160. Low Rate of Progression Independent of Relapse Activity (PIRA) in Patients with Relapsing Multiple Sclerosis Treated with Cladribine Tablets
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Authors
De Stefano N.
Wiendl H.
Barkhof F.
Achiron A.
Derfuss T.
Chan A.
Hodgkinson S.
Prat A.
Leocani L.
Schmierer K.
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Issue Date
2024
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Conference Proceedings
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Background/Objective(s): People with multiple sclerosis (PwMS) accrue disability through both relapse-associated worsening (RAW) or progression independent of relapse activity (PIRA). The effect of cladribine tablets (CladT) on PIRA has not been previously assessed. We investigated confirmed disability accumulation (CDA), including RAW and PIRA, in the 2-year MAGNIFY-MS study (NCT03364036). Material(s) and Method(s): All analyses were exploratory, performed for the total population, or by subgroups: Tx-naive vs Tx-exp. Six-month confirmed PIRA (no relapse occurring within 90 days of the event) was estimated using two definitions: PIRA based on Expanded Disability Status Scale progression (6-month confirmed disability progression; 6mCDP); or composite (c)PIRA, defined as the presence of 6mCDP, or 20% progression on either timed 25-foot walk (T25FW) or 9-hole peg test. Time-to-first cPIRA event was estimated using the Kaplan-Meier (K-M) method. cRAW was defined as any event within 90 days of relapse. cCDA included any cRAW or cPIRA event. Result(s): Analyses included 270 PwMS: 43.3% Tx-naive, 66.7% female, and 56.3% aged =2 relapses within 12m prior to BL (Tx-exp, 42.5%); 49.6% had >=1 T1 Gd+ lesions (Tx-exp, 51.0%) and 23.1% had >=1 new T2 lesions (Tx-exp, 26.8%) during the BL period. At 24m, rates for all disability measures were low: CDA was 7.8% (6.3% PIRA, 1.5% RAW). Rate of cCDA was 16.3% (14.1% cPIRA, 2.6% cRAW). Tx-naive PwMS had lower rates vs Tx-exp PwMS: PIRA, 3.4% vs 8.5%; RAW, 0.9% vs 2.0%; CDA, 4.3% vs 10.5%; cPIRA, 10.3% vs 17.0%; cRAW, 0.9% vs 3.9%; cCDA, 10.3% vs 20.9%, respectively. In Tx-naive PwMS, all 3 cPIRA components contributed equally to cPIRA rate, while in Tx-exp PwMS, 6mCDP and T25FW were major contributors. At 24m, the K-M estimated probability to be free of cPIRA was 85.0% overall (Tx-naive 89.0%; Tx-exp PwMS 81.9%). The probability to be free of cCDA was 89.0% for Tx-naive and 77.9% for Tx-exp PwMS. No new safety signals were observed. Conclusion(s): These results indicate low overall disability accrual in highly active CladT-treated PwMS. Tx-naive PwMS had consistently lower PIRA, RAW, and CDA, supporting the benefit of early initiation of CladT on slowing overall disability accumulation.
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Multiple Sclerosis and Related Disorders