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Abstract Details

Tailoring B-cells depleting therapy in MS according to memory B-cells monitoring: a pilot study
Multiple Sclerosis
P15 - Poster Session 15 (12:00 PM-1:00 PM)
9-012
To evaluate rituximab (RTX) efficacy using a memory B-cell based reinfusion regimen, with a variable reinfusion cut-off, according to year of treatment.

Phase II and III clinical trials revealed the potent suppressive activity on MRI activity and ARR of CD20 directed antibodies in MS. However, no studies to dissect the optimal infusion regimen have been performed. Infusion regimens with higher infusion intervals and lower drug dosage might maintain the same efficacy than current (fixed-dose) treatment schedule.
This is a retrospective and prospective bicentric study including patients with MS treated with RTX. All patients were treated with rituximab induction, followed by maintenance infusion, according to memory B-cells repopulation. Predefined cut-off values for reinfusion (percentage of memory B cells among peripheral blood PBMC) were: 0.05% for the first two years of treatment, with subsequent doubling for each year of treatment

101 patients were included in the analysis, 32 patients had a relapsing remitting phenotype, while 69 had a progressive phenotype.

Mean FU was 1.75 years (range 0.29-6.56). 

ARR was 0.67 (95% Confidence Interval (CI): 0.53-0.85) in the year before RTX start and decreased to 0.02 (95%CI 0.004-0.04) during the whole FU. 

Proportion of patient with MS activity (i.e.: relapse or MRI activity) was 74/101 (73.3%) in the year before RTX start and decreased to 11/71 (15.5%) and 1/27 (3.70%) in the two years after RTX initiation.

Annualized RTX infusion rate was 1.70 (95%CI:1.45-1.99), 1.41 (95%CI:1.09-1.80), 0.97 (95%CI:0.62-1.43) and 0.85 (95%CI:0.36-1.64) for the first four years after RTX initiation, respectively.
Results of this study show that memory B cells based RTX reinfusion protocol is able to reduce mean number of RTX reinfusion with persistent reduction of disease activity. A memory B cells threshold for disease activity recrudescence could be possibly identified with longer follow-up (and higher reinfusion cut-off). 
Authors/Disclosures

PRESENTER 		No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
Giacomo Boffa (Department of Neuroscience, University of Genova) Mr. Boffa has nothing to disclose.
Maria Cellerino, MD (University of Genoa) Maria Cellerino has nothing to disclose.
Caterina Lapucci, MD (DINOGMI, University of Genoa) Dr. Lapucci has nothing to disclose.
Nicolo Bruschi Mr. Bruschi has nothing to disclose.
Elisabetta Capello, MD (Ospedale San Martino - Clinica Neurologica) No disclosure on file
Alice Laroni Alice Laroni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Alice Laroni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Alice Laroni has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Alice Laroni has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Alice Laroni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Alice Laroni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Alice Laroni has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Alice Laroni has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Alice Laroni has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. The institution of Alice Laroni has received research support from Fondazione Italiana Sclerosi MUltipla . The institution of Alice Laroni has received research support from Ministero Salute. The institution of Alice Laroni has received research support from Ministero UNiversità.
No disclosure on file
Maria Pia Sormani (University of Genoa) Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol meyer. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunic. Maria Pia Sormani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis, Roche. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche.
Matilde Inglese, MD, PhD (University of Genoa) Dr. Inglese has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for SANOFI GENZYME. Dr. Inglese has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for BIOGEN. Dr. Inglese has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for NOVARTIS. Dr. Inglese has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for MERCK-SERONO. Dr. Inglese has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for ROCHE. Dr. Inglese has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MS Journal.
Antonio Uccelli, MD (Ospedale S. Martino - Genova) An immediate family member of Dr. Uccelli has received personal compensation for serving as an employee of Biogen. The institution of Dr. Uccelli has received research support from Merck. The institution of Dr. Uccelli has received research support from Roche.