Introduction Human recombinant interferon beta (IFN-β) is one of the first line treatments for Relapsing-Remitting Multiple Sclerosis (RRMS). However, the production of neutralizing antibodies (NAb) ...can impair its function. The aim of this study was to investigate the production of neutralizing antibodies against Rebif® and ReciGen® (two brands of IFN-β-1a) and to evaluate its correlation with Expanded Disability Status Scale (EDSS). Materials and methods Serum samples of 71 RRMS patients (34 in ReciGen®, 37 in Rebif® group) were collected. Neutralizing antibody was measured by Myxo-virus resistance protein A (MxA) assay using A549 cell line. The MxA concentration was measured by enzyme-linked immunosorbent assay (ELISA) kit. Results The median period of treatment with IFN-β-1a was 18 months in ReciGen® and 24 months in Rebif® arms. The percentage of patients with positive titer of neutralizing antibody (NAb+) had no statistically significant difference between groups (P = 0.6). In both ReciGen® and Rebif® groups, the increase in EDSS score was significantly higher in NAb+ patients compared to NAb− patients (p ≤ 0.05). The duration of using ReciGen® or Rebif® for >24 months was influential in the NAb positivity (OR = 3.78). Conclusion Receiving interferon beta-1a for >24 months is correlated with higher possibility of NAb production. The type of IFN-β used in the study had no significant impact on NAb positivity. In addition, both groups had comparable EDSS score changes, and NAb status of patients was correlated with their EDSS score.
•The S-CVI values of the relevance, clarity, and simplicity for the whole form were 0.92, 0.96, and 0.93, respectively.•The presented minimum data set had a significantly high content validity in ...terms of relevance, clarity, and simplicity.•The Persian version of minimum data set found to be valid and reliable in national MS registry system of Iran.
As the prevalence and incidence of Multiple Sclerosis (MS) are increasing remarkably in Iran, gathering standardized information regarding the individual's diagnosis, care, and outcomes through a uniform registry system would enable policy-makers to systematically plan for care quality improvements.
To design a valid and reliable Persian version of a minimum data set to be utilized and integrated into the national MS registry system of Iran.
The minimum data set consisted of six domains including patient identification, family history of MS, diagnosis, disease course, disability status, and medications. The content validity was assessed based on 27 experts’ opinions. Item-Content Validity Index (I-CVI) and Scale-Content Validity Index (S-CVI) were used to assess the questions and their validities. Reliability was evaluated using the intra-class correlation coefficient (ICC) of the test-retest results.
For validity appraisal, 27 experts reviewed the developed minimum data set. All the items had I-CVI values higher than the critical value of 0.78 in terms of relevance, clarity, and simplicity, except for “medication start date” and “medication end date” in relevance (I-CVI = 0.75 and 0.73, respectively) and “MS type” in simplicity (I-CVI = 0.76). The total S-CVI scores for relevance, clarity, and simplicity were higher than 0.9. In reliability assessment, 27 patients (out of 74 interviewed patients) were re-interviewed to assess the test-retest reliability. All ICCs were higher than the critical value of 0.7 (in 14 items out of 16), except for “progression to secondary-progressive MS” with the ICC = 0.68 and “the reason for medication discontinuance” with the ICC = 0.64.
The use of standardized validated minimum data set has the potential to enable the researchers and policy-makers to systematically compare and analyze patient information. The Persian version of the minimum data set found to be valid and reliable in Iran.
To determine optic nerve and retinal damage in aquaporin-4 antibody (AQP4-IgG)-seropositive neuromyelitis optica spectrum disorders (NMOSD) in a large international cohort after previous studies have ...been limited by small and heterogeneous cohorts.
The cross-sectional Collaborative Retrospective Study on retinal optical coherence tomography (OCT) in neuromyelitis optica collected retrospective data from 22 centers. Of 653 screened participants, we included 283 AQP4-IgG-seropositive patients with NMOSD and 72 healthy controls (HCs). Participants underwent OCT with central reading including quality control and intraretinal segmentation. The primary outcome was thickness of combined ganglion cell and inner plexiform (GCIP) layer; secondary outcomes were thickness of peripapillary retinal nerve fiber layer (pRNFL) and visual acuity (VA).
Eyes with ON (NMOSD-ON, N = 260) or without ON (NMOSD-NON, N = 241) were assessed compared with HCs (N = 136). In NMOSD-ON, GCIP layer (57.4 ± 12.2 μm) was reduced compared with HC (GCIP layer: 81.4 ± 5.7 μm,
< 0.001). GCIP layer loss (-22.7 μm) after the first ON was higher than after the next (-3.5 μm) and subsequent episodes. pRNFL observations were similar. NMOSD-NON exhibited reduced GCIP layer but not pRNFL compared with HC. VA was greatly reduced in NMOSD-ON compared with HC eyes, but did not differ between NMOSD-NON and HC.
Our results emphasize that attack prevention is key to avoid severe neuroaxonal damage and vision loss caused by ON in NMOSD. Therapies ameliorating attack-related damage, especially during a first attack, are an unmet clinical need. Mild signs of neuroaxonal changes without apparent vision loss in ON-unaffected eyes might be solely due to contralateral ON attacks and do not suggest clinically relevant progression but need further investigation.
Human recombinant interferon beta (IFN-β) is one of the first line treatments for Relapsing-Remitting Multiple Sclerosis (RRMS). However, the production of neutralizing antibodies (NAb) can impair ...its function. The aim of this study was to investigate the production of neutralizing antibodies against Rebif® and ReciGen® (two brands of IFN-β-1a) and to evaluate its correlation with Expanded Disability Status Scale (EDSS).
Serum samples of 71 RRMS patients (34 in ReciGen®, 37 in Rebif® group) were collected. Neutralizing antibody was measured by Myxo-virus resistance protein A (MxA) assay using A549 cell line. The MxA concentration was measured by enzyme-linked immunosorbent assay (ELISA) kit.
The median period of treatment with IFN-β-1a was 18 months in ReciGen® and 24 months in Rebif® arms. The percentage of patients with positive titer of neutralizing antibody (NAb+) had no statistically significant difference between groups (P = 0.6). In both ReciGen® and Rebif® groups, the increase in EDSS score was significantly higher in NAb+ patients compared to NAb− patients (p ≤ 0.05). The duration of using ReciGen® or Rebif® for >24 months was influential in the NAb positivity (OR = 3.78).
Receiving interferon beta-1a for >24 months is correlated with higher possibility of NAb production. The type of IFN-β used in the study had no significant impact on NAb positivity. In addition, both groups had comparable EDSS score changes, and NAb status of patients was correlated with their EDSS score.
•Neutralizing Antibody (NAb) against recombinant IFNβ can impair the function of IFNβ•Bio-assay of NAb in patient’s sera can be used as a prognostic test for IFNβ effectiveness.•ReciGen and Rebif, two brands of recombinant IFNβ had no significant difference on NAb production•The type of IFN-β used in the study had no significant impact on NAb production. Both groups had comparable EDSS scores
Introduction: Sexual dysfunctions are relatively prevalent in female patients with multiple sclerosis (MS) and affect their quality of life. This study was performed with aim to evaluate the effect ...of Bupropion on sexual function in women with multiple sclerosis. Methods: This randomized controlled clinical trial study was performed in 2019 on 60 women with relapsing and remitting MS, receiving routine MS treatment and had sexual dysfunction. The subjects were divided to two groups of 30 persons receiving Bupropion and placebo. Multiple sclerosis intimacy and sexuality questionnaire, female sexual function index, fatigue severity scale and Beck depression questionnaire were filled out for all the patients before, 4 and 8 weeks after the interventions initiation. Data were analyzed by SPSS software (version 20) and Analysis of variance (AOVA) and repeated measure tests. P<0.05 was considered statistically significant. Results: Multiple sclerosis intimacy and sexuality scores 8 weeks after the intervention were significantly lower in bupropion group (9.96±45.85) compared to placebo group (53.56±11.46) (P= 0.007). Also, the score of depression in the two stages after the intervention in the bupropion group (11.26 ± 23.03) was lower than the placebo group (37.86 ± 13.43) and decreased during the intervention (p <0.0001). FSFI score and its subscales showed an improvement in bupropion group (2.67±25.88) compared with placebo group (17.44±2.8) which indicated continuity of effectiveness of Bupropion independently from depression and fatigue scores alteration during treatment (p<0.001). Conclusion: The results of the present study showed the effectiveness of bupropion on improvement of sexual function in female patients with MS.
•Around 1.6% of registered Iranian MS cases are in the late-onset (LOMS) category.•The age-standardized LOMS prevalence was around 75 per 100,000 people.•About half of the Iranian LOMS cases suffered ...relapsing-remitting course.•Nearly 23% of LOMS patients did not receive any disease-modifying treatment.
Today, it is estimated that around 5% of multiple sclerosis (MS) patients are in the late-onset category (age at disease onset ≥ 50). Diagnosis and treatment in this group could be challenging. Here, we report the latest update on the characteristics of Iranian patients with late-onset MS (LOMS).
This cross-sectional study used the information provided by the nationwide MS registry of Iran (NMSRI). The registrars from 14 provinces entered data of patients with a confirmed diagnosis of MS by neurologists. Patients with disease onset at or later than 50 years of age were considered LOMS.
Of 20,036 records, the late-onset category included 321 patients (1.6%). The age-standardized LOMS prevalence was around 75 per 100,000 people. 215 patients (67%) were female. Median Expanded Disability Status Scale (EDSS) was 3 (interquartile range: 1.5–5). The majority of the cases (56%) suffered from relapsing-remitting (RR) course while 20% were diagnosed with primary progressive (PP) MS. Significantly higher proportion of male sex, PPMS, and higher EDSS were seen in the late-onset group compared with early-onset and adult-onset cases (p-value < 0.05). Seventy-five (23%) patients did not receive any disease-modifying treatment.
The more prominent degenerative pathology of LOMS may be the underlying mechanism of the observed differences in comparison to non-LOMS.
There are substantial differences and knowledge gaps regarding LOMS which could be the subject of further research.
BACKGROUND : Several studies have suggested an association between Chlamydia pneumonia infection and atherosclerosis. This study was designed to investigate the association between this organism and ...atherosclerotic plaque formation in right and left common carotid arteries (CCAs) and extracranial portions of internal carotid arteries (ICAs).
METHODS : Antibodies to Chlamydia pneumoniae (IgA and IgG) were measured and compared in 42 patients who had plaque in at least one CCA or ICA (detected by duplex ultrasound) and 82 patients without any plaque in these arteries. Cp.IgG and Cp.IgA titers over 1.10 ISR were defined to be positive.
RESULTS : We found that 6.1% of control subjects and 16.7% of cases were Cp.IgA seropositive. The difference between these two groups was prominent but was not statistically significant (P = 0.104). 4.2% of females without atherosclerotic plaque and 31.6% of females with plaque were Cp.IgA seropositive. This difference is statistically significant (P = 0.005). There was no significant difference in seropositivity of Cp.IgG between case and control subjects or in male and female groups with or without plaque.
CONCLUSIONS : Cp.IgA is a predictor of atherosclerosis in women, but Cp.IgG has no predictive value for plaque formation in either gender.
KEY WORDS : Atherosclerotic plaque, Chlamydia pneumoniae, serum antibody.
Introduction
Sexual dysfunction (SD) is a common complaint in patients with multiple sclerosis (MS). The aim of this study was to assess the prevalence of SD and its related risk factors in men with ...MS in Iran.
Methods
In this cross-sectional study, 320 men who had been diagnosed with MS according to the McDonald revised criteria were recruited from January to June 2019, from the north, south, east, west, and central parts of Iran. Patients were assessed using the Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function (IIEF), The Multiple Sclerosis Intimacy and Sexuality Questionnaire-(MSISQ 19), Sexual Quality of Life-Men (SQOL-M), and Standard General Health Questionnaire (GHQ).
Results
Sexual dysfunction, defined as total IIEF score ≤ 45 was present in 114 patients (35.6%). The results of univariate logistic regression showed that there were significant direct relations between age (OR 1.050, 95% CI 1.02–1.08), Expanded Disability Status Scale (EDSS) (OR 1.45, 95% CI 1.24–1.7), duration of MS (OR 1.005, 95% CI 1.002–1.009), MSISQ-19 (OR 1.103, 95% CI 1.078–1.128), GHQ (OR 1.04, 95% CI 1.03–1.06), SQOL-M (OR 0.930, 95% CI 0.914–0.947), smoking (OR 1.941, 95% CI 1.181–3.188), non-MS chronic disease (OR 1.91, 95% CI 1.20–3.04), having a main sexual partner (OR 2.56, 95% CI 1.32–4.94), and significant inverse relations between exercise (OR 0.584, 95% CI 0.364–0.936) and regular sexual activity (OR 0.241, 95% CI 0.15–0.40), with the prevalence of SD. The results of multiple logistic regression indicated that the age, MSISQ-19, and SQOL-M were the only independent predictive factors for SD in these patients.
Conclusion
The prevalence of SD in men with MS in Iran is relatively high. These patients should be screened, diagnosed, and treated for SD and influencing factors.
PurposeOptical coherence tomography (OCT) has recently emerged as a source for powerful biomarkers in neurodegenerative diseases such as multiple sclerosis (MS) and neuromyelitis optica (NMO). The ...application of machine learning techniques to the analysis of OCT data has enabled automatic extraction of information with potential to aid the timely diagnosis of neurodegenerative diseases. These algorithms require large amounts of labeled data, but few such OCT data sets are available now. MethodsTo address this challenge, here we propose a synthetic data generation method yielding a tailored augmentation of three-dimensional (3D) OCT data and preserving differences between control and disease data. A 3D active shape model is used to produce synthetic retinal layer boundaries, simulating data from healthy controls (HCs) as well as from patients with MS or NMO. ResultsTo evaluate the generated data, retinal thickness maps are extracted and evaluated under a broad range of quality metrics. The results show that the proposed model can generate realistic-appearing synthetic maps. Quantitatively, the image histograms of the synthetic thickness maps agree with the real thickness maps, and the cross-correlations between synthetic and real maps are also high. Finally, we use the generated data as an augmentation technique to train stronger diagnostic models than those using only the real data. ConclusionsThis approach provides valuable data augmentation, which can help overcome key bottlenecks of limited data. Translational RelevanceBy addressing the challenge posed by limited data, the proposed method helps apply machine learning methods to diagnose neurodegenerative diseases from retinal imaging.
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