during follow-up compared with baseline, while EDSS-DDI remained stable. All-cause and MS-related HRU decreased during follow-up.

Conclusion: CladT-treated patients with RMS had low switch rates, reduced ARR, disease severity, corticosteroid use, and HRU.

Keywords: Cladribine tablets; Disability; Healthcare resource utilization; Multiple sclerosis; Relapse; Treatment pattern.

MeSH terms

  • Adrenal Cortex Hormones
  • Adult
  • Cladribine / adverse effects
  • Female
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Male
  • Middle Aged
  • Multiple Sclerosis* / chemically induced
  • Multiple Sclerosis, Relapsing-Remitting* / chemically induced
  • Multiple Sclerosis, Relapsing-Remitting* / drug therapy
  • Recurrence
  • Tablets
  • United States

Substances

  • Cladribine
  • Tablets
  • Adrenal Cortex Hormones
  • Immunosuppressive Agents