Abstract Details

Title Updated safety analysis of cladribine tablets in the treatment of patients with multiple sclerosis

Topic Multiple Sclerosis

Presentation(s) P4 - Poster Session 4 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-046

Objective To provide integrated safety data for cladribine tablets (CT) 10 mg (3.5 mg/kg cumulative dose over 2 years; referred to as CT3.5): an update to the previously reported serious treatment emergent adverse event (TEAE) profile. Additionally, to report initial (1-year) post-approval safety data from Europe.

Background Pooling of long-term safety data for integrated analysis allowed comprehensive characterization of the CT safety profile in patients at the earliest stages, or more advanced stages, of relapsing multiple sclerosis (RMS).

Design/Methods The monotherapy oral cohort (CT3.5; N=923, placebo [PBO]; N=641) was derived from the CLARITY, CLARITY Extension, and ORACLE-MS trials, and the PREMIERE registry. Adjusted adverse events incidences per 100 patient-years (Adj-AE per 100PY) were calculated, cumulative to May 2017. Serious adverse drug reactions (ADR; implied causality) from post-marketing sources are also summarized.

Results Demographics reported at first dosing date, including age (37.8 years, CT3.5), proportion of females (66.3%, CT3.5) and prior disease modifying drug experience, were balanced among treatment groups. Adj-AE per 100PY for experiencing ≥1 serious TEAE were 3.88 (CT3.5) and 3.24 (PBO). Adj-AE per 100PY for serious lymphopenia (preferred term [PT]) was 0.11 for CT3.5, with no serious lymphopenia observed with PBO. For serious infections and infestations (system organ class [SOC]), adj-AE per 100PY were 0.63 (CT3.5) and 0.44 (PBO); for serious herpes zoster (PT): 0.05 (CT3.5), no serious herpes zoster observed with PBO. Neoplasm imbalance was consistent with previous findings. Regarding post-marketing data, 47 serious ADRs were reported; none are new safety findings for CT3.5.

Conclusions This integrated analysis, exclusively focused on the frequency of serious TEAEs with CT3.5 in RMS patients, further establishes the safety profile of this dose. This profile is consistent with the previously published integrated safety analysis profile. No new major safety findings were identified in this latest dataset.

Authors/Disclosures
Stuart D. Cook, MD, FAAN (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, FAAN (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.
Sana Syed, MD (Sanofi Genzyme)	Dr. Syed has received personal compensation for serving as an employee of Sanofi US.
	No disclosure on file
	No disclosure on file
	No disclosure on file

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