At the 2026 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held February 5-7, in San Diego, California, researchers recently presented a real-world comparative study of patients with multiple sclerosis (MS) treated with cladribine (Mavenclad; EMD Serono) over 4 years. Overall, use of this therapy led to significantly fewer treatment switches, reduced outpatient visits, and lower medical costs compared with other traditional treatments like fingolimod (Gilenya; Novartis), dimethyl fumarate (Tecfidera; Biogen), or teriflunomide (Aubagio; Sanofi).1
A total of 3038 patients with MS met the inclusion criteria for the analysis from a large US administrative claims database. Among these patients, 140 received cladribine tablets, 454 received fingolimod, 1465 received dimethyl fumarate, and 979 received teriflunomide. The study, presented by lead author Ajay S. Gupta, MD, assistant professor of neurology at Indiana University Medical School, showed that treatment switching occurred less frequently in those treated with cladribine tablets than patients who received comparator disease-modifying therapies (DMTs) over the 4-year follow-up period.
The proportion of patients who switched to another DMT was 11% in the cladribine tablet cohort, compared with 42% in the fingolimod cohort, 57% in the dimethyl fumarate cohort, and 42% in the teriflunomide cohort. Relative to cladribine tablets, the odds of switching treatments were significantly higher for all 3 comparator therapies. Results revealed that the odds ratio for switching was 7.05 for fingolimod (95% CI, 3.65-14.57), 11.27 for dimethyl fumarate (95% CI, 5.90-23.07), and 6.43 for teriflunomide (95% CI, 3.38-13.01), with all confidence intervals indicating statistically significant differences.
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In the analysis, investigators drew data from the Komodo Healthcare Map Database, covering the period from April 1, 2018, to March 31, 2024. Eligible patients had at least 2 MS claims recorded at least 30 days apart and at least 1 claim for cladribine tablets, fingolimod, dimethyl fumarate, or teriflunomide. The index date was defined as the first claim for the respective DMT.
Patients were also required to have continuous enrollment for 12 months before and 48 months after the index date. After applying propensity score weighting, baseline demographic and clinical characteristics were largely balanced across cohorts. In the weighted population, researchers noted that the mean age was 48 years, and approximately 74% to 77% of patients were women.
In terms of health care resource utilization, the analysis showed that all-cause outpatient visits were lower among patients treated with cladribine tablets compared with those receiving dimethyl fumarate or teriflunomide. However, outpatient visit rates for cladribine tablets were similar to those observed in the fingolimod cohort. No statistically significant differences were observed between cohorts with respect to emergency department visits or hospitalizations, suggesting comparable rates of more acute health care use across therapies.
Cost analyses showed lower all-cause medical costs per patient per year (PPPY) in the cladribine tablet cohort, which averaged $13,377. Compared with cladribine tablets, adjusted mean differences (AMD) in medical costs were higher for fingolimod (AMD, $10,073; 95% CI, $5,006-$15,148), dimethyl fumarate (AMD, $12,013; 95% CI, $7,490-$16,706), and teriflunomide (AMD, $9,917; 95% CI, $6,558-$13,997), with confidence intervals indicating statistically significant differences.
All-cause total costs PPPY were also lower for cladribine tablets, at $53,007, compared with fingolimod (AMD, $14,140; 95% CI, $7,181-$22,021) and teriflunomide (AMD, $6652; 95% CI, $567-$12,395). Total costs for cladribine tablets were similar to those observed in the dimethyl fumarate cohort (AMD, $4472; 95% CI, -$2011-$11,111), with the AMD not reaching statistical significance.
In another study presented at ACTRIMS Forum 2026, findings showed that cladribine, an FDA-approved disease-modifying therapy for relapsing MS, maintained its favorable risk-benefit profile in older patients aged 65 and up. Investigators concluded that data from this 24-month, observational, single-arm, real-world, phase 4 trial supported the therapeutic value of cladribine in older patients with RMS, regardless of age at treatment initiation..2
Of 115 patients included (mean age, 60.8 years) in the study, 84 (73.0%) were less than 65 years of age and 31 (27.0%) were older than that mark. After 24 months of treatment, annualized relapse rates, the primary end point, were low across all study groups, regardless of age. This included those above 50 (0.07; 95% CI, 0.03-0.12), 65 and younger (0.10; 95% CI, 0.03-0.16), and those above 65 (0.02; 95% CI, –0.02 to 0.05). In addition, regardless of age, the discontinuation treatment rate remained low as well (total study population: 7.8%; <65 y: 8.3%; ≥65 y: 6.5%).
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REFERENCES
1. Gupta A, MacEwan JP, Anderson J, et al. Comparative Assessment of Switching, Healthcare Resource Utilization, and Cost Outcomes for Cladribine Tablets Versus Other Oral Disease-Modifying Therapies Among US Patients with Multiple Sclerosis Over 4 Years. Presented at ACTRIMS Forum 2026; February 5-7; San Diego, California. P397.
2. Katz J, Hughes B, Gutierrez A, et al. P404. Real-World Effectiveness and Safety of Cladribine Tablets in Older Patients with Relapsing Multiple Sclerosis: Insights from the 'Aging' Study Subgroup Analysis. Presented at: 2026 ACTRIMS Forum; Feb 5-7; San Diego, CA. Abstract P404.