Treating multiple sclerosis with generic cladribine
Author(s): ,
C Alvarez-Gonzalez
Affiliations:
Blizard Institute (Neuroscience), Queen Mary University London, Barts and the London School of Medicine and Dentistry;Emergency Care & Acute Medicine Neuroscience Clinical Academic Group
,
K Allen-Philbey
Affiliations:
Emergency Care & Acute Medicine Neuroscience Clinical Academic Group
,
J Mathews
Affiliations:
Neurology and Medicines Safety, Barts Health NHS Trust, London, United Kingdom
,
M Espasandin
Affiliations:
Emergency Care & Acute Medicine Neuroscience Clinical Academic Group
,
B.P Turner
Affiliations:
Blizard Institute (Neuroscience), Queen Mary University London, Barts and the London School of Medicine and Dentistry;Emergency Care & Acute Medicine Neuroscience Clinical Academic Group
,
S Gnanapavan
Affiliations:
Blizard Institute (Neuroscience), Queen Mary University London, Barts and the London School of Medicine and Dentistry;Emergency Care & Acute Medicine Neuroscience Clinical Academic Group
,
M Marta
Affiliations:
Blizard Institute (Neuroscience), Queen Mary University London, Barts and the London School of Medicine and Dentistry;Emergency Care & Acute Medicine Neuroscience Clinical Academic Group
,
G Giovannoni
Affiliations:
Blizard Institute (Neuroscience), Queen Mary University London, Barts and the London School of Medicine and Dentistry;Emergency Care & Acute Medicine Neuroscience Clinical Academic Group
,
D Baker
Affiliations:
Blizard Institute (Neuroscience), Queen Mary University London, Barts and the London School of Medicine and Dentistry
K Schmierer
Affiliations:
Blizard Institute (Neuroscience), Queen Mary University London, Barts and the London School of Medicine and Dentistry;Emergency Care & Acute Medicine Neuroscience Clinical Academic Group
ECTRIMS Online Library. Alvarez-Gonzalez C. 09/16/16; 145845; P1161
Cesar Alvarez-Gonzalez
Cesar Alvarez-Gonzalez
Contributions
Abstract

Abstract: P1161

Type: Poster

Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression

Background: Trial evidence suggests Cladribine, a purine analogue licensed for treatment of people with hairy cell leukaemia, is also an effective, safe and convenient disease modifying therapy (DMT) for people with multiple sclerosis (pwMS)1-4. Cladribine appears to exert its effect through selective long-term suppression of lymphocytes and reduction of pro-inflammatory cytokines and chemokines whilst leaving other cell types relatively unaffected.

Objective: To report our clinical experience with Cladribine in pwMS using a dosing scheme that adapts to individual lymphocyte level.

Methods: Cladribine was offered to pwMS with clinical and/or MRI disease activity, but restricted choice of DMT. Treatment consisted of 1-2 annual cycles of subcutaneous Cladribine (Litak). During each cycle 10mg Cladribine was given for up to 7 days in 5 weeks. The number of injections was adjusted to individual lymphocyte count to avoid levels below 0.5x10*9/L. One way ANOVA was used to analyse differences in white cell counts. We report results after a mean follow-up of 4 months.

Results: Eighteen pwMS (10 women and 8 men) had a first treatment cycle of Cladribine. Mean age was 44 (34-60) years, median EDSS was 5 (2-8). No acute side effects or serious treatment-related adverse event were observed, and neither any clinical disease activity within the follow-up period. Lymphocyte counts dropped from a mean of 1.81 (range: 0.9-3.4 x10*9) at baseline to 1.41 (0.7-3) at 4 weeks, and to 1.02 (0.6-1.6) at 8 weeks, p=0.02. Other white cells remained within normal range.

Conclusion: Cladribine was well tolerated and led to a controlled decrease in lymphocyte counts leaving other cell lines largely unaffected. So far no new disease activity has been detected. Follow-up continues.

References:

1Stelmasiak, et al. Mult Scler J 2009;15:767-70

2Giovannoni, et al. New Engl J Med 2010;362:416-26.

3Giovannoni, et al. Lancet Neurol 2011;10:329-37.

4Rice, et al. Neurology 2000;54:1145-55.

Disclosure: Some of the authors have received compensations from various pharmaceutical companies including:

KS, GG, BT: from Roche, Teva, Novartis, Merck-Serono, Sanofi-Genzyme, and Biogen.

KS, DB, GG: from Canbex Therapeutics and Sanofi-Genzyme.

GG: from AbbVie, Bayer Schering Healthcare, Eisai, Elan, Five Prime Therapeutics, Genentech, GlaxoSmithKline, Ironwood Pharmaceuticals, Pfizer, Synthon BV, UCB and Vertex Pharmaceuticals.

KS: from BIAL, Cytokinetics, National MS Society (US), MS Society of Great Britain & Northern Ireland, Royal College of Radiologists, and Barts Charity.

Abstract: P1161

Type: Poster

Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression

Background: Trial evidence suggests Cladribine, a purine analogue licensed for treatment of people with hairy cell leukaemia, is also an effective, safe and convenient disease modifying therapy (DMT) for people with multiple sclerosis (pwMS)1-4. Cladribine appears to exert its effect through selective long-term suppression of lymphocytes and reduction of pro-inflammatory cytokines and chemokines whilst leaving other cell types relatively unaffected.

Objective: To report our clinical experience with Cladribine in pwMS using a dosing scheme that adapts to individual lymphocyte level.

Methods: Cladribine was offered to pwMS with clinical and/or MRI disease activity, but restricted choice of DMT. Treatment consisted of 1-2 annual cycles of subcutaneous Cladribine (Litak). During each cycle 10mg Cladribine was given for up to 7 days in 5 weeks. The number of injections was adjusted to individual lymphocyte count to avoid levels below 0.5x10*9/L. One way ANOVA was used to analyse differences in white cell counts. We report results after a mean follow-up of 4 months.

Results: Eighteen pwMS (10 women and 8 men) had a first treatment cycle of Cladribine. Mean age was 44 (34-60) years, median EDSS was 5 (2-8). No acute side effects or serious treatment-related adverse event were observed, and neither any clinical disease activity within the follow-up period. Lymphocyte counts dropped from a mean of 1.81 (range: 0.9-3.4 x10*9) at baseline to 1.41 (0.7-3) at 4 weeks, and to 1.02 (0.6-1.6) at 8 weeks, p=0.02. Other white cells remained within normal range.

Conclusion: Cladribine was well tolerated and led to a controlled decrease in lymphocyte counts leaving other cell lines largely unaffected. So far no new disease activity has been detected. Follow-up continues.

References:

1Stelmasiak, et al. Mult Scler J 2009;15:767-70

2Giovannoni, et al. New Engl J Med 2010;362:416-26.

3Giovannoni, et al. Lancet Neurol 2011;10:329-37.

4Rice, et al. Neurology 2000;54:1145-55.

Disclosure: Some of the authors have received compensations from various pharmaceutical companies including:

KS, GG, BT: from Roche, Teva, Novartis, Merck-Serono, Sanofi-Genzyme, and Biogen.

KS, DB, GG: from Canbex Therapeutics and Sanofi-Genzyme.

GG: from AbbVie, Bayer Schering Healthcare, Eisai, Elan, Five Prime Therapeutics, Genentech, GlaxoSmithKline, Ironwood Pharmaceuticals, Pfizer, Synthon BV, UCB and Vertex Pharmaceuticals.

KS: from BIAL, Cytokinetics, National MS Society (US), MS Society of Great Britain & Northern Ireland, Royal College of Radiologists, and Barts Charity.

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