Long-Term Effectiveness of Natalizumab in Patients with Relapsing-Remitting Multiple Sclerosis Treated in the Routine Care in Greece: Results from the Multicenter, Observational 5-Year Prospective Study ‘TOPICS Greece’

Abstract

Background and Objectives For chronic diseases like multiple sclerosis (MS), real-world evidence on long-term treatment outcomes is essential. The study aimed to provide long-term data on the safety and effectiveness of natalizumab in patients with relapsing-remitting MS (RRMS) treated in a routine care setting in Greece. Methods TOPICS Greece was a multicenter, single-country, prospective 5-year observational study. Results Between 19-Apr-2012 and 18-Dec-2014, 304 eligible adults [females: 63.2%; median age at natalizumab initiation: 38.0 years; median disease duration: 6.2 years; median Expanded Disability Status Scale (EDSS) score at baseline: 3.5] were enrolled in the study by 20 hospital-based neurologists. The 1-year annualized relapse rate (ARR) before treatment initiation was 1.859, while the ARR during the first year of treatment was 0.131, representing a significant 93% reduction (p < 0.001). The ARR over the median treatment period of 59.4 months was 0.109. Patients with ≤1 relapse in the prenatalizumab year (46.1%) and those having received ≤1 prior disease-modifying therapy (57.9%) displayed significantly lower on-natalizumab ARR. The 1-, 2-, 3-, 4-and 5-year cumulative probabilities of EDSS progression were 3.2, 6.2, 9.7, 13.4, and 17.4%, respectively; the respective probabilities of EDSS disability improvement were 18.3, 25.1, 27.4, 28.0, and 30.1%. Over a median safety data collection period of 48.7 months, 4.6% of the patients experienced ≥ 1 serious adverse event, with infections (reported in 1.0%) being the most common. Conclusion In real-world settings in Greece, natalizumab displayed beneficial long-term effects on disease activity and disability progression consistent with previous studies with no new serious safety signals emerging.

Use of natalizumab in persons with multiple sclerosis: 2022 update

“…When initiated early in the disease course, natalizumab was associated with fewer relapses and reduced disability worsening (Butzkueven et al, 2020a;Wiendl et al, 2021). The long-term effectiveness of natalizumab was also described in other real-world studies (Boziki et al, 2021;Davidescu et al, 2021;Efthimios et al, 2021;Guger et al, 2021;Horakova et al, 2020;Prosperini et al, 2017). Results from these studies indicate that, when administered long-term, natalizumab is effective and has an adequate safety profile, provided subjects are closely monitored.…”

Real-world treatment outcomes and safety of natalizumab in Finnish multiple sclerosis patients

“…These results on disability and relapse rate are in line with previous long-term observational studies. 6 – 8 , 20 In the TOP study, the reported cumulative probabilities of confirmed disability worsening and disability improvement were 28% and 33% at 10 years, respectively. 7 , 20 The mean ARR was 0.1 during the follow-up of this study which is similar to previous long-term studies that have reported mean ARRs between 0.1 and 0.2 during NTZ treatment.…”

“…7,20 The mean ARR was 0.1 during the follow-up of this study which is similar to previous long-term studies that have reported mean ARRs between 0.1 and 0.2 during NTZ treatment. [6][7][8] Also, recent studies and meta-analysis have demonstrated that NTZ is still highly effective and viable immunotherapy for RRMS in comparison to other high-efficacy DMTs. [21][22][23] Previous registry-based studies, including one Finnish study, have indicated that initiating treatment with a high-efficacy DMT in RRMS may reduce long-term disability progression and relapses compared to moderate-efficacy DMTs.…”

“… 7 , 20 The mean ARR was 0.1 during the follow-up of this study which is similar to previous long-term studies that have reported mean ARRs between 0.1 and 0.2 during NTZ treatment. 6 – 8 Also, recent studies and meta-analysis have demonstrated that NTZ is still highly effective and viable immunotherapy for RRMS in comparison to other high-efficacy DMTs. 21 – 23 …”

“…2 NTZ has been demonstrated as highly efficacious in the treatment of RRMS both in clinical trials and real-world settings and has a well-established safety profile. [3][4][5][6][7][8] However, real-world data on longterm treatment with NTZ is still limited, especially in patients with different anti-John Cunningham virus antibody statuses (JCV status).…”