Response to interferon-beta therapy in relapsing-remitting multiple sclerosis: a comparison of different clinical criteria

2006 ◽  
Vol 12 (3) ◽  
pp. 281-286 ◽  
Author(s):  
E Portaccio ◽  
V Zipoli ◽  
G Siracusa ◽  
S Sorbi ◽  
M P Amato
Keyword(s):  
Multiple Sclerosis ◽  
Relapse Rate ◽  
Interferon Beta ◽  
Clinical Criteria ◽  
Predictors Of Response ◽  
Lower Baseline ◽  
Disability Status ◽  
Relapsing Remitting ◽  
One Year ◽  
Relapsing Remitting Multiple Sclerosis

We assessed the proportion and potential predictors of response to interferon-beta (IFNβ) therapy in relapsing-remitting (RR) multiple sclerosis (MS) patients, comparing different definitions of response: a) lower relapse rate during therapy compared to the year and the two years before therapy, b) reduction of relapse rate during therapy of at least 30% compared to the two years before therapy, c) no relapse during treatment, d) no progression on the Expanded Disability Status Scale (EDSS). Among 147 RR patients treated for at least one year, 33 received IFNβ-1b subcutaneously (SC) (Betaferon), 59 IFNβ-1a intramuscularly (Avonex) and 55 IFNβ-1a SC (Rebif). Using definitions a), b) and d), 72%, 73% and 73% patients, respectively, were considered responders. Forty-four per cent of our patients were completely relapse free. In the logistic regression model, using definitions a) and b), a higher relapse rate in the two years preceding the therapy turned out to be a significant predictor of response. Considering definition c), lower baseline relapse rate was associated with a more favourable response.

Smoking affects the interferon beta treatment response in multiple sclerosis

Neurology ◽  
2018 ◽  
Vol 90 (7) ◽  
pp. e593-e600 ◽  
Author(s):  
Eva R. Petersen ◽  
Annette B. Oturai ◽  
Nils Koch-Henriksen ◽  
Melinda Magyari ◽  
Per S. Sørensen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Relapse Rate ◽  
Interferon Beta ◽  
Human Leukocyte ◽  
Leukocyte Antigen ◽  
End Of Treatment ◽  
Relapsing Remitting ◽  
Observational Cohort ◽  
Treatment Register ◽  
Relapsing Remitting Multiple Sclerosis

ObjectiveTo investigate whether smoking in patients with relapsing-remitting multiple sclerosis (RRMS) treated with interferon beta (IFN-β) is associated with the relapse rate and whether there is an interaction between smoking and human leukocyte antigen (HLA)–DRB1*15:01, HLA-A*02:01, and the N-acetyltransferase-1 (NAT1) variant rs7388368A.MethodsDNA from 834 IFN-β–treated patients with RRMS from the Danish Multiple Sclerosis Biobank was extracted for genotyping. Information about relapses from 2 years before the start of treatment to either the end of treatment or the last follow-up visit was obtained from the Danish Multiple Sclerosis Treatment Register. Smoking information came from a comprehensive questionnaire.ResultsWe found that the relapse rate in patients with RRMS during IFN-β treatment was higher in smokers compared to nonsmokers, with an incidence rate ratio (IRR) of 1.20 (95% confidence interval [CI] 1.021–1.416, p = 0.027) and with an IRR increase of 27% per pack of cigarettes per day (IRR 1.27, 95% CI 1.056–1.537, p = 0.012). We found no association or interaction with HLA and the NAT1 variant.ConclusionIn this observational cohort study, we found that smoking is associated with increased relapse activity in patients with RRMS treated with IFN-β, but we found no association or interaction with HLA or the NAT1 variant.

Interferon beta in relapsing-remitting multiple sclerosis: an independent postmarketing study in southern Italy

2003 ◽  
Vol 9 (5) ◽  
pp. 451-457 ◽  
Author(s):  
Maria Trojano ◽  
Maria Liguori ◽  
Damiano Paolicelli ◽  
Giovanni Bosco Zimatore ◽  
Francesca De Robertis ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Interferon Beta ◽  
Population Based ◽  
First Year ◽  
Independent Population ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

This independent, population-based surveillance study monitored the efficacy and safety of interferon beta (IFNb) products in 1033 patients with relapsing -remitting multiple sclerosis (RRMS) from 15 centres in Italy. Relapses, Expanded Disability Status Scale (EDSS) scores, and adverse events were evaluated for up to 24 months. Data of patients with a baseline EDSS score 5-3.5 are reported. The proportions of relapse-free patients were similar among the groups at 12 and 24 months (P =0.10). IFNb products produced significant reductio ns from baseline in relapse rates at 12 and 24 months (P B-0.001), with no differences among treatments (P =0.2). There were no significant differences in mean EDSS change among groups at 12 or 24 months. The IFNb-1b group showed a higher incidence of adverse events during the first year of treatment (P B-0.05) than IFNb-1a groups, and more withdrawals (10%) compared with Avonex (5%) at 24 months. IFNb products are equally effective in low disability RRMS, but IFNb-1a may have a more favorable efficacy/tolerability ratio.

The Danish National Project of interferon-beta treatment in relapsing-remitting multiple sclerosis

2000 ◽  
Vol 6 (3) ◽  
pp. 172-175 ◽  
Author(s):  
Nils Koch-Henriksen ◽  
Per Soelberg Sùrensen ◽  
Keyword(s):  
Multiple Sclerosis ◽  
Relapse Rate ◽  
Interferon Beta ◽  
Randomised Trial ◽  
Neutralizing Antibody ◽  
The European Union ◽  
Relapsing Remitting ◽  
First Relapse ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

After approval by the European Union in 1996 of interferon-beta for treatment of relapsing-remitting multiple sclerosis (RRMS), 862 patients in Denmark have received treatment (by April 1999), and 304 of those were enrolled into an open labelled randomised trial to compare the efficacy and tolerability of treatment with interferon-beta-1b (Betaferon) 8 MIU subcutaneous every other day and interferon-beta-1a (Rebif) 6 MIU subcutaneous once a week. Primary and secondary end-points included: (1) the relapse rate, (2) tolerability, (3) neutralizing antibody formation using the same specialised laboratory and validated assay, (4) time to first relapse, (5) time to sustained progression, and (6) number of gadolinium-enhancing lesions in T1-weighted MRI and the total lesion load in T2-weighted MRI. All the records are kept in a nationwide clinical database connected with the Danish Multiple Sclerosis Registry. The randomised trial will be completed by the end of 1999, and the results are not yet available. The annual relapse rate in all treated patients until April 1999 was 0.73, the annual rate of steroid treated relapses was 0.21. By 1 April 1999 8.8% of the patients had discontinued treatment and 10.4% had changed to another interferon-beta preparation. It has been planned to extend the follow-up of all patients treated according to the Danish National Protocol for a period of several years. The continuous and nation-wide registration of the course of the disease in interferon-beta treated RRMS patients may provide valuable knowledge of the treatment-modified long-term course of the disease in a cohort of patients, selected on the basis of well-defined criteria.

scholarly journals GP.02 A population-based study of “no evident disease activity” (NEDA) in multiple sclerosis

2018 ◽  
Vol 45 (s2) ◽  
pp. S8-S8
Author(s):  
NE Parks ◽  
SJ Pittock ◽  
J Mandrekar ◽  
OH Kantarci ◽  
CF Lucchinetti ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Retrospective Chart Review ◽  
Population Based ◽  
Disease Modifying Therapy ◽  
Disability Status ◽  
Relapsing Remitting ◽  
One Year ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Incident Cases ◽  
Referral Bias

Background: NEDA is a composite measure that may ultimately influence clinical decisions concerning switches of disease modifying therapy (DMT) for relapsing remitting multiple sclerosis (RRMS) patients. Cohort studies from MS clinics suggest NEDA is not sustained over time in most patients despite DMT but may be limited by referral bias. We investigated NEDA in a population-based RRMS cohort. Methods: We identified all incident cases of RRMS in Olmsted County from 01/01/2000-12/31/2011. Retrospective chart review was conducted to determine persistence of NEDA -following RRMS diagnosis. NEDA failure was defined as new MRI activity, relapse, or expanded disability status scale (EDSS) -worsening. Results: There were 93 incident cases of RRMS with 82 individuals having sufficient follow-up to determine persistence of NEDA. Prior to NEDA failure 44 were not on DMT, 37 were on first-tier, injectable DMT, and 1 received mitoxantrone. NEDA was maintained by 63% at 1 year, 38% at 2 years, 19% at 5 years, and 12% at 10 years. Disability measured by EDSS was no different at 10 years in patients maintaining NEDA versus those that failed NEDA at one year (p=0.3). Conclusions: Maintenance of NEDA beyond 2 years is infrequent among a population-based cohort of newly diagnosed RRMS patients and similar to prior clinic-based cohorts.

scholarly journals First Experience and the Effectiveness of Immunomodulating Treatment in Inflammatory Demyelinating CNS Diseases: Analysis of Nine Patients / Imūnmodulējošās Terapijas Efektivitāte Centrālās Nervu Sistēmas Iekaisīgu Saslimšanu Gadījumos: Deviņu Pacientu Analīze

2015 ◽  
Vol 69 (5) ◽  
pp. 269-273
Author(s):  
Lana Vainšteine ◽  
Andrejs Kostiks ◽  
Guntis Karelis ◽  
Viktorija Ķēniņa ◽  
Natalja Zlobina ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Neurological Status ◽  
Spectrum Disorder ◽  
University Hospital ◽  
Clinical Criteria ◽  
Mcdonald Criteria ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Spectrum Disorders ◽  
Relapsing Remitting Multiple Sclerosis

Abstract Therapeutic plasma exchange (TPE) is used in many neurological disorders to remove immunoglobulin and other immunologically active substances. We observed patients that were admitted in Rīga East Clinical University Hospital “Gaiļezers”, Clinic of Neurology and Neurosurgery, Multiple Sclerosis Unit, and were diagnosed with relapsing remitting multiple sclerosis (MS), according to McDonald criteria 2010 (five patients), Neuromyelitis optica (NMO) spectrum disorders (three patients) and one with NMO, according to Wingerchuk 2006 criteria. All relapses were confirmed according to clinical criteria. Visual acuity was assessed by an ophthalmologist, and neurological status by a neurologist. All patients received at least 1 cycle of 1000 mg methylprednisolone intravenous for five to seven days. The expanded disability status scale score in the MS patient group was in range 4.0-9.0 before TPE and 3.5-6.5 range after TPE. Best improvement was observed in the MS group: mean symptom reduction of 20%. Patients with NMO spectrum disorder had an EDSS score of 8.0-8.5 range on admission and 6.5-8.0 range after TPE. After one month, one patient in the NMO spectrum disorder group had good response to TPE and EDSS was 3.5, two patients had only slight improvement (EDSS scores 8.0 and 7.5). Condition of patients with NMO did not improve even after a month.

A randomized study of two interferon- beta treatments in relapsing–remitting multiple sclerosis

Neurology ◽  
2006 ◽  
Vol 66 (7) ◽  
pp. 1056-1060 ◽  
Author(s):  
N. Koch-Henriksen ◽  
P. S. Sørensen ◽  
T. Christensen ◽  
J. Frederiksen ◽  
M. Ravnborg ◽  
...  
Keyword(s):  
Relapse Rate ◽  
Interferon Beta ◽  
Randomized Study ◽  
Neutralizing Antibody ◽  
Open Label ◽  
Disability Status ◽  
Relapsing Remitting ◽  
First Relapse ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Relapse Rates

Objective: To investigate whether the efficacy of interferon-beta (IFNβ) treatment of relapsing–remitting MS (RR-MS) was influenced by type, dose, and frequency of administration.Methods: From June 1996 through October 1997, the authors offered participation to all Danish RR-MS patients who met the following criteria: definite MS, at least two relapses within 2 years, age 18 to 55, and an Expanded Disability Status Scale (EDSS) score of ≤5.5. The study was multicenter, controlled, open-label, randomized, head-to-head comparing IFNβ-1a 22 μg once a week (n = 143) with IFNβ-1b 250 μg every other day (n = 158), both subcutaneously, for 24 months. Patients who declined randomization were offered treatment with IFNβ-1b 250 μg every other day (n = 120). The primary end-points were the annualized relapse rate, the time to first relapse, and neutralizing antibody formation. The secondary endpoint was time to sustained progressionResults: The annual relapse rates were virtually equal in the two arms of the randomized study (IFNβ-1a: 0.70; IFNβ-1b: 0.71); so were the time to first relapse and the time to sustained progression. In the nonrandomized patients (IFNβ-1b), the annual relapse rate was not significantly different, but the time to progression was shorter.Conclusion: In this study, 250 μg interferon-beta-1b administered every other day did not prove clinically superior to once-a-week administration of 22 μg interferon-beta-1a.

scholarly journals Interferon beta-1b in treatment-naïve paediatric patients with relapsing–remitting multiple sclerosis: Two-year results from the BETAPAEDIC study

2017 ◽  
Vol 3 (4) ◽  
pp. 205521731774762 ◽  
Author(s):  
Jutta Gärtner ◽  
Wolfgang Brück ◽  
Almuth Weddige ◽  
Hannah Hummel ◽  
Christiane Norenberg ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Standard Deviation ◽  
Interferon Beta ◽  
Expanded Disability Status Scale ◽  
Paediatric Patients ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Treatment Naïve ◽  
Relapsing Remitting Multiple Sclerosis

Background and objective Study evaluating Betaferon(R)'s safety and tolerability in paediatric patients with multiple sclerosis (BETAPAEDIC) is a prospective, open-label observational multicentre study to assess the safety and effectiveness of interferon beta-1b in paediatric patients with relapsing–remitting multiple sclerosis. Methods Treatment-naïve patients (12–16 years) scheduled to start interferon beta-1b were enrolled with follow-up visits every six months for two years. Effectiveness was evaluated by annualised relapse rate, Expanded Disability Status Scale progression, cranial magnetic resonance imaging and cognitive testing. Fatigue was assessed by the Fatigue Severity Scale. Results Sixty-eight patients were screened and 67 enrolled, with mean (standard deviation) age 14.2 (1.3) years ( n=65 in the effectiveness analysis). Mean disease duration was 11 months before study enrolment; at baseline, mean (standard deviation) Expanded Disability Status Scale was 0.6 (1.0); T2 lesion number 18.3 (15.1). Mean annualised relapse rate during the study was 0.7 ( n=57), 28/57 patients (49.1%) had no relapses and for 40/52 (76.9%) no Expanded Disability Status Scale progression was observed; 23/56 (41.1%) were relapse- and progression-free to last follow-up. Neuropsychological test and fatigue scores were within normal ranges (baseline and last follow-up). Eighteen patients had fatigue at some point. New T2 and gadolinium-enhancing (Gd+) lesions were seen in 43/55 (66.2%) and 29/55 (52.7%) patients respectively. Most frequent adverse events were influenza-like illness, headache, injection-site reactions and elevated liver enzymes. Conclusion Interferon beta-1b is an effective treatment with a favourable safety profile for paediatric patients.

Longitudinal analyses of the effects of neutralizing antibodies on interferon beta-1b in relapsing-remitting multiple sclerosis

2004 ◽  
Vol 10 (2) ◽  
pp. 126-138 ◽  
Author(s):  
A John Petkau ◽  
Richard A White ◽  
George C Ebers ◽  
Anthony T Reder ◽  
William A Sibley ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Neutralizing Antibodies ◽  
Interferon Beta ◽  
Neutralizing Antibody ◽  
High Dose ◽  
Exacerbation Rate ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

We have analysed data on exacerbation rates, Expanded Disability Status Scale (EDSS) scores, and lesion burdens using the results of two neutralizing antibody (NA B) assays (C PE and MxA) from the pivotal relapsing-remitting multiple sclerosis (MS) trial of interferon beta-1b (IFNB) with a longitudinal appro ach, where the influence of NA Bs in individual patients is assessed by comparing responses during NAB- positive and NA B-negative periods. There are apparent influences on exacerbation rate related to dose of IFNB, titer level, and duration of positivity. With the MxA assay, exacerbation rates after switching to NA B-positive status are estimated to be 28% higher [95% confidence interval (CI): (-15%, 92%)] and -2% higher [95% CI: (-21%, 21%)] on the low- and high-dose IFNB arms, respectively. When compared with all NA B-negative periods, exacerbation rates during NA B-positive periods are estimated to be 29% higher [95% C I: (0%, 67%)] and 18% higher [95% CI: (0%, 40%)] on the low- and high-dose IFNB arms, respectively. When NA B-positive patients again become NA B-negative, no evidence of increased exacerbation rates could then be demonstrated. More detailed exploratory analyses indicate that the effects are most evident in the approximately 20% of patients developing high titers. In these patients, the influence of NABs may be self-limited, as titers often diminish or NA Bs become undetectable with time.

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