Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia.
<h4>Background</h4>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.<h4>...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2019-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0217303 |
| _version_ | 1819029057183940608 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Evgeniy Evdoshenko |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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. |
| first_indexed | 2024-12-21T06:08:12Z |
| format | Article |
| id | doaj.art-5d0bf15288324e78ba2dafd9cff30116 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-21T06:08:12Z |
| publishDate | 2019-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-5d0bf15288324e78ba2dafd9cff301162022-12-21T19:13:36ZengPublic Library of Science (PLoS)PLoS ONE1932-62032019-01-01145e021730310.1371/journal.pone.0217303Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia.Evgeniy EvdoshenkoAlexandra StepanovaMaria ShumilinaMaria DavydovskayaNatalia KhachanovaNikolay NeofidovIvan KalininEkaterina PopovaEkaterina DubchenkoNatalia PozhidaevaAndrey VolkovStella SivertsevaAnna PrilenskayaNadezhda MalkovaDenis KorobkoIlona VergunovaSergey ShchurGleb Makshakov<h4>Background</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.https://doi.org/10.1371/journal.pone.0217303 |
| spellingShingle | 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 Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia. PLoS ONE |
| title | Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia. |
| title_full | Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia. |
| title_fullStr | Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia. |
| title_full_unstemmed | Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia. |
| title_short | Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia. |
| title_sort | real world study of efficacy risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in russia |
| url | https://doi.org/10.1371/journal.pone.0217303 |
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