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Clinical Drug Investigation

, Volume 32, Issue 1, pp 15–27 | Cite as

Reduction in Healthcare and Societal Resource Utilization Associated with Cladribine Tablets in Patients with Relapsing-Remitting Multiple Sclerosis

Analysis of Economic Data from the CLARITY Study
  • Shehzad Ali
  • Noman ParachaEmail author
  • Stuart Cook
  • Gavin Giovannoni
  • Giancarlo Comi
  • Kottil Rammohan
  • Peter Rieckmann
  • Per Soelberg Sørensen
  • Patrick Vermersch
  • Steven Greenberg
  • David A. Scott
  • Alexandre Joyeux
Original Research Article

Abstract

Background: Multiple sclerosis (MS) is a common, chronic, neurodegenerative condition associated with substantial healthcare and societal economic burden. Disease-modifying MS treatments have the potential to reduce health resource utilization (HRU), thereby reducing the attendant socioeconomic burden.

Objective: This study aimed to compare health and societal resource use and productivity in patients with relapsing-remitting MS (RRMS) receiving cladribine tablets versus placebo over 96 weeks in the CLARITY study.

Methods: The CLARITY study was a 96-week, randomized, double-blind, placebo-controlled study in patients with RRMS. HRU data, societal resource use and productivity data were collected at baseline and during scheduled patient visits, at 6-month intervals. The recall period for the HRU questionnaire was 3 months. The study was carried out at 155 sites across 32 countries worldwide. The intent-to-treat population comprised 1326 patients with RRMS randomized to cladribine 3.5 mg/kg (n = 433) or 5.25 mg/kg (n = 456) tablets or placebo (n = 437). Patient subgroups with high baseline disease activity were identified based on criteria of ≥2 relapses in the previous year (n = 392); ≥1 T1 gadolinium-enhancing (Gd+) lesion (n = 413); and ≥2 relapses in the previous year plus ≥1 T1 Gd+ lesion (n= 138). Cladribine tablets were administered in two (3.5 mg/kg group) or four (5.25 mg/kg group) short courses given at 4-week intervals at the start of a 48-week treatment period, followed by another two courses at the start of a subsequent 48-week re-treatment period. Interferon-β rescue therapy was permitted from week 24. Intravenous corticosteroids were available for the treatment of neurological relapses. HRU outcomes included mean number of hospital days and emergency room (ER), clinic and home visits during each study period. Societal resource use and productivity outcomes included mean number of hours and days of paid assistance, mean patient and carer work days missed, and self-reported productivity.

Results: The mean number of hospital days per patient over 96 weeks was lower in the cladribine tablets groups (3.5 mg/kg group: −3.19 days; 5.25 mg/kg group: −1.54 days [both p<0.01]) versus placebo. Likewise the mean number of ER visits was lower in both cladribine tablet groups compared with placebo (3.5 mg/kg group: −0.09 visits; 5.25 mg/kg group: −0.11 visits [both p<0.01]), and the mean number of clinic visits was also lower in both cladribine tablet groups (3.5 mg/kg group: −0.68 visits; 5.25 mg/kg group: −0.66 visits [both p = 0.01]). Furthermore, treatment with cladribine tablets was associated with reduced mean numbers of missed work days for patients (3.5 mg/kg group: −2.42 days [p < 0.01]; 5.25 mg/kg group: −0.60 days [p = 0.50]). Corticosteroid use was lower amongst patients in the cladribine tablet groups than in the placebo group. The reduction in hospital days following treatment with cladribine tablets was also observed in patients with high disease activity at study baseline.

Conclusion: This study provides evidence that the efficacy of cladribine tablets observed during the CLARITY study was associated with a reduced consumption of healthcare resources and a decreased need for medical and societal support.

Keywords

Multiple Sclerosis Expand Disability Status Scale Emergency Room Visit Cladribine High Disease Activity 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

Funding for the study and manuscript: This study was supported by Merck Serono S.A. — Geneva, Switzerland, a branch of Merck Serono S.A., Coinsins, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany. Editorial assistance and medical writing support in the preparation of this manuscript was provided by Alex Millis of ACUMED®, Tytherington, UK, funded by Merck Serono.

Role of the sponsor: Merck Serono sponsored the conduct of the CLARITY study, which included collection of health resource utilization data. Merck Serono sponsored the independent health outcomes consultancy Oxford Outcomes Ltd to conduct an evaluation of CLARITY data on health resource utilization, including analysis, costing and interpretation of the data, as well as preparation, review and approval of the manuscript. Merck Serono contributed to the interpretation of the data, as well as to the preparation, review and approval of the manuscript.

Author conflicts of interests: Mr Paracha and Mr Scott are employees of Oxford Outcomes Ltd. Dr Ali was employed by Oxford Outcomes Ltd at the time the study was undertaken.

Professor Cook has received honoraria for lectures from Merck Serono and Bayer Healthcare; and consultation fees from Sanofi-Aventis, Bayer Healthcare, Merck Serono, Actinobac Scientific Inc and Biogen Idec. He has served on scientific advisory boards for Bayer Healthcare, Merck Serono, Actinobac Scientific Inc and Biogen Idec. He has received research grants for the BEYOND (Betaferon® Efficacy Yielding Outcomes of a New Dose) and BECOME (Betaseron vs Copaxone in MS with Triple-Dose Gadolinium and 3-T MRI Endpoints) studies from Bayer Healthcare and the CLARITY and CLARITY EXTENSION studies from Merck Serono.

Professor Giovannoni has received consulting fees for participating on advisory boards in relation to clinical trial design, trial steering committees and data and safety monitoring committees from Bayer Schering Healthcare, Biogen Idec, Elan, Five Prime Therapeutics, Genzyme, GlaxoSmithKline, GW Pharmaceuticals, Merck Serono, Novartis, Protein Discovery Laboratories, Teva-Aventis, UCB Pharma and Vertex Pharmaceuticals; lecture fees from Bayer Schering Healthcare, Biogen Idec, Genzyme, Merck Serono, Pfizer, Teva-Aventis and Vertex Pharmaceuticals; and grant support from Bayer Schering Healthcare, Biogen Idec, GW Pharmaceuticals, Ironwood Pharmaceuticals, Merck Serono, Merz, Novartis, Teva-Aventis and UCB Pharma.

Professor Comi has received consulting fees for participating on advisory boards in relation to clinical trial design, trial steering committees and data and safety monitoring committees from Novartis, Teva, Sanofi-Aventis, Merck Serono, and Bayer Schering; lecture fees from Novartis, Teva, Sanofi-Aventis, Merck Serono, Biogen Dompè, Bayer Schering and Serono Symposia International Foundation; and clinical trial grant support from Novartis, Teva, Sanofi-Aventis, Merck Serono, Biogen Dompè, and Bayer Schering.

Professor Rammohan has received consulting fees for speaker and consultancy activities from Bayer Pharmaceuticals, EMD Serono/Pfizer, Teva, Genentech, Biogen, Genzyme, Acorda, UCB Pharma and Novartis; lecture fees from Bayer, EMD Serono/Pfizer, Teva, Biogen, Genzyme, Acorda, and UCB Pharma; and clinical trial and investigator initiated research grant support from Bayer, EMD Serono/Pfizer, Teva, Acorda, Biogen, Genzyme, UCB Pharma and Novartis.

Professor Rieckmann has received consulting fees for speaker and consultancy activities from Merck Serono, Biogen Idec, Teva, Bayer and Novartis; lecture fees from Merck Serono, Biogen Idec and Teva; and grant support from Merck Serono, Bayer, Teva, the MS Society of Canada, and the Ilich Foundation.

Professor Soelberg Sørensen has received consulting fees for speaker and advisory board activities from Merck Serono, Biogen Idec, Elan, Teva, Bayer Schering, Genmab, Sanofi-Aventis and Novartis; lecture fees from Merck Serono, Biogen Idec, Sanofi-Aventis and Teva; and grant support from Biogen Idec, BioMS, Merck Serono, Teva, Sanofi-Aventis and Novartis.

Professor Vermersch has received consulting fees for speaker and advisory board activities from Merck Serono, Bayer Schering, Teva-Aventis, Biogen Idec and Novartis; lecture fees from Merck Serono, Biogen Idec, Bayer Schering and Novartis; and grant support from Biogen Idec, Merck Serono and Teva-Aventis.

Dr Greenberg was an employee of Merck Serono S.A. — Geneva, Switzerland, a branch of Merck Serono S.A. Coinsins, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany.

Dr Joyeux is an employee of Merck Serono S.A. — Geneva, Switzerland, a branch of Merck Serono S.A. Coinsins, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany.

Other significant contributors: The authors thank Eduardo Vianna (Merck Serono) for his assistance in facilitating the development of this manuscript.

Dr Ali and Mr Paracha contributed equally to this work. Other members of the CLARITY study group are as reported previously.[21]

Supplementary material

40261_2012_32010015_MOESM1_ESM.pdf (19 kb)
Supplementary material, approximately 20 KB.

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Copyright information

© Adis Data Information BV 2012

Authors and Affiliations

  • Shehzad Ali
    • 1
  • Noman Paracha
    • 1
    Email author
  • Stuart Cook
    • 2
  • Gavin Giovannoni
    • 3
  • Giancarlo Comi
    • 4
  • Kottil Rammohan
    • 5
  • Peter Rieckmann
    • 6
  • Per Soelberg Sørensen
    • 7
  • Patrick Vermersch
    • 8
  • Steven Greenberg
    • 9
  • David A. Scott
    • 1
  • Alexandre Joyeux
    • 9
  1. 1.Oxford Outcomes, Seacourt TowerOxfordUK
  2. 2.University of Medicine and Dentistry, New Jersey Medical SchoolNewarkUSA
  3. 3.Blizard Institute of Cell and Molecular ScienceBarts and The London School of Medicine and Dentistry, Queen Mary University LondonLondonUK
  4. 4.Department of Neurology and Institute of Experimental NeurologyUniversità Vita-Salute San RaffaeleMilanItaly
  5. 5.Multiple Sclerosis Center, Department of NeurologyUniversity of MiamiFLUSA
  6. 6.Bamberg Hospital and University of ErlangenBambergGermany
  7. 7.Copenhagen University HospitalRigshospitalet, CopenhagenDenmark
  8. 8.University of Lille - Nord de FranceLilleFrance
  9. 9.Merck Serono S.A.GenevaSwitzerland

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