Ambulation benefit with laquinimod in patients with worsening MS (EDSS over 3) is consistent with reduction in confirmed disability progression
ECTRIMS Online Library. Vollmer T. Oct 11, 2014; 63775
Prof. Timothy Vollmer
Prof. Timothy Vollmer
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Background: In pooled data from the Phase III ALLEGRO and BRAVO studies of oral laquinimod (LAQ) 0.6mg once-daily (QD) vs. placebo (PBO) in RRMS, a 46% reduction in 6-month confirmed disability progression (CDP) (Vollmer, ECTRIMS 2011) was not accompanied by a significant treatment (Tx) effect on the Multiple Sclerosis Functional Composite (MSFC). However, for a subgroup of LAQ-treated patients (pts) with worsening MS (EDSS >3 at baseline [BL]), a 53% reduction in 6-month CDP was accompanied by a significant MSFC effect vs. PBO.
Objectives: To investigate LAQ 0.6mg QD Tx effects on individual MSFC components in the pooled ALLEGRO and BRAVO pt subgroup with BL EDSS score >3, and to determine the association between MSFC component scores and improvements in CDP.
Methods: Pooled data from ALLEGRO and BRAVO (N=1990) were used for this post hoc analysis of LAQ vs. PBO Tx effects on change in MSFC subscores at 24 months for the Paced Auditory Serial Addition Test (PASAT), 9-Hole Peg Test (9HPT), and Timed 25-Foot Walk (T25FW), in pts with EDSS >3 at BL. Adjusted mean z-score differences and 95%CIs were evaluated by ANCOVA. CDP was defined as an increase of 1 point if BL EDSS was ?5.0, or of >0.5 point if BL EDSS was 5.5.
Results: Overall, 655 pts (33%) had a BL EDSS score >3 (LAQ n=328, PBO n=327), with a mean (SD) BL EDSS score of 4.1 (0.7). At BL, pts in the EDSS >3 subgroup were older than pts with BL EDSS ?3 (mean age 41 vs. 37 years, respectively), had longer disease duration (5.2 vs. 3.7 years), and less brain volume (1547 vs. 1601 cm3). Mean (SD) T25FW time at BL was 8.29 (6.8) seconds (5.40 [5.3] seconds in the EDSS ?3 subgroup). A 59% LAQ Tx effect on mean [SE] T25FW time (-2.79 [0.96] seconds, 95%CI -4.66, -0.92; p=.0035) appeared to drive the overall MSFC benefit in the EDSS >3 subgroup. There was no significant difference between LAQ and PBO for change in PASAT or 9HPT z-scores, though change directions favored LAQ. Further, an interaction between LAQ Tx effect on T25FW and CDP was found: pts on PBO in the EDSS >3 subgroup who also showed CDP declined by 8.6 seconds more than equivalent LAQ-treated pts.
Conclusions: In pts with worsening MS and EDSS >3 at BL, LAQ was associated with a substantial benefit on ambulatory function as measured by the T25FW, consistent with LAQ CDP benefit in these pts.
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