Contributions
Abstract: EP1649
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: In multiple sclerosis (MS) natalizumab (NTZ) withdrawal may lead to a “rebound” of inflammatory activity defined, in several patient series, as a severe relapse and unusually high inflammatory MRI activity increase. In our MS center two different schedules with intravenously metilprednisolone (IVMP) were established to reduce the probability rise of inflammatory activity.
Objectives: To assess the clinical disease activity following cessation of natalizumab therapy.
Methods: Retrospective analysis data of patients treated with NTZ during more than 2 years that was discontinued between January 2012 and January 2017 for inefficacy or safety reasons. A new disease modifying treatment (DMT) was initiated after NTZ withdrawal through two IVMP schedules within NTZ washout period (WP): Schedule 1 (years 2012 and 2013): 3 months WP. 1, 2 and 3 IVMP grams, every month respectively. Schedule 2 (years 2014, 2015 and 2016): 2 months WP. 1 and 2 IVMP grams every month respectively. Ten days after every schedule, new DMT was initiated. Clinical and MRI evaluations were performed at 3rd, 6th, 12th and 24th months after NTZ-washout. Clinical variables and MRI activity (new/enlarged T2 and gadolinium enhancing lesions) were studied.
Results: Fifty patients discontinued NTZ in the analyzed period (68% women, mean age -years- 40.39+/-11.12, mean EDSS 3.59+/-1.74). New DMT was fingolimod in 80% of cases. At 6th month relapse or MRI activity (return to previous MS activity) was observed in 32% and 38.5% of patients respectively, “rebound” criteria (severe relapse and unusually high inflammatory MRI activity) was observed in 6% (n=3) and 8% (n=4) presented only high inflammatory MRI activity. No relapses during WP was observed. No differences of clinical and MRI activity between both schedule IVMP was observed. Return to previous MS activity was found in younger patients and was associated with higher annualized relapse rate (ARR) during the two years after cessation of NTZ and a higher presence of MRI activity, with no differences in EDSS scores after two years of follow-up.
Conclusions: IVMP schedule 1 and 2 during NTZ washout period was well tolerated and “rebound” phenomenon was observed in only 6% of cases. In our study IVMP could have reduced the possibility of rebound since in other patient series the proportion is higher. Return to previous clinical and MRI activity at 6th month after NTZ cessation could imply a worse prognostic in the following two years.
Disclosure: L. Fuentes Rumí: Nothing to disclose.
J. Meca-Lallana has received consulting or speaking fees from Almirall, Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva.
The other authors disclose neither conflict of interest in the elaboration of this communication. Authors have not received any funding for the elaboration of this study.
Abstract: EP1649
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: In multiple sclerosis (MS) natalizumab (NTZ) withdrawal may lead to a “rebound” of inflammatory activity defined, in several patient series, as a severe relapse and unusually high inflammatory MRI activity increase. In our MS center two different schedules with intravenously metilprednisolone (IVMP) were established to reduce the probability rise of inflammatory activity.
Objectives: To assess the clinical disease activity following cessation of natalizumab therapy.
Methods: Retrospective analysis data of patients treated with NTZ during more than 2 years that was discontinued between January 2012 and January 2017 for inefficacy or safety reasons. A new disease modifying treatment (DMT) was initiated after NTZ withdrawal through two IVMP schedules within NTZ washout period (WP): Schedule 1 (years 2012 and 2013): 3 months WP. 1, 2 and 3 IVMP grams, every month respectively. Schedule 2 (years 2014, 2015 and 2016): 2 months WP. 1 and 2 IVMP grams every month respectively. Ten days after every schedule, new DMT was initiated. Clinical and MRI evaluations were performed at 3rd, 6th, 12th and 24th months after NTZ-washout. Clinical variables and MRI activity (new/enlarged T2 and gadolinium enhancing lesions) were studied.
Results: Fifty patients discontinued NTZ in the analyzed period (68% women, mean age -years- 40.39+/-11.12, mean EDSS 3.59+/-1.74). New DMT was fingolimod in 80% of cases. At 6th month relapse or MRI activity (return to previous MS activity) was observed in 32% and 38.5% of patients respectively, “rebound” criteria (severe relapse and unusually high inflammatory MRI activity) was observed in 6% (n=3) and 8% (n=4) presented only high inflammatory MRI activity. No relapses during WP was observed. No differences of clinical and MRI activity between both schedule IVMP was observed. Return to previous MS activity was found in younger patients and was associated with higher annualized relapse rate (ARR) during the two years after cessation of NTZ and a higher presence of MRI activity, with no differences in EDSS scores after two years of follow-up.
Conclusions: IVMP schedule 1 and 2 during NTZ washout period was well tolerated and “rebound” phenomenon was observed in only 6% of cases. In our study IVMP could have reduced the possibility of rebound since in other patient series the proportion is higher. Return to previous clinical and MRI activity at 6th month after NTZ cessation could imply a worse prognostic in the following two years.
Disclosure: L. Fuentes Rumí: Nothing to disclose.
J. Meca-Lallana has received consulting or speaking fees from Almirall, Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva.
The other authors disclose neither conflict of interest in the elaboration of this communication. Authors have not received any funding for the elaboration of this study.