Long-term disease stability assessed by the expanded disability status scale in patients treated with Cladribine tablets in the CLARITY and CLARITY extension studies
ECTRIMS Online Library. Giovannoni G. 279715; EP1573
Gavin Giovannoni
Gavin Giovannoni
Contributions
Abstract

Abstract: EP1573

Type:

Abstract Category: Therapy - Long-term treatment monitoring

G. Giovannoni1, G. Comi2, K. Rammohan3, P. Rieckmann4, P. Vermersch5, F. Dangond6, B. Keller7, D. Jack7

1Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, United Kingdom, 2Department of Neurology and Institute of Experimental Neurology, Università Vita-Salute San Raffaele, Ospedale San Raffaele, Milan, Italy, 3Department of Neurology, University of Miami School of Medicine, MS Research Center, Miami, FL, United States, 4Department of Neurology, Medical Park Loipl, and University of Erlangen, Erlangen, Germany, 5Univ. Lille, INSERM U995, CHU Lille, FHU Imminent, Lille, France, 6EMD Serono Research & Development Institute Inc., Billerica, MA, United States, 7Merck Healthcare KGaA, Darmstadt, Germany

Introduction: Treatment with Cladribine Tablets 10 mg (cumulative dose 3.5 mg/kg [CT3.5] over 2 years) in CLARITY and CLARITY Extension reduced relapse rate and slowed disability progression versus placebo in patients with relapsing-remitting multiple sclerosis (RRMS).
Objectives: The objective of this post hoc analysis was to evaluate long-term disease stability assessed by the Expanded Disability Status Scale (EDSS) after treatment with CT3.5 in patients with RRMS enrolled in CLARITY and CLARITY Extension.
Methods: Patients who were randomised to CT3.5 in CLARITY and then randomised to placebo in CLARITY Extension, with at least 1 post-baseline EDSS measurement were included (CP3.5; n=98). This analysis assessed EDSS score over-time (from CLARITY randomisation to end of follow-up in CLARITY Extension, including the bridging interval between studies), at 6-monthly intervals, and separately time to 3- and 6-month confirmed EDSS score progression from CLARITY baseline. EDSS score worsening or improvement in each year was defined as any increase or decrease, respectively, in minimum EDSS score at 6-monthly intervals; all other cases were classified as stable. An increase or decrease was defined as an EDSS score change of 1 point (baseline EDSS ≤4.5), 1.5 points (baseline EDSS 0) or 0.5 point (baseline EDSS ≥5.0).
Results: Five years after CLARITY baseline, median EDSS remained stable compared with baseline values. Median EDSS score (95% confidence interval [CI]) for patients in the CP3.5 group was 2.5 (2.0-3.5) compared with 3.0 (2.5-3.5) at baseline. In each 12-month period, EDSS score stability was observed in >50% of patients, EDSS improved in 21-30% of patients and EDSS worsened in 0-25%. During Year 5 in the CP3.5 group, EDSS stability was observed in 53.9% of patients, EDSS improvement in 21.3% and EDSS worsening in 24.7%. Less than 30% of patients reached 3- or 6-month confirmed EDSS progression by Year 5.
Conclusions: EDSS score was stable up to 5 years post-CLARITY baseline for the CP3.5 group. Between 20% and 30% of patients demonstrated improvement in EDSS score versus baseline each year.
The CLARITY Study: NCT00213135
The CLARITY Extension Study: NCT00641537
Disclosure: This study was sponsored by EMD Serono Inc, a business of Merck KGaA, Darmstadt, Germany (in the USA), and Merck Serono SA, Geneva, an affiliate of Merck KGaA Darmstadt, Germany (ROW).
GG has received speaker honoraria and consulting fees from Abbvie, Actelion, Atara Bio, Almirall, Bayer Schering Pharma, Biogen Idec, FivePrime, GlaxoSmithKline, GW Pharma, Merck & Co., Merck Healthcare KGaA, Pfizer Inc, Protein Discovery Laboratories, Teva Pharmaceutical Industries Ltd, Sanofi-Genzyme, UCB, Vertex Pharmaceuticals, Ironwood, and Novartis; and has received research support unrelated to this study from Biogen Idec, Merck & Co., Novartis, and Ironwood.
GC has received consulting fees from Novartis, Teva Pharmaceutical Industries Ltd., Sanofi-Aventis, Merck, Receptos, Biogen Idec, Genentech-Roche, and Bayer Schering; lecture fees from Novartis, Teva Pharmaceutical Ind. Ltd., Sanofi-Aventis, Merck, Biogen Dompè, Bayer Schering, and Serono Symposia International Foundation; and trial grant support from Novartis, Teva Pharmaceutical Ind. Ltd., Sanofi-Aventis, Receptos, Biogen Idec, Genentech-Roche, Merck, Biogen Dompè, and Bayer Schering.
KR has received honoraria for lectures and steering committee meetings from EMD Serono, Biogen Idec, Sanofi-Aventis, Genzyme, Novartis, Teva Neurosciences, Acorda and Roche/Genentech.
PR has received honoraria for lectures/steering committee meetings from Merck, Biogen Idec, Bayer Schering Pharma, Boehringer-Ingelheim, Sanofi-Aventis, Genzyme, Novartis, Teva Pharmaceutical Industries, and Serono Symposia International Foundation.
PV has received honoraria or consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Merck Healthcare KGaA, Celgene, Roche and Almirall; and research support from Biogen, Sanofi-Genzyme, Bayer, and Merck Healthcare KGaA.
FD is an employee of EMD Serono Research & Development Institute Inc., a business of Merck KGaA, Darmstadt, Germany.
BK is an employee of Merck Healthcare KGaA, Darmstadt, Germany.
DJ is an employee of Merck Healthcare KGaA, Darmstadt, Germany.

Abstract: EP1573

Type:

Abstract Category: Therapy - Long-term treatment monitoring

G. Giovannoni1, G. Comi2, K. Rammohan3, P. Rieckmann4, P. Vermersch5, F. Dangond6, B. Keller7, D. Jack7

1Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, United Kingdom, 2Department of Neurology and Institute of Experimental Neurology, Università Vita-Salute San Raffaele, Ospedale San Raffaele, Milan, Italy, 3Department of Neurology, University of Miami School of Medicine, MS Research Center, Miami, FL, United States, 4Department of Neurology, Medical Park Loipl, and University of Erlangen, Erlangen, Germany, 5Univ. Lille, INSERM U995, CHU Lille, FHU Imminent, Lille, France, 6EMD Serono Research & Development Institute Inc., Billerica, MA, United States, 7Merck Healthcare KGaA, Darmstadt, Germany

Introduction: Treatment with Cladribine Tablets 10 mg (cumulative dose 3.5 mg/kg [CT3.5] over 2 years) in CLARITY and CLARITY Extension reduced relapse rate and slowed disability progression versus placebo in patients with relapsing-remitting multiple sclerosis (RRMS).
Objectives: The objective of this post hoc analysis was to evaluate long-term disease stability assessed by the Expanded Disability Status Scale (EDSS) after treatment with CT3.5 in patients with RRMS enrolled in CLARITY and CLARITY Extension.
Methods: Patients who were randomised to CT3.5 in CLARITY and then randomised to placebo in CLARITY Extension, with at least 1 post-baseline EDSS measurement were included (CP3.5; n=98). This analysis assessed EDSS score over-time (from CLARITY randomisation to end of follow-up in CLARITY Extension, including the bridging interval between studies), at 6-monthly intervals, and separately time to 3- and 6-month confirmed EDSS score progression from CLARITY baseline. EDSS score worsening or improvement in each year was defined as any increase or decrease, respectively, in minimum EDSS score at 6-monthly intervals; all other cases were classified as stable. An increase or decrease was defined as an EDSS score change of 1 point (baseline EDSS ≤4.5), 1.5 points (baseline EDSS 0) or 0.5 point (baseline EDSS ≥5.0).
Results: Five years after CLARITY baseline, median EDSS remained stable compared with baseline values. Median EDSS score (95% confidence interval [CI]) for patients in the CP3.5 group was 2.5 (2.0-3.5) compared with 3.0 (2.5-3.5) at baseline. In each 12-month period, EDSS score stability was observed in >50% of patients, EDSS improved in 21-30% of patients and EDSS worsened in 0-25%. During Year 5 in the CP3.5 group, EDSS stability was observed in 53.9% of patients, EDSS improvement in 21.3% and EDSS worsening in 24.7%. Less than 30% of patients reached 3- or 6-month confirmed EDSS progression by Year 5.
Conclusions: EDSS score was stable up to 5 years post-CLARITY baseline for the CP3.5 group. Between 20% and 30% of patients demonstrated improvement in EDSS score versus baseline each year.
The CLARITY Study: NCT00213135
The CLARITY Extension Study: NCT00641537
Disclosure: This study was sponsored by EMD Serono Inc, a business of Merck KGaA, Darmstadt, Germany (in the USA), and Merck Serono SA, Geneva, an affiliate of Merck KGaA Darmstadt, Germany (ROW).
GG has received speaker honoraria and consulting fees from Abbvie, Actelion, Atara Bio, Almirall, Bayer Schering Pharma, Biogen Idec, FivePrime, GlaxoSmithKline, GW Pharma, Merck & Co., Merck Healthcare KGaA, Pfizer Inc, Protein Discovery Laboratories, Teva Pharmaceutical Industries Ltd, Sanofi-Genzyme, UCB, Vertex Pharmaceuticals, Ironwood, and Novartis; and has received research support unrelated to this study from Biogen Idec, Merck & Co., Novartis, and Ironwood.
GC has received consulting fees from Novartis, Teva Pharmaceutical Industries Ltd., Sanofi-Aventis, Merck, Receptos, Biogen Idec, Genentech-Roche, and Bayer Schering; lecture fees from Novartis, Teva Pharmaceutical Ind. Ltd., Sanofi-Aventis, Merck, Biogen Dompè, Bayer Schering, and Serono Symposia International Foundation; and trial grant support from Novartis, Teva Pharmaceutical Ind. Ltd., Sanofi-Aventis, Receptos, Biogen Idec, Genentech-Roche, Merck, Biogen Dompè, and Bayer Schering.
KR has received honoraria for lectures and steering committee meetings from EMD Serono, Biogen Idec, Sanofi-Aventis, Genzyme, Novartis, Teva Neurosciences, Acorda and Roche/Genentech.
PR has received honoraria for lectures/steering committee meetings from Merck, Biogen Idec, Bayer Schering Pharma, Boehringer-Ingelheim, Sanofi-Aventis, Genzyme, Novartis, Teva Pharmaceutical Industries, and Serono Symposia International Foundation.
PV has received honoraria or consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Merck Healthcare KGaA, Celgene, Roche and Almirall; and research support from Biogen, Sanofi-Genzyme, Bayer, and Merck Healthcare KGaA.
FD is an employee of EMD Serono Research & Development Institute Inc., a business of Merck KGaA, Darmstadt, Germany.
BK is an employee of Merck Healthcare KGaA, Darmstadt, Germany.
DJ is an employee of Merck Healthcare KGaA, Darmstadt, Germany.

By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS).

Cookie Settings
Accept Terms & all Cookies