Contributions
Abstract: P601
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Young patients with relapsing MS (RMS) have higher disease activity compared with the adult RMS population. In clinical settings, fingolimod (FTY) 0.5mg significantly improved clinical and radiological outcomes in young patients compared with placebo and interferon β-1a. However, real-world evidence of FTY in young patients with RMS is limited.
Objectives: To describe baseline (BL) characteristics and evaluate the effect of FTY 0.5mg on disease activity in young versus older patients with RMS from pooled global Phase IV studies: TRANSITION, PASSAGE US, PASSAGE Europe & Rest of the World, and Cardiac sub-study PASSAGE EU.
Methods: Patients with RMS from Phase IV studies treated with FTY 0.5mg were included in the analysis, stratified by age: 18−25 years (youngest), 26−30 years (younger) and >30 years (older). EDSS change from BL to Month (M) 12 and M24 was analysed. On study annualised relapse rate (ARR) reduction compared to estimated ARR in 2 years prior and time to 6-month confirmed disability progression (6m-CDP− defined as 6 months of confirmed EDSS worsening by ≥1.5/≥1/≥0.5 if BL EDSS=0/1−5/>5, respectively) were retrospectively analysed up to M36. Negative binomial (ARR) and Cox (6m-CDP) regression models were used and p-values derived using the Wilcoxon rank sum test.
Results: Of the 5240 patients included, 7.6% were youngest, 11.0% younger, and 81.3% older with a mean (±SD) age of 22.6 (±2.06), 28.1 (±1.41) and 43.8 (±8.49) years, respectively. At BL, youngest and younger patients (vs older patients) had significantly lower mean disease duration (4.1 and 5.7 years vs 11.5 years, p< 0.0001 for both), higher number of relapses in the previous 2 years (2.0 and 2.0 vs 1.7, p< 0.0001 for both) and lower median EDSS scores (1.5 and 2.0 vs 3.0, p< 0.0001 for both). The effect of FTY 0.5mg on ARR was observed across the age groups with 67%, 75% and 76% reductions in youngest, younger and older patients, respectively. Change in EDSS from BL to M24 was similar in the youngest (p=0.1785) but improved in the younger (p< 0.0001) patients versus older patients. No significant difference was observed in the proportion of patients with time to 6m-CDP in youngest and younger patients versus older patients.
Conclusions: At BL, young patients had shorter disease duration, a higher number of relapses in the previous 2 years and lower EDSS scores versus older patients. The beneficial effect of FTY on clinical outcomes was observed across the age groups.
Disclosure: This study was funded by Novartis Pharma AG, Basel, Switzerland.
Tanuja Chitnis has received personal compensation for advisory boards/consulting from Biogen Idec and Novartis Pharmaceuticals, and financial support for research activities from Merck Serono and Novartis Pharmaceuticals.
Angelo Ghezzi has received honoraria for speaking from Bayer Schering, Biogen Idec, Merck Serono, Novartis, and Sanofi Aventis; and for consultancy from Merck Serono, Biogen Idec, Teva and Novartis.
Daniela Pohl has received personal compensation for activities with Bayer Schering, Biogen Idec, Merck Serono, Novartis Pharmaceuticals and Teva.
Rolf Meinert has nothing to disclose.
Gustavo Seifer, Annik K. Laflamme and Dieter A. Häring are employees of Novartis Pharma AG, Basel, Switzerland.
Abstract: P601
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Young patients with relapsing MS (RMS) have higher disease activity compared with the adult RMS population. In clinical settings, fingolimod (FTY) 0.5mg significantly improved clinical and radiological outcomes in young patients compared with placebo and interferon β-1a. However, real-world evidence of FTY in young patients with RMS is limited.
Objectives: To describe baseline (BL) characteristics and evaluate the effect of FTY 0.5mg on disease activity in young versus older patients with RMS from pooled global Phase IV studies: TRANSITION, PASSAGE US, PASSAGE Europe & Rest of the World, and Cardiac sub-study PASSAGE EU.
Methods: Patients with RMS from Phase IV studies treated with FTY 0.5mg were included in the analysis, stratified by age: 18−25 years (youngest), 26−30 years (younger) and >30 years (older). EDSS change from BL to Month (M) 12 and M24 was analysed. On study annualised relapse rate (ARR) reduction compared to estimated ARR in 2 years prior and time to 6-month confirmed disability progression (6m-CDP− defined as 6 months of confirmed EDSS worsening by ≥1.5/≥1/≥0.5 if BL EDSS=0/1−5/>5, respectively) were retrospectively analysed up to M36. Negative binomial (ARR) and Cox (6m-CDP) regression models were used and p-values derived using the Wilcoxon rank sum test.
Results: Of the 5240 patients included, 7.6% were youngest, 11.0% younger, and 81.3% older with a mean (±SD) age of 22.6 (±2.06), 28.1 (±1.41) and 43.8 (±8.49) years, respectively. At BL, youngest and younger patients (vs older patients) had significantly lower mean disease duration (4.1 and 5.7 years vs 11.5 years, p< 0.0001 for both), higher number of relapses in the previous 2 years (2.0 and 2.0 vs 1.7, p< 0.0001 for both) and lower median EDSS scores (1.5 and 2.0 vs 3.0, p< 0.0001 for both). The effect of FTY 0.5mg on ARR was observed across the age groups with 67%, 75% and 76% reductions in youngest, younger and older patients, respectively. Change in EDSS from BL to M24 was similar in the youngest (p=0.1785) but improved in the younger (p< 0.0001) patients versus older patients. No significant difference was observed in the proportion of patients with time to 6m-CDP in youngest and younger patients versus older patients.
Conclusions: At BL, young patients had shorter disease duration, a higher number of relapses in the previous 2 years and lower EDSS scores versus older patients. The beneficial effect of FTY on clinical outcomes was observed across the age groups.
Disclosure: This study was funded by Novartis Pharma AG, Basel, Switzerland.
Tanuja Chitnis has received personal compensation for advisory boards/consulting from Biogen Idec and Novartis Pharmaceuticals, and financial support for research activities from Merck Serono and Novartis Pharmaceuticals.
Angelo Ghezzi has received honoraria for speaking from Bayer Schering, Biogen Idec, Merck Serono, Novartis, and Sanofi Aventis; and for consultancy from Merck Serono, Biogen Idec, Teva and Novartis.
Daniela Pohl has received personal compensation for activities with Bayer Schering, Biogen Idec, Merck Serono, Novartis Pharmaceuticals and Teva.
Rolf Meinert has nothing to disclose.
Gustavo Seifer, Annik K. Laflamme and Dieter A. Häring are employees of Novartis Pharma AG, Basel, Switzerland.