Contributions
Abstract: P1668
Type: LB Poster
Abstract Category: Late Breaking News
Background: Over the past two decades, there has been an exponential increase in approved MS (multiple sclerosis) disease modifying drugs (DMDs), requiring neurologists and patients to make comparative decisions without sufficient head-t0-head trials. Recently, there has been an interest in using the inverse of absolute risk reduction (number needed to treat or NNT) rather than simply relative risk reduction. Simultaneously, there has been interest not only in reducing disability accrual but in disability improvement. There have not been prior NNT analyses of confirmed disability improvement (CDI).
Objectives: To perform a NNT analysis of confirmed disability improvement of monoclonal antibody clinical trials in MS.
Methods: NNT of CDI is the inverse of absolute risk difference of confirmed disability improvement (≥1-point reduction in EDSS or Expanded Disability Status Scale score among patients with baseline EDSS ≥2) . Data on CDI was obtained from the reported pivotal clinical trials of Alemtuzumab, Daclizumab, Natalizumab and Ocreluzumab.
Results: The NNT for one patient to have improvement of disability for Alemtuzumab (over 24 weeks compared to interferon-beta-1a or INF) is 7 (6.29);for Natalizumab (over 12 weeks as compared to placebo) is 10 (9.17);for Ocrelizumab (over 12 weeks as compared to INF) is 20 (19.6) and for Ocelizumab (over 24 weeks as compared to INF) is 25. Daclizumab did not reach statistical significance in CDI.
Conclusions: There is an increasing need to develop novel mechanisms to compare the efficacy of MS DMDs across clinical trials. NNT is an emerging method to reduce inter-trial differences of MS DMDs.
Disclosure: Dr. Kantor has received research support or honoraria from Abbvie, Biogen, Genentech and Sanofi Genzyme.
Abstract: P1668
Type: LB Poster
Abstract Category: Late Breaking News
Background: Over the past two decades, there has been an exponential increase in approved MS (multiple sclerosis) disease modifying drugs (DMDs), requiring neurologists and patients to make comparative decisions without sufficient head-t0-head trials. Recently, there has been an interest in using the inverse of absolute risk reduction (number needed to treat or NNT) rather than simply relative risk reduction. Simultaneously, there has been interest not only in reducing disability accrual but in disability improvement. There have not been prior NNT analyses of confirmed disability improvement (CDI).
Objectives: To perform a NNT analysis of confirmed disability improvement of monoclonal antibody clinical trials in MS.
Methods: NNT of CDI is the inverse of absolute risk difference of confirmed disability improvement (≥1-point reduction in EDSS or Expanded Disability Status Scale score among patients with baseline EDSS ≥2) . Data on CDI was obtained from the reported pivotal clinical trials of Alemtuzumab, Daclizumab, Natalizumab and Ocreluzumab.
Results: The NNT for one patient to have improvement of disability for Alemtuzumab (over 24 weeks compared to interferon-beta-1a or INF) is 7 (6.29);for Natalizumab (over 12 weeks as compared to placebo) is 10 (9.17);for Ocrelizumab (over 12 weeks as compared to INF) is 20 (19.6) and for Ocelizumab (over 24 weeks as compared to INF) is 25. Daclizumab did not reach statistical significance in CDI.
Conclusions: There is an increasing need to develop novel mechanisms to compare the efficacy of MS DMDs across clinical trials. NNT is an emerging method to reduce inter-trial differences of MS DMDs.
Disclosure: Dr. Kantor has received research support or honoraria from Abbvie, Biogen, Genentech and Sanofi Genzyme.