OBJECTIVE

To assess the efficacy and safety of cladribine in patients with highly active multiple sclerosis (MS) in the Moscow region.

MATERIAL AND METHODS

The analysis was based on data from 62 patients treated with cladribine between March 2021 and January 2024. The diagnosis of VAMS was confirmed in 51 patients, PPMS in 4 patients, and SPMS with exacerbations was diagnosed in 7 cases. Of these, 3 patients completely completed therapy more than a year ago, 20 people received 2 courses of the drug less than a year ago, 39 patients underwent 1 course of therapy. The effect of cladribine on reducing disease activity and progression, as well as the safety of therapy, was evaluated.

RESULTS

After 1 course, the number of patients with activity decreased by 66.4%, after 2 years of therapy — by 72.7%. The mean annual frequency of exacerbations decreased from 1.32 to 0.2 after 12 months, and to 0.086 exacerbations per year after 24 months. The level of disability assessed by the EDSS scale remained virtually unchanged throughout the follow-up. The most common adverse events were haematological abnormalities in the form of lymphopenia and leukopenia. Most patients had mild grade 1—2 lymphopenia on the toxicity scale and recovered to the recommended values (>0.8·109/l) by the beginning of the second course of therapy. No cases of serious adverse events were reported.

CONCLUSIONS

The results obtained indicate the high efficacy and favorable safety profile of cladribine and are consistent with the data of clinical trials of the drug.