scholarly journals Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register

2021 ◽  
Author(s):  
Emanuele D’Amico ◽  
Aurora Zanghì ◽  
Marzia Romeo ◽  
Eleonora Cocco ◽  
Giorgia Teresa Maniscalco ◽  
...  
Keyword(s):  
Lower Risk ◽  
First Line ◽  
Real World Data ◽  
Event Time ◽  
Disease Modifying Therapies ◽  
Oral Group ◽  
Relapse Time ◽  
First Relapse ◽  
Disease Modifying ◽  
The Impact

AbstractThe current study aims to compare injectable and oral first-line disease-modifying therapies (DMTs) for time to first relapse, time to confirmed disability progression (CDP), and time to discontinuation using a cohort of relapsing remitting multiple sclerosis (RRMS) patients, with data extracted from the Italian MS Register. This multicenter, observational, retrospectively acquired, and propensity-adjusted cohort study utilized RRMS-naïve patients from the Italian MS Register who started either injectable or oral first-line DMTs between January 1, 2010, and December 31, 2017, to evaluate the impact on disability outcomes in patients. Enrolled patients were divided into two groups, namely the injectable group (IG) and the oral group (OG). Of a cohort of 11,416 patients, 4602 were enrolled (3919 in the IG and 683 in the OG). The IG had a higher rate of women (67.3% vs 63.4%, p < 0.05) and a lower mean age (36.1 ± 10.9 vs 38.9 ± 11.8, p < 0.001). The event time to first relapse demonstrated a lower risk in the OG (HR = 0.58; CI 95% 0.48–0.72, p < 0.001). However, no differences were found between the two groups with respect to the risk of CDP (HR = 0.94; CI 95% 0.76–1.29, p = 0.941), while a lower risk of DMT was found in the OG (HR = 0.72; CI 95% 0.58–0.88, p = 0.002) for the event time to discontinuation. Real-world data from the Italian MS Register suggests that first-line oral DMTs are associated with a lower risk of experiencing a new relapse and of therapy discontinuation compared to injectable DMTs.

scholarly journals P.051 Patient-reported adverse events on Multiple Sclerosis disease-modifying therapies in an urban tertiary MS clinic

2016 ◽  
Vol 43 (S2) ◽  
pp. S33-S33
Author(s):  
ZJ Liao ◽  
L Lee ◽  
K Carr
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Real Life ◽  
Retrospective Chart Review ◽  
First Line ◽  
Disease Modifying Therapies ◽  
Multiple Sclerosis Disease ◽  
Patient Reported ◽  
Disease Modifying ◽  
The Impact

Background: Disease-modifying therapies (DMT) have been shown to reduce relapses and delay disability in individuals with relapsing-remitting multiple sclerosis (MS). However, these medications can cause adverse events (AE) leading to poor adherence. To better understand their clinical utility, this study examined real-life experiences with DMT in a tertiary MS clinic. Methods: A retrospective chart review (1999-2015) was conducted to evaluate the prevalence of AE and discontinuation rates of Health Canada approved DMT. Results: 445 MS patients who have used at least one DMT in their lifetime were reviewed. Among first-line injectable therapies, interferon beta (IFNβ) 1-α IM users (49.6%) were most likely to report an AE. Flu-like reactions and injection site reactions were the most commonly reported AE. Among first-line oral therapies, BG-12 users (58.5%) were most likely to report an AE. The most common AE were flushing and gastrointestinal upset. DMT that were most frequently discontinued as a result of AE were IFNβ 1-α SC (39.3%), IFNβ 1-α IM (36.8%) and BG-12 (34.6%). Conclusions: The prevalence of AE and discontinuation rate were congruent. In comparison with recent literature, this study demonstrated lower prevalence of AE but equivocal or higher discontinuation rates. This discrepancy could represent a more realistic depiction of the impact that DMT AE have on patients.

scholarly journals Selection of patients with myelodysplastic syndromes from a large electronic medical records database and a study of the use of disease-modifying therapy in the United States

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e019955 ◽  
Author(s):  
Xiaomei Ma ◽  
David P Steensma ◽  
Bart L Scott ◽  
Pavel Kiselev ◽  
Mary M Sugrue ◽  
...  
Keyword(s):  
Myelodysplastic Syndromes ◽  
Cox Regression ◽  
Patient Characteristics ◽  
The United States ◽  
Treatment Patterns ◽  
First Line ◽  
Disease Modifying Therapy ◽  
Disease Modifying Therapies ◽  
The Usa ◽  
Disease Modifying

ObjectivesTreatment patterns for patients with myelodysplastic syndromes (MDS) outside clinical trials are not well described. Our objective was to evaluate treatment patterns and patient characteristics that influence time to disease-modifying therapy in patients with MDS in the USA.Design, participants and outcome measuresPatients with MDS treated with erythropoiesis-stimulating agents (ESAs), iron chelation therapy, lenalidomide (LEN) and the hypomethylating agents (HMAs) azacitidine and decitabine, were retrospectively identified in the GE Centricity Electronic Medical Record database between January 2006 and February 2014; LEN and HMAs were defined as ‘disease-modifying’ therapies. Multivariable Cox regression models were used to ascertain patient characteristics associated with time to disease-modifying therapy.ResultsOf the 5162 patients with MDS, 35.7%, 40.3% and 4.6% received 1, ≥1 and ≥2 therapies, respectively. ESAs were the first-line (72.5%) and only (64.0%) treatment in the majority of patients who received ≥1 therapy. ESA-only patients were older and had more comorbidities, including isolated anaemia. LEN and HMAs were first-line treatment in 12.4% of patients each; 32.7% received LEN or HMAs at any time. The majority of del(5q) patients (77.6%) received ≥1 therapy, most commonly LEN, compared with 40% of patients without del(5q). A shorter time to disease-modifying therapy was significantly associated with absence of comorbidities, diagnosis after February 2008, lower baseline haemoglobin level, age <80 years and male gender (p<0.002 for all).ConclusionsA high proportion of patients diagnosed with MDS in the USA do not receive approved disease-modifying therapies. It is important to improve access to these therapies.

scholarly journals PND1 RELAPSE-RELATED OUTCOMES IN PATIENTS WITH MULTIPLE SCLEROSIS TREATED WITH FIRST-LINE DISEASE-MODIFYING THERAPIES

2019 ◽  
Vol 22 ◽  
pp. S737
Author(s):  
S. Cohan ◽  
F.A. Corvino ◽  
D. Oliveri ◽  
J.H. Heo ◽  
W. Wang ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
First Line ◽  
Disease Modifying Therapies ◽  
Disease Modifying

Switching first-line disease-modifying therapy after failure: impact on the course of relapsing–remitting multiple sclerosis

2009 ◽  
Vol 15 (1) ◽  
pp. 50-58 ◽  
Author(s):  
A Gajofatto ◽  
P Bacchetti ◽  
B Grimes ◽  
A High ◽  
E Waubant
Keyword(s):  
Multiple Sclerosis ◽  
Initial Therapy ◽  
First Line ◽  
Disease Modifying Therapy ◽  
Disease Modifying Therapies ◽  
Relapsing Remitting ◽  
Disease Modifying ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Background Options for non-responders to relapsing–remitting multiple sclerosis (RRMS) first-line disease-modifying therapies (DMT) are limited. We explored whether switching first-line DMT is effective. Methods Patients with RRMS who first received interferon-beta (IFNB) or glatiramer acetate (GA) were classified in three categories: DMT change because of suboptimal response, DMT change because of other reasons, and no DMT change during follow-up. Outcomes included annualized relapse rate (ARR) and relapse-free proportions. Results We identified 597 patients who initiated first-line DMT. For patients who did not change DMT ( n = 240), pre-DMT and on-DMT median ARR were 0.50 and 0 ( P < 0.0001). At 24 months, 76% (95%CI = 69–81%) of patients who did not change DMT were relapse-free. Of the 155 who switched because of suboptimal response, 101 switched to another first-line DMT. Median ARR pre-DMT, on first DMT and second DMT were: 0.50, 0.55, and 0.25 for switchers from IFNB to GA (IFNB/GA, n = 12) (pre-DMT versus first DMT: P = 0.92; first versus second DMT: P = 0.31); 0.90, 0.50, and 0 for switchers from GA to IFNB (GA/IFNB, n = 18; P = 0.19; P = 0.01); 0.50, 0.68, and 0 for switchers from an IFNB to another IFNB (IFNB/IFNB’, n = 71; P = 0.34; P = 0.02). Estimated relapse-free proportion after 24 months of treatment was 42% (95%CI=15–66%) during the period on IFNB versus 53% (95%CI = 17–80%) on GA for IFNB/GA ( P = 0.21); 12% (95%CI = 0–40%) on GA versus 87% (95%CI = 59–97%) on IFNB for GA/IFNB ( P = 0.001); and 41% (95%CI = 29–52%) on initial IFNB versus 67% (95%CI = 53–79%) on subsequent IFNB for IFNB/IFNB’ ( P = 0.0001). Conclusions Switching first-line DMT in patients with RRMS failing initial therapy may be effective in many cases.

scholarly journals Early High Efficacy Treatment in Multiple Sclerosis Is the Best Predictor of Future Disease Activity Over 1 and 2 Years in a Norwegian Population-Based Registry

2021 ◽  
Vol 12 ◽  
Author(s):  
Cecilia Smith Simonsen ◽  
Heidi Øyen Flemmen ◽  
Line Broch ◽  
Cathrine Brunborg ◽  
Pål Berg-Hansen ◽  
...  
Keyword(s):  
Disease Activity ◽  
Treatment Guidelines ◽  
Population Based ◽  
World Population ◽  
High Efficacy ◽  
Disease Modifying Therapies ◽  
First Choice ◽  
Disease Modifying ◽  
Population Based Registry ◽  
The Impact

Background: Moderate and high efficacy disease modifying therapies (DMTs) have a profound effect on disease activity. The current treatment guidelines only recommend high efficacy DMTs for patients with highly active MS. The objective was to examine the impact of initial treatment choice in achieving no evidence of disease activity (NEDA) at year 1 and 2.Methods: Using a real-world population-based registry with limited selection bias from the southeast of Norway, we determined how many patients achieved NEDA on moderate and high efficacy DMTs.Results: 68.0% of patients who started a high efficacy DMT as the first drug achieved NEDA at year 1 and 52.4% at year 2 as compared to 36.0 and 19.4% of patients who started a moderate efficacy DMT as a first drug. The odds ratio (OR) of achieving NEDA on high efficacy drugs compared to moderate efficacy drugs as a first drug at year 1 was 3.9 (95% CI 2.4–6.1, p &lt; 0.001). The OR for high efficacy DMT as the second drug was 2.5 (95% CI 1.7–3.9, p &lt; 0.001), and was not significant for the third drug. Patients with a medium or high risk of disease activity were significantly more likely to achieve NEDA on a high efficacy therapy as a first drug compared to moderate efficacy therapy as a first drug.Conclusions: Achieving NEDA at year 1 and 2 is significantly more likely in patients on high-efficacy disease modifying therapies than on moderate efficacy therapies, and the first choice of treatment is the most important. The immunomodulatory treatment guidelines should be updated to ensure early, high efficacy therapy for the majority of patients diagnosed with MS.

scholarly journals Use of Disease-Modifying Therapies in Pediatric Relapsing-Remitting Multiple Sclerosis in the United Kingdom

2021 ◽  
Vol 8 (4) ◽  
pp. e1008
Author(s):  
Omar A. Abdel-mannan ◽  
Celeste Manchoon ◽  
Thomas Rossor ◽  
Justine-Clair Southin ◽  
Carmen Tur ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Modifying Therapies ◽  
Increased Risk ◽  
Relapsing Remitting ◽  
Relapse Time ◽  
Disease Modifying ◽  
Edss Score ◽  
Remitting Multiple Sclerosis ◽  
Time To Relapse ◽  
Relapsing Remitting Multiple Sclerosis

ObjectivesTo compare the real-world effectiveness of newer disease-modifying therapies (DMTs) vs injectables in children with relapsing-remitting multiple sclerosis (RRMS).MethodsIn this retrospective, multicenter study, from the UK Childhood Inflammatory Demyelination Network, we identified children with RRMS receiving DMTs from January 2012 to December 2018. Clinical and paraclinical data were retrieved from the medical records. Annualized relapse rates (ARRs) before and on treatment, time to relapse, time to new MRI lesions, and change in Expanded Disability Status Scale (EDSS) score were calculated.ResultsOf 103 children treated with DMTs, followed up for 3.8 years, relapses on treatment were recorded in 53/89 (59.5%) on injectables vs 8/54 (15%) on newer DMTs. The ARR was reduced from 1.9 to 1.1 on injectables (p < 0.001) vs 1.6 to 0.3 on newer DMTs (p = 0.002). New MRI lesions occurred in 77/89 (86.5%) of patients on injectables vs 26/54 (47%) on newer DMTs (p = 0.0001). Children on newer DMTs showed longer time to relapse, time to switch treatment, and time to new radiologic activity than patients on injectables (log-rank p < 0.01). After adjustment for potential confounders, multivariable analysis showed that injectables were associated with 12-fold increased risk of clinical relapse (adjusted hazard ratio [HR] = 12.12, 95% CI = 1.64–89.87, p = 0.015) and a 2-fold increased risk of new radiologic activity (adjusted HR = 2.78, 95% CI = 1.08–7.13, p = 0.034) compared with newer DMTs. At 2 years from treatment initiation, 38/103 (37%) patients had MRI activity in the absence of clinical relapses. The EDSS score did not change during the follow-up, and only 2 patients had cognitive impairment.ConclusionNewer DMTs were associated with a lower risk of clinical and radiologic relapses in patients compared with injectables. Our study adds weight to the argument for an imminent shift in practice toward the use of newer, more efficacious DMTs in the first instance.Classification of EvidenceThis study provides Class IV evidence that newer DMTs (oral or infusions) are superior to injectables (interferon beta/glatiramer acetate) in reducing both clinical relapses and radiologic activity in children with RRMS.

Initial high-efficacy disease-modifying therapy in multiple sclerosis

Neurology ◽  
2020 ◽  
Vol 95 (8) ◽  
pp. e1041-e1051 ◽  
Author(s):  
Mathias Due Buron ◽  
Thor Ameri Chalmer ◽  
Finn Sellebjerg ◽  
Ismael Barzinji ◽  
Jeppe Romme Christensen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Lower Probability ◽  
Matched Sample ◽  
Class Iii ◽  
High Efficacy ◽  
Disease Modifying Therapies ◽  
Baseline Activity ◽  
First Relapse ◽  
Disease Modifying ◽  
Edss Score

ObjectiveTo determine the effectiveness of high-efficacy disease-modifying therapies (heDMTs) vs medium-efficacy disease-modifying therapies (meDMT) as the first treatment choice in treatment-naive patients with multiple sclerosis (MS) on disability worsening and relapses. We assessed this using a nationwide population-based MS registry.MethodsWe identified all patients starting a heDMT as first-time treatment from the Danish Multiple Sclerosis Registry and compared treatment outcomes with a propensity score matched sample of patients starting meDMT.ResultsWe included 388 patients in the study: 194 starting initial therapy with heDMT matched to 194 patients starting meDMT. At 4 years of follow-up, the probabilities of a 6-month confirmed Expanded Disability Status Scale (EDSS) score worsening were 16.7% (95% confidence interval [CI] 10.4%–23.0%) and 30.1% (95% CI 23.1%–37.1%) for heDMT and meDMT initiators, respectively (hazard ratio [HR] 0.53, 95% CI 0.33–0.83, p = 0.006). Patients initiating heDMT also had a lower probability of a first relapse (HR 0.50, 95% CI 0.37–0.67). Results were similar after pairwise censoring and in subgroups with high baseline activity, diagnosis after 2006, or information on baseline T2 lesion load.ConclusionWe found a lower probability of 6-month confirmed EDSS score worsening and lower probability of a first relapse in patients starting a heDMT as first therapy, compared to a matched sample starting meDMT.Classification of evidenceThis study provides Class III evidence that for patients with MS, starting heDMT lowers the risk of EDSS worsening and relapses compared to starting meDMT.

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