Research Article: Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia

Date Published: May 28, 2019

Publisher: Public Library of Science

Author(s): Evgeniy Evdoshenko, Alexandra Stepanova, Maria Shumilina, Maria Davydovskaya, Natalia Khachanova, Nikolay Neofidov, Ivan Kalinin, Ekaterina Popova, Ekaterina Dubchenko, Natalia Pozhidaeva, Andrey Volkov, Stella Sivertseva, Anna Prilenskaya, Nadezhda Malkova, Denis Korobko, Ilona Vergunova, Sergey Shchur, Gleb Makshakov, Aristeidis H. Katsanos.

http://doi.org/10.1371/journal.pone.0217303

Abstract

NTZ is approved in Russia for the treatment of highly active relapsing remitting multiple sclerosis and is reimbursed via federal budget program. However, no data about NTZ treatment in Russia and the effect of federal reimbursement have been performed so far.

To characterize the population of patients receiving natalizumab and assess the efficacy and risk-management plan (RMP) implementation of NTZ therapy in routine clinical practice in Russia.

We analyzed data for 334 patients, who received at least one infusion of NTZ. Relapse rate, MRI activity, NEDA-3 status after 2 years were assessed. Anti-JC virus antibodies status and RMP implementation were evaluated. Drop-out rate and reasons for therapy discontinuation were analyzed.

Patients switched to natalizumab in Russia are mainly female (63%), with median EDSS score of 3.5 and high disease activity: 93% had at least 1 relapse and 58% had both T1Gd+ and new T2 lesion a year before therapy initiation. Introduction of federal reimbursement allowed patients with less relapses to start therapy with natalizumab. The only predictor of 6-month progression was EDSS score at the baseline of therapy (HR = 2.1375, 95%CI 1.0026–4.5570, p = 0.0492). 82% patients reached NEDA-3 at 24 month of therapy. 25% of patients discontinued NTZ for reasons: tolerability (14.5%), JCV antibody status (61%), and patient’s decision (17%). RMP was implemented in only 36% patients.

Natalizumab appeared to have high efficacy in Russian clinical practice. Federal reimbursement allowed less active patients to start natalizumab. More efforts should be done to improve RMP implementation.

Partial Text

Multiple sclerosis is a major medical and social problem in Russia with up to 150 000 people affected [1]. Administration of highly efficacious disease modifying drugs (DMDs), such as Natalizumab (NTZ) can significantly improve disease outcomes and patients’ quality of life [2].

Data were collected in 2018 from 7 multiple sclerosis centers in 4 regions: Saint-Petersburg (Center of Multiple Sclerosis and AID at SBIH City Clinical Hospital #31); Moscow (City Clinical Hospital # 81, City Clinical Hospital # 71, City Clinical Hospital # 15, City Clinical Hospital # 24); Tyumen (Multiple Sclerosis Center in Medical sanitary unit «Neftyanik»); Novosibirsk (State Novosibirsk Regional Clinical Hospital, Center of MS and other AID of nervous system).

The patients’ profile, efficacy and safety of the drug in routine clinical practice may significantly differ from clinical trials. Also, local healthcare features may predetermine a specific patient’s profile receiving the drug. The profile of patients who were transferred to NTZ in Russia, appeared different from that seen in observational studies, like STRATA, where patients had higher age and disease duration, but lower EDSS score, clinical and radiological activity of MS [9]. However, these results were nearly comparable with RUS-TYS data [3]. These data indicate, that in Russia, NTZ is administered to patients with more aggressive MS and this pattern has not much changed since 2012 [3].

 

Source:

http://doi.org/10.1371/journal.pone.0217303

 

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