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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

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
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

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.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00213135; EudraCT number: 2004-005148-28.

Cladribine/therapeutic use, Double-Blind Method, Health Care Rationing, Humans, Immunosuppressive Agents/therapeutic use, Multiple Sclerosis, Relapsing-Remitting/drug therapy, Placebos, Tablets
1173-2563
15-27
Ali, Shehzad
bf2b5300-97ba-4bf9-97d5-f11e29aae594
Paracha, Noman
7e6db99f-1943-4121-b74d-110f82ec843b
Cook, Stuart
2c9730f9-0c9b-4d81-a32b-2fa1180b8153
Giovannoni, Gavin
8453ec93-f894-42f1-a1e1-6fa85589a5d0
Comi, Giancarlo
ff7b57f3-fe70-4e28-b47f-b1ed92d2124c
Rammohan, Kottil
e7edad86-e393-43a3-b1b0-88a3eecbce61
Rieckmann, Peter
12084db0-b649-4d1b-818f-bccab9e93ef2
Sørensen, Per Soelberg
3aed6f93-8b42-45a6-9091-5b5d5d48e77d
Vermersch, Patrick
55298712-d4ac-4a79-bf91-0f2a2cea0ead
Greenberg, Steven
cfc6d52b-7b53-4ae1-9e1a-de7adb0bcf4a
Scott, David A
19b5fd34-9974-4ae4-8be0-27a693639e20
Joyeux, Alexandre
15167fc4-cf97-429c-975c-ec0bec084a54
CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) Study Group
Ali, Shehzad
bf2b5300-97ba-4bf9-97d5-f11e29aae594
Paracha, Noman
7e6db99f-1943-4121-b74d-110f82ec843b
Cook, Stuart
2c9730f9-0c9b-4d81-a32b-2fa1180b8153
Giovannoni, Gavin
8453ec93-f894-42f1-a1e1-6fa85589a5d0
Comi, Giancarlo
ff7b57f3-fe70-4e28-b47f-b1ed92d2124c
Rammohan, Kottil
e7edad86-e393-43a3-b1b0-88a3eecbce61
Rieckmann, Peter
12084db0-b649-4d1b-818f-bccab9e93ef2
Sørensen, Per Soelberg
3aed6f93-8b42-45a6-9091-5b5d5d48e77d
Vermersch, Patrick
55298712-d4ac-4a79-bf91-0f2a2cea0ead
Greenberg, Steven
cfc6d52b-7b53-4ae1-9e1a-de7adb0bcf4a
Scott, David A
19b5fd34-9974-4ae4-8be0-27a693639e20
Joyeux, Alexandre
15167fc4-cf97-429c-975c-ec0bec084a54

CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) Study Group (2012) 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. Clinical Drug Investigation, 32 (1), 15-27. (doi:10.2165/11593310-000000000-00000).

Record type: 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.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00213135; EudraCT number: 2004-005148-28.

Full text not available from this repository.

More information

Published date: 29 August 2012
Keywords: Cladribine/therapeutic use, Double-Blind Method, Health Care Rationing, Humans, Immunosuppressive Agents/therapeutic use, Multiple Sclerosis, Relapsing-Remitting/drug therapy, Placebos, Tablets

Identifiers

Local EPrints ID: 441413
URI: http://eprints.soton.ac.uk/id/eprint/441413
ISSN: 1173-2563
PURE UUID: b698cdbc-7c86-42b0-a910-f4f92502ae93
ORCID for David A Scott: ORCID iD orcid.org/0000-0001-6475-8046

Catalogue record

Date deposited: 11 Jun 2020 16:39
Last modified: 12 Jun 2020 00:47

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Contributors

Author: Shehzad Ali
Author: Noman Paracha
Author: Stuart Cook
Author: Gavin Giovannoni
Author: Giancarlo Comi
Author: Kottil Rammohan
Author: Peter Rieckmann
Author: Per Soelberg Sørensen
Author: Patrick Vermersch
Author: Steven Greenberg
Author: David A Scott ORCID iD
Author: Alexandre Joyeux
Corporate Author: CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) Study Group

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