scholarly journals Real-World Effectiveness of Natalizumab in Korean Patients With Multiple Sclerosis

2021 ◽  
Vol 12 ◽  
Author(s):  
Ki Hoon Kim ◽  
Su-Hyun Kim ◽  
Na Young Park ◽  
Jae-Won Hyun ◽  
Ho Jin Kim
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Real World ◽  
Brain Magnetic Resonance Imaging ◽  
Clinical Relapse ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Korean Patients ◽  
Relapsing Remitting ◽  
The Mean

Background and Purpose: Natalizumab is a highly efficacious disease-modifying therapy for relapsing-remitting multiple sclerosis (MS). Data on the efficacy and safety profile of natalizumab in Asian patients with MS are limited. This study assessed the efficacy and safety of natalizumab in Korean patients with MS in a real-world setting.Methods: This study enrolled consecutive Korean patients with active relapsing-remitting MS who were treated with natalizumab for at least 6 months between 2015 and 2021. To evaluate the therapeutic outcome of natalizumab, we used the Expanded Disability Status Scale (EDSS) scores and brain magnetic resonance imaging; adverse events were assessed at regular intervals. No evidence of disease activity (NEDA) was defined as no clinical relapse, no worsening of EDSS score, and no radiological activities.Results: Fourteen subjects with MS were included in the study. The mean age at initiation of natalizumab therapy was 32 years. All patients were positive for anti-John Cunningham virus antibodies before natalizumab administration. The mean annual relapse rate was markedly reduced from 2.7 ± 3.2 before natalizumab therapy to 0.1 ± 0.4 during natalizumab therapy (p = 0.001). Disability was either improved or stabilized after natalizumab treatment in 13 patients (93%). During the 1st year and 2 years after initiating natalizumab, NEDA-3 was achieved in 11/12 (92%) and 9/11 (82%) patients, respectively. No progressive multifocal leukoencephalopathy or other serious adverse events leading to the discontinuation of natalizumab were observed.Conclusions: Natalizumab therapy showed high efficacy in treating Korean patients with active MS, without unexpected safety problems.

scholarly journals Alemtuzumab in the long-term treatment of relapsing-remitting multiple sclerosis: an update on the clinical trial evidence and data from the real world

2017 ◽  
Vol 10 (10) ◽  
pp. 343-359 ◽  
Author(s):  
Tjalf Ziemssen ◽  
Katja Thomas
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Mechanism Of Action ◽  
Real World ◽  
Continuous Treatment ◽  
The Real ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Alemtuzumab is a humanized monoclonal antibody approved for the treatment of relapsing-remitting multiple sclerosis (RRMS), given as two annual courses on five consecutive days at baseline and on three consecutive days 12 months later. Here we provide an update on the long-term efficacy and safety of alemtuzumab in RRMS, including real-world experience, and advances in our understanding of its mechanism of action. Recent data from the phase II/III extension study have demonstrated that alemtuzumab reduces relapse rates, disability worsening, and the rate of brain volume loss over the long term, with many patients achieving no evidence of disease activity. In high proportions of patients, preexisting disability remained stable or improved. Alemtuzumab is associated with a consistent safety profile over the long term, with no new safety signals emerging and the overall annual incidence of reported adverse events decreasing after the first year on treatment. Acyclovir prophylaxis reduces herpetic infections, and monitoring has been shown to mitigate the risk of autoimmune adverse events, allowing early detection and overall effective management. Data from clinical practice and ongoing observational studies are providing additional information on the real-world use of alemtuzumab. Recent evidence on the mechanism of action of alemtuzumab indicates that in addition to its previously known effects of inducing depletion and repopulation of T and B lymphocytes, it also results in a relative increase of cells with memory and regulatory phenotypes and a decrease in cells with a proinflammatory signature, and may further promote an immunoregulatory environment through an impact on other innate immune cells (e.g. dendritic cells) that play a role in MS. These effects may allow preservation of innate immunity and immunosurveillance. Together, these lines of evidence help explain the durable clinical efficacy of alemtuzumab, in the absence of continuous treatment, in patients with RRMS.

scholarly journals Clinical efficacy and safety of alemtuzumab in postmarketing practice

2019 ◽  
pp. 56-62
Author(s):  
N. V. Khachanova
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Drug Efficacy ◽  
Safety Monitoring ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Treatment Benefit ◽  
Dosing Schedule ◽  
The World ◽  
Multiple Sclerosis Treatment

Clinical trials confirm alemtuzumab efficacy for multiple sclerosis treatment in terms of both conventional measures and combined criteria such as NEDA (no evidence of disease activity). However, established drug efficacy and convenient dosing schedule are balanced by the risk of serious adverse events. Therefore, it is necessary to inform physicians about the benefits of alemtuzumab therapy along with the pattern of its safety profile.The present review provides the analysis of alemtuzumab real-world studies in Europe, USA and other parts of the world. The information obtained can help physicians to prescribe and administer the drug properly and to perform effective safety monitoring for early detection of adverse events and saving the maximum treatment benefit for the patient.

Mitoxantrone treatment in patients with early relapsing-remitting multiple sclerosis

2007 ◽  
Vol 13 (8) ◽  
pp. 975-980 ◽  
Author(s):  
E. Cocco ◽  
P. Marchi ◽  
C. Sardu ◽  
P. Russo ◽  
A. Paolillo ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Relapse Rate ◽  
Serious Adverse Events ◽  
T2 Lesions ◽  
End Of Treatment ◽  
Relapsing Remitting ◽  
Annualized Relapse Rate ◽  
Relapsing Remitting Multiple Sclerosis

We investigated the clinical and MRI effects of mitoxantrone (MITOX) administered to 45 patients during the first five years of highly active relapsing-remitting multiple sclerosis. Differences occurring between the end of treatment and follow-up (clinical mean: 3.6 years; brain MR: 1.8 years) with respect to baseline variables (EDSS, annualized relapse rate, active T2 lesions, new T1 lesions and number of Gd-enhancing lesions) were analysed using parametric and non-parametric tests. One patient developed leukemia four months after the end of the treatment; no other serious adverse events occurred during treatment and the follow-up period. A clinically relevant reduction in the annualized relapse rate ( P < 0.0001 at end of treatment and P < 0.0001 at follow-up) and improvement in the EDSS ( P < 0.0001 at end of treatment and P = 0.0005 at follow-up) was found. At the end of treatment, 53% of patients experienced no increase in active T2 lesions, while 73% showed no increase in the number of new T1 lesions. At follow-up, 41 out of 45 (91%) patients showed a stable MRI pattern and were active-scan free. Despite potential serious adverse events, MITOX may be considered an option in selected patients with very active early MS. Multiple Sclerosis 2007; 13: 975—980. http://msj.sagepub.com

A phase 2, 24-week, randomized, placebo-controlled, double-blind study examining the efficacy and safety of an anti-interleukin-12 and -23 monoclonal antibody in patients with relapsing–remitting or secondary progressive multiple sclerosis

2010 ◽  
Vol 17 (2) ◽  
pp. 181-191 ◽  
Author(s):  
Timothy L Vollmer ◽  
Daniel R Wynn ◽  
M Shamsul Alam ◽  
Joaquin Valdes
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Relapse Rate ◽  
Interleukin 12 ◽  
Double Blind Study ◽  
Cumulative Number ◽  
Efficacy And Safety ◽  
Treatment Groups ◽  
Secondary Progressive ◽  
Relapsing Remitting

Background: Interleukins 12 and 23 (IL-12/23) have been implicated in multiple sclerosis (MS) pathogenesis. This study assessed the efficacy and safety of ABT-874, a monoclonal anti-IL-12/23 antibody, in active relapsing–remitting MS (RRMS) or secondary progressive MS (SPMS). Methods: In this 24-week study, patients with RRMS or SPMS received ABT-874 200 mg every other week (EOW), ABT-874 200 mg every week (EW), or placebo. The cumulative number of gadolinium-enhanced lesions, relapse rate, disability progression, and adverse events were measured. Results: 215 patients were randomized (ABT-874 200 mg EOW, N = 76; ABT-874 200 mg EW, N = 70; placebo, N = 69). At week 24, gadolinium-enhanced lesions were statistically significantly reduced with ABT-874 200 mg EOW vs. placebo (mean number [SD]: 5.4 [8.1] vs. 7.6 [14.4], p = 0.003), but not with ABT-874 200 mg EW (6.8 [11.3], p = 0.134). Mean relapse rate (relapses/y) was significantly lower for ABT-874 200 mg EW vs. placebo (0.1 [95% CI −0.0, 0.3] vs. 0.5 [0.2, 0.8], p = 0.007). Changes from baseline in disability scores and incidences of adverse events were not significantly different across treatment groups, although a numerically greater percentage of serious adverse events was reported for ABT-874 treatment groups. Conclusions: Although rates of adverse events were not significantly different between ABT-874 treatment groups and placebo, the magnitude of ABT-874 efficacy was less than that observed with other agents currently in development for MS treatment. Anti-IL-12/23 monotherapy does not appear to warrant further testing as monotherapy treatment for MS.

scholarly journals Effectiveness and safety of 12-month certolizumab pegol treatment for axial spondyloarthritis in real-world clinical practice in Europe

Rheumatology ◽  
2020 ◽  
Vol 60 (1) ◽  
pp. 113-124
Author(s):  
Xenofon Baraliakos ◽  
Torsten Witte ◽  
Luc De Clerck ◽  
Bruno Frediani ◽  
Eduardo Collantes-Estévez ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Axial Spondyloarthritis ◽  
Certolizumab Pegol ◽  
Signs And Symptoms ◽  
Serious Adverse Events ◽  
The Mean ◽  
One Year

Abstract Objectives The efficacy and safety of certolizumab pegol (CZP), an Fc-free, PEGylated anti-TNF, in axial spondyloarthritis (axSpA) has been established in clinical trial settings. We report CZP effectiveness and safety in European clinical practice in patients with axSpA, including radiographic (r-) and non-radiographic (nr-) axSpA. Methods CIMAX (NCT02354105), a European non-interventional multicentre prospective study, observed CZP treatment response and safety over 12 months in a real-world axSpA cohort. The primary outcome was change from baseline in BASDAI to week 52, with additional outcomes pertaining to effectiveness and safety. Patients who received ≥1 dose CZP were followed up for adverse events, and those with baseline and ≥1 post-baseline BASDAI assessment were included in effectiveness analyses. Results A total of 672 patients (r-axSpA: 469; nr-axSpA: 201; unconfirmed diagnosis: 2) from 101 sites received ≥1 dose of CZP, of whom 564 (r-axSpA: 384; nr-axSpA: 179; unconfirmed: 1) were included in the effectiveness analyses. The mean baseline BASDAI was 6.1 in the overall axSpA population and r-axSpA and nr-axSpA subpopulations. At week 52, the mean (s.d.) change in BASDAI was −2.9 (2.3; n = 439); for r-axSpA and nr-axSpA, it was −2.9 (2.2; n = 301) and −2.8 (2.4; n = 137), respectively (P &lt;0.0001 for all). Similar improvements were seen across other axSpA disease measures. In total, 37.9% (255/672) patients experienced adverse events, and 1.8% (12/672) experienced ≥1 serious adverse events. Conclusion Improvements observed in signs and symptoms of axSpA following one year of CZP treatment in real-world clinical practice were similar to those from previous randomized clinical trials, with no new safety concerns.

scholarly journals Fingolimod Treatment in Relapsing-Remitting Multiple Sclerosis Patients: A Prospective Observational Multicenter Postmarketing Study

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Rocco Totaro ◽  
Caterina Di Carmine ◽  
Gianfranco Costantino ◽  
Roberta Fantozzi ◽  
Paolo Bellantonio ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Activity ◽  
Real World ◽  
Convincing Evidence ◽  
Clinical Relapse ◽  
Disability Progression ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Objective. The aim of this prospective observational multicenter postmarketing study was to evaluate fingolimod efficacy in a real world clinical setting.Methods. One hundred forty-two subjects with relapsing-remitting multiple sclerosis (RRMS) were enrolled in three multiple sclerosis centers throughout Central and Southern Italy between January 2011 and September 2013. After enrollment, regular visits and EDSS assessment were scheduled every 3 months, and MRI scan was obtained every 12 months. Patients were followed up from 1 to 33 months (mean 14.95 ± 9.15 months). The main efficacy endpoints included the proportion of patients free from clinical relapses, from disability progression, from magnetic resonance imaging activity, and from any disease activity.Results. Out of 142 patients enrolled in the study, 88.1% were free from clinical relapse and 69.0% were free from disability progression; 68.5% of patients remained free from new or newly enlarging T2 lesions and 81.7% of patients were free from gadolinium enhancing lesions. Overall the proportion of patients free from any disease activity was 41.9%.Conclusions. Our data in a real world cohort are consistent with previous findings that yield convincing evidence for the efficacy of fingolimod in patients with RRMS.

Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results

2009 ◽  
Vol 16 (2) ◽  
pp. 197-207 ◽  
Author(s):  
G. Comi ◽  
P. O'Connor ◽  
X. Montalban ◽  
J. Antel ◽  
E-W. Radue ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Controlled Trial ◽  
Phase Iii ◽  
Initial Increase ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
T2 Lesions ◽  
Study Programme ◽  
Large Phase

In a 6-month, placebo-controlled trial, oral fingolimod (FTY720) 1.25 or 5.0 mg, once daily, significantly reduced MRI inflammatory activity and annualized relapse rate compared with placebo in patients with relapsing multiple sclerosis (MS). The objectives were to monitor the 36-month, interim efficacy and safety results of the ongoing extension of this study. In the extension (months 7—36), placebo-treated patients were re-randomized to either dose of fingolimod; fingolimod-treated patients continued at the same dose. During months 15—24, all patients receiving fingolimod 5.0 mg switched to 1.25 mg. Of the 250 patients who entered the extension study, 173 (69%) continued to month 36. Most patients were free from gadolinium-enhanced lesions (88—89%) or new T2 lesions (70—78%) at month 36. Patients receiving continuous fingolimod treatment had sustained low annualized relapse rates of 0.20—0.21, and 68—73% remained relapse-free at month 36. Over 36 months, nasopharyngitis (34%), headache (30%), fatigue (19%) and influenza (18%) were the most commonly reported adverse events. Pulmonary function remained stable and blood pressure was stable after an initial increase (3—5 mmHg) during the first 6 months of fingolimod treatment; serious adverse events included infections and skin cancer. The low MRI and clinical disease activity at 6 months were maintained at 36 months with fingolimod, which was generally well tolerated by most patients. The efficacy and safety of oral fingolimod are being further evaluated in a large phase III MS study programme.

Natalizumab versus fingolimod in patients with relapsing-remitting multiple sclerosis non-responding to first-line injectable therapies

2016 ◽  
Vol 22 (10) ◽  
pp. 1315-1326 ◽  
Author(s):  
Damiano Baroncini ◽  
Angelo Ghezzi ◽  
Pietro O Annovazzi ◽  
Bruno Colombo ◽  
Vittorio Martinelli ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Activity ◽  
Brain Magnetic Resonance Imaging ◽  
Lower Percentage ◽  
First Line ◽  
Serious Adverse Events ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Background: Natalizumab and fingolimod have not been compared in controlled trials but only in observational studies, with inconclusive results. Objectives: The objective of this study is to compare the effect of natalizumab and fingolimod in reducing disease activity in relapsing-remitting multiple sclerosis (RRMS). Methods: We included all consecutive RRMS patients switched from first-line agents (glatiramer acetate/interferons) to natalizumab or fingolimod, with a follow-up of 24 months. Data of relapses, Expanded Disability Status Scale score and brain magnetic resonance imaging (MRI) scans were collected. We used propensity score (PS) matching and intention-to-treat analysis. Results: We retained 102 patients in each cohort after PS matching, with similar baseline characteristics. More patients discontinued natalizumab compared to fingolimod (33% vs 11%, p < 0.001), mainly for progressive multifocal leukoencephalopathy (PML) concern. No serious adverse events occurred in the two cohorts. Compared to fingolimod, the natalizumab group presented a higher percentage of relapse-free patients (66% vs 80%, p = 0.015), a higher percentage of disability-improved patients (6% vs 15%, p = 0.033), a lower percentage of MRI-active patients (38% vs 14%, p = 0.001) and a higher percentage of patients with no evidence of disease activity (NEDA-3; 44% vs 70%, p < 0.001) after 2 years of follow-up. Disability worsening was not statistically different in the two groups. Conclusion: Natalizumab is superior to fingolimod in RRMS patients non-responding to first-line agents.

scholarly journals Efficacy and safety of canakinumab for colchicine-resistant or colchicine-intolerant familial Mediterranean fever: A single-centre observational study

2021 ◽  
Author(s):  
Takuya Tomokawa ◽  
Tomohiro Koga ◽  
Yushiro Endo ◽  
Toru Michitsuji ◽  
Atsushi Kawakami
Keyword(s):  
Familial Mediterranean Fever ◽  
Adverse Events ◽  
Real World ◽  
Clinical Setting ◽  
Japanese Patients ◽  
Efficacy And Safety ◽  
Attack Frequency ◽  
Serious Adverse Events ◽  
Targeted Next Generation Sequencing ◽  
Mediterranean Fever

ABSTRACT Objectives To evaluate the efficacy and safety of canakinumab in Japanese patients with colchicine-resistant or colchicine-intolerant familial Mediterranean fever (FMF) in a real-world clinical setting. Methods We reviewed 13 Japanese FMF patients to whom canakinumab was introduced during the period of October 2017 to December 2020. All patients were diagnosed as FMF according to Tel-Hashomer criteria. We performed genetic analyses for Mediterranean fever or MEFV by targeted next-generation sequencing. Efficacy was assessed by attack frequency and the percentage of patients who achieved attack improvement at 24 weeks. Safety was assessed by adverse events observed during canakinumab treatment. Results The median duration and follow-up of canakinumab treatment were 13 and 16 months, respectively. The median attack frequency was 0.50 [0.30–1.00] at 24 weeks, which was a significant decrease from 2.00 [0.85–2.88] at the time of induction (p = .019). There were three patients (23%) with complete resolution of attacks at 24 weeks. No serious adverse events were observed. However, one patient had small intestinal ulceration which led to the discontinuation of canakinumab. Conclusions Although the number of cases is small, this study suggests that canakinumab is efficacious and safe for use in Japanese patients with colchicine-resistant or colchicine-intolerant FMF in a real-world clinical setting in Japan.

scholarly journals Real-world experience of ocrelizumab in multiple sclerosis patients in Latin America

2021 ◽  
Vol 79 (4) ◽  
pp. 305-309
Author(s):  
Juan Ignacio ROJAS ◽  
Liliana PATRUCCO ◽  
Manuel FRUNS ◽  
Giesela HORNUNG ◽  
José FLORES ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Latin America ◽  
Real World ◽  
Phase Iii ◽  
Imaging Results ◽  
Relapsing Remitting ◽  
Patient Profiles ◽  
The Mean ◽  
Multiple Sclerosis Patients

ABSTRACT Background: Despite the abundance of information concerning ocrelizumab in phase III clinical trials, there is scarce evidence regarding real-world patient profiles. Objective: The aim of this study was to investigate patient profiles, effectiveness and persistence with treatment among patients who used ocrelizumab for treatment of multiple sclerosis in Latin America. Methods: This was a retrospective multicenter study in Argentina, Chile and Mexico. Medical record databases on patients who received ocrelizumab were analyzed. Demographic and clinical variables were described, along with effectiveness outcomes, which included the proportions of patients free from clinical relapses, from disability progression and from new or enlarging T2 or T1 gadolinium-enhancing lesions, on annual magnetic resonance imaging. Results: A total of 81 patients were included. The most frequent phenotype was relapsing-remitting MS, in 64.2% of the patients. The mean age at study entry was 41.3 ± 12.0 years and 51.8% were women. A total of 38% had had relapse activity during the 12 months before starting on ocrelizumab, with a mean relapse rate of 1.3 ± 0.6 during that period. 75% were free from clinical relapses and 91% were free from gadolinium-enhancing lesions in the relapsing-remitting course. Ocrelizumab discontinuation during the first 12 months was observed in three patients (3.7%). The mean persistence observed during the first-year follow-up was 338 ± 24 days. Conclusions: Our study is in line with previous randomized clinical trials and recent real-world studies describing patient profiles, effectiveness and persistence regarding ocrelizumab treatment in multiple sclerosis patients in Latin America.

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