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

“I HAVE GONE BEYOND MY SPHERE”: NETWORK ANALYSIS AND RHETORICAL FEMINISM IN WOMEN’S WRITING 1650-1750

The concept of a contrasting public sphere and private sphere is both enduring and contested. The model of the eighteenth century public sphere offered by Jürgen Habermas offers a rational-critical approach to public discourse, while bracketing difference. Interlocutors of Habermas see such exclusion as problematic, particularly from a feminist standpoint. In contrast to Habermas’ static model, this project offers a networked, motile vision of public and private spheres that allows for interconnections and relationships, and which not only incorporates conceptual differences, but in fact relies on them. In this flexible model, rhetorical feminism, where the ideology of feminism is brought to bear on rhetorical studies, reveals itself. Rhetorical feminism offers alternatives to traditional and dominant forms of writing and rhetoric. It does not require an explicit intentionality to advance the standing of women or their equal rights, but in practice, rhetorical feminism often has that effect. Cheryl Glenn finds the beginnings of this concept in the nineteenth century, yet I locate it as early as 1650. Considering a networked “lifeworld,” to use Bruno Latour’s term, rather than binaries of public and private spheres allows us to re-engage with the writings of women in this period, and understand them as case studies in of rhetorical feminism. Margaret Fell Fox and Mary Astell operated in religious and philosophical networks, and Eliza Haywood, as a periodicalist, helped create networks of discourse that crossed the realms of public and private. Quaker women created one of the first international faith movements, built and sustained by networked circulation of printed texts. Mary Astell was known in her day as a High Church Tory, and inserted herself into discussions on weighty philosophical matters. Eliza Haywood was a mogul in her time, with enormous commercial success across fiction and periodicals. Women writers in this study were able to deploy rhetorical feminism to renegotiate some of the terms of various patriarchal systems in their period, thereby advancing the standing of women. Themes of particular concern to women, including education, marriage, authorship, and coffeehouse culture productively intersect with discourses of religion and politics

Early Intervention in Mental Health for Adolescents and Young Adults: A Systematic Review.

OBJECTIVE. The purpose of this systematic review was to describe the evidence for the effectiveness of early intervention to improve and maintain performance in occupations for youths with or at risk for serious mental illness (SMI). METHOD. Titles and abstracts of 670 articles were reviewed, 234 were retrieved for full review, and 30 met inclusion criteria. RESULTS. Moderate to strong evidence supports cognitive remediation (CR) and mixed evidence supports cognitive--behavioral therapy (CBT) as an adjunct modality to improve general functioning. Moderate to strong evidence supports use of supported employment and supported education (SE/E) to improve social and occupational outcomes in employment and academics. Strong evidence supports family psychoeducation (FPE) to prevent relapse and rehospitalization and improve problem-solving skills and general functioning. CONCLUSION. Occupational therapy practitioners should integrate CR, SE/E, and FPE into early intervention with youth with or at risk for SMI. In addition, CBT is an effective modality for use with this population

Portland Identification and Early Referral: A Community-Based System for Identifying and Treating Youths at High Risk of Psychosis

OBJECTIVE: The Portland [Maine] Identification and Early Referral (PIER) program was established in 2000 as a prevention system for identifying and treating youths at high risk of an initial psychotic episode. METHODS: During six years, 7,270 professionals from the educational, medical, and mental health sectors were provided information on prodromal symptoms and means for rapid referral of at-risk youths, which resulted in referral of 780 youths who met eligibility criteria. RESULTS: After screening, 37% of the community referrals were found to be at high risk of psychosis, and another 20% had untreated or early psychosis, yielding an efficiency ratio of 57%. Prodromal cases identified were 46% of the expected incidence of psychosis in the catchment area. Community educational presentations were significantly associated with referrals about six months later; half of referrals were from outside the mental health system. CONCLUSIONS: Community-based identification is an efficient public health strategy, offering the opportunity for preventive intervention

Non-Navigable Streams and Adjacent Wetlands: Addressing Science Needs Following the Supreme Court\u27s Rapanos Decision

In June of 2006, the US Supreme Court ruled in two cases concerning jurisdiction under the Clean Water Act (CWA). The decisions suggest that hydrological permanence of non-navigable streams and adjacent wetlands (NNSAWs) and their effects on the chemical, physical, and biological integrity of navigable waters ( signifi cant nexus ) are relevant in determining CWA jurisdiction. This has increased the need for scientific informa tion to support regulatory determinations and to inform future policies, rule making, and legislation. Here, we propose an approach for addressing these science needs. We define a metric - maximum duration of continu ous flow - to assess hydrological permanence. We also define two metrics to evaluate significant nexus: pro portion of total benefit to the navigable water contributed by an NNSAW class, and proportion of time that a navigable water receives benefit from an NNSAW. These metrics could be useful in implementing the Court\u27s new legal standards

Imp(a/o)sto(r) / The Erotic/Neurotic / Glut : Culture as Accumulation / Documeditations : The Robert Downing Archive : Curatorial Laboratory Projects #2, #4, #6, #8.

Holubizky's introduction challenges accepted exhibition practice for museum collections; it is followed by several atypical approaches to the treatment of the Hamilton collection. Girling presents a selection of works displaying fraud in their imagery; Lypchuk discusses a selection of erotically and neurotically charged images; and Fisher reflects on the bequest of an artist's life work, donated by Robert Downing (publishing an excerpt from Downing's memoirs). 20 bibl. ref