Contributions
Abstract: P1201
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Efficacy of extended interval dosing (EID) of Natalizumab (NTZ) has been rarely reported, mainly from combined data of different centers; it's not a real life setting. We have already demonstrated the interest of assessing CD49d expression, the biological target of NTZ, to follow its clinical efficacy (Defer et al 2012).
Objective
To report, in a real life setting, long term experience of our MS center in EID of NTZ, associated to the follow-up of CD49d expression, on clinical and radiological efficacy of NTZ.
Method: Between August 2007 and March 2017, moving from standard interval dosing to EID was proposed to stable RR-MS patients treated with NTZ for at least 2 years.
We compared the annualised relapse rate (ARR), the Expended Disability Status Scale (EDSS), MRI activity and CD49d expression in the same patients, under standard interval dosing (ID) then EID of 5 and 6 weeks. CD49d expression was determined on peripheral blood mononuclear cells before each infusion. For variables comparison, we used parametric tests before treatment then between interval dosing of 4 and 5 weeks; and Wilcoxon test between ID of 5 and 6 weeks.
Results: 52 patients had EID of 5 weeks during 20,6±15 months; 18 of them had EID of 6 weeks during 18,7±12 months. The median age was of 36.1 ± 8.4 years, sex ratio 3F/1M, the ARR and EDSS before treatment were respectively of 1,47±1,04, and 3.3 ± 1,7. Almost half of the patients (48%) had positive JCV serology.
No significant differences were found between ID of 4 and 5 weeks : ARR 4 weeks 0,24±0,52; and ARR 5 weeks 0,22±0,65; p=0.837. EDSS 4 weeks 2.7±1.74 and EDSS 5 weeks 2.6±1.86; p=0.314. Average CD49d expression 4 weeks 40.5±7.3, and 5 weeks 39.8±9.4; p=0.26. The average number of T2 lesions on MRI at 4 weeks was of 16.1±7.2, and at 5 weeks of 15.3±7.1; p=0.076. No significant difference was found between 5 and 6 weeks, p-value > 0.05 for all compared parameters.
Conclusion: Our findings reveal that EID didn't affect the clinical, radiological nor biological effectiveness of NTZ. This therapeutic strategy can be proposed within the first year of treatment with NTZ in order to evaluate prospectively the effect on JCV index evolution and rate of seroconversion.
Disclosure: D. Ciocanu nothing to disclose
N. Derache received funding for speaker honoraria from Merck-Serono, Biogen-Idec, Novartis, Teva and Sanofi-Genzyme
M. Berro nothing to disclose
P. Branger received funding for speaker honoraria from Novartis and Sanofi-Genzyme. D. Mariotte nothing to disclose
B. Le Mauff nothing to disclose
G. Defer received personal compensation for serving on scientific advisory boards for Biogen Idec, Merck-Serono, Novartis, Sanofi Aventis, Genzyme and Teva Pharmaceutical Industries Ltd. He has received funding for travel and/or speaker honoraria from Merck Serono, Biogen, Guerbet, Sanofi Aventis, Novartis, Genzyme and Teva Pharmaceutical Industries Ltd. His institution received grants supporting research in his department from Merck Serono, Biogen, Sanofi Aventis and Novartis.
Abstract: P1201
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Efficacy of extended interval dosing (EID) of Natalizumab (NTZ) has been rarely reported, mainly from combined data of different centers; it's not a real life setting. We have already demonstrated the interest of assessing CD49d expression, the biological target of NTZ, to follow its clinical efficacy (Defer et al 2012).
Objective
To report, in a real life setting, long term experience of our MS center in EID of NTZ, associated to the follow-up of CD49d expression, on clinical and radiological efficacy of NTZ.
Method: Between August 2007 and March 2017, moving from standard interval dosing to EID was proposed to stable RR-MS patients treated with NTZ for at least 2 years.
We compared the annualised relapse rate (ARR), the Expended Disability Status Scale (EDSS), MRI activity and CD49d expression in the same patients, under standard interval dosing (ID) then EID of 5 and 6 weeks. CD49d expression was determined on peripheral blood mononuclear cells before each infusion. For variables comparison, we used parametric tests before treatment then between interval dosing of 4 and 5 weeks; and Wilcoxon test between ID of 5 and 6 weeks.
Results: 52 patients had EID of 5 weeks during 20,6±15 months; 18 of them had EID of 6 weeks during 18,7±12 months. The median age was of 36.1 ± 8.4 years, sex ratio 3F/1M, the ARR and EDSS before treatment were respectively of 1,47±1,04, and 3.3 ± 1,7. Almost half of the patients (48%) had positive JCV serology.
No significant differences were found between ID of 4 and 5 weeks : ARR 4 weeks 0,24±0,52; and ARR 5 weeks 0,22±0,65; p=0.837. EDSS 4 weeks 2.7±1.74 and EDSS 5 weeks 2.6±1.86; p=0.314. Average CD49d expression 4 weeks 40.5±7.3, and 5 weeks 39.8±9.4; p=0.26. The average number of T2 lesions on MRI at 4 weeks was of 16.1±7.2, and at 5 weeks of 15.3±7.1; p=0.076. No significant difference was found between 5 and 6 weeks, p-value > 0.05 for all compared parameters.
Conclusion: Our findings reveal that EID didn't affect the clinical, radiological nor biological effectiveness of NTZ. This therapeutic strategy can be proposed within the first year of treatment with NTZ in order to evaluate prospectively the effect on JCV index evolution and rate of seroconversion.
Disclosure: D. Ciocanu nothing to disclose
N. Derache received funding for speaker honoraria from Merck-Serono, Biogen-Idec, Novartis, Teva and Sanofi-Genzyme
M. Berro nothing to disclose
P. Branger received funding for speaker honoraria from Novartis and Sanofi-Genzyme. D. Mariotte nothing to disclose
B. Le Mauff nothing to disclose
G. Defer received personal compensation for serving on scientific advisory boards for Biogen Idec, Merck-Serono, Novartis, Sanofi Aventis, Genzyme and Teva Pharmaceutical Industries Ltd. He has received funding for travel and/or speaker honoraria from Merck Serono, Biogen, Guerbet, Sanofi Aventis, Novartis, Genzyme and Teva Pharmaceutical Industries Ltd. His institution received grants supporting research in his department from Merck Serono, Biogen, Sanofi Aventis and Novartis.