The results of the phase III clinical study were presented as late-breaking presentation at the 63rd AAN meeting, in Honolulu. The study involved 1,106 people with RRMS. Study participants received either a once-daily oral dose of 0.6 mg of laquinimod or placebo for two years. 80% taking laquinimod and 77% taking the placebo finished the two-year study.
1. Laquinimod reduced the annual relapse rate by 23%
2. Laquinimod reduced disability progression by 36%
3. Laquinimod’s effect on MRI – 37% reduction Gd-enhancing lesions, 30% reduction in new T2 lesions, 27% reduction in new T1 lesions and a 32% reduction in brain atrophy.
4. Laquinimod was safe and well tolerated; the frequencies of adverse events were low and comparable to those observed in the placebo group.
5. Liver enzyme elevations were higher in laquinimod treated patients; these elevations were temporary, reversible and did not lead to any signs of long-term liver problems.
“It is hard to imagine Laquinimod as a first choice oral monotherapy in RRMS based on these results. Laquinimod appears to have a disproportionate effect on brain atrophy given its very modest impact on relapse rate; this could be a chance finding and will need to be confirmed in the second phase 3 study, or Laquinimod could be “neuroprotective”. Unfortunately, without data on the impact of Laquinimod on cognitive impairment in MS it is impossible to relate the effects of Laquinimod on brain atrophy to a clinical meaningful outcome. The study also had a high-drop out rate of 20% in the actively treated arm; we need to know why. Could it be because of lack of efficacy or poor tolerability? On balance, disappointing results.”
COI: Barts and The London participated in this study and I was the PI.