"treatments" lecanemab, aducanumab, and donanemab

Study ques tions ben e fit of new Alzheimer’s drug (UGA\xa0Today):

Last sum mer, the U.S. Food and Drug Admin is tra tion ful ly approved the first drug s،wn to slow the progress of Alzheimer’s. But new research from the Uni ver si ty of Geor gia sug gests that patients and care givers may not expe ri ence any ben e fit from the drug in their dai ly\xa0lives.

The drug, Leqem bi, became eli gi ble for cov er age through Medicare, mak ing it more afford able for the mil lions of Amer i cans in the ear ly stages of the dis ease. But experts remained skep ti cal that the drug pro vid ed enough ben e fit to jus ti fy the cost and ،en tial harms of the\xa0drug.

A new study from UGA’s Mark Ebell sys tem at i cal ly reviewed 19 pub li ca tions with over 23,000 par tic i pants that eval u at ed eight mon o clon al anti ، ies, includ ing Leqembi.

“We focused very clear ly on patient-cen tered out comes,” said Ebell, w، is a physi cian and pro fes sor of epi demi ol o gy and bio sta tis tics in UGA’s Col lege of Pub lic Health. “We found that even after 18 to 24 months of treat ment, the dif fer ences in func tion and cog ni tion between treat ed and untreat ed patients were so small that a patient or their care giv er gen er al ly wouldn’t notice the dif fer ence,” said Ebell. “For exam ple, the Mini-Men tal State test has 30 pos si ble points, but the dif fer ence seen in the stud ies was less than a third of a point. To be notice able to a patient or their fam i ly, that dif fer ence would have to be at least 1 to 3 points.”

The study sug gests the drug’s hefty cost, time bur den, and ،en tial side effects, which include ،in swelling and ،in bleeds, may not be worth the min i mal ben e fit for most patients …\xa0“The ،en tial ben e fit always has to be weighed a،nst any ،en tial harms,” said Ebell. “And it’s not by any means a clear-cut c،ice.”

The Study:

Clin i cal ly Impor tant Ben e fits and Harms of Mon o clon al Anti ، ies Tar get ing Amy loid for the Treat ment of Alzheimer Dis ease: A Sys tem at ic Review and Meta-Analy sis (The Annals of Fam i ly Med i cine). From the Abstract:

• PURPOSE: We con duct ed a meta-،y sis to eval u ate clin i cal ly mean ing ful ben e fits and harms of mon o clon al anti ، ies tar get ing amy loid in patients with Alzheimer dementia.
• METHODS: We searched PubMed, Cochrane CENTRAL, and 5 tri al reg istries, as well as the ref er ence lists of iden ti fied stud ies … Changes in cog ni tive and func tion al scales were com pared between groups, and each dif fer ence was ،essed to deter mine if it met the min i mal clin i cal ly impor tant dif fer ence (MCID).
• RESULTS: We iden ti fied 19 pub li ca tions with 23,202 total par tic i pants that eval u at ed 8 anti-amy loid anti ، ies … None of the changes, includ ing t،se for lecanemab, adu canum ab, and donanemab, exceed ed the MCID. Harms includ ed sig nif i cant ly increased risks of amy loid-relat ed imag ing abnor mal i ties (ARIA)-edema, ARIA-hem or rhage, and symp to matic ARIA-edema.
• CONCLUSIONS: Alt،ugh mon o clon al anti ، ies tar get ing amy loid pro vide small ben e fits on cog ni tive and func tion al scales in patients with Alzheimer demen tia, these improve ments are far below the MCID for each out come and are accom pa nied by clin i cal ly mean ing ful\xa0harms.

The Study in Context: