Contributions
Abstract: P1213
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In RRMS patients, relapses vary in severity and may affect daily activities, requiring steroid intervention and hospitalization. Relapse frequency is often associated with MS prognosis. In the fingolimod (FTY) phase 3 core studies (FREEDOMS/FREEDOMS II and TRANSFORMS), frequency of overall and severe relapses were significantly reduced in the FTY vs placebo or interferon (IFN) treated RRMS patients.
Objective: To report the effect of FTY on relapse severity and associated healthcare utilization in RRMS patients who continued with or switched to FTY during the extensions of the phase 3 studies.
Methods: This post hoc descriptive analysis of data from pooled FREEDOMS and FREEDOMS II studies and from TRANSFORMS study analyzed 2 groups: patients randomized to FTY 0.5mg from the start (continuous group) or re-randomized to FTY in the extension (switch group). ARR was calculated for severe relapses (SR; EDSS score increase >1 point or >2-point change in 1 or 2 (or >1-point change in >4) functional systems), relapses requiring steroid use (RSU), or hospitalization (RH) or those affected daily activities (RADA).
Results: In the pooled FREEDOMS/FREEDOMS II extensions, the continuous group had sustained reductions in ARR over 4 years for SR (core: 0.032 vs extension: 0.015), RSU (0.149 vs 0.123), RH (0.049 vs 0.039) or RADA (0.155 vs 0.112) and lower percentage of relapses being SR (15.8 vs 9.3%). Similarly, in the TRANSFORMS extension at year 2, continuous group had sustained reductions in ARR for SR (core: 0.024 vs extension: 0.018), RSU (0.156 vs 0.161), RH (0.027 vs 0.033) or RADA
(0.112 vs 0.109) and lower percentage of SR (11.8 vs 9.8%).
During the TRANSFORMS extension, ARR decreased post switch (IFN to FTY) for SR (core: 0.079 to extension: 0.029), RSU (0.366 to 0.232), RH (0.092 to 0.055) or RADA (0.285 to 0.144). Numerically fewer confirmed relapses were severe upon switch from IFN to FTY (18.0 vs 11.1%). Results were consistent in the FREEDOMS/FREEDOMS II extensions post switch from placebo to FTY.
Complete recovery was reported for majority of relapses during core and extension in both the continuous and switch groups (FREEDOMS pooled: 59.7-67.7%; TRANSFORMS: 65.4-80.0%).
Conclusions: In RRMS, frequency of severe relapses and relapse severity remained low in the continuous FTY group over 4 years. Reduction in the frequency of severe relapses post switch from IFN to FTY, underscores the gain in clinical benefit and the relevance of early switch to FTY in RRMS.
Disclosure:
Funding Source: The study is supported by Novartis Pharma AG, Basel Switzerland.
Judith Haas has received compensation from Almiral, Biogen, Bayer, Octapharma, Teva, Allergan, and Novartis.
Timothy Vollmer received research grants from Teva Neuroscience, Biogen Idec, Novartis Pharma, Genzyme, Lilly Research Labs, Orasi, Sanofi Aventis, HoffmannLa Roche, Jensen Research, Avanir, and MedImmune, and honoraria for consulting from Teva Neuroscience, Biogen Idec, Elan Pharma, HoffmannLaRoche, Genzyme, Novartis, Acorda, Xenoport, Medscape, Sanofi, and Rocky Mountain MS Center.
Douglas Jeffery received honoraria for speaking and consulting from Bayer, Biogen, Teva, Serono, Pfizer, Glaxo, Novartis, Acorda, Genzyme, Xenoport, and Questcor; research support from Bayer, Biogen, Teva, Serono, Pfizer, Genzyme, and Novartis.
Jeffrey Cohen has received personal compensation for consulting for Genentech, Genzyme, Novartis, and Receptos; as a speaker for Teva; and as Co-Editor of Multiple Sclerosis Journal - Experimental, Translational and Clinical.
Hans Peter Hartung has received honoraria for consulting, serving on steering committees and speaking at scientific symposia from Bayer, Biogen, GeNeuro, Genzyme, MedImmune, Merck Serono, Novartis, Octapharma, opexa, Roche, Teva, Sanofi with approval by the Rector of Heinrich Heine University.
Daniela Piani Meier, Bianca Stadler and Shannon Ritter are employees of Novartis.
Abstract: P1213
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In RRMS patients, relapses vary in severity and may affect daily activities, requiring steroid intervention and hospitalization. Relapse frequency is often associated with MS prognosis. In the fingolimod (FTY) phase 3 core studies (FREEDOMS/FREEDOMS II and TRANSFORMS), frequency of overall and severe relapses were significantly reduced in the FTY vs placebo or interferon (IFN) treated RRMS patients.
Objective: To report the effect of FTY on relapse severity and associated healthcare utilization in RRMS patients who continued with or switched to FTY during the extensions of the phase 3 studies.
Methods: This post hoc descriptive analysis of data from pooled FREEDOMS and FREEDOMS II studies and from TRANSFORMS study analyzed 2 groups: patients randomized to FTY 0.5mg from the start (continuous group) or re-randomized to FTY in the extension (switch group). ARR was calculated for severe relapses (SR; EDSS score increase >1 point or >2-point change in 1 or 2 (or >1-point change in >4) functional systems), relapses requiring steroid use (RSU), or hospitalization (RH) or those affected daily activities (RADA).
Results: In the pooled FREEDOMS/FREEDOMS II extensions, the continuous group had sustained reductions in ARR over 4 years for SR (core: 0.032 vs extension: 0.015), RSU (0.149 vs 0.123), RH (0.049 vs 0.039) or RADA (0.155 vs 0.112) and lower percentage of relapses being SR (15.8 vs 9.3%). Similarly, in the TRANSFORMS extension at year 2, continuous group had sustained reductions in ARR for SR (core: 0.024 vs extension: 0.018), RSU (0.156 vs 0.161), RH (0.027 vs 0.033) or RADA
(0.112 vs 0.109) and lower percentage of SR (11.8 vs 9.8%).
During the TRANSFORMS extension, ARR decreased post switch (IFN to FTY) for SR (core: 0.079 to extension: 0.029), RSU (0.366 to 0.232), RH (0.092 to 0.055) or RADA (0.285 to 0.144). Numerically fewer confirmed relapses were severe upon switch from IFN to FTY (18.0 vs 11.1%). Results were consistent in the FREEDOMS/FREEDOMS II extensions post switch from placebo to FTY.
Complete recovery was reported for majority of relapses during core and extension in both the continuous and switch groups (FREEDOMS pooled: 59.7-67.7%; TRANSFORMS: 65.4-80.0%).
Conclusions: In RRMS, frequency of severe relapses and relapse severity remained low in the continuous FTY group over 4 years. Reduction in the frequency of severe relapses post switch from IFN to FTY, underscores the gain in clinical benefit and the relevance of early switch to FTY in RRMS.
Disclosure:
Funding Source: The study is supported by Novartis Pharma AG, Basel Switzerland.
Judith Haas has received compensation from Almiral, Biogen, Bayer, Octapharma, Teva, Allergan, and Novartis.
Timothy Vollmer received research grants from Teva Neuroscience, Biogen Idec, Novartis Pharma, Genzyme, Lilly Research Labs, Orasi, Sanofi Aventis, HoffmannLa Roche, Jensen Research, Avanir, and MedImmune, and honoraria for consulting from Teva Neuroscience, Biogen Idec, Elan Pharma, HoffmannLaRoche, Genzyme, Novartis, Acorda, Xenoport, Medscape, Sanofi, and Rocky Mountain MS Center.
Douglas Jeffery received honoraria for speaking and consulting from Bayer, Biogen, Teva, Serono, Pfizer, Glaxo, Novartis, Acorda, Genzyme, Xenoport, and Questcor; research support from Bayer, Biogen, Teva, Serono, Pfizer, Genzyme, and Novartis.
Jeffrey Cohen has received personal compensation for consulting for Genentech, Genzyme, Novartis, and Receptos; as a speaker for Teva; and as Co-Editor of Multiple Sclerosis Journal - Experimental, Translational and Clinical.
Hans Peter Hartung has received honoraria for consulting, serving on steering committees and speaking at scientific symposia from Bayer, Biogen, GeNeuro, Genzyme, MedImmune, Merck Serono, Novartis, Octapharma, opexa, Roche, Teva, Sanofi with approval by the Rector of Heinrich Heine University.
Daniela Piani Meier, Bianca Stadler and Shannon Ritter are employees of Novartis.