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.

Identifying Relapses in Multiple Sclerosis Patients through Administrative Data: A Validation Study in the Lazio Region, Italy

2017 ◽  
Vol 48 (3-4) ◽  
pp. 171-178 ◽  
Author(s):  
Paola Colais ◽  
Nera Agabiti ◽  
Marina Davoli ◽  
Fabio Buttari ◽  
Diego Centonze ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measure ◽  
Administrative Databases ◽  
Predictive Values ◽  
Lazio Region ◽  
Relapsing Remitting ◽  
The Mean ◽  
Using Data ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Background: Relapse is frequently considered an outcome measure of disease activity in relapsing-remitting multiple sclerosis (MS). The objectives of this study were to identify relapse episodes in patients with MS in the Lazio region using health administrative databases and to evaluate the validity of the algorithm using patients enrolled at MS treatment centers. Methods: MS cases were identified in the period between January 1, 2006 and December 31, 2009 using data from regional Health Information Systems (HIS). An algorithm based on HIS was used to identify relapse episodes, and patients recruited at MS centers were used to validate the algorithm. Positive and negative predictive values (PPV, NPV) and the Cohen's kappa coefficient were calculated. Results: The overall MS population identified through HIS consisted of 6,094 patients, of whom 67.1% were female and the mean age was 41.5. Among the MS patients identified by the algorithm, 2,242 attended the centers and 3,852 did not. The PPV was 58.9%, the NPV was 76.3%, and the kappa was 0.36. Conclusions: The proposed algorithm based on health administrative databases does not seem to be able to reliably detect relapses; however, it may be a helpful tool to detect healthcare utilization, and therefore to identify the worsening condition of a patient's health.

scholarly journals The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study

PLoS ONE ◽  
2017 ◽  
Vol 12 (4) ◽  
pp. e0176174 ◽  
Author(s):  
Guillermo Izquierdo ◽  
Fátima Damas ◽  
Maria Dolores Páramo ◽  
Juan Luis Ruiz-Peña ◽  
Guillermo Navarro
Keyword(s):  
Multiple Sclerosis ◽  
Observational Study ◽  
Real World ◽  
The Real ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

scholarly journals P166 Multimorbidity in SLE, a barrier to clinical trial eligibility: results from the BILAG-BR

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Sarah Dyball ◽  
Sophie Collinson ◽  
Emily Sutton ◽  
Eoghan McCarthy ◽  
Ben Parker ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Phase Iii ◽  
Research Support ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Chi Squared ◽  
The Mean ◽  
Double Blinded ◽  
Age And Sex

Abstract Background/Aims  Stringent inclusion and exclusion criteria are employed in SLE clinical trials. Organ dysfunction and co-morbidities are common exclusion criteria which may affect how representative trials are of real-world SLE populations. We aimed to apply published trial eligibility criteria to patients with SLE in a large national register. Methods  A literature review of all major published double-blinded randomised phase III trials in non-renal SLE was performed. Common inclusion and exclusion criteria were applied to all patients recruited to the BILAG-Biologics Register (BILAG-BR), a large UK-wide register of SLE patients. Data on comorbidities for all patients registered was collected. The mean (SD) number of co-morbidities was calculated. Patients were then classified as being eligible or ineligible. Groups were compared initially using a chi-squared or Wilcoxon rank-sum test and logistic regression model was used to test the age and sex adjusted association between trial eligibility and comorbidities. Results  Common inclusion and exclusion criteria were identified from 12 published trials. When applied to the 837 patients recruited to BILAG-BR, 562 (67%) patients would not be eligible for inclusion in these trials. Ineligible patients had a shorter disease duration (2.9 vs. 5.1 years, p < 0.01), but were similar in age (P = 1.0), sex (P = 0.7) and ethnicity (p = 0.5) to those who were eligible. Of eligible patients, 128 (53%) had 1 or more comorbidities compared with 340 (60%) who were ineligible (p = 0.05). The mean (SD) number of comorbidities was 0.9 (1.2) vs 1.2 (1.3) for eligible and ineligible patients respectively. After adjusting for age and sex, inclusion in clinical trials was associated with fewer comorbidities (OR 0.81, 95% CI 0.70, 0.94, p < 0.01). Conclusion  Patients with multi-morbidity are more likely to be ineligible for SLE clinical trials. Evidence from real world studies and registers are therefore needed to fully understand the safety and effectiveness of new therapies. Our data also underscores the need to develop more pragmatic eligibility criteria for clinical trials. Disclosure  S. Dyball: None. S. Collinson: None. E. Sutton: None. E. McCarthy: None. B. Parker: Consultancies; GSK, AstraZenica, UCB, Abbvie, Pfizer, BMS, Celltrion. Grants/research support; GSK, Sanofi Genzyme. I. Bruce: Consultancies; GSK, Medimmune, AstraZenica, Eli Lilly, Merck Serono, UCB, ILTOO. Member of speakers’ bureau; AstraZeneca, Medimmune, GSK, UCB. Grants/research support; GSK, Genzyme Sanofi, UCB.

scholarly journals Effect of applying inclusion and exclusion criteria of phase III clinical trials to multiple sclerosis patients in routine clinical care

2021 ◽  
pp. 135245852098511
Author(s):  
Kris Oliver Jalusic ◽  
David Ellenberger ◽  
Paulus Rommer ◽  
Alexander Stahmann ◽  
Uwe Zettl ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Care ◽  
Routine Care ◽  
Phase Iii ◽  
Exclusion Criteria ◽  
Phase Iii Clinical Trial ◽  
Phase Iii Clinical Trials ◽  
Multiple Sclerosis Patients

Background: Newly approved, drug-modifying therapies are associated with still unknown adverse events, although clinical trials leading to approval have strict inclusion and exclusion criteria and analyse safety and efficacy. Objectives: The aim of this study was to analyse the eligibility of multiple sclerosis (MS) patients treated in routine care into the phase III clinical trial of the respective drug. Methods: In total, 3577 MS patients with 4312 therapies were analysed. Patients with primary-progressive MS were excluded. Inclusion and exclusion criteria of phase III clinical trials in relapsing–remitting MS were adopted and subsequently applied. A comparison in clinical and sociodemographic characteristics was made between patient who met the criteria and those who did not. Results: 83% of registered patients would not have been eligible to the respective phase III clinical trial. Relapse was the single most frequent criterion not fulfilled (74.7%), followed by medication history (21.2%). Conclusion: The majority of MS patients treated in routine care would not have met clinical trials criteria. Thus, the efficacy and safety of therapies in clinical trials can differ from those in the real world. Broader phase III inclusion criteria would increase their eligibility and contribute to a better generalizability of the results in clinical trials.

Interferon beta treatment for multiple sclerosis: persisting questions

1996 ◽  
Vol 1 (6) ◽  
pp. 321-324 ◽  
Author(s):  
Donald E Goodkin
Keyword(s):  
Multiple Sclerosis ◽  
Interferon Beta ◽  
Neutralizing Antibody ◽  
Optimal Dose ◽  
Phase Iii ◽  
Exacerbation Rate ◽  
Phase Iii Trial ◽  
Imaging Results ◽  
Relapsing Remitting ◽  
Ambulatory Patients

Doctors Noteworthy and Summerfield have reviewed the results of placebo-controlled, double-masked, clinical trials of interferon beta-1b (IFNB-1b, Betaseron) and interferons beta-1a (IFNB-1a, Avonex,) in patients with relapsing multiple sclerosis (MS). IFNB-1b, administered subcutaneously every other day to ambulatory patients with relapsing-remitting MS, significantly reduces annual exacerbation rate and percentage change from baseline MRI T2-weighted total lesion area.1-4 There is also evidence that IFNB-1b reduces the number of new gadolinium-enhancing lesions in patients with relapsing-remitting MS.5 IFNB-1a (Avonex), administered intramuscularly every week to patients with relapsing MS, significantly reduces annual exacerbation rate, the number and volume of new focal gadolinium-enhanced T1-weighted lesions, and slows the accumulation of physical disability over time.6 However, questions remain regarding the efficacy of these treatments, the significance of neutralizing antibody formation, indications for therapy, adverse events, optimal dose, and route of administration. Design limitations of the Phase III trial of IFNB-1b have been reviewed elsewhere, 7 and a critical review of the results of the Phase III trial of IFNB-1a should be undertaken after the publication of the clinical and imaging results of that study.

scholarly journals Safety and Efficacy of Fingolimod in Treatment-Naïve Multiple Sclerosis Patients

2011 ◽  
Vol 3 ◽  
pp. JCNSD.S5120 ◽  
Author(s):  
James J. Marriott
Keyword(s):  
Multiple Sclerosis ◽  
The United States ◽  
Phase Iii ◽  
Disease Modifying Therapy ◽  
Relapsing Remitting ◽  
Treatment Naïve ◽  
Disease Modifying ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Fingolimod was recently approved for use in the United States after two phase III trials confirmed its effectiveness in reducing disease activity in relapsing-remitting multiple sclerosis. These positive results, coupled with the important fact that this is the first oral disease-modifying therapy, has lead to considerable enthusiasm amongst physicians and patients. However, fingolimod is associated with rare but serious adverse events. In addition, unlike conventional disease-modifying therapies, cardiopulmonary, ophthalmological and dermatological safety monitoring unfamiliar to both neurologists and patients is required before and during treatment. This paper will discuss these issues from the perspective of using fingolimod as a first-line disease-modifying therapy in treatment-Naïve relapsing-remitting multiple sclerosis patients

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