tbuckley/cabot-search huggingface dataset:
FRI0042 Anakinra improves functional status in patients with rheumatoid arthritis using methotrexate
Authors: SB Cohen, JM Woolley, WW Chan
Journal: Annals of the Rheumatic Diseases (2001)

<h3>Background</h3> <h3>Objectives</h3> To evaluate the effect of anakinra, with respect to dose response and speed of effect, on the functional status of subjects with rheumatoid arthritis (RA) who were using methotrexate. <h3>Methods</h3> In a large, multidose, placebo-controlled study of anakinra, 419 patients with active RA were randomised to receive, in addition to Methotrexate (MTX), either. 04 to 2.0 mg/kg of anakinra (daily SC injection) or placebo. Functional status was evaluated at baseline and after 4, 8, 12, 16, 20, and 24 weeks of therapy using the Health Assessment Questionnaire (HAQ). Comparisons between MTX alone and anakinra + MTX were analysed using change scores from baseline. <h3>Results</h3> Patients receiving higher doses of anakinra experienced rapid and sizeable improvements in their HAQ scores. In percentage terms, HAQ scores improved more than 35 percent over baseline for the two highest doses (data not shown). These improvements occurred rapidly, were related to dose (p = 0.0014), and by week 4 the two highest doses were statistically significantly superior to placebo. <h3>Conclusion</h3> In patients with active disease despite methotrexate therapy, the addition of anakinra led to rapid and clinically important improvements in functional status. These improvements were related to dose. Anakinra improves functional status in subjects with rheumatoid arthritis.
Severe mental illness and European COVID-19 vaccination strategies
Authors: Livia J De Picker, Marisa Casanova Dias, Michael E Benros, Benedetta Vai, Igor Branchi, Francesco Benedetti, Alessandra Borsini, Juan Carlos Leza, Hilkka Kärkkäinen, Miia Männikkö, Carmine M Pariante, Ekin Sönmez Güngör, Anna Szczegielniak, Ryad Tamouza, Afra van der Markt, Paolo Fusar-Poli, Julian Beezhold, Marion Leboyer
Journal: The Lancet Psychiatry (2021)
Case Mix, Costs, and Outcomes
Authors: Alan M. Garber, Victor R. Fuchs, James F. Silverman
Journal: New England Journal of Medicine (1984)

Abstract To gain insight into the possible consequences of prospective payment for university hospitals, we studied 2025 admissions to the faculty and community services of a university hospital, measuring differences in case mix, costs, and mortality in the hospital. The faculty service had more of the patients with costly diagnoses, but even after adjustment for diagnosis-related groups (DRGs), costs were 11 per cent higher on the faculty service (95 per cent confidence limits, 4 to 18 per cent). The percentage differential was greatest for diagnostic costs. The differential was particularly large — 70 per cent (95 per cent confidence limits, 33 to 107 per cent) — for patients with a predicted probability of death of 0.25 or greater. The in-hospital mortality rate was significantly lower on the faculty service after adjustment for case mix and patient characteristics (P<0.05); the difference was particularly large for patients in the high-death-risk category. Comparision of a matched sample of 51 pairs of admissions from the high-death-risk category confirmed the above results with respect to costs and in-hospital mortality, but follow-up revealed that the survival rates were equal for the two services at nine months after discharge. The effect of prospective payment on the cost of care will be closely watched; we conclude that it will also be important to monitor the effect on outcomes, including hospital mortality rates. (N Engl J Med 1984; 310:1231–7.)
Effect of Text Messaging on Bowel Preparation and Appointment Attendance for Outpatient Colonoscopy
Authors: Nadim Mahmud, David A. Asch, Jessica Sung, Catherine Reitz, Mary S. Coniglio, Caitlin McDonald, Donna Bernard, Shivan J. Mehta
Journal: JAMA Network Open (2021)

<h3>Importance</h3> Outpatient colonoscopy is important for colorectal cancer screening. However, nonadherence and poor bowel preparation are common. <h3>Objective</h3> To determine if an automated text messaging intervention with a focus on informational and reminder functions could improve attendance rates and bowel preparation quality for outpatient colonoscopy. <h3>Design, Setting, and Participants</h3> This randomized clinical trial was conducted in an endoscopy center at an urban academic medical center. Adult patients scheduled for outpatient colonoscopy between January and September 2019 were enrolled by telephone call (early phase) or by automated text message (late phase). Data were analyzed from October 2019 to January 2020. <h3>Interventions</h3> After enrollment, patients were randomized in a 1:1 ratio to usual care (ie, written instructions and nurse telephone call) or to the intervention (ie, usual care plus an automated series of 9 educational or reminder text messages in the week prior to scheduled colonoscopy). <h3>Main Outcomes and Measures</h3> The primary outcome was appointment attendance rate with good or excellent bowel preparation. Secondary outcomes included appointment attendance rate, bowel preparation quality (poor or inadequate, fair or adequate, and good or excellent), and cancellation lead time (in days). <h3>Results</h3> Among 753 patients included and randomized in the trial (median [interquartile range] age, 56 [49-64] years; 364 [48.3%] men; 429 [57.2%] Black), 367 patients were randomized to the intervention group and 386 patients were randomized to the control group. There was no significant difference in the primary outcome between groups (patients attending appointments with good or excellent bowel preparation: intervention, 195 patients [53.1%]; control, 210 patients [54.4%];<i>P</i> = .73), including when stratified by early or late phase enrollment groups. Similarly, there were no significant differences in secondary outcomes. <h3>Conclusions and Relevance</h3> This randomized clinical trial found no significant difference in appointment attendance or bowel preparation quality with an automated text messaging intervention compared with the usual care control. Future work could optimize the content and delivery of text message interventions or identify patient subgroups that may benefit from this approach. <h3>Trial Registration</h3> ClinicalTrials.gov Identifier:NCT03710213
FRI0064 Pentoxifylline therapy for remission maintenance in rheumatoid vasculitis
Authors: LO Damian, S Rednic, A Cristea, H Bolosiu
Journal: Annals of the Rheumatic Diseases (2001)

<h3>Background</h3> Pentoxifylline (PTX), a phosphodiesterase inhibitor, is a vasodilator and antiplatelet drug credited with TNFα transcription inhibition as well. PTX was successfully used in refractory cases of rheumatoid arthritis and in some vasculitides, mainly cutaneous. <h3>Objectives</h3> The study aim was to evaluate the efficacy of PTX given as monotherapy after induction of remission in systemic rheumatoid vasculitis (RV). <h3>Methods</h3> 12 systemic RV patients (diagnosed according to the Scott&amp;Bacon criteria) were taken into study after the induction of clinical remission (irrespective of the remissive therapy). Each patient received a daily dose of 600 mg PTX. The following were evaluated upon enrollment and after 3 months: clinical signs of vasculitis (on a modified BVAS log), morning stiffness, ESR, CRP and C4 (Mancini), TNFα (ELISA- R&amp;D). The data were compared using the Student?s t test for paired variables. <h3>Results</h3> A relapse presenting with constitutional signs appeared only in one of the 12 patients; however, new ocular signs (?red eye?) appeared in 2 patients. Minor cutaneous vasculitis resolved in 1 patient and appeared newly in 3 patients on PTX. Morning stiffness reduced from 107 ± 79 to 75 ± 442 min (p = 0.01). ESR decreased (50.4 ± 21.3 to 42.9 ± 13.8 mm/h, p = 0.02), but CRP and C4 did not vary significantly. TNFα decreased from 4.2 ± 2.5 to 3.8 ± 1.8 ng/ml (p = 0.05). <h3>Conclusion</h3> PTX seems to be useful in maintaining the remission of systemic RV and possibly for the prophylaxis of occlusive vasculopathy in these patients. Moreover, PTX is useful also for managing the arthritis of these patients. Its effects in the long-term prevention of relapse of RV have to be evaluated. <h3>References</h3> Anaya JM, Espinoza LR. Phosphodiesterase inhibitor pentoxifylline: an antiinflammatory/immunomodulatory drug potentially useful in some rheumatic diseases. J Rheumatol. 1995;22: 595–9 Kitas GD, Bacon PA, Luqmani R. Therapy of other vasculitis syndromes. In: van de Putte LBA, Furst DE, Williams HJ, van Riel PLCM, eds. <i>Therapy of systemic rheumatic disorders</i>. New York: Marcel Dekker, 1998 Maksymowych WP, Avina-Zubieta A, Luong MH, Russel AS. An open study of pentoxifylline in the treatment of severe rheumatoid arthritis. J Rheumatol. 1995;22(4):625–9 Zabel P, Schlaak M, Schade FU. Inhibition of cytokines by pentoxifylline. J Immunobiol. 1993;187:447–63
Challenges of a Supplemental Private Option Under National Health Insurance—Observations From Australia
Authors: Bruce E. Landon, Shaun Larkin, Adam G. Elshaug
Journal: JAMA Internal Medicine (2021)

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FRI0066 SUBCLINICAL CORONARY CALCIFICATION ASSOCIATED WITH LONG-TERM CARDIOVASCULAR OUTCOMES IN RHEUMATOID ARTHRITIS
Authors: G. Karpouzas, S. Ormseth, E. Hernandez, M. Budoff
Journal: Annals of the Rheumatic Diseases (2020)

Background: Large, multicenter studies established the strong prognostic value of coronary artery calcium (CAC) scoring in asymptomatic individuals. Increasing CAC score is an independent predictor of worsening cardiovascular disease event risk in general patients. The prognostic significance of higher CAC score strata in the long-term cardiovascular risk in rheumatoid arthritis (RA) is unknown. Objectives: To evaluate the long-term cardiovascular event risk across CAC strata in a prospective, single center cohort of established RA patients without symptoms or prior diagnosis of cardiovascular disease. Methods: One hundred-fifty patients underwent computed tomography angiography for coronary atherosclerosis evaluation. CAC score was measured according to Agatston. CVD events were prospectively recorded, including cardiac death, myocardial infarction, unstable angina, revascularization, stroke, claudication, and heart failure hospitalization over 6.0±2.4 years of follow-up. Unadjusted, robust Cox proportional hazards regression models evaluated CVD event risk across higher CAC strata (CAC=1-99, CAC=100-399 and CAC≥400) compared to CAC=0. Additional multivariable robust Cox regression models with time-varying covariates evaluated the impact of log transformed CAC or different CAC thresholds (CAC&gt;0 vs. CAC=0, CAC≥100 vs. CAC&lt;100 and CAC≥400 vs. CAC&lt;400) on future CVD events. Models were controlled for Framingham-D’Agostino clinical risk score, time-varying current bDMARD use and time-varying CRP. Results: Sixteen patients incurred 19 events, for a total of 2.1 (95% CI 1.3-3.3) events/100 patient-years. Increasing HR for cardiovascular events was observed for ascending CAC strata; 3.87 (1.03-14.48), 6.31 (1.38-28.91) and 16.98 (4.50-64.10) for CAC=1-99, CAC=100-399 and CAC≥400 respectively compared to CAC=0 (figure 1). In fully adjusted models, CAC score associated with future event risk independently of Framingham D’Agostino score, time-varying bDMARD use and time-varying CRP (HR=1.31 [95%CI 1.04-1.66]). CAC thresholds ≥100 (vs. &lt;100) and CAC≥400 (vs. &lt;400) in fully adjusted models similarly constituted independent predictors of long-term cardiovascular events (Figure 2). Figure 1. Increasing CAC scores associated with higher cardiovascular event risk in RA Figure 2. Impact of different CAC thresholds on cardiovascular event risk in RA Conclusion: Increasing CAC scores are strong, independent predictors of long-term cardiovascular events in RA patients without symptoms or prior diagnosis of cardiovascular disease. Disclosure of Interests: George Karpouzas Grant/research support from: Pfizer, Consultant of: Sanofi-Genzyme-Regeneron, Janssen, Speakers bureau: Sanofi-Genzyme-Regeneron, BMS, Sarah Ormseth: None declared, Elizabeth Hernandez: None declared, Matthew Budoff: None declared
SP0064 Drug therapy in fibromyalgia. a review
Authors: E Thomas, F Blotman
Journal: Annals of the Rheumatic Diseases (2001)

<h3></h3> Since the cause and pathophysiology of fibromyalgia (FM) remain unknown, treatment is often limited; fewer than 50% of patients have significant and sustained clinical improvement. No pharmacologic agent are indicated specifically for FM treatment, although many have been tried to date. Controlled trials with non-steroidal anti-inflammatory drugs have been shown them to be of little help, despite their use in a majority of patients. Steroidal anti-inflammatory drugs are not efficacious and often deleterious. Among analgesics, preliminary data suggest that tramadol, affecting norepinephrine at the receptor site, may be useful for FM pain. No clinical data are available to suggest efficacy of opioids in FM. Tricyclic antidepressants and selective serotonin reuptake inhibitors may diminish the sleep disturbance, pain and depression associated with FM. they remain the cornerstone of drug therapy in FM. Blockade of the serotonin receptor subtype 5-HT3 with Tropisetron or Ondansetron has been reported to significantly decrease the number of tender points, despite poor digestive tolerance. The findings of low levels of insulin-like growth factor 1 in FM led to give daily growth hormone (GH) injections to 22 women (vs placebo to 23), enrolled in a controlled study. A 9 months, the tender point score was significantly improved with GH. other agents like 5-hydroxytryptophan, gamma-hydroxybutyrate and S-adenosyl-L-Methionine also shown promising results. FM symptoms may be alleviated in a short term manner with various pharmacologic treatments but a minority of patients still experience remission at a few years follow-up.
Tuberculosis and COVID-19 interaction: A review of biological, clinical and public health effects
Authors: D. Visca, C.W.M. Ong, S. Tiberi, R. Centis, L. D’Ambrosio, B. Chen, J. Mueller, P. Mueller, R. Duarte, M. Dalcolmo, G. Sotgiu, G.B. Migliori, D. Goletti
Journal: Pulmonology (2021)

Evidence is accumulating on the interaction between tuberculosis (TB) and COVID-19. The aim of the present review is to report the available evidence on the interaction between these two infections. Differences and similarities of TB and COVID-19, their immunological features, diagnostics, epidemiological and clinical characteristics and public health implications are discussed. The key published documents and guidelines on the topic have been reviewed. Based on the immunological mechanism involved, a shared dysregulation of immune responses in COVID-19 and TB has been found, suggesting a dual risk posed by co-infection worsening COVID-19 severity and favouring TB disease progression. The available evidence on clinical aspects suggests that COVID-19 happens regardless of TB occurrence either before, during or after an active TB diagnosis. More evidence is required to determine if COVID-19 may reactivate or worsen active TB disease. The role of sequeale and the need for further rehabilitation must be further studied Similarly, the potential role of drugs prescribed during the initial phase to treat COVID-19 and their interaction with anti-TB drugs require caution. Regarding risk of morbidity and mortality, several risk scores for COVID-19 and independent risk factors for TB have been identified: including, among others, age, poverty, malnutrition and co-morbidities (HIV co-infection, diabetes, etc.). Additional evidence is expected to be provided by the ongoing global TB/COVID-19 study.
Aspirin Use and Risk of Colorectal Cancer Among Older Adults
Authors: Chuan-Guo Guo, Wenjie Ma, David A. Drew, Yin Cao, Long H. Nguyen, Amit D. Joshi, Kimmie Ng, Shuji Ogino, Jeffrey A. Meyerhardt, Mingyang Song, Wai K. Leung, Edward L. Giovannucci, Andrew T. Chan
Journal: JAMA Oncology (2021)

<h3>Importance</h3> Although aspirin is recommended for the prevention of colorectal cancer (CRC) among adults aged 50 to 59 years, recent data from a randomized clinical trial suggest a lack of benefit and even possible harm among older adults. <h3>Objective</h3> To examine the association between aspirin use and the risk of incident CRC among older adults. <h3>Design, Setting, and Participants</h3> A pooled analysis was conducted of 2 large US cohort studies, the Nurses' Health Study (June 1, 1980–June 30, 2014) and Health Professionals Follow-up Study (January 1, 1986–January 31, 2014). A total of 94 540 participants aged 70 years or older were included and followed up to June 30, 2014, for women or January 31, 2014, for men. Participants with a diagnosis of any cancer, except nonmelanoma skin cancer, or inflammatory bowel disease were excluded. Statistical analyses were conducted from December 2019 to October 2020. <h3>Main Outcomes and Measures</h3> Cox proportional hazards models were used to calculate multivariable adjusted hazard ratios (HRs) and 95% CIs for incident CRC. <h3>Results</h3> Among the 94 540 participants (mean [SD] age, 76.4 [4.9] years for women, 77.7 [5.6] years for men; 67 223 women [71.1%]; 65 259 White women [97.1%], 24 915 White men [96.0%]) aged 70 years or older, 1431 incident cases of CRC were documented over 996 463 person-years of follow-up. After adjustment for other risk factors, regular use of aspirin was associated with a significantly lower risk of CRC at or after age 70 years compared with nonregular use (HR, 0.80; 95% CI, 0.72-0.90). However, the inverse association was evident only among aspirin users who initiated aspirin use before age 70 years (HR, 0.80; 95% CI, 0.67-0.95). In contrast, initiating aspirin use at or after 70 years was not significantly associated with a lower risk of CRC (HR, 0.92; 95% CI, 0.76-1.11). <h3>Conclusions and Relevance</h3> Initiating aspirin at an older age was not associated with a lower risk of CRC in this pooled analysis of 2 cohort studies. In contrast, those who used aspirin before age 70 years and continued into their 70s or later had a reduced risk of CRC.
Matching Prescription Drugs and Consumers
Authors: Alison Masson, Paul H. Rubin
Journal: New England Journal of Medicine (1985)

Prescription drugs are seldom advertised directly to consumers, partly because of strict regulation by the Food and Drug Administration. In fact, there has been a moratorium on direct consumer advertising since 1983. The two types of consumer advertising permitted as exceptions to the moratorium are circumscribed in such a way as to weaken greatly the incentive to advertise. Even before the moratorium, the requirement that the ads include a "fair balance" of information about effectiveness, side effects, and contraindications1 made advertising very costly. Thus, public policy has consistently opposed the routine advertising of prescription drugs to consumers.This policy is . . .
Gut Microbiota Condition the Therapeutic Efficacy of Trastuzumab in HER2-Positive Breast Cancer
Authors: Martina Di Modica, Giorgio Gargari, Viola Regondi, Arianna Bonizzi, Stefania Arioli, Beatrice Belmonte, Loris De Cecco, Elena Fasano, Francesca Bianchi, Alessia Bertolotti, Claudio Tripodo, Laura Villani, Fabio Corsi, Simone Guglielmetti, Andrea Balsari, Tiziana Triulzi, Elda Tagliabue
Journal: Cancer Research (2021)

Abstract Emerging evidence indicates that gut microbiota affect the response to anticancer therapies by modulating the host immune system. In this study, we investigated the impact of gut microbiota on immune-mediated trastuzumab antitumor efficacy in preclinical models of HER2-positive breast cancer and in 24 patients with primary HER2-positive breast cancer undergoing trastuzumab-containing neoadjuvant treatment. In mice, the antitumor activity of trastuzumab was impaired by antibiotic administration or fecal microbiota transplantation from antibiotic-treated donors. Modulation of the intestinal microbiota was reflected in tumors by impaired recruitment of CD4+ T cells and granzyme B–positive cells after trastuzumab treatment. Antibiotics caused reductions in dendritic cell (DC) activation and the release of IL12p70 upon trastuzumab treatment, a mechanism that was necessary for trastuzumab effectiveness in our model. In patients, lower α-diversity and lower abundance of Lachnospiraceae, Turicibacteraceae, Bifidobacteriaceae, and Prevotellaceae characterized nonresponsive patients (NR) compared with those who achieved pathologic complete response (R), similar to antibiotic-treated mice. The transfer of fecal microbiota from R and NR into mice bearing HER2-positive breast cancer recapitulated the response to trastuzumab observed in patients. Fecal microbiota β-diversity segregated patients according to response and positively correlated with immune signature related to interferon (IFN) and NO2-IL12 as well as activated CD4+ T cells and activated DCs in tumors. Overall, our data reveal the direct involvement of the gut microbiota in trastuzumab efficacy, suggesting that manipulation of the gut microbiota is an optimal future strategy to achieve a therapeutic effect or to exploit its potential as a biomarker for treatment response. Significance: Evidence of gut microbiota involvement in trastuzumab efficacy represents the foundation for new therapeutic strategies aimed at manipulating commensal bacteria to improve response in trastuzumab-resistant patients. See related commentary by Sharma, p. 1937