Long-term effectiveness in patients previously enrolled in the Cladribine Tablets pivotal trials: a real-world evidence analysis using data from the Italian multiple sclerosis registry (CLARINET-MS)
ECTRIMS Online Library. Patti F. 09/11/19; 278977; P617
Francesco Patti
Francesco Patti
Contributions
Abstract

Abstract: P617

Type: Poster Sessions

Abstract Category: Therapy - Immunomodulation/Immunosuppression

F. Patti1, A. Visconti2, A. Capacchione2, M. Trojano3, CLARINET-MS Study Group

1Azienda Ospedaliera-Universitaria, Policlinico Vittorio Emanuele, Catania, 2Medical Affair Department, Merck Serono S.p.A., Rome, 3Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy

Introduction: Continuous collection of real-world clinical data from patients with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS, including secondary progressive multiple sclerosis [SPMS] with superimposed relapses) treated with Cladribine Tablets in the clinical development programme allows for investigation of long-term efficacy, extending beyond the trials.
Objectives: To assess the time-to-treatment change in clinical practice as a surrogate marker for long-term effectiveness of Cladribine Tablets in patients with CIS or RMS, following use of the drug in clinical studies.
Methods: CLARINET-MS is an ongoing non-interventional, retrospective exploratory investigation of data available in the Italian MS Registry, from a cohort of patients with multiple sclerosis (MS) who participated in the Cladribine Tablets clinical development programme (ONWARD, CLARITY, CLARITY Extension and ORACLE-MS). Data are descriptive, with no formal comparison with other treatments. The planned analyses will include patients who received at least a single dose (two doses investigated) of cladribine previously, and outcome events collected during the observational period in the Registry, from the last day of the randomised controlled trial (RCT) + 1 day, or the first visit after RCT completion, ending at the last visit or treatment switch.
Results: Preliminary aggregate data are reported for 120 patients who received at least a single dose of study treatment in the previously completed studies and registered in CLARINET-MS study (26 Italian MS centres); 59% of patients were female. At baseline visit, the median age and years since MS diagnosis of the patients were 39 and 5 years, respectively. Median baseline expanded disability status scale (EDSS) was 2.0 (interquartile range 1-3) with recorded EDSS≥ 6.0 in 2.5% patients. The median follow-up period for the patients in the Registry was 90 months (108 months total). At 60 months, approximately 38% of patients had received no further treatment. Of 72 patients who received disease modifying treatment (DMT) in the follow-up, almost half (49%) received interferon.
Conclusions: Patients participating in the phase 2 and 3 studies with Cladribine Tablets in RMS were followed up for 9 years in the CLARINET-MS study. The most common DMT received during the follow-up was interferon-beta.
CLARINET-MS: MS700568-0027
Disclosure: This study was sponsored by Merck Serono S p.A. Italy, an affiliate of Merck Healthcare KGaA Darmstadt, Germany
FP has served on scientific Advisory Boards for Almirall, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi and TEVA; he also received speaker honoraria from the same companies and research grants for his department by Biogen and Merck.
AV is an employee of Merck Serono S.p.A., an affiliate of Merck Healthcare KGaA, Darmstadt, Germany.
AC is an employee of Merck Serono S.p.A., an affiliate of Merck Healthcare KGaA, Darmstadt, Germany.
MT has served on scientific Advisory Boards for Biogen, Novartis, Roche and Genzyme; has received speaker honoraria from Biogen Idec, Merck Serono, Roche, Teva, Sanofi-Genzyme and Novartis; and has received research grants for her Institution from Biogen Idec, Merck Serono, Roche and Novartis.

Abstract: P617

Type: Poster Sessions

Abstract Category: Therapy - Immunomodulation/Immunosuppression

F. Patti1, A. Visconti2, A. Capacchione2, M. Trojano3, CLARINET-MS Study Group

1Azienda Ospedaliera-Universitaria, Policlinico Vittorio Emanuele, Catania, 2Medical Affair Department, Merck Serono S.p.A., Rome, 3Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy

Introduction: Continuous collection of real-world clinical data from patients with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS, including secondary progressive multiple sclerosis [SPMS] with superimposed relapses) treated with Cladribine Tablets in the clinical development programme allows for investigation of long-term efficacy, extending beyond the trials.
Objectives: To assess the time-to-treatment change in clinical practice as a surrogate marker for long-term effectiveness of Cladribine Tablets in patients with CIS or RMS, following use of the drug in clinical studies.
Methods: CLARINET-MS is an ongoing non-interventional, retrospective exploratory investigation of data available in the Italian MS Registry, from a cohort of patients with multiple sclerosis (MS) who participated in the Cladribine Tablets clinical development programme (ONWARD, CLARITY, CLARITY Extension and ORACLE-MS). Data are descriptive, with no formal comparison with other treatments. The planned analyses will include patients who received at least a single dose (two doses investigated) of cladribine previously, and outcome events collected during the observational period in the Registry, from the last day of the randomised controlled trial (RCT) + 1 day, or the first visit after RCT completion, ending at the last visit or treatment switch.
Results: Preliminary aggregate data are reported for 120 patients who received at least a single dose of study treatment in the previously completed studies and registered in CLARINET-MS study (26 Italian MS centres); 59% of patients were female. At baseline visit, the median age and years since MS diagnosis of the patients were 39 and 5 years, respectively. Median baseline expanded disability status scale (EDSS) was 2.0 (interquartile range 1-3) with recorded EDSS≥ 6.0 in 2.5% patients. The median follow-up period for the patients in the Registry was 90 months (108 months total). At 60 months, approximately 38% of patients had received no further treatment. Of 72 patients who received disease modifying treatment (DMT) in the follow-up, almost half (49%) received interferon.
Conclusions: Patients participating in the phase 2 and 3 studies with Cladribine Tablets in RMS were followed up for 9 years in the CLARINET-MS study. The most common DMT received during the follow-up was interferon-beta.
CLARINET-MS: MS700568-0027
Disclosure: This study was sponsored by Merck Serono S p.A. Italy, an affiliate of Merck Healthcare KGaA Darmstadt, Germany
FP has served on scientific Advisory Boards for Almirall, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi and TEVA; he also received speaker honoraria from the same companies and research grants for his department by Biogen and Merck.
AV is an employee of Merck Serono S.p.A., an affiliate of Merck Healthcare KGaA, Darmstadt, Germany.
AC is an employee of Merck Serono S.p.A., an affiliate of Merck Healthcare KGaA, Darmstadt, Germany.
MT has served on scientific Advisory Boards for Biogen, Novartis, Roche and Genzyme; has received speaker honoraria from Biogen Idec, Merck Serono, Roche, Teva, Sanofi-Genzyme and Novartis; and has received research grants for her Institution from Biogen Idec, Merck Serono, Roche and Novartis.

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