- Reasons for and against offering aducanumab and lecanemab to Saudi patients at this stage.
| For | Against |
|---|---|
| Statistically significant cognitive and behavioral benefits were demonstrated in the EMERGE clinical trial | The clinical significance of benefits demonstrated in the EMERGE trial is questionable |
| Subgroup analysis of data collected from thr ENGAGE clinical trial showed cognitive benefits of a sufficient duration exposure to 10 mg/kg of aducanumab | No statistically significant cognitive and behavioral benefits demonstrated in the ENGAGE trial |
| Clarity-AD trial demonstrates benefit in AD patients | Lecanemab is only supported with one trial with other trial results pending |
| Effective, dose-dependent clearance of cerebral amyloid as determined by amyloid PET scance | Clearance of cerebral amyloid has not been confirmed as a biomarker that correlated with clinical efficacy |
| There is a huge unmet need to develop disease-modifying therapies for patients with AD and decrease the family and socioeconomic burdens of the disease | There is a risk of doing harm and even increasing the risk of mortality associated with some forms of ARIA. Careful monitoring of AD patients throughout treatment is essential to detect early signs of ARIA |
| Approving AD immunotherapies takes a long time; these are the first new for AD in nearly 2 decades | Approval of new, potentially better, immunotherapies may be impending, eligibility for which may be complicated if patients were already treated with aducanumab |
| Lack of representation of patients with different genetic and ethnic backgrounds in clinical trials | |
| Saudi-specific gaps in the patient care journey, including lack of streamlined clinical care pathways, definitively validated neuropsychological and behavioral assessment tools, availability of CSF and PET scan biomarkers |