ECTRIMS eLearning

Switching from natalizumab to alemtuzumab in patients with RRMS: real-world experience
Author(s): ,
J Fortin
Affiliations:
Clinique Neuro-Outaouais, Gatineau
,
F.H Jacques
Affiliations:
Clinique Neuro-Outaouais, Gatineau
,
V Sikati Fokko
Affiliations:
Clinique Neuro-Outaouais, Gatineau
,
F Grand'Maison
Affiliations:
Clinique Neuro-Rive Sud, Montréal
,
F Emond
Affiliations:
CHU de Québec - Hôp. Enfant-Jésus, Quebec, QC
F Bakdache
Affiliations:
Sanofi Genzyme, Mississauga, ON, Canada
ECTRIMS Learn. Fortin J. 09/14/16; 145593; EP1498
Jacynthe Fortin
Jacynthe Fortin
Contributions
Abstract

Abstract: EP1498

Type: ePoster

Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression

Objectives: To evaluate safety and effectiveness of alemtuzumab in patients with Relapsing-Remitting MS (RRMS) previously treated with natalizumab.

Background: Since approval in Canada in December 2013, alemtuzumab has demonstrated significant reductions in risk of relapse and showed benefit on many radiological outcomes versus SC IFN-B1a in clinical trials in active RRMS patients. Clinical trial experience in patients switching directly from natalizumab to alemtuzumab is limited.

Design/Methods: This multi-centre, retrospective chart review from June 2014 to March 2016 reports on natalizumab-treated patients who, due to inadequate disease control, switched to treatment with alemtuzumab.

Results: The medical charts of 13 patients were reviewed. Mean disease duration was 110 months (range 18-336); the mean natalizumab treatment duration was 35 months (7-132); the mean washout period between therapies was 13.2 weeks (4-72); the mean follow-up was 12 months (4-18) after switching to alemtuzumab (8 of 13 patients received 2 cycles). Mean Expanded Disability Status Scale (EDSS) score on natalizumab was 3.9 (0.0-6.0) and decreased to 3.6 (0.0-6.0) after alemtuzumab; Annualized Relapse Rate (ARR) on natalizumab was 1.8 (in prior year) and decreased to 0.2 after alemtuzumab. No unexpected adverse events were reported after switching to alemtuzumab. One case of hypothyroidism, one case of cystitis and one oral candida infection were reported; causality was not determined. No serious infections occurred. Almost all patients reported infusion-associated reactions. One previously treated patient with disease duration of 22 years showed evidence of disability progression.

Conclusions: The retrospective chart review of this Canadian dataset supports alemtuzumab as a viable alternative therapy after treatment with natalizumab. It is reassuring that after switching, these patients continued to improve or stabilize both their EDSS score and ARR. The safety profile of these treated patients was similar to that observed in the alemtuzumab clinical trials. To note, one patient with long disease duration did not respond favourably, indicating the need to use alemtuzumab earlier in the course of the disease. Further real-world clinical experience is needed to provide additional data about the effectiveness and safety of switching from natalizumab to alemtuzumab.

Disclosure:

Dr Jacques, Emond and Grand Maison have received honoraria from different companies

Dr Jacques operates an infusion clinic where alemtuzumab is infused

Fabien Backdache is an employee of Sanofi Genzyme

Editorial support was provided by Adel Gehchan, MD of Sanofi Genzyme

Abstract: EP1498

Type: ePoster

Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression

Objectives: To evaluate safety and effectiveness of alemtuzumab in patients with Relapsing-Remitting MS (RRMS) previously treated with natalizumab.

Background: Since approval in Canada in December 2013, alemtuzumab has demonstrated significant reductions in risk of relapse and showed benefit on many radiological outcomes versus SC IFN-B1a in clinical trials in active RRMS patients. Clinical trial experience in patients switching directly from natalizumab to alemtuzumab is limited.

Design/Methods: This multi-centre, retrospective chart review from June 2014 to March 2016 reports on natalizumab-treated patients who, due to inadequate disease control, switched to treatment with alemtuzumab.

Results: The medical charts of 13 patients were reviewed. Mean disease duration was 110 months (range 18-336); the mean natalizumab treatment duration was 35 months (7-132); the mean washout period between therapies was 13.2 weeks (4-72); the mean follow-up was 12 months (4-18) after switching to alemtuzumab (8 of 13 patients received 2 cycles). Mean Expanded Disability Status Scale (EDSS) score on natalizumab was 3.9 (0.0-6.0) and decreased to 3.6 (0.0-6.0) after alemtuzumab; Annualized Relapse Rate (ARR) on natalizumab was 1.8 (in prior year) and decreased to 0.2 after alemtuzumab. No unexpected adverse events were reported after switching to alemtuzumab. One case of hypothyroidism, one case of cystitis and one oral candida infection were reported; causality was not determined. No serious infections occurred. Almost all patients reported infusion-associated reactions. One previously treated patient with disease duration of 22 years showed evidence of disability progression.

Conclusions: The retrospective chart review of this Canadian dataset supports alemtuzumab as a viable alternative therapy after treatment with natalizumab. It is reassuring that after switching, these patients continued to improve or stabilize both their EDSS score and ARR. The safety profile of these treated patients was similar to that observed in the alemtuzumab clinical trials. To note, one patient with long disease duration did not respond favourably, indicating the need to use alemtuzumab earlier in the course of the disease. Further real-world clinical experience is needed to provide additional data about the effectiveness and safety of switching from natalizumab to alemtuzumab.

Disclosure:

Dr Jacques, Emond and Grand Maison have received honoraria from different companies

Dr Jacques operates an infusion clinic where alemtuzumab is infused

Fabien Backdache is an employee of Sanofi Genzyme

Editorial support was provided by Adel Gehchan, MD of Sanofi Genzyme

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