Modified Delphi consensus on the use of cladribine tablets in relapsing-remitting multiple sclerosis in North-West...

Cladribine tablets are an oral immune reconstitution therapy with demonstrated efficacy and durable disease control in relapsing-remitting multiple sclerosis (RRMS). While global evidence supports their use, region-specific guidance adapted to healthcare variability, access constraints, and real-world practice in North-West Africa (NWA) remains limited.

To develop expert-based, region-specific consensus recommendations on the optimal use of cladribine tablets in RRMS in the NWA region.

A modified Delphi methodology was conducted during a face-to-face advisory board meeting in May 2025 in Tunisia. Senior neurologists with expertise in multiple sclerosis from across NWA reviewed available evidence, discussed key clinical questions, and voted on consensus statements addressing treatment positioning, early use, switching strategies, long-term management, safety, and special populations. Consensus was predefined as agreement by ≥75% of voting experts.

All consensus statements met the predefined threshold after discussion and refinement, achieving high to unanimous agreement. Experts endorsed cladribine tablets as a high-efficacy option for treatment-naïve patients with moderate-to-high disease activity and as a switch option following suboptimal response to platform therapies and in selected patients previously treated with high-efficacy therapies. Benefits include early initiation, durable disease control without continuous immunosuppression, and suitability for patients with limited access to hospital-based care. Expert consensus recommendations also addressed long-term management beyond Year 4, retreatment strategies, safety monitoring, pregnancy planning, and use in older patients, recognizing that some areas are supported mainly by emerging real-world evidence and expert clinical experience.

This Delphi consensus provides practical, region-specific guidance to optimize the use of cladribine tablets in RRMS across NWA, aiming to harmonize treatment practices and improve long-term outcomes.