Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2025 Feb;53(2):3000605241311437.
doi: 10.1177/03000605241311437.

Efficacy and safety of laquinimod versus placebo in relapsing-remitting multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials

Malik Waleed Zeb Khan  1 , Aizaz Ali  2 , Amna Hussain  3 , Safeena Khan  2 , Ammara Tahir  3 , Muhammad Haris Khan  4 , Touba Azeem  2 , Abdul Moeez  2 , Arysha Monis  5 , Aban Masaud Mian  2 , Fazia Khattak  2 , Moosa Ali  6 , Jibran Ikram  7
Affiliations
Meta-Analysis

Efficacy and safety of laquinimod versus placebo in relapsing-remitting multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials

Malik Waleed Zeb Khan et al. J Int Med Res. 2025 Feb.

Abstract

Objective: To investigate the safety and efficacy of laquinimod in treating relapsing-remitting multiple sclerosis (RRMS).

Methods: An extensive electronic search was conducted across PubMed, Embase, Cochrane Database of Systematic Reviews, and ClinicalTrials.gov to identify suitable studies. Risk of bias was assessed using Cochrane's Risk of Bias tool. Statistical analysis was performed using RevMan 5.4.1.

Results: The meta-analysis of four randomized controlled trials including 3665 patients found that laquinimod significantly reduced the annualized relapse rate compared with placebo (mean difference = -0.08, 95% confidence interval [CI] = -0.12, -0.04, I2 = 0%). For disability progression confirmed at 3 months, laquinimod provided a significant advantage over placebo (hazard ratio [HR] = 0.75, 95% CI = 0.59, 0.96, I2 = 25%), whereas no benefit was achieved at 6 months (HR = 0.69, 95% CI = 0.45, 1.06, I2 = 66%). Laquinimod was also significantly better than placebo in maintaining a relapse-free status (risk ratio [RR] = 1.14 95% CI = 1.06, 1.22, I2 = 10%). Laquinimod had a comparable safety profile as placebo (RR = 1.06, 95% CI = 0.81, 1.39, I2 = 33%).

Conclusions: These findings support the efficacy of laquinimod in managing RRMS but necessitate careful monitoring during treatment.

Keywords: Multiple sclerosis; adverse event; disability; disease-modifying therapy; laquinimod; meta-analysis; randomized controlled trial; relapsing-remitting; secondary progressive multiple sclerosis.

PubMed Disclaimer

Conflict of interest statement

Declaration of conflicting interestThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram.
Figure 2.
Figure 2.
Traffic light plot for the risk of bias assessment.
Figure 3.
Figure 3.
Forest plot of the annualized relapse rate. CI, confidence interval; SE, standard error.
Figure 4.
Figure 4.
Forest plot of disability progression confirmed at 3 months. CI, confidence interval; SE, standard error.
Figure 5.
Figure 5.
Forest plot of disability progression confirmed at 6 months. CI, confidence interval; SE, standard error.
Figure 6.
Figure 6.
Forest plot of relapse-free survival. CI, confidence interval; SE, standard error.
Figure 7.
Figure 7.
Forest plot of disease progression at 6 months after excluding the CONCERTO trial. CI, confidence interval; SE, standard error.
Figure 8.
Figure 8.
Forest plot of serious adverse events. CI, confidence interval; SE, standard error.
Figure 9.
Figure 9.
Forest plot of mortality. CI, confidence interval; SE, standard error.
Figure 10.
Figure 10.
Forest plot of alanine aminotransferase elevation. CI, confidence interval; SE, standard error.
Figure 11.
Figure 11.
Forest plot of arthralgia. CI, confidence interval; SE, standard error.
See this image and copyright information in PMC

References

    1. Marcus R. What Is Multiple Sclerosis? Jama 2022; 328: 2078. DOI: 10.1001/jama.2022.14236. - PubMed
    1. Ghasemi N, Razavi S, Nikzad E. Multiple Sclerosis: Pathogenesis, Symptoms, Diagnoses and Cell-Based Therapy. Cell J 2017; 19: 1–10. 20161221. DOI: 10.22074/cellj.2016.4867. - PMC - PubMed
    1. The Multiple Sclerosis International Federation Atlas of MS, 3rd ed, September, 2020, https://www.atlasofms.org.
    1. Walton C, King R, Rechtman L, et al.. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler 2020; 26: 1816–1821. 20201111. DOI: 10.1177/1352458520970841. - DOI - PMC - PubMed
    1. Rae-Grant A, Day GS, Marrie RA, et al.. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology 2018; 90: 777–788. DOI: 10.1212/wnl.0000000000005347. - PubMed

MeSH terms

LinkOut - more resources