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Alemtuzumab after natalizumab SWitch in evolving rapidly severe multiple sclerosis (ANSWERS MS): long-term UK & Ireland experience
ECTRIMS Online Library. Gallagher P. Oct 12, 2018; 232017
Paul Gallagher
Paul Gallagher
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Abstract: 264

Type: Scientific Session

Abstract Category: Therapy - Risk management for disease modifying treatments

Background: The safety and efficacy of alemtuzumab (AZB) after natalizumab (NZB) in RRMS is unknown.
Methods: 13 UK and Irish centres provided long-term data on patients switched to AZB from NZB since pre-licensing use began in 1999.
Results: 79 patients were included. 51 patients had more than 2 years follow-up after their initial AZB infusion. Independent blinded MRI analysis was conducted in 20 patients.
Data were analysed in 5 phases: before NZB (PRE-NZB), NZB, switch period (SWITCH), AZB and POST-AZB (starting 2 years after first AZB infusion). Mean EDSS increased from PRE-NZB (3.4) to SWITCH (4.7), but fell in the AZB (4.4) and POST-AZB (4.3) phase. Mean annualised relapse rate (ARR) fell from PRE-NZB (2.3) to NZB (0.8), and further during AZB (0.4) and POST-AZB (0.5). The mean number of new or worsened MRI lesions was highest during SWITCH (4.32/MRI/year), lowest in AZB (0.006/MRI/year), and remained low in POST-AZB (0.017/MRI/year).
Median SWITCH lasted 115 days. ARR increased during SWITCH periods with increasing duration (< 3 months = 0.36, 3-6 months = 0.5, 6-9 months = 1.9), and EDSS increased during SWITCH for durations > 3 months. Fingolimod bridging was given to 6 patients, who had a median SWITCH of 233 days, a SWITCH ARR of 1.3, and an EDSS increase during SWITCH.
Three serious adverse events occurred (one urinary infection (UTI), one cytomegalovirus infection and one death from sepsis unrelated to alemtuzumab). Other significant infections occurred in 8 patients: zoster (n=3), UTI (n=2), fungal (n=1), tonsillitis (n=1) and norovirus (n=1). 12 patients developed thyroid disease. Thrombocytopaenia occurred in 2 patients. 1 patient developed proteinuria during POST-AZB.
Conclusions: Long-term data show no unexpected safety signals from the use of AZB after NZB. A shorter SWITCH without bridging was associated with the best outcomes, and no evident risk.
Disclosure: The project was funded by Sanofi Genzyme. Paul Gallagher received salary payment from Sanofi Genzyme for this project and has received travel funding for educational events from this company as well as Novartis and Biogen. Christopher McGuigan: Consultancy/speaker fees from Biogen, Genzyme, Merck, Novartis & Roche. Research support from Biogen, Novartis and Genzyme. Jeremy Hobart has received consulting/advisor fees, honoraria, clinical service or research support from: Acorda, Biogen, Brickell Biotec, Genzyme, Global Blood Therapeutics, LORA group, Merck Serono, Novartis, Oxford Pharmogenesis, Roche, Tigercat and Vanita.
Neil Robertson: Consultancy/speaker fees from Biogen, Sanofi, Genzyme, Novartis, Roche. Research support from Novartis, Biogen and Genzyme. Helen L Ford: Consultancy/speaker fees and support to attend educational meetings from Merck, Novartis, Teva and Genzyme. Kate Petheram: Consultancy/travel/speaker fees: Biogen, Roche and Genzyme. Gordon Mazibrada: Consultancy/speaker fees from Biogen, Genzyme, Novartis, Merck-Serono, Teva and Roche. Research support from Novartis, Biogen, Genzyme, Teva and Merck-Serono. Neil Scolding: Nothing to disclose. Joanne Jones: Consultancy and speaker fees from Genzyme. Eli Silber: Support/ hospitality/ fees from Biogen, Genzyme, Merck-Serono, Novartis, Roche. Richard Nicholas: Novartis, Genzyme, Biogen Idec honorarium for speaking, advisory boards,Roche - advisory boards, CASTINGS committee member. Owen Pearson: served on the scientific advisory board for Biogen, Novartis, Roche, UK MS Register and has received travel funding and/or speaker honoraria from Biogen, Roche, Merck Serono, Novartis, Teva, Genzyme Sanofi. James Overell has received honoraria for speaking engagements and attendance at advisory boards from Teva, Novartis, Merck-Serono, Genzyme, Roche, Allergan and Biogen. Additionally his department has received educational grants, research funding and funds to provide nursing and administrative staff from these companies.

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