Chariot MS Study of Off-Label Cladribine in Advanced MS: Kimberly Allen-Philbey

“This work has been the foundation for the Chariot MS trial. Chariot MS will look at the use of cladribine tablets in a controlled setting. So, work thus far is uncontrolled, [in] an uncontrolled cohort of patients. But Chariot MS will be a multicenter, placebo-controlled trial of cladribine tablets and patients with advanced MS.”

Subcutaneous cladribine personalized dosing (CPD) is well-tolerated in patients with relapsing multiple sclerosis (RMS), with efficacy in line with oral cladribine (Mavenclad; EMD Serono) trial data, according to data from a recent study. These findings were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2021, February 25-27, by first author Kimberley Allen-Philbey, PhD candidate, Barts MS Center, London.

Allen-Philbey 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. 

EDSS remained stable or improved in 99 (82%) patients with MS with baseline and 2-year follow-up data. Of the 23 patients with MS that had elevated baseline cerebrospinal fluid neurofilament light (median, 652 pg/mL; interquartile range [IQR], 458-1063), 22 had normal levels at follow-up (median, 344 pg/mL; IQR, 186-505).

NeurologyLive spoke with Allen-Philbey to learn more about the Chariot MS study her team has planned. She also discussed further research she would like to conduct with off-label cladribine.

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.