159. Cladribine Tablets Use in People with Multiple Sclerosis Up to 4 Years and Beyond Following Treatment Initiation: Results from Multi-country Patient Support Programmes

• Published in: Multiple sclerosis and related disorders 2024-12, Vol.92
• Main Authors: Oh, Jiwon, Ayer, Mavis, Alroughani, Raed, Ahmed, Samar Farouk, Khoury, Mounir, De Souza, Sabrina, Bossolasco, Michela, Morgan, Kate, Deramo, Mariana, Negrotto, Laura, Quinn, Tracey, Luca, Mariken, Boshra, Amir, Youssef, Joseph, Al-Naqshbandi, Murad, Sabido-Espin, Meritxell, Silva, Berenice
• Format: Article
• Language: English
• ISSN: 2211-0348
• DOI: 10.1016/j.msard.2024.106120

The nurse-/pharmacy-led patient support programmes (PSPs) adveva® (worldwide) and MS LifeLines® (US) collect clinical information on people with multiple sclerosis (PwMS) receiving cladribine tablets (CladT; 3.5 mg/kg cumulative dose over 2 years followed by a 2-year treatment-free period per product label). Data extracted from these PSPs can provide information on completion of CladT treatment and the timing of additional treatment initiation. Data were extracted from the PSPs between 05 Dec 2017–01 Dec 2023. PwMS were followed from treatment initiation until the cut-off date, loss to follow-up, or treatment discontinuation. Prior use of disease-modifying therapy (DMT), initiation and completion of the full 2-year course of CladT, and time to initiation of Year 2 of treatment (among PwMS with ≥18 months’ follow-up since treatment initiation) are reported. Individuals with ≥4 years’ follow-up since treatment initiation who received additional CladT treatment were also captured. Overall, 22,070 PwMS (female [range]: 70.7%–81.3%) initiated CladT during the specific period (Aus, n=797; Canada, n=3665; Gulf, n=258; LatAm, n=1854; Near East, n=75; NL, n=681; UK, n=2320; US, n=12,418). Most PwMS had ≥1 prior DMT (Aus, no contribution [NC] to analysis; Canada, 100%; Gulf, 52.7%; LatAm, 57.7%; Near East, 86.7%; NL, 81.4%; UK, 30.0%; US, 79.5%) most common being oral DMTs (range 36.5%–69.3%). In PwMS with ≥18 months’ follow-up, ≥82.8% initiated Year 2 of treatment with a mean time (± standard deviation) to initiation of 12.4 (3.8) to 13.9 (3.5) months. Completion of Year 2 of CladT was observed in ≥93.6% (Aus, NC). Overall, in PwMS with ≥4 years’ follow-up, additional CladT treatment was observed as follows: Canada, n=159/1294 (12.3%); LatAm, n=14/116 (12.1%); NL, n=15/133 (11.3%); UK, n=36/766 (4.7%). Of these, the additional treatment was administered ≥4 years from treatment initiation as follows: Canada, n=72; LatAm, n=5; NL, n=5; UK, n=14. Data from global PSPs demonstrate that the majority of PwMS completed the full 2-year course of CladT. Among those with ≥4 years’ follow-up from treatment initiation, only a small proportion received additional CladT treatment.