Background Adherence to disease-modifying therapies is determinant to attain maximal clinical benefit in multiple sclerosis (MS). RebiSmart® is an electronic auto-injector for subcutaneous delivery of interferon β-1a (INF-β1a) that monitors adherence by featuring a log of each drug administration for objective evaluation. The aim of this study was to assess long-term adherence to INF-β1a by using the RebiSmart® device in Mexican patients with relapsing MS. Methods This is an observational multicenter study on patients with relapsing MS treated with INF-β1a subcutaneously delivered by the RebiSmart® device. Adherence was computed as the number of injections received during the study period divided by the number of injections scheduled and expressed as percent. Results A total of 66 patients from 6 specialized MS centers were evaluated (45 females and 21 males, mean age 43.91±13.32 years). Mean adherence was 79.51±18% (median: 85.54%, range: 34.4-100%). During a median follow-up of 27.5 months (mean 33.36±29.39 months) the annualized relapse rate had a mean of 0.50±1.63. Mean initial EDSS was 1.90±1.52, and mean EDSS at the end of follow-up was 1.80±1.74. Compared with their counterparts, the mean number of relapses was significantly lower among patients with high (>80%) adherence (0.25±0.44 vs 0.67±92 relapses, respectively; P = 0.03). The proportion of relapse-free patients was 75.0% among patients with high adherence and 53.3% in low-PLOS ONE
MATRIX (Measuring neutralizing Antibodies in patients TReated with Interferon beta-1a IM in MeXico) was primarily a cross-sectional phase 4 study of patients with relapsing multiple sclerosis (RMS) that evaluated neutralizing antibody (NAb) frequency in Mexican and Colombian patients treated with intramuscular interferon (IFN) beta-1a in the form of Avonex ® or the biosimilar drug Jumtab ®. A secondary long-term retrospective observational evaluation of safety, tolerability, and relapses was also performed for patients in each arm of the study. In the cross-sectional portion of the study, patients with multiple sclerosis who had been treated with once-weekly Avonex (n=36) or Jumtab (n=29) self-injections as their first and only diseasemodifying therapy for 1-3 years were retrospectively identified. The primary and secondary endpoints were proportion of patients with NAb levels .100 tenfold reduction units (TRU) and .20 TRU. The biological response to IFN beta-1a injections was assessed by change in serum neopterin levels and by pre-versus post-dose concentration difference. Safety, tolerability, and relapse-related information were also retrospectively assessed. No patients developed NAb levels .100 TRU. Neopterin levels were significantly higher relative to baseline with Avonex than with Jumtab. Supporting this result, flu-like symptoms were reported in a greater proportion of Avonex-treated than Jumtab-treated patients. No unexpected adverse events or significant differences in relapses were observed. In conclusion, Avonex and Jumtab exhibited minimal immunogenicity; Jumtab was associated with significantly lower neopterin activation and flu-like symptom frequency compared with Avonex, suggesting less IFN bioactivity with Jumtab.
We analyzed the neurological manifestations in Mexican patients hospitalized with pneumonia due to COVID-19 and investigated the association between demographic, clinical, and biochemical variables and outcomes, including death. A retrospective, analytical study was conducted using the electronic records of patients hospitalized between 1 April 2020 and 30 September 2020. Records of 1040 patients were analyzed: 31.25% died and 79.42% had neurological symptoms, including headache (80.62%), anosmia (32.20%), ageusia (31.96%), myopathy (28.08%), disorientation (14.89%), encephalopathy (12.22%), neuropathy (5.4%), stroke (1.3%), seizures (1.3%), cerebral hemorrhage (1.08%), encephalitis (0.84%), central venous thrombosis (0.36%), and subarachnoid hemorrhage (0.24%). Patients also had comorbidities, such as hypertension (42.30%), diabetes mellitus (38.74%), obesity (61.34%), chronic obstructive pulmonary disease (3.17%), and asthma (2.01%). Factors associated with neurological symptoms were dyspnea, chronic obstructive pulmonary disease, advanced respiratory support, prolonged hospitalization, and worsening fibrinogen levels. Factors associated with death were older age, advanced respiratory support, amine management, chronic obstructive pulmonary disease, intensive care unit management, dyspnea, disorientation, encephalopathy, hypertension, neuropathy, diabetes, male sex, three or more neurological symptoms, and obesity grade 3. In this study we designed a profile to help predict patients at higher risk of developing neurological complications and death following COVID-19 infection.
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