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Myositis
Published in Jason Liebowitz, Philip Seo, David Hellmann, Michael Zeide, Clinical Innovation in Rheumatology, 2023
Abatacept is a cytotoxic T-lymphocyte protein 4 (CTLA4) agonist that blocks T cell costimulation and decreases the antigen- presenting capability of myocytes, with possible effects that could disrupt the pathogenesis of DM.100 Efficacy was reported in multiple refractory PM/ DM cases.101, 102 Additionally, a randomized, open-label trial suggested a beneficial response in half of the patients included in the study.103 These positive results have led to an ongoing phase 3, randomized, double-blind trial evaluating the efficacy and safety of abatacept in myositis and IIM-associated ILD.
Cope
Published in Anka A. Vujanovic, Sudie E. Back, Posttraumatic Stress and Substance Use Disorders, 2019
Sudie E. Back, Therese Killeen, Kathleen T. Brady
More recently, an open-label trial was conducted in Sweden by Anna Persson and colleagues (Persson et al., 2017). After translating the COPE manual, the researchers applied the treatment to 22 women (average age = 46 years old) with current PTSD and alcohol dependence. The mean number of traumatic events experienced was 7.3, and the mean age at first trauma was 9 years. Almost all (90%) experienced childhood trauma, and 46% reported sexual abuse during childhood. Notably, almost half (46%) reported at least one suicide attempt in their lifetime, with 14% reporting a suicide attempt in the past year. Significant reductions in PTSD symptoms, alcohol consumption, and depression were observed as well as strong retention rates; participants attended 82.6% of available sessions, and the mean number of sessions attended was 9.9 (total of 12). A larger RCT is currently under way in Sweden.
Viral-Specific and Immune-Based Nonspecific Antiviral Therapies for CFS
Published in Roberto Patarca-Montero, Treatment of Chronic Fatigue Syndrome in the Antiviral Revolution Era, 2014
After an encouraging open-label trial, a placebo-controlled, double-blind, multicenter trial, involving ninety-two subjects, was conducted. After twenty-four weeks of Ampligen treatment, there were significant improvements in physical performance as measured by the primary endpoint, the Karnofsky performance score (KPS), which increased by 43 percent from 53 to 76. Secondary endpoints, which were also met, included reduced cognitive deficit (as assessed by the cognitive subscale of SCL 90-R or neuro-psychological function tests); enhanced capacity to perform activities of everyday living; and improvements on treadmill testing (oxygen uptake increased from 1.16 L/min to 1.48 L/min). Notably, a significant reduction in the need for other medications and for extended hospital stays were also observed.
A long-term open-label safety study of galcanezumab in Japanese patients with migraine
Published in Expert Opinion on Drug Safety, 2021
Koichi Hirata, Takao Takeshima, Fumihiko Sakai, Yoshihisa Tatsuoka, Norihiro Suzuki, Hisaka Igarashi, Tomomi Nakamura, Akichika Ozeki, Hiroyoshi Yamazaki, Vladimir Skljarevski
Patients with EM who completed the treatment period from the previous placebo-controlled trial and consented to transition to the open-label trial, and newly recruited patients with CM, were enrolled. Eligible patients were aged between 18 and 65 years at the time of screening and had migraine onset prior to age 50 years. All patients had to agree to use a reliable method of contraception during the open-label trial and for 5 months following the last dose. Concomitant use of medications for the acute treatment of migraine headache or other pain was allowed. Use of preventive treatments for migraine headache was not allowed during the study; however, 1 month after the last follow-up visit, patients were allowed to start migraine preventive treatment if clinically warranted and at the discretion of the investigator.
Investigational drugs in early-stage clinical trials for autism spectrum disorder
Published in Expert Opinion on Investigational Drugs, 2019
Michael P. Hong, Craig A. Erickson
Studies in adults have primarily focused on high-functioning ASD with an aim to better understand the mechanism underlying effects of oxytocin. An open-label trial using positron-emission tomography (PET) to evaluate serotonin transporter activity found increased serotonin transporter level in the striatum that was correlated with an increased hostility response to emotional faces, suggesting a link between social behavior and downstream serotonergic effects of oxytocin [81]. Oxytocin has also been found to improve social interpretation skills and ADOS social reciprocity in ASD, a finding that was linked to enhanced resting-state functional connectivity between the anterior cingulate cortex and dorsomedial prefrontal cortex [82]. Most recently, a phase II, randomized, double-blind, placebo-controlled clinical trial of daily oxytocin with additional open-label arms revealed that single nucleotide polymorphisms in the oxytocin receptor (OXTR) gene predicted clinician-rated improvement in individuals with ASD treated with low dose oxytocin [83]. While these findings are interesting, further research is needed to determine how oxytocin treats the underlying pathology involved in ASD and which individuals would best respond to treatment.
Comparative effectiveness of oral pharmacologic interventions for knee osteoarthritis: A network meta-analysis
Published in Modern Rheumatology, 2018
Sun-Young Jung, Eun Jin Jang, Seoung Wan Nam, Hyuk Hee Kwon, Seul Gi Im, Dam Kim, Soo-Kyung Cho, Dalho Kim, Yoon-Kyoung Sung
Because the outcomes reported in the different trials differed, the number of studies (number of participants) that contributed to the analyses were as follows: 32 trials (16,230 participants) for WOMAC pain, 31 trials (15,272 participants) for WOMAC function, 24 trials (11,686 participants) for WOMAC stiffness, 21 trials (9762 participants) for WOMAC total, and 25 trials (9742 participants) for pain VAS. Of these 44 studies, 5 included Asians as study participants (4 were conducted in Asian countries, and 1 was conducted in the US but included only Asian patients). In the trials, mean ages ranged from 52.4 to 71.5 years, and the proportions of women ranged from 39.3% to 100% (median 67.4%) (details of the characteristics of the trials are presented in Table S2). The risk of bias was low in the blinding of outcome assessments (65.9%) and incomplete outcome data (77.3%) domains. Most of the trials were not prone to high risk of bias for the methodological quality items, apart from the blinding of participants and outcome assessments–there was only one open label trial, and a substantial (50% or more) proportion of the enrolled patients withdrew from just three of the studies. The risk of bias was highest in the other bias domain because 36 studies (81.8%) included one or more industry employees as authors (Figure S3).