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Clinical Trial
. 2020 Feb;61(2):218-221.
doi: 10.1002/mus.26740. Epub 2019 Nov 11.

Long-term edaravone efficacy in amyotrophic lateral sclerosis: Post-hoc analyses of Study 19 (MCI186-19)

Jeremy Shefner  1 , Terry Heiman-Patterson  2 , Erik P Pioro  3 , Martina Wiedau-Pazos  4 , Shawn Liu  5 , Jeffrey Zhang  6 , Wendy Agnese  7 , Stephen Apple  8
Affiliations
Clinical Trial

Long-term edaravone efficacy in amyotrophic lateral sclerosis: Post-hoc analyses of Study 19 (MCI186-19)

Jeremy Shefner et al. Muscle Nerve. 2020 Feb.

Abstract

Background: In a Phase 3 study, amyotrophic lateral sclerosis (ALS) patients experienced significantly less physical functional decline with 24-week edaravone vs placebo, followed by open-label treatment for an additional 24 weeks.

Methods: Outcome (the change in ALS Functional Rating Scale-Revised, ALSFRS-R, from baseline) was projected for placebo patients through 48 weeks and compared with 48-week edaravone or 24-week edaravone after switching from placebo.

Results: A total of 123 patients received open-label treatment (65 edaravone-edaravone; 58 placebo-edaravone). The projected ALSFRS-R decline for placebo from baseline through week 48 was greater than for 48-week edaravone (P < .0001). For patients switching from placebo to edaravone, ALSFRS-R slope approached that of continued edaravone for 48 weeks. ALSFRS-R decline did not differ between actual and projected edaravone through week 48.

Conclusions: Compared with placebo, these analyses suggest that edaravone is beneficial in ALS patients even after 6 mo of receiving placebo, and efficacy is maintained for up to 1 year.

Keywords: ALSFRS-R; chronic; disease progression; functional decline; linear regression; oxidative stress.

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Conflict of interest statement

J.S., T.H.P., E.P.P., and M.W.P. are consultants for MTPA. S.A. is an employee of MTPA. W.A. is a former employee of MTPA. S.L. is an employee of MTDA. J.Z. is under contract with MTPA.

Figures

Figure 1
Figure 1
Changes in ALSFRS‐R scores from baseline to week 48. Mean change in ALSFRS‐R scores from baseline to week 48 for measured values from actual treatment as well as projected estimates [Color figure can be viewed at http://wileyonlinelibrary.com]
Figure 2
Figure 2
Change in ALSFRS‐R scores for actual treatment and projected estimates from baseline through week 48. Changes in ALSFRS‐R scores are shown for patients who received edaravone or placebo through week 24 and their estimated projection through week 48. Also shown are the changes in ALSFRS‐R score for patients who either continued on edaravone or switched from placebo to edaravone at the end of week 24 through week 48. The number of patients in each study arm at each time point is listed at the bottom of the graph. Linear regression equations are in ALSFRS‐R units/month [Color figure can be viewed at http://wileyonlinelibrary.com]
See this image and copyright information in PMC

Comment in

References

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