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Abstract

Background:

Interventions targeting the adaptive immune response are needed in multiple sclerosis (MS).

Objective:

Evaluate laquinimod’s efficacy, safety, and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS).

Methods:

CONCERTO was a randomized, double-blind, placebo-controlled, phase-3 study. RRMS patients were randomized 1:1:1 to receive once-daily oral laquinimod 0.6 or 1.2 mg or placebo for ⩽24 months (n = 727, n = 732, and n = 740, respectively). Primary endpoint was time to 3-month confirmed disability progression (CDP). The laquinimod 1.2-mg dose arm was discontinued (1 January 2016) due to cardiovascular events at high doses. Safety was monitored throughout the study.

Results:

CONCERTO did not meet the primary endpoint of significant effect with laquinimod 0.6-mg versus placebo on 3-month CDP (hazard ratio: 0.94; 95% confidence interval: 0.67–1.31; p = 0.706). Secondary endpoint p values were nominal and non-inferential. Laquinimod 0.6 mg demonstrated 40% reduction in percent brain volume change from baseline to Month 15 versus placebo (p < 0.0001). The other secondary endpoint, time to first relapse, and annualized relapse rate (an exploratory endpoint) were numerically lower (both, p = 0.0001). No unexpected safety findings were reported with laquinimod 0.6 mg.

Conclusion:

Laquinimod 0.6 mg demonstrated only nominally significant effects on clinical relapses and magnetic resonance imaging (MRI) outcomes and was generally well tolerated.

Clinical trial registration number:

ClinicalTrials.gov (NCT01707992).

Keywords

Multiple sclerosis relapsing-remitting laquinimod disability progression

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CONCERTO: A randomized,placebo-controlled trial of oral laquinimod in relapsing-remitting multiple sclerosis

Abstract

Background:

Objective:

Methods:

Results:

Conclusion:

Clinical trial registration number:

Keywords

Get full access to this article

References

Supplementary Material