024  CLARITY study: efficacy outcomes among patients receiving disease-modifying therapies prior to treatment with cladribine tablets. Issue 6 (27th May 2022)

• Record Type: Journal Article
• Authors: Vermersch, Patrick; Rammohan, Kottil; Damian, Doris; Jack, Dominic; Harty, Gerard; Wong, Schiffon
• Is Part Of: Journal of neurology, neurosurgery and psychiatry. Volume 93:Issue 6(2022)
• Page Start: A21
• Page End: A21
• Publication Date: 2022-05-27
• Subjects: Neurology -- Periodicals; Nervous system -- Surgery -- Periodicals; Psychiatry -- Periodicals; 616.8
• DOI: 10.1136/jnnp-2022-ABN.63
• Languages: English
• ISSNs: 0022-3050

Abstract

Abstract : Background: Cladribine tablets 10mg (cumulative dose 3.5mg/kg [CT3.5] over 2 years) showed efficacy vs placebo in patients with relapsing-remitting multiple sclerosis in the CLARITY study. This post-hoc analysis investigated efficacy outcomes for patients with a history of disease-modifying therapy (DMT) use prior to entering CLARITY. Methods: CLARITY included patients previously treated with 0–2 DMTs (patients treated with >2 DMTs were excluded). Analysis of efficacy, annualised relapse rate (ARR), relapse-free rate, MRI activity, and time to 3-month and 6-month confirmed disability progression (CDP), were stratified by prior DMT therapy. P-Values <0.05 were considered nominally significant. Results: Prior DMT patients were randomised to CT3.5 (n=110) and placebo (n=132). Treatment with CT3.5 vs placebo resulted in a nominally significant reduction in ARR (0.22 vs 0.42; P<0.005), higher relapse-free rate (70.4% vs 55.9%; P=0.0204), numerically lower risk of 3-month CDP (hazard ratio [HR]=0.64, P=0.1589) and 6-month CDP (HR=0.62, P=0.2071), and reductions in brain lesion counts (P<0.001 for each lesion type). Conclusions: Patients who received prior DMT treatment showed significant improvements in efficacy outcomes with CT3.5 compared to placebo. Findings therefore support a consistent effect of cladrib- ine tablets across a broad range of patients, including patients who have used other DMTs. CLARITY: NCT00213135 [e-mail]