Abstract Details

Title Cladribine Holds its Weight: Comparable Lymphocyte Dynamics in People With Multiple Sclerosis Above and Below 110 kg

Topic Multiple Sclerosis

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 19-001

Objective To evaluate whether body weight > 110 kg influences lymphodepletion and recovery dynamics in multiple sclerosis (MS) patients treated with cladribine.

Background MS is a chronic demyelinating disorder of the central nervous system resulting in progressive disability through neuroinflammation and neurodegeneration. Among the over 20 FDA-approved disease-modifying therapies (DMTs), oral cladribine is the only agent with a weight-based dosing regimen. However, beyond 110 kg, dosing is fixed and no longer scaled to weight. To date, no study has evaluated the lymphocyte dynamics of patients weighing > 110 kg. Concerns for attenuated responses at weights above the scaled dosing range have led to clinical apprehension for prescribing cladribine, thereby limiting the accessibility of this DMT.

Design/Methods A retrospective chart review was performed on MS patients treated with cladribine at Froedtert and the Medical College of Wisconsin from March 2019 to May 2025. Inclusion criteria consisted of completion of the full treatment cycle, body weight ≥ 40 kg, and a baseline lymphocyte count ≥ 1000 cells/μL. Lymphocyte counts were collected at baseline and months 2, 11, 14, and 18 following drug exposure. Counts were analyzed using linear mixed-effects models through the lmerTest package in RStudio.

Results A total of 162 MS patients treated with cladribine were included in the analysis (122 female, mean age = 43.9 ± 9.4 years, mean weight = 81.3 kg (≤ 110 kg group); 131.0 kg (> 110 kg group)). There were no statistically significant differences between groups (p = 0.274). Pairwise contrasts at individual timepoints were similarly not significant.

Conclusions Lymphocyte dynamics were comparable between weight groups, indicating that cladribine’s capped dosing strategy remains effective at higher body weights. This finding supports the use of cladribine in patients weighing over 110 kg, thereby expanding confidence in prescribing cladribine to a broader patient population.

Authors/Disclosures
Thomas Hosseini (Medical College of Wisconsin) PRESENTER	Mr. Hosseini has nothing to disclose.
Michelle Maynard, PharmD (Froedtert Neurosciences Clinic)	Dr. Maynard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Maynard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Maynard has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono.
Ahmed Z. Obeidat, MD, PhD (Medical College of Wisconsin)	Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Obeidat has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Genentech. Dr. Obeidat has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for EMD Serono. Dr. Obeidat has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi/Genzyme . Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon pharmaceuticals . Dr. Obeidat has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sandoz. Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. Dr. Obeidat has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Alexion. Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Obeidat has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for EMD Serono. Dr. Obeidat has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Banner life sciences . Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi/genzyme. Dr. Obeidat has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Horizon therapeutics . Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for TG Therapeutics . Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AstraZeneca. The institution of Dr. Obeidat has received research support from NIH. The institution of Dr. Obeidat has received research support from NMSS and PCORI. Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Expert opinion and key opinion leader with MJH life sciences . Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Faculty Speaker with CMSC. Dr. Obeidat has a non-compensated relationship as a Board member with CMSC that is relevant to AAN interests or activities. Dr. Obeidat has a non-compensated relationship as a Editorial Board Member with IJMSC that is relevant to AAN interests or activities. Dr. Obeidat has a non-compensated relationship as a Reviewer Editor with Frontiers Neurology that is relevant to AAN interests or activities. Dr. Obeidat has a non-compensated relationship as a Board of Trustee Member with National MS Society that is relevant to AAN interests or activities.
Sam Hooshmand, DO (Medical College of Wisconsin)	Dr. Hooshmand has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genetech USA. Dr. Hooshmand has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics . Dr. Hooshmand has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Hooshmand has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genetech USA. Dr. Hooshmand has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Hooshmand has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for TG Therapeutics . Dr. Hooshmand has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen . The institution of Dr. Hooshmand has received research support from Novartis .

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