Contributions
Abstract: P621
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: In 2011, 144 patients with multiple sclerosis (MS) were treated with cladribine through the Australian patient familiarisation program (PFP).
Objective: To characterise the Australian MSBase cladribine cohort.
Methods: Longitudinal data from 90 patients who received oral cladribine (1mg per kg, initial treatment consisting of 2 courses completed in 2 weeks) were captured in MSBase, including 66 patients with disability information before and after cladribine. Descriptive evaluation of the demographic and clinical information was carried out.
Results: Characteristics of the MSBase cladribine PFP cohort: 72% female, mean age 47 years (SD 12), mean MS duration 13 years (SD 9), 77% relapsing-remitting, 20% secondary progressive and 3% active primary progressive MS, median baseline EDSS 5 (quartiles 3-6), EDSS trajectory +0.3 step per year (quartiles 0.2-0.6) and annualised relapse rate 1 (quartiles 0.5-1.9). In 62 (69%) patients exposure to another disease modifying therapy (DMT) was recorded after cladribine, including 16 patients treated within a year of commencing cladribine. Most commonly, these included fingolimod (42%), dimethyl fumarate (23%) and natalizumab (15%). Seventeen patients experienced relapses prior to starting the subsequent DMT.
Mean on-cladribine relapse rate reached 0.6-0.75 per year (quartiles 0-1). Median time to the first post-cladribine relapse was 3.3 years. The proportions of patients reaching 6-month confirmed EDSS progression were 12% and 20% at years 1 and 2, respectively. EDSS trajectory post-cladribine was increasing at +0.1 step per year (quartiles 0-0.2). In contrast to the pre-cladribine EDSS trajectory, the post-cladribine trajetory stabilised for approximately 18 months, after which the EDSS has resumed its ascending trajectory.
Nineteen adverse events (of which 6 were reported as unrelated to cladribine) were recorded in 15 patients (17%). These included moderate cephalalgia that was likely retated to cladribine, and severe gastrointestinal symptoms and moderate arterial hypertension in which the relationship to cladribine was not suggested. During the treatment with the subsequent DMTs, 12 adverse events in 10 (11%) patients were recorded. It should be noted that the records of adverse events in MSBase are likely to be incomplete.
Conclusion: The Australian cladrbine PFP suggested temporary amelioration of disability accrual in a cohort that was enriched for patients with progressive MS forms.
Disclosure: The study was supported by Merck.
Tomas Kalincik served on scientific advisory boards for Roche, Genzyme, Novartis, Merck and Biogen, has received conference travel support and/or speaker honoraria from WebMD Global, Novartis, Biogen, Sanofi, Genzyme, Teva, BioCSL and Merck and has received research support from Biogen.
Nathaniel Lizak did not disclose any conflict of interests.
Vilija Jokubaitis received conference travel support from Novartis and Merck Serono.
Ernest Butler did not disclose any conflict of interests.
Jeannette Lechner-Scott accepted travel compensation from Novartis, Biogen and Merck Serono. Her institution receives the honoraria for talks and advisory board commitment and also clinic support from Bayer Health Care, Biogen, CSL, Genzyme Sanofi, Merck Serono, Novartis and Teva.
Mark Slee has participated in, but not received honoraria for, advisory board activity for Biogen, Merck Serono, Bayer Schering, Sanofi Aventis and Novartis.
Pamela McCombe did not disclose any conflict of interests.
Cameron Shaw received travel assistance from Biogen and Novartis.
Olga Skibina did not disclose any conflict of interests.
Steve Vucic did not disclose any conflict of interests.
Neil Shuey received travel compensation from Bayer Schering, Novartis, and Biogen Idec.
Michael Barnett served on scientific advisory boards for Biogen, Novartis and Genzyme and has received conference travel support from Biogen and Novartis. He serves on steering committees for trials conducted by Novartis. His institution has received research support from Biogen, Merck-Serono and Novartis.
John Parratt did not disclose any conflict of interests.
Helmut Butzkueven served on scientific advisory boards for Biogen, Novartis and Sanofi-Aventis and has received conference travel support from Novartis, Biogen and Sanofi Aventis. He serves on steering committees for trials conducted by Biogen and Novartis, and has received research support from Merck Serono, Novartis and Biogen.
Abstract: P621
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: In 2011, 144 patients with multiple sclerosis (MS) were treated with cladribine through the Australian patient familiarisation program (PFP).
Objective: To characterise the Australian MSBase cladribine cohort.
Methods: Longitudinal data from 90 patients who received oral cladribine (1mg per kg, initial treatment consisting of 2 courses completed in 2 weeks) were captured in MSBase, including 66 patients with disability information before and after cladribine. Descriptive evaluation of the demographic and clinical information was carried out.
Results: Characteristics of the MSBase cladribine PFP cohort: 72% female, mean age 47 years (SD 12), mean MS duration 13 years (SD 9), 77% relapsing-remitting, 20% secondary progressive and 3% active primary progressive MS, median baseline EDSS 5 (quartiles 3-6), EDSS trajectory +0.3 step per year (quartiles 0.2-0.6) and annualised relapse rate 1 (quartiles 0.5-1.9). In 62 (69%) patients exposure to another disease modifying therapy (DMT) was recorded after cladribine, including 16 patients treated within a year of commencing cladribine. Most commonly, these included fingolimod (42%), dimethyl fumarate (23%) and natalizumab (15%). Seventeen patients experienced relapses prior to starting the subsequent DMT.
Mean on-cladribine relapse rate reached 0.6-0.75 per year (quartiles 0-1). Median time to the first post-cladribine relapse was 3.3 years. The proportions of patients reaching 6-month confirmed EDSS progression were 12% and 20% at years 1 and 2, respectively. EDSS trajectory post-cladribine was increasing at +0.1 step per year (quartiles 0-0.2). In contrast to the pre-cladribine EDSS trajectory, the post-cladribine trajetory stabilised for approximately 18 months, after which the EDSS has resumed its ascending trajectory.
Nineteen adverse events (of which 6 were reported as unrelated to cladribine) were recorded in 15 patients (17%). These included moderate cephalalgia that was likely retated to cladribine, and severe gastrointestinal symptoms and moderate arterial hypertension in which the relationship to cladribine was not suggested. During the treatment with the subsequent DMTs, 12 adverse events in 10 (11%) patients were recorded. It should be noted that the records of adverse events in MSBase are likely to be incomplete.
Conclusion: The Australian cladrbine PFP suggested temporary amelioration of disability accrual in a cohort that was enriched for patients with progressive MS forms.
Disclosure: The study was supported by Merck.
Tomas Kalincik served on scientific advisory boards for Roche, Genzyme, Novartis, Merck and Biogen, has received conference travel support and/or speaker honoraria from WebMD Global, Novartis, Biogen, Sanofi, Genzyme, Teva, BioCSL and Merck and has received research support from Biogen.
Nathaniel Lizak did not disclose any conflict of interests.
Vilija Jokubaitis received conference travel support from Novartis and Merck Serono.
Ernest Butler did not disclose any conflict of interests.
Jeannette Lechner-Scott accepted travel compensation from Novartis, Biogen and Merck Serono. Her institution receives the honoraria for talks and advisory board commitment and also clinic support from Bayer Health Care, Biogen, CSL, Genzyme Sanofi, Merck Serono, Novartis and Teva.
Mark Slee has participated in, but not received honoraria for, advisory board activity for Biogen, Merck Serono, Bayer Schering, Sanofi Aventis and Novartis.
Pamela McCombe did not disclose any conflict of interests.
Cameron Shaw received travel assistance from Biogen and Novartis.
Olga Skibina did not disclose any conflict of interests.
Steve Vucic did not disclose any conflict of interests.
Neil Shuey received travel compensation from Bayer Schering, Novartis, and Biogen Idec.
Michael Barnett served on scientific advisory boards for Biogen, Novartis and Genzyme and has received conference travel support from Biogen and Novartis. He serves on steering committees for trials conducted by Novartis. His institution has received research support from Biogen, Merck-Serono and Novartis.
John Parratt did not disclose any conflict of interests.
Helmut Butzkueven served on scientific advisory boards for Biogen, Novartis and Sanofi-Aventis and has received conference travel support from Novartis, Biogen and Sanofi Aventis. He serves on steering committees for trials conducted by Biogen and Novartis, and has received research support from Merck Serono, Novartis and Biogen.