Abstract Details

Title Natalizumab Discontinuation after the 24th Course: Which Is Way? The TY-STOP Study

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 197

Objective

Background BACKGROUND: Natalizumab may cause Progressive Multifocal Leucoencephalopathy (PML). According to risk stratification after the 24th course, patients can decide whether to continue Natalizumab.

Design/Methods DESIGN/METHODS: Multicenter prospective observational study, involving 7 centers, 88 patients enrolled (56 female; average age 40) with relapsing-remitting multiple sclerosis (RRMS) clinically and radiologically stable, treated with 24 Natalizumab administrations. The study provides 6 visits at month (M) 0, 1, 3, 6, 9, 12 and 3 brain MRI at M0, M6, M12. Enrolled patients reached the following timepoints: 80 patients M3, 68 patients M6, 55 patients M9, 31 patients M12. We calculated the percentage of relapses and MRI activity stratified by therapy.

Results RESULTS: The percentage of patients with relapses during the year after Natalizumab discontinuation was 35.6%: 3.7% among patients continuing Natalizumab, 17.8% among those who started other immunomodulatory or immunosuppressive therapy and 16.7% among patients without therapy. The percentage of patients with MRI activity after 24th Natalizumab course was 34.8%: 3.7% among patients continuing Natalizumab, 20.5% among those who started other immunomodulatory or immunosuppressive therapy and 21.4% among patients without therapy. Evaluation of HR with relative 95% CI for relapses, EDSS score > 3, MRI activity. Data show a protective effect of therapy with Natalizumab vs no therapy on MRI activity (HR 0.81; 95% CI 0.68-0.96; p=0.015).The average of relapses and MRI activity is similar in those patients who discontinued any therapy and in those who started a first line therapy.

Conclusions CONCLUSIONS: Our data show a protective effect of Natalizumab on MRI activity during the 12 months of follow-up. Considering the protective effect on MRI activity, Natalizumab should be continued over the 24 administrations according to the evaluation of patients' risk to develop PML.

Authors/Disclosures
Marinella Clerico, MD (University of Torino) PRESENTER	Dr. Clerico has nothing to disclose.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Vincenzo Brescia Morra, MD (Universita Federico II - Napoli)	Dr. Brescia Morra has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Brescia Morra has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NOVARTIS. Dr. Brescia Morra has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIOGEN. Dr. Brescia Morra has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ROCHE. Dr. Brescia Morra has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA. Dr. Brescia Morra has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ALMIRALL. Dr. Brescia Morra has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MERK. Dr. Brescia Morra has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MERK. The institution of Dr. Brescia Morra has received research support from FISM. Dr. Brescia Morra has a non-compensated relationship as a PI with FISM that is relevant to AAN interests or activities.
Roberta Lanzillo	Roberta Lanzillo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck, Biogen. Roberta Lanzillo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen, Roche, Novartis.
	No disclosure on file
	No disclosure on file
Mario Quarantelli, MD (CNR Edificio 10)	No disclosure on file
Angelo Ghezzi, MD	No disclosure on file
	No disclosure on file
Damiano Baroncini	No disclosure on file
	No disclosure on file
	No disclosure on file
Giuseppe Salemi, MD (Istituto Di Neuropsichiatria)	No disclosure on file
	No disclosure on file
	No disclosure on file
Francesca Vitetta, MD (Osp. Sant'Agostino)	No disclosure on file
Patrizia Sola (Nuovo Ospedale Civile S. Agostino-Estense)	Patrizia Sola has nothing to disclose.
Damiano Paolicelli	Damiano Paolicelli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck Serono. Damiano Paolicelli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi.
Maria Trojano (Policlinico - Bari)	Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi_Genzyme. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi-Genzyme. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen.
Luca Durelli, MD (Divisione Universitaria di Neurologia)	No disclosure on file

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