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Meeting Coverage: Lemtrada (alemtuzumab) Has NNT Edge Over New MS Drug


Battle begins over which agent is better

Alemtuzumab may have an advantage over ocrelizumab (Ocrevus) when it comes to the number of relapsing-remitting MS patients who need to be treated (NNT) to prevent adverse disease events, researchers supported by alemtuzumab drugmaker Sanofi reported here.

In a post-hoc analysis of data from the phase III clinical trials programs of both drugs, alemtuzumab beat ocrelizumab on NNTs for preventing relapses and confirmed disability worsening, Aaron Boster, MD, of OhioHealth in Columbus, Ohio, reported at the Consortium of Multiple Sclerosis Centers meeting here.

The NNT can be calculated in this case because both drugs used interferon beta-1a (Rebif) as an active comparator, Boster told MedPage Today.

"What we learned is that both therapies are more effective than Rebif. We also learned that to achieve a decrease in annualized relapse rate or 6-month confirmed disability progression over Rebif, fewer patients need to be treated with alemtuzumab compared to ocrelizumab," he said. "I find this information to be valuable because it helps inform a better understanding of these newer, highly effective agents."

Both alemtuzumab and ocrelizumab have shown superior efficacy outcomes over subcutaneous interferon beta-1a in relapsing MS in randomized controlled trials over 2 years; alemtuzumab in the CARE-MS I and CARE-MS II trials, in which patients were followed for 6 years plus 4 years in an extension study, and ocrelizumab in the OPERA I & II trials.

Boster noted that alemtuzumab's somewhat more potent effects are due to its selective depletion and repopulation of circulating CD52-expressing T and B lymphocytes. Following depletion, there's a distinct pattern of T and B cell repopulation that begins within weeks and includes a relative increase in regulatory T cells and a decrease in proinflammatory cytokines, which "rebalances" the immune system, Boster said. Ocrelizumab, on the other hand, targets CD20-expressing B cells.

For their post-hoc study, Boster and colleagues assessed data on 786 patients from CAMMS223/CARE-MS I; 628 patients from CARE-MS II; 821 patients from OPERA I; and 835 patients from OPERA II. They calculated the NNT to prevent one relapse, to prevent one patient from experiencing relapse, and to prevent confirmed disability worsening.

Overall, they found that the alemtuzumab trials offered a lower NNT in all three outcomes compared with ocrelizumab.

The NNT to prevent one relapse with alemtuzumab versus interferon was 5 patients in CAMMS223/CARE-MS I and 4 patients in CARE-MS II; that was lower than an NNT of 8 patients with ocrelizumab versus interferon in both of the OPERA trials.

The NNT was also lower for preventing one patient from experiencing relapse with alemtuzumab: 6 patients in both alemtuzumab trials compared with 8 patients in the OPERA trials.

Finally, the NNT was once again lower for alemtuzumab in terms of confirmed disability worsening, with 15 patients in CAMMS223/CARE-MS I and 13 patients in CARE-MS II compared with 23 patients for OPERA I and 21 patients for OPERA II, Boster reported.

He noted that the study was limited because annualized relapse rates with interferon were higher in the alemtuzumab groups than in the ocrelizumab trials, which may affect the NNT calculations. Also, differences in the trials used in this post-hoc analysis are an uncontrolled confounder -- thus, Boster concluded that further real-world data would be important to confirm these findings.

Story Source: The above story is based on materials provided by MEDPAGETODAY
Note: Materials may be edited for content and length

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