Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension

OBJECTIVE: To evaluate whether eculizumab helps patients with anti-acetylcholine receptor-positive (AChR+) refractory generalized myasthenia gravis (gMG) achieve the Myasthenia Gravis Foundation of America (MGFA) post-intervention status of minimal manifestations (MM), we assessed patients' status throughout REGAIN (Safety and Efficacy of Eculizumab in AChR+ Refractory Generalized Myasthenia Gravis) and its open-label extension. METHODS: Patients who completed the REGAIN randomized controlled trial and continued into the open-label extension were included in this tertiary endpoint analysis. Patients were assessed for the MGFA post-intervention status of improved, unchanged, worse, MM, and pharmacologic remission at defined time points during REGAIN and through week 130 of the open-label study. RESULTS: A total of 117 patients completed REGAIN and continued into the open-label study (eculizumab/eculizumab: 56; placebo/eculizumab: 61). At week 26 of REGAIN, more eculizumab-treated patients than placebo-treated patients achieved a status of improved (60.7% vs 41.7%) or MM (25.0% vs 13.3%; common OR: 2.3; 95% CI: 1.1-4.5). After 130 weeks of eculizumab treatment, 88.0% of patients achieved improved status and 57.3% of patients achieved MM status. The safety profile of eculizumab was consistent with its known profile and no new safety signals were detected. CONCLUSION: Eculizumab led to rapid and sustained achievement of MM in patients with AChR+ refractory gMG. These findings support the use of eculizumab in this previously difficult-to-treat patient population. CLINICALTRIALSGOV IDENTIFIER: REGAIN, NCT01997229; REGAIN open-label extension, NCT02301624. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that, after 26 weeks of eculizumab treatment, 25.0% of adults with AChR+ refractory gMG achieved MM, compared with 13.3% who received placebo

Minimal Symptom Expression' in Patients With Acetylcholine Receptor Antibody-Positive Refractory Generalized Myasthenia Gravis Treated With Eculizumab

The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension

An Investigation Into the Electrical Activity of Tender, Resting Paraspinal Muscles Using Surface Electromyography: A Pilot Study

Abnormal resting paraspinal muscle activity has been claimed to be responsible for changes in spinal tissue texture which are detectible by manual palpation. This pilot study investigated whether there was significant electrical activity in paraspinal musculature that was tender and that appeared to have altered tissue texture on palpation. Sixteen healthy volunteers between 18 and 35 years of age had their thoracic erector spinae mass palpated bilaterally from spinal levels T3 to T10 to identify paraspinal regions exhibiting altered tissue texture relative to the contralateral muscle mass. Surface electromyography (sEMG) was used to measure electrical activity in the muscle mass at the selected levels. No significant differences in electrical activity were observed between the tender and non-tender muscle masses, although a large difference existed in the one symptomatic subject. All muscle sites displayed EMG activity at rest, although the source of activity is not clear. A number of methodological problems with the EMG recording were encountered and are discussed. Future research is recommended using symptomatic participants

Aplicaciones emergentes de inteligencia competitiva en las universidades

Different authors have pointed out the importance of applying competitive intelligence (CI) to non-business sectors (public administration, universities, non-governmental organizations, etc.). Besides, universities increasingly apply management tools and techniques coming from the business field. On the other hand, in recent years universities have perceived an environmental pressure as a consequence of a) their implication in regional development where they are located, and b) their need to reform their program offerings according to the needs of society and the requirements of the labour market, as well as a result of the process of adapting their degrees to the European Higher Education Area (Bologna process). This paper describes and characterises CI practices in the universities and analyses the CIcontribution to the design of degree courses. The research is based on qualitative methods, and data were collected through interviews. Results suggest that the use of CI in universities is mainly reactive, and addressed only to organisational tactics