Off-Label, Personalized Cladribine Dosing: Kimberly Allen-Philbey

“Being able to offer cladribine on an off-label basis has meant that we've been able to offer patients with treatment options that wouldn't previously have access to it. We've been able to provide treatments to patients who have evidence of disease activity on MRI indices, neurofilaments, or lumbar puncture but otherwise wouldn’t have been eligible for a licensed disease modifying treatment.”

Data from a recent study presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2021, February 25-27, suggest that subcutaneous cladribine personalized dosing (CPD) was well-tolerated in patients with relapsing multiple sclerosis (RMS), with efficacy in line with oral cladribine (Mavenclad; EMD Serono) trial data. 

First author Kimberley Allen-Philbey, PhD candidate, Barts MS Center, London, and colleagues utilized a treatment schedule that consisted of 10 mg on 3 consecutive days in week 1 (4 days in people over 90 kg), followed by another 0-3 doses in week 5 based on total lymphocyte count in week 4. A second cycle of CPD was administered 11 months later. They found that over the follow-up period, 1 myocardial infarction, 1 breast cancer, 1 pulmonary embolism, and 3 severe allergic skin reactions without long-term sequelae occurred with CPD. Death occurred in 2 severely disabled patients with MS, 1 from influenza and 1 from encephalitis. Lymphopenia of at least grade 3 occurred in 7% of patients.

NeurologyLive spoke with Allen-Philbey to learn more about the advantages of treating patients with off-label CPD. She stressed the importance of treating patients early in their disease course in order to delay disability.

For more coverage of ACTRIMS Forum 2021, click here.

REFERENCE

Allen-Philbey K, De Trane S, Stennett A, et al. Cladribine personalised dosing to treat active multiple sclerosis - follow-up in 250 patients. Presented at ACTRIMS Annual Forum; February 25-27, 2021. Abstract P160.