This study evaluates the real-world safety and discontinuation rate of Zadiva
(generic product of dimethyl fumarate (DMF)) in Iranian patients with relapsing-remitting multiple sclerosis (RRMS), ...supplementing existing clinical evidence from randomized controlled trials.
This retrospective observational study evaluated the real-world safety and discontinuation rate of DMF in RRMS patients from Amir A'lam referral hospital's neurology clinic. Data on safety, discontinuation rate, and clinical disease activity were collected retrospectively. The study aimed to assess the discontinuation rate, safety, and reasons for discontinuation, as well as the number of patients experiencing a relapse, MRI activity, and EDSS scores.
In total, 142 RRMS patients receiving DMF were included in the study, with 15 discontinuing treatment due to adverse events, lack of efficacy, or pregnancy. Notably, a significant reduction in relapse rates was observed, with 90.8% of patients remaining relapse-free throughout the study period. After 1 year of treatment with Zadiva
, only 17.6% of patients experienced MRI activity, whereas the EDSS score remained stable.
This study provides important real-world data on the safety and tolerability of Zadiva
in RRMS patients. The results indicate that Zadiva
is generally well tolerated and safe, with a low discontinuation rate due to adverse events or lack of efficacy. These findings suggest that Zadiva
is an effective and safe treatment option for RRMS patients in real-world practice.
Multiple sclerosis (MS) is an inflammatory autoimmune disease of the central nervous system, in which proinflammatory cytokines play a critical role in the pathogenic formation of lesions. Caspase-1 ...is a cysteine protease that proteolytically cleaves precursors of interleukin (IL)-18 and IL-1β and turns them into their active forms. These inflammatory cytokines play an important role in the development of MS. The aim of the present study was the investigation of caspase-1 and its downstream products, IL-18 and IL-1β, in relapsing-remitting MS (RRMS) patients. In this study, we used an ELISA assay to measure serum and cellular caspase-1 and serum levels of IL-18 and IL-1β in RRMS patients in the relapse phase (n=23) and healthy age-and gender-matched controls (n=19). We observed that the caspase-1 level was significantly increased in the serum of MS patients compared to the healthy controls (p=0.03). Although caspase-1 concentration in the lysate of peripheral blood mononuclear cells (PBMCs) was higher than serum among patients and controls (p<0.001), no significant difference was found in cellular levels of caspase-1 between the two groups. There was no significant difference in serum levels of IL-18 and IL-1β between patients and controls. In this study, we found an elevation of extracellular caspase-1, as a reflection of its intracellular level, in the serum of RRMS patients during the relapse phase. Therefore, it suggests being a suitable peripheral biomarker of disease activity in multiple sclerosis.
This study was designed to evaluate ALS progression among different subgroups of Iranian patients.
Three hundred and fifty-eight patients from centres around the country were registered and their ...progression rate was evaluated using several scores including Manual Muscle Test scoring (MMT) and the revised ALS Functional Rating Scale (ALSFRS-R). Progression rate was analysed separately in subgroups regarding gender, onset site, stage of disease and riluzole consumption. A significant difference in MMT deterioration rate (p = 0.01) was noted between those who used riluzole and those who did not. No significant difference was observed in progression rates between male/female and bulbar-onset/limb-onset groups using riluzole. In conclusion, riluzole has a significant effect on muscle force deterioration rate but not functional scale. Progression rate was not influenced by site of onset or gender.
Celotno besedilo
Dostopno za:
DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Migraine is a neurologic disease, which often is associated with a unilateral headache. Vestibular abnormalities are common in migraine. Vestibular evoked myogenic potentials (VEMPs) assess otolith ...function in particular functional integrity of the saccule and the inferior vestibular nerve. We used VEMP to evaluate if the migraine headache can affect VEMP asymmetry parameters. A total of 25 patients with migraine (22 females and 3 males) who were diagnosed according to the criteria of IHS-1988 were enrolled in this cross-sectional study. Control group consisted of 26 healthy participants (18 female and 8 male), without neurotological symptoms and history of migraine. The short tone burst (95 dB nHL, 500 Hz) was presented to ears. VEMP was recorded with surface electromyography over the contracted ipsilateral sternocleidomastoid (SCM) muscle. Although current results showed that the amplitude ratio is greater in migraine patients than normal group, there was no statistical difference between two groups in mean asymmetry parameters of VEMP. Asymmetry measurements in vestibular evoked myogenic potentials probably are not indicators of unilateral deficient in saccular pathways of migraine patients.
Introduction: High frequency of adverse drug reactions (ADRs) challenges multiple sclerosis (MS) treatment. We aimed to assess the nature and frequency of ADRs induced by MS medications in an ...observational cross-sectional study.Material and Methods: ADRs of all outpatients who had been visiting a neurologist and had been receiving at least one disease-modifying therapy (DMT) for MS during the last three months were investigated.Results: A total number of 484 ADRs were detected in these patients. The preventability rate was 5.9%, and 0.61% of reactions were serious.Discussion: The high frequency of adverse drug reactions in this study shows a strong need for planning a strategy to increase patients' adherence to treatment.
The aim of this study was to evaluate the safety, tolerability, and efficacy of a brand-generic glatiramer acetate product in patients with relapsing-remitting multiple sclerosis over a 12-month ...period. A noninterventional cohort study was conducted on 185 patients. The patients had a confirmed and documented diagnosis of relapsing-remitting multiple sclerosis as defined by the Revised McDonald Criteria (2010), were ambulatory with a Kurtzke Expanded Disability Status Scale score of 0 to 5.5, and their treatment by glatiramer acetate 40 mg/mL was just started.
Adverse drug reactions, relapse rate, magnetic resonance imaging parameters, and Expanded Disability Status Scale score were evaluated over 1 year.
Of 185 enrolled patients from 21 different cities, 170 completed the study. The mean (SD) Expanded Disability Status Scale score was 1.97 (0.75) at the time of screening. The mean age was 33 years with an average of 4-year multiple sclerosis history, and 83% were women. Hepatic disorder and depression were the most frequent medical history. The most common adverse drug reactions were local pain (45.4%) and erythema (38.9%). The immediate postinjection reactions included dyspnea (10.3%), anxiety (9.7%), palpitation (8.1%), urticaria (5.4%), flushing (3.24%), chest pain (2.16%), and throat constriction (0.54%). The percentage of relapse-free patients at Month 12 was 87%, and the annual relapse rate was 0.134. An increase in the Expanded Disability Status Scale score was observed in 20% of patients, and new T2 and gadolinium-enhancing lesions were found in 34.7% and 9.4%, respectively. The rate of treatment failure was 1.6% and 4.3% according to the Modified Rio and Rio scores, respectively.
The 40 mg brand-generic glatiramer acetate product was well tolerated in this selected group of Iranian patients with relapsing-remitting multiple sclerosis, and patient adherence was favorable over 1 year.
Abstract Background Amyotrophic lateral sclerosis (ALS) is an incurable progressive neurodegenerative disease and thus the assessment of quality of life (QOL) changes and factors that may influence ...its course is valuable in the meantime. Objectives The present study aimed to assess the deterioration rate of QOL and influencing factors in different subgroups of Iranian ALS patients. Methods 132 patients were evaluated in this prospective multicenter observational study. QOL was measured using ALS Assessment Questionnaire (ALSAQ-40) during 1 year follow up and its progression rate was assessed in different subgroups of patients according to age, sex, stage of disease, riluzole consumption, onset type. Also physical disability and functional disability were measured using MMT and ALSFRS-R scores respectively and their progression rates were compared with ALSAQ-40 changes. Results Significant deterioration of the scores of ALSAQ-40 during study was consistent in all of its domains ( p = 0.000). There was a significant negative correlation between ALSFRS-R and MMT changes and ALSAQ-40 change ( p = 0.000) and this was consistently observed in all domains of ALSAQ-40 ( p = 0.00). ALSAQ-40 deterioration rate was shown to be significantly lower in severe/terminal stages compared to mild/moderate stages ( p = 0.00). Significantly higher deterioration rate was observed in bulbar onset versus limb onset patients F (1,
130) = 4.52, p = 0.04 but no significant difference was observed among other subgroups according to age, sex and riluzole consumption. Conclusion All domains of QOL significantly deteriorate during ALS course and there is a significant correlation between their changes and progression of physical and functional disabilities. Rate of degradation of QOL may be different at different stages of the disease. QOL worsens independent of factors such as sex, age and consumption of riluzole; but onset type (bulbar versus limb) is an imperative factor in quality of life changes during the disease course.
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