Neurological

Sustainable long-term effects of cladribine in multiple sclerosis

According to the study results published in the Multiple Sclerosis Journal, cladribine has shown lasting efficacy in reducing the frequency and severity of relapses in patients with relapsing-remitting multiple sclerosis.

Treatment with cladribine tablets 3.5 mg / kg in patients with relapsing-remitting multiple sclerosis reduced the annual relapse rate compared to placebo in the CLARITY study (CLAdRIbine tablets for the treatment of multiple sclerosis oral) (Clinicaltrials.gov Identifier: NCT00213135) sustained significantly in the CLARITY extension study (Clinicaltrials.gov Identifier: NCT00641537) without further treatment.

The aim of the post-hoc analysis was to determine the frequency and severity of relapses in patients treated with cladribine compared to placebo in the CLARITY study and to assess the long-term effect without further treatment in patients who received placebo in the CLARITY study. Extension received study after treatment with cladribine in CLARITY.

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Qualifying relapses were defined as a 2 point increase with at least 1 Kurtzke Functional Systems Score or 1 point increase with at least 2 Kurtzke Functional Systems Scores. All relapses included both qualifying relapses and non-qualifying relapses. Severe relapses were defined as relapses that required steroid treatment or hospitalization.

The current post-hoc analysis included data from 433 patients treated with cladribine 3.5 mg / kg in the CLARITY study and 437 patients treated with placebo, as well as data from 98 patients in the cladribine treatment group enrolled in the CLARITY – Extension study received placebo.

In the CLARITY study, the risk of qualified or all relapse and the risk of major relapse in patients treated with cladribine 3.5 mg / kg compared to placebo were significant at Month 6, End of Year 1, and End of Year 2 With placebo, treatment with cladribine tablets reduced the annual relapse rates for both relapses that required steroid treatment or resulted in hospitalization by more than 50% compared to placebo.

The reduction in annualized relapse rates for both qualified and all relapses in the cladribine group in year 2 in CLARITY was sustained in patients who were initially treated with cladribine for 2 years, followed by placebo in CLARITY extension. For qualified and all relapses, 84.7% and 73.5% of patients, respectively, had no relapses at year 4 in the CLARITY extension. These results suggest that the treatment effect of cladribine tablets 3.5 mg / kg can be maintained without further treatment after 2 years.

The longevity of the effects of cladribine was also supported by a lower relapse rate in patients in the cladribine treatment group who received placebo in the CLARITY Extension study compared to those who received placebo in CLARITY.

The overall safety profile of patients in the placebo or cladribine tablet groups at 3.5 mg / kg in the CLARITY and CLARITY extensions were similar.

This study was limited by the fewer patients enrolled in the CLARITY extension study compared to the previous CLARITY study. In addition, some patients enrolled in CLARITY Extension may have had a milder condition.

“[P]Patients receiving cladribine tablets 3.5 mg / kg had a significant reduction in the frequency and severity of relapses during CLARITY. Additional descriptive analyzes suggested that this benefit was retained in CLARITY Extension without further treatment, ”the study researchers concluded.

Disclosure: This study was supported by Merck KGaA, Darmstadt, Germany. For a full list of specifications, see the original reference.

reference

De Stefano N., Sormani MP, Giovannoni G, et al. Analysis of the frequency and severity of relapse in patients with multiple sclerosis treated with cladribine tablets or placebo: the CLARITY and CLARITY Extension studies. Mult Scler. Published online May 10, 2021. doi: 10.1177 / 13524585211010294

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