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Abstract Details

An analysis of the relationship between cladribine dose and risk of malignancies in patients with multiple sclerosis
Multiple Sclerosis
P8 - Poster Session 8 (8:00 AM-9:00 AM)
9-011
To use data integrated from clinical trials and a safety follow-up registry (up to 5/2017) to further characterize malignancy risk of cladribine tablets (CT) in patients with MS and investigate dose-dependence.

Malignancy risk was previously characterized in a Monotherapy Oral cohort of patients with multiple sclerosis (MS) treated with CT 10mg (3.5mg/kg cumulative dose over 2 years; CT3.5) including data up to 2/2015. In clinical studies, an imbalance in the number of malignancies with CT3.5 vs placebo (PBO) suggested malignancy risk may be increased.
Cohorts were Monotherapy Oral: patients with MS receiving CT as monotherapy; All exposed: patients with MS receiving any formulation of cladribine.
In the Monotherapy Oral cohort, patient numbers (patient–years [PY]) were: PBO N=641 (2275), CT3.5 N=923 (3754), CT 5.25 mg/kg (CT5.25) N=632 (2610). The incidence per 100PY for malignant tumors was: PBO: 0.13, CT3.5: 0.27 and CT5.25: 0.23. The risk difference vs PBO was: CT3.5: 0.14 and CT5.25: 0.10. In CLARITY CT3.5 (N=195) and CT5.25 (N=195) patients randomized to CT3.5 in CLARITY Extension, incidence per 100PY by CLARITY dose was: 0.55 (CT3.5, 1301PY) and 0.31 (CT5.25, 1286PY) for the entire follow-up; 0.91 (CT3.5, 790PY) and 0.52 (CT5.25, 784PY) for the period following treatment-initiation in year 3. In the All Exposed cohort (cladribine N=1976; PBO N=802) stratified by cumulative cladribine dose, the number of patients with a malignant event (incidence per 100PY) was: >0­–3.5 mg/kg = 6 (0.37), >3.5–5.25 = 14 (0.40), >5.25–7.0 = 6 (0.29), >7.0–8.75 = 6 (0.46), >8.75 = 2 (0.21). No hematological malignancies were observed.
There was no clear evidence of a dose effect of cladribine on malignancy risk in patients with MS based on >9500PY of exposure. 
Authors/Disclosures
Stuart D. Cook, MD, FÂ鶹´«Ã½Ó³»­ (Rutgers)
PRESENTER 		No disclosure on file
Gavin Giovannoni, MD (QMUL) Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck KGaA. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche-Genentech. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Astoria Biologica. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas. Dr. Giovannoni 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. Giovannoni 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. Giovannoni 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. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape.
Thomas Leist, MD, PhD, FÂ鶹´«Ã½Ó³»­ (Thomas Jefferson University) Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Leist has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Horizon. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Seono. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Expert Wittness with DHHS HRSA.
Giancarlo Comi, MD (University Vita-Salute) Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Aspen Healthcare. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sanofi. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Rewind.
No disclosure on file
No disclosure on file
Dominic Jack (Merck Serono Ltd) Dominic Jack has received personal compensation for serving as an employee of Merck KGaA, Darmstadt, Germany.
No disclosure on file
No disclosure on file