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

BACKGROUND

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.

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

Déclaration de conflit d'intérêts

E.Evdoshenko has received honoraria for lectures and speaking in the past 2 years from Merck, Biogen, Roche, Johnson & Johnson, Novartis, GlaxoSmithKline, Sanofi, Genzyme, Generium. A.Stepanova has nothing to declare. M.Shumilina has received honoraria for consulting services in the field of scientific and educational activities (educational services, scientific articles, participation in expert councils, participation in clinical trials, etc.) in the past 2 years from Roche, Johnson & Johnson/Janssen, Genzyme/Sanofi, Novartis, Generium. M.Davydovskaya has received honoraria for lectures from Janssen, Roche, Sanofi, Biogen, Novartis, Merck, Biocad, Generium. N.Khachanova has received honoraria for participation in clinical trials from Actelion Pharmaceuticals, Generium, TG Therapeutics, Osmotica Pharmaceuticals US LLC, Sanofi-Aventis, Rosh, Novartis, Biogen, Teva, Octapharma AG. N.Neofidov has received honoraria for lectures and speaking in the past 2 years Genzyme/Sanofi. I.Kalinin has nothing to declare. E.Popova has received honoraria for consulting services in the field of scientific and educational activities (educational services, scientific articles, participation in expert councils, participation in clinical trials, etc.) in the past 2 years from Roche, Johnson & Johnson/Janssen, Sanofi, Biocad, Generium. E.Dubchenko has nothing to declare. N.Pozhidaeva has nothing to declare. A.Volkov has received honoraria for lectures from Janssen S.Sivertseva has received honoraria for lectures and speaking in the past 2 years from Merck, Biogen, Roche, Johnson & Johnson, Novartis, GlaxoSmithKline, Sanofi, Genzyme, Generium. A.Prilenskaya has nothing to declare. N.Malkova has received honoraria as member of working groups, advisory boards, and participated in clinical trials supported by Biogen / Janssen, Merck, Teva, Novartis, Sanofi-Genzyme, Cellgene, Biocad, Generium. D.Korobko participated in clinical trials supported by Biogen, Teva, Novartis, Sanofi-Genzyme, Cellgene, Biocad, Generium. I.Vergunova participated in clinical trials supported by Biogen, Teva, Novartis, Sanofi-Genzyme, Cellgene, Biocad. S.Shchur has nothing to declare. G.Makshakov has received honoraria for lectures and speaking in the past 2 years from Roche, Johnson & Johnson/Janssen and Genzyme. This does not alter our adherence to PLOS ONE policies on sharing data and materials.