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Communication

Possible Reasons for the Suboptimal Response of the Cladribine Course in Daily Practice: An Independent Analysis of Data from 12 Russian Clinics and the Results of Post-Registration Studies in Other Countries

by
Alexey N. Boyko
1,2,*,
Valentina M. Alifirova
3,
Daria V. Pashkovskaya
3,
Ekaterina I. Kuchina
3,
Stella A. Sivertseva
4,
Elena L. Turova
5,
Zoya A. Goncharova
6,
Olga Yu Rudenko
6,
Yulia Yu Pogrebnova
6,
Farid A. Khabirov
7,
Timur I. Khaibullin
7,
Natalia N. Babicheva
7,
Natalia L. Khoroshilova
8,
Oksana V. Dzundza
9,
Olga A. Soldatova
10,
Anna N. Belova
11,12,
Gennadyi E. Sheiko
11,12,
Anastasia E. Makarova
11,12 and
Natalia G. Glavinskaya
13
1
Federal Center of Brain and Neurotechnology, 117513 Moscow, Russia
2
Department of Neurology, Neurosurgery and Medical Genetics, Pirogov Russian National Research Medical University, 117997 Moscow, Russia
3
Department of Neurology and Neurosurgery, Siberian State Medical University, 634050 Tomsk, Russia
4
Tyumen Regional MS Center, 634050 Tyumen, Russia
5
Sverdlovsk Regional Clinical Hospital No. 1, 620102 Yekaterinburg, Russia
6
Department of Neurology and Neurosurgery, Rostov State Medical University, 344009 Rostov-on-Don, Russia
7
Kazan State Medical Academy, Republican Clinical and Diagnostic Center for Demyelinating Diseases, 420054 Kazan, Russia
8
Department of Neurology and Neurosurgery, Turgenev Orel State University, 302026 Orel, Russia
9
Sergeev Regional Clinical Hospital of the Khabarovsk Region, 680000 Khabarovsk, Russia
10
Clinical Diagnostic Center of Omsk, 644011 Omsk, Russia
11
Department of Neurology and Neurorehabilitation, Privolzhsky Research Medical University, 603950 Nizhny Novgorod, Russia
12
City Clinical Hospital No. 3, 603950 Nizhny Novgorod, Russia
13
Sakhalin Regional Clinical Hospital, 693000 Yuzhno-Sakhalinsk, Russia
 
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*
Author to whom correspondence should be addressed.
Sclerosis 2025, 3(4), 34; https://doi.org/10.3390/sclerosis3040034 (registering DOI)
Submission received: 24 March 2025 / Revised: 30 September 2025 / Accepted: 20 October 2025 / Published: 24 October 2025
Versions Notes

Abstract

Objectives: The purpose of this study was to analyze the effect of daily intake of cladribine tablets on the course of multiple sclerosis (MS) while monitoring for 1–4 years during and after the course in several neurological clinics from different regions of the Russian Federation. Materials and Methods: Information was collected on 235 patients from 12 neurological clinics and regional centers for MS, who were observed for an average of 3.4 years after starting treatment with cladribine. Results: An independent analysis of cases of prescription of cladribine in tablets showed that the reason for prescription of cladribine was highly active MS (HAMS) in 159 patients (67.7%), rapidly progressive MS (RPMS) in 20 patients (8.5%), active remitting MS in 50 patients (21.3%) and secondary progressive MS (SPMS) with exacerbations in 6 (2.5%). Among them, only 12 patients (5.1%) had not previously received DMTs, i.e., in these cases, the drug was prescribed as the first DMT. In total, 22 patients had previously received natalizumab, 5—ocrelizumab, and in 1 case—fingolimod. The remaining 207 patients were crossed over from the first-line DMTs. In all cases, there was a decrease in the frequency of exacerbations during and after the completion of the course of cladribine. Exacerbations between the first and second courses of cladribine were noted in 36 patients (15.3% of all treated), almost half of the cases—those who previously received natalizumab (17 exacerbations, or 47.2% of all exacerbations between the 1st and 2nd courses of cladribine), and in 3 cases—from ocrelizumab (in 60% of all patients crossed over from ocrelizumab). During 4 years of follow-up after a full course of cladribine, exacerbations were in 14 patients (6% of all patients included in the analysis), of which in 6 cases—after crossover from natalizumab. Discussion and Conclusions: The data obtained are generally consistent with the results of meta-analyses and reviews published recently, but high probability of exacerbations in patients who were crossed over from second-line drugs such as natalizumab and ocrelizumab were seen. The crossover from natalizumab is carried out more often due to the increased risk of developing progressive multifocal encephalopathy (PML). It is likely that the restoration of MS activity after the withdrawal of natalizumab is quite frequent, cladribine tablets were not able to fully prevent this. Such a crossover does not seem to be optimal, unlike the crossover from first-line DMTs. If such a crossover is still planned, it could be performed within 4 weeks after stopping natalizumab.
Keywords: real clinical practice; DMT; observational study; cladribine real clinical practice; DMT; observational study; cladribine

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MDPI and ACS Style

Boyko, A.N.; Alifirova, V.M.; Pashkovskaya, D.V.; Kuchina, E.I.; Sivertseva, S.A.; Turova, E.L.; Goncharova, Z.A.; Rudenko, O.Y.; Pogrebnova, Y.Y.; Khabirov, F.A.; et al. Possible Reasons for the Suboptimal Response of the Cladribine Course in Daily Practice: An Independent Analysis of Data from 12 Russian Clinics and the Results of Post-Registration Studies in Other Countries. Sclerosis 2025, 3, 34. https://doi.org/10.3390/sclerosis3040034

AMA Style

Boyko AN, Alifirova VM, Pashkovskaya DV, Kuchina EI, Sivertseva SA, Turova EL, Goncharova ZA, Rudenko OY, Pogrebnova YY, Khabirov FA, et al. Possible Reasons for the Suboptimal Response of the Cladribine Course in Daily Practice: An Independent Analysis of Data from 12 Russian Clinics and the Results of Post-Registration Studies in Other Countries. Sclerosis. 2025; 3(4):34. https://doi.org/10.3390/sclerosis3040034

Chicago/Turabian Style

Boyko, Alexey N., Valentina M. Alifirova, Daria V. Pashkovskaya, Ekaterina I. Kuchina, Stella A. Sivertseva, Elena L. Turova, Zoya A. Goncharova, Olga Yu Rudenko, Yulia Yu Pogrebnova, Farid A. Khabirov, and et al. 2025. "Possible Reasons for the Suboptimal Response of the Cladribine Course in Daily Practice: An Independent Analysis of Data from 12 Russian Clinics and the Results of Post-Registration Studies in Other Countries" Sclerosis 3, no. 4: 34. https://doi.org/10.3390/sclerosis3040034

APA Style

Boyko, A. N., Alifirova, V. M., Pashkovskaya, D. V., Kuchina, E. I., Sivertseva, S. A., Turova, E. L., Goncharova, Z. A., Rudenko, O. Y., Pogrebnova, Y. Y., Khabirov, F. A., Khaibullin, T. I., Babicheva, N. N., Khoroshilova, N. L., Dzundza, O. V., Soldatova, O. A., Belova, A. N., Sheiko, G. E., Makarova, A. E., & Glavinskaya, N. G. (2025). Possible Reasons for the Suboptimal Response of the Cladribine Course in Daily Practice: An Independent Analysis of Data from 12 Russian Clinics and the Results of Post-Registration Studies in Other Countries. Sclerosis, 3(4), 34. https://doi.org/10.3390/sclerosis3040034

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