Substantial and comparable suppression of disease activity following early initiation of cladribine tablets, ocrelizumab or alemtuzumab as first pharmacologic treatment for relapsing multiple sclerosis: A real world study

• Published in: Clinical neurology and neurosurgery 2024-05, Vol.240, p.108249-108249, Article 108249
• Main Authors: Alroughani, Raed, Al-Hashel, Jasem, Ahmed, Samar Farouk
• Format: Article
• Language: English
• Subjects: Adult; Alemtuzumab; Alemtuzumab - administration & dosage; Alemtuzumab - therapeutic use; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - therapeutic use; Cladribine; Cladribine - administration & dosage; Cladribine - therapeutic use; Cladribine tablets; Cross-Sectional Studies; Disease-modifying therapy; Female; Gadolinium; Humans; Immunologic Factors - administration & dosage; Immunologic Factors - therapeutic use; Immunosuppressive Agents - administration & dosage; Immunosuppressive Agents - therapeutic use; Magnetic resonance imaging; Male; Middle Aged; Monoclonal antibodies; Multiple sclerosis; Multiple Sclerosis, Relapsing-Remitting - diagnostic imaging; Multiple Sclerosis, Relapsing-Remitting - drug therapy; Ocrelizumab; Patients; Retrospective Studies; Tablets; Treatment Outcome
• ISSN: 0303-8467; 1872-6968
• DOI: 10.1016/j.clineuro.2024.108249

We describe the efficacy and safety of recent high efficacy disease DMTs in DMT-naive patients with highly active RMS. This was a retrospective, cross sectional study from the Kuwait national MS registry. Patients with RMS who received alemtuzumab, cladribine tablets or ocrelizumab as their first DMT for RMS, with ≥2 year of follow up were included. The primary endpoint was the change in relapse rate from treatment initiation to 1 year; changes in disability (Expanded Disability Status Scale [EDSS]), radiologic activity, the proportion with no evidence of disease activity-3 (NEDA-3), and the frequency of adverse events were secondary endpoints. Among 123 RRMS patients, 59 received ocrelizumab, 32 received cladribine tablets and 32 received alemtuzumab. About two-thirds (65%) were women. Substantial and similar (p>0.05) reductions occurred at the end of follow-up in annual relapse rate (by 93.2% for ocrelizumab, 87.5% for cladribine tablets, and 90.6% for alemtuzumab). The proportion with new T2 of gadolinium-enhancing MRI lesions across the three groups was reduced from 85–100% to 7–13%. Rates of confirmed disability progression were low (ocrelizumab 6.9%, cladribine tablets 3.1%, alemtuzumab 0%; p=0.280); disability was reduced in 15%, 22% and 38%, respectively. NEDA-3 was observed in 89.8%, 87.5%, and 84.4, respectively (p=0.784). No new or unexpected safety issues occurred. Ocrelizumab, cladribine tablets and alemtuzumab reduced relapse rates and MRI activity, and prevented disease progression, when are initiated early in DMT-naive RMS patients. These data support the early use of high-efficacy DMTs for people with highly active RMS. •Few data are available on the efficacy and safety of highly active disease modifying therapies (DMTs) given early in the course of relapsing MS (RMS).•This real world study compared the effects of cladribine tablets, ocrelizumab and alemtuzumab in 123 DMT-naive people with highly active RRMS.•Annual relapse rates were reduced markedly and similarly (by 88-93%) and rates of disability progression were low (0-7%) across the three treatment groups with no statistically significant difference between them.•No new or unexpected safety issues occurred.•These findings support the early use of high-efficacy DMTs for people with highly active RMS.