Multiple sclerosis and related disorders · 2026
Long-term Real-world Safety and Efficacy of Cladribine Tablets in Patients with Relapsing-Remitting Multiple Sclerosis: The UAE Experience.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Yamout Bassem, Shatila Ahmad, Inshasi Jihad, Hassan Ali, Szolics Miklos, Hassan Ahmed, Farw Ahmed, Beriam Basma, Ismail Ghida, Zeineddine Maya
Аннотация
BACKGROUND: Although oral cladribine received approval for treating relapsing-remitting multiple sclerosis (RRMS), real-world evidence regarding its long-term effectiveness and safety in the United Arab Emirates (UAE) remains limited.
OBJECTIVE: To evaluate efficacy and safety outcomes of RRMS patients treated with cladribine tablets (CladT) and identify early predictors of response.
METHODS: This is a multicenter, observational, retrospective study of RRMS patients treated with CladT from four tertiary MS centers in the UAE. Relapses, disability worsening, occurrence of new or enlarging T2-hyperintense magnetic resonance imaging (MRI) lesions and the proportion of patients achieving no-evidence-of-disease-activity-3 (NEDA-3) status were assessed. Safety outcomes included lymphocyte counts, infections and malignancy. The association between baseline characteristics and outcomes was tested to identify potential predictors of response.
RESULTS: A total of 163 MS patients were included, 120 (73.6%) of whom were females. Patients were treated with CladT, with a median (IQR) follow-up of 2.0 (1.0-2.6) years. A total of 121 (74.2%) patients had received another disease-modifying therapy (DMT) before cladribine. By the end of follow-up, the mean annualized relapse rate decreased by 84.4% (p<0.001). Most patients (91.8%) showed no disability progression, 74.1% had no new MRI activity, and 70.5% achieved NEDA-3. The number of relapses prior to CladT was the only predictor of NEDA-3. Safety outcomes included 7 adverse events (2.5%), with no hospitalizations. One patient developed a malignancy (astrocytoma) 1.2 years after treatment initiation.
CONCLUSION: Our study results confirm the safety and efficacy profiles of CladT reported in Phase 3 clinical trials and other real-world studies.
OBJECTIVE: To evaluate efficacy and safety outcomes of RRMS patients treated with cladribine tablets (CladT) and identify early predictors of response.
METHODS: This is a multicenter, observational, retrospective study of RRMS patients treated with CladT from four tertiary MS centers in the UAE. Relapses, disability worsening, occurrence of new or enlarging T2-hyperintense magnetic resonance imaging (MRI) lesions and the proportion of patients achieving no-evidence-of-disease-activity-3 (NEDA-3) status were assessed. Safety outcomes included lymphocyte counts, infections and malignancy. The association between baseline characteristics and outcomes was tested to identify potential predictors of response.
RESULTS: A total of 163 MS patients were included, 120 (73.6%) of whom were females. Patients were treated with CladT, with a median (IQR) follow-up of 2.0 (1.0-2.6) years. A total of 121 (74.2%) patients had received another disease-modifying therapy (DMT) before cladribine. By the end of follow-up, the mean annualized relapse rate decreased by 84.4% (p<0.001). Most patients (91.8%) showed no disability progression, 74.1% had no new MRI activity, and 70.5% achieved NEDA-3. The number of relapses prior to CladT was the only predictor of NEDA-3. Safety outcomes included 7 adverse events (2.5%), with no hospitalizations. One patient developed a malignancy (astrocytoma) 1.2 years after treatment initiation.
CONCLUSION: Our study results confirm the safety and efficacy profiles of CladT reported in Phase 3 clinical trials and other real-world studies.