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7 result(s) for "Norton, Hillary"
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Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials
Introduction We assessed tofacitinib efficacy and safety in ankylosing spondylitis (AS) by body mass index (BMI) category. Methods Data were pooled from phase 2/3 trials; analyses included patients with active AS randomized (1:1) to tofacitinib 5 mg twice daily or placebo, who were stratified by baseline BMI into < 25, ≥ 25 to < 30, and ≥ 30 kg/m 2 categories. Efficacy was assessed at week 12 and safety to week 16. Results Of 370 patients, 153, 131, and 86 had a baseline BMI  of < 25, ≥ 25 to < 30, and ≥ 30 kg/m 2 , respectively. At baseline, patients with BMI < 25 kg/m 2 were younger and more likely to be current smokers/Asian, and patients with BMI ≥ 30 kg/m 2 had higher mean waist circumference/swollen joint count (SJC) and were more likely to have enthesitis, high-sensitivity C-reactive protein (hsCRP) > 5 mg/L, an inadequate response to tumor necrosis factor inhibitors (TNFi), and prior biologic disease-modifying anti-rheumatic drug (bDMARD) use versus other categories. Across categories, tofacitinib responses/improvements were greater than with placebo, except for ≥ 40% Assessment of SpondyloArthritis international Society improvement (ASAS40), ASAS partial remission, 50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Activity Index score (BASDAI50), and Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) inactive disease rates, which were similar for tofacitinib and placebo in the BMI ≥ 30 kg/m 2 category. Treatment effects were similar across categories, except for BASDAI50, which was smaller in the BMI ≥ 30 category versus  the < 25 kg/m 2 category. More adverse events (AEs) and serious adverse events (SAEs) with tofacitinib were reported in the BMI < 25 kg/m 2 category, which had a higher proportion of current smokers versus other categories. Conclusions Regardless of baseline BMI category, efficacy was greater with tofacitinib versus placebo in patients with AS, and no treatment effect differences between categories were observed, with exceptions for BMI ≥ 30 kg/m 2 (more active/treatment-refractory disease and a smaller sample size). Overall, tofacitinib safety was generally comparable across categories; however, AE/SAE rates with tofacitinib were higher in the BMI < 25 kg/m 2 category (which had more current smokers). This post hoc analysis demonstrates that tofacitinib can be considered as a treatment option for AS, regardless of baseline BMI category; however, interpretation was limited by small sample sizes and differences in sample sizes and baseline characteristics across categories. Trial Registration ClinicalTrials.gov identifiers, NCT01786668 and NCT03502616.
Identification of Gaps in Quality of Care and Good Practice Interventions in Rheumatoid Arthritis: Insights From a Literature Review and Qualitative Study of Nine Centers in North America
Objective Quality of care (QoC) delivery in rheumatoid arthritis (RA) continues to suffer from various challenges (eg, delay in diagnosis and referral) that can lead to poor patient outcomes. This study aimed to identify good practice interventions that address these challenges in RA care in North America. Methods The study was conducted in three steps: (1) literature review of existing publications and guidelines (April 2005 to April 2021) on QoC in RA; (2) in‐person visits to >50 individual specialists and health care professionals across nine rheumatology centers in the United States and Canada to identify challenges in RA care and any corresponding good practice interventions; and (3) collation and organization of findings of the two previous methods by commonalities to identify key good practice interventions, followed by further review by RA experts to ensure key challenges and gaps in RA care were captured. Results Several challenges and eight good practice interventions were identified in RA care. The interventions were prioritized based on the perceived positive impact on the challenges in care and ease of implementation. High‐priority interventions included the use of technology to improve care, streamlining specialist treatment, and facilitating comorbidity assessment and care. Other interventions included enabling patient access to optimal medication regimens and improving patient self‐management strategies. Conclusion Learnings from the study can be implemented in other rheumatology centers throughout North America to improve RA care. Although the study was completed before the COVID‐19 pandemic, the findings remain relevant.
Sonographically guided hydrodissection and corticosteroid injection for scleroderma hand
Scleroderma is associated with intractable hand pain from vasospasm, digital ischemia, tenosynovitis, and nerve entrapment. This study investigated the effect of hydrodissection of the carpal tunnel followed by corticosteroid injection for the painful scleroderma hand. Twenty-six consecutive subjects [12 with painful scleroderma hand and 14 with rheumatoid arthritis and carpal tunnel syndrome (RA/CTS)] underwent sonographically observed carpal tunnel hydrodissection with 3 ml of 1% lidocaine administered with a 25-gauge 1-in. needle on a 3-ml RPD mechanical syringe (reciprocating procedure device). After hydrodissection, a syringe exchange was performed, and 80 mg of triamcinolone acetonide was injected. Baseline pain, procedural pain, pain at outcome, responders, therapeutic duration, and reinjection interval were determined. Hydrodissection and injection with corticosteroid significantly reduced pain scores by 67% in scleroderma ( p  < 0.001) and by 47% in RA/CT ( p  < 0.001). Scleroderma and RA/CTS were similar in outcome measures: injection pain ( p  = 0.47), pain scores at outcome ( p  = 0.13), responders (scleroderma, 83.3%; RA/CTS, 57.1%, p  = 0.15), pain at 6 months ( p  = 0.15), and therapeutic duration ( p  = 0.07). Scleroderma patients responded better in time to next injection (scleroderma, 8.5 ± 3.0 months; RA/CTS, 5.2 ± 3.1 months, p  = 0.03). Reduced Raynaud’s attacks and healing of digital ulcers occurred in 83% of subjects. There were no complications. Hydrodissection with lidocaine followed by injection of triamcinolone reduces pain and vasomotor changes in the scleroderma hand. The mechanism may be a combination of hydrodissection-mediated mechanical freeing of entrapped arteries, nerves, and tendinous structures and corticosteroid-induced reduction of inflammatory vasospasm.
Congress must protect access to complex care
Medicare data shows hospital-administered infusions can cost taxpayers more than twice as much as those provided in physician offices. The Protecting Patient Access to Cancer and Complex Therapies Act would preserve the stability of community-based care while still delivering the same savings to Medicare and Medicare beneficiaries. Rather than slashing provider reimbursement, the bill would have manufacturers issue a rebate to the federal government to make up the difference between the current average sales price and the new negotiated price.
Sex-Based Differences in Food Consumption: Foodborne Diseases Active Surveillance Network (FoodNet) Population Survey, 2006—2007
Background. This analysis used data from the most recent Foodborne Diseases Active Surveillance Network (FoodNet) Population Survey (May 2006 through April 2007) to examine differences in the consumption of various types of foods between men and women. Methods. Participants were surveyed by telephone and asked whether or not they had consumed certain foods in the past 7 days, including the following \"high-risk\" foods commonly associated with foodborne illness: pink hamburger, raw oysters, unpasteurized milk, cheese made from unpasteurized milk, runny eggs, and alfalfa sprouts. Data were weighted to adjust for survey design and to reflect the age and sex distribution of the population under FoodNet surveillance. Results. A total of 14 878 persons ≥18 years were interviewed, of whom 5688 (38%) were men. A higher proportion of men reported eating meat and certain types of poultry than women, whereas a higher proportion of women ate fruits and vegetables. A higher proportion of men than women reported consuming runny eggs (12% versus 8%), pink hamburger (7% versus 4%), and raw oysters (2% versus 0.4%). A higher proportion of women than men ate alfalfa sprouts (3% versus 2%). No differences by sex were observed for consumption of unpasteurized milk or cheese. Conclusions. Data from the FoodNet Population Surveys can be useful in efforts to design targeted interventions regarding consumption of high-risk foods. Moreover, understanding the background rates of food consumption, stratified by sex, may help investigators identify the kinds of foods likely to be associated with outbreaks in which a preponderance of cases occur among members of one sex.