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1.
Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease.
Mahadevan, U, Long, MD, Kane, SV, Roy, A, Dubinsky, MC, Sands, BE, Cohen, RD, Chambers, CD, Sandborn, WJ, ,
Gastroenterology. 2021;(4):1131-1139
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Abstract
BACKGROUND & AIMS Pregnant women with inflammatory bowel disease (IBD) may require biologic or thiopurine therapy to control disease activity. Lack of safety data has led to therapy discontinuation during pregnancy, with health repercussions to mother and child. METHODS Between 2007 and 2019, pregnant women with IBD were enrolled in a prospective, observational, multicenter study across the United States. The primary analysis was a comparison of 5 outcomes (congenital malformations, spontaneous abortions, preterm birth, low birth weight, and infant infections) among pregnancies exposed vs unexposed in utero to biologics, thiopurines, or a combination. Bivariate analyses followed by logistic regression models adjusted for relevant confounders were used to determine the independent effects of specific drug classes on outcomes of interest. RESULTS Among 1490 completed pregnancies, there were 1431 live births. One-year infant outcomes were available in 1010. Exposure was to thiopurines (n = 242), biologics (n = 642), or both (n = 227) vs unexposed (n = 379). Drug exposure did not increase the rate of congenital malformations, spontaneous abortions, preterm birth, low birth weight, and infections during the first year of life. Higher disease activity was associated with risk of spontaneous abortion (hazard ratio, 3.41; 95% confidence interval, 1.51-7.69) and preterm birth with increased infant infection (odds ratio, 1.73; 95% confidence interval, 1.19-2.51). CONCLUSIONS Biologic, thiopurine, or combination therapy exposure during pregnancy was not associated with increased adverse maternal or fetal outcomes at birth or in the first year of life. Therapy with these agents can be continued throughout pregnancy in women with IBD to maintain disease control and reduce pregnancy-related adverse events. ClinicalTrials.gov, Number: NCT00904878.
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Modifiable lifestyle risk factors and C-reactive protein in patients with coronary artery disease: Implications for an anti-inflammatory treatment target population.
Blaum, C, Brunner, FJ, Kröger, F, Braetz, J, Lorenz, T, Goßling, A, Ojeda, F, Koester, L, Karakas, M, Zeller, T, et al
European journal of preventive cardiology. 2021;(2):152–158
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Abstract
BACKGROUND Modifiable lifestyle risk factors (modRF) of coronary artery disease (CAD) are associated with increased inflammation represented by elevated C-reactive protein (CRP) levels. Lifestyle changes may influence the inflammatory burden in patients with CAD, relevantly modifying the target population for emerging anti-inflammatory compounds. AIMS The aims of this study were to analyse the association of modRF and CRP levels in CAD patients, and to define a potential target population for anti-inflammatory treatment with and without the optimisation of modRF. METHODS We included all patients with angiographically documented CAD from the observational cohort study INTERCATH. Patients with recent myocardial infarction, malignancy, infectious disease, and pre-existing immunosuppressive medication including a history of solid organ transplantation were excluded. Overweight (body mass index (BMI) ≥ 25 kg/m2), smoking, lack of physical activity (PA; <1.5 h/week), and poor diet (≤12 points of an established Mediterranean diet score (MDS), range 0-28 points) were considered as modRF. CRP was measured by a high-sensitivity assay (hsCRP) at baseline. We performed multivariable linear regressions with log-transformed hsCRP as the dependent variable. Based on these associations, we calculated potential hsCRP levels for each patient, assuming optimisation of the individual modRF. RESULTS Of 1014 patients, 737 (73%) were male, the mean age was 69 years, and 483 (48%) had an hsCRP ≥ 2 mg/l. ModRF were significantly overrepresented in patients with hsCRP ≥ 2 mg/l compared to patients with an hsCRP < 2 mg/l (BMI ≥ 25 kg/m2: 76% vs 61%; PA < 1.5 h/week: 69% vs 57%; MDS ≤ 12: 46% vs 37%; smoking: 61% vs 54%; p < 0.05 for all). hsCRP increased with the incremental number of modRF present (median hsCRP values for N = 0, 1, 2, 3, and 4 modRF: 1.1, 1.0, 1.6, 2.4, 2.8 mg/l, p < 0.001). Multivariable linear regression adjusting for age, sex, intake of lipid-lowering medication, and diabetes mellitus revealed independent associations between log-transformed hsCRP and all modRF (BMI ≥ 25 kg/m2: exp(ß) = 1.55, p < 0.001; PA < 1.5 h/week: exp(ß) = 1.33, p < 0.001; MDS ≤ 12: exp(ß) = 1.18, p = 0.018; smoking: exp(ß) = 1.18, p = 0.019). Individual recalculation of hsCRP levels assuming optimisation of modRF identified 183 out of 483 (38%) patients with hsCRP ≥ 2 mg/l who could achieve an hsCRP < 2 mg/l via lifestyle changes. CONCLUSION modRF are strongly and independently associated with CRP levels in patients with CAD. A relevant portion of CAD patients with high inflammatory burden could achieve an hsCRP < 2 mg/l by lifestyle changes alone. This should be considered both in view of the cost and side-effects of pharmacological anti-inflammatory treatment and for the design of future clinical trials in this field.
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Early short-course corticosteroids and furosemide combination to treat non-critically ill COVID-19 patients: An observational cohort study.
Kevorkian, JP, Riveline, JP, Vandiedonck, C, Girard, D, Galland, J, Féron, F, Gautier, JF, Mégarbane, B
The Journal of infection. 2021;(1):e22-e24
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Dietary anti-inflammatory index, metabolic syndrome and transition in metabolic status; a gender-specific analysis of ATTICA prospective study.
Kouvari, M, Panagiotakos, DB, Naumovski, N, Chrysohoou, C, Georgousopoulou, EN, Yannakoulia, M, Tousoulis, D, Pitsavos, C, ,
Diabetes research and clinical practice. 2020;:108031
Abstract
AIMS: To examine the association between dietary anti-inflammatory index (D-AII) and metabolic syndrome (MetS)prevalence, 10-year (2002-2012) diabetes, hypertension, hypercholesterolaemia incidence and 10-year transition from healthy (absence of all MetS traits, excluding waist circumference) to unhealthy metabolic status. METHODS In 2001-2002, n = 1514 men and n = 1528 women (>18 years old) in Athens, Greece, free of cardiovascular disease were recruited. MetS was defined according to the revised NCEP ATP III (2005) or the IDF criteria or the harmonized criteria. The validated D-AII was calculated using a standardized procedure (range 10-77). RESULTS Inverse associations were observed between D-AII and transition from healthy to unhealthy metabolic status (Odds Ratio (OR)3rd vs. 1st tertile = 0.88 95% Confidence Interval (95%CI)(0.73, 0.98)) and diabetes (OR3rd vs. 1st tertile = 0.55, 95%CI(0.29, 0.77)). In women, D-AII was inversely associated with transition from healthy to unhealthy metabolic status (OR3rd vs. 1st tertile = 0.55, 95%CI(0.26, 0.90), diabetes (OR3rd vs. 1st tertile = 0.41, 95%CI(0.18, 0.64) and hypertension (OR3rd vs. 1st tertile = 0.75, 95%CI(0.20, 0.95), yet only with diabetes incidence in men (OR3rd vs. 1st tertile = 0.62, 95%CI(0.38, 0.93). CONCLUSIONS Diet with high anti-inflammatory load seems an effective preventive measure to retain a metabolically benign status, principally in terms of glycemic control.
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The journey for US psoriasis patients prescribed a topical: a retrospective database evaluation of patient progression to oral and/or biologic treatment.
Wu, JJ, Lu, M, Veverka, KA, Smulders, M, Papademetriou, E, Yu, J, Feldman, SR
The Journal of dermatological treatment. 2019;(5):446-453
Abstract
Background: A specific sequence for psoriasis (PsO) therapy has not been defined. Objectives: This retrospective, observational cohort study characterized pathways of PsO treatment over 3 years for newly diagnosed patients initially treated with a topical medication. Methods: Adult PsO patients from the Explorys database (March 1 2011 to June 30 2015) were grouped according to medication-use patterns: 1) discontinued therapy; 2) topical therapy only; 3) switched/added an oral agent; and 4) switched/added a biologic agent. Results: Of 6875 patients, 907 (13.2%) discontinued treatment; 2544 (37.0%) used topical only, and 3319 (45.7%) and 819 (11.9%) switched/added-on an oral and/or biologic agent, respectively. Patients progressed to biologic treatment faster than to oral agents (median 254 vs. 378 d; p < .0001). Using an oral agent before a biologic significantly delayed biologic initiation compared to progressing to biologic directly from topical (median 456 vs. 90 d; p < .0001). Limitations: Disease severity and the reason for treatment transitions were not assessed. Conclusions: Patients initiating topical PsO treatment progressed to biologics faster than to oral agent using an oral agent prior to a biologic significantly delayed biologic initiation. Maintaining patients on an effective topical treatment may minimize the need for a switch to oral and biologics.
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Real-World Assessment of Dexamethasone Intravitreal Implant in DME: Findings of the Prospective, Multicenter REINFORCE Study.
Singer, MA, Dugel, PU, Fine, HF, Capone, A, Maltman, J
Ophthalmic surgery, lasers & imaging retina. 2018;(6):425-435
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Abstract
BACKGROUND AND OBJECTIVE Dexamethasone intravitreal implant (DEX) (Ozurdex; Allergan plc, Dublin, Ireland) is approved for the treatment of diabetic macular edema (DME). This study assessed the real-world effectiveness, safety, and reinjection interval of DEX in adult patients with DME. PATIENTS AND METHODS This was a phase 4, prospective, multicenter (18 U.S. sites), observational study. RESULTS The study population comprised 177 patients (180 eyes; 93.8% previously treated). Baseline mean best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were 54.4 letters and 424.6 μm, respectively. DEX was administered as monotherapy or with other DME therapy (55%/45%). The mean reinjection interval was 5.0 months. Mean maximum BCVA change from baseline after the first three DEX injections was +9.1 letters, +7.7 letters, and +7.0 letters, respectively (P < .001); 36.0% of eyes achieved 15-letter or greater BCVA improvement. Mean maximum CRT change from baseline was -137.7 μm (P < .001). CONCLUSION DEX used alone or with other DME therapy improved visual and anatomic outcomes in DME patients in clinical practice, with no new safety concerns. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:425-435.].
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Anti-TNFα Treatment in Children and Adolescents With Combined Inflammatory Bowel Disease and Autoimmune Liver Disease.
Nedelkopoulou, N, Vadamalayan, B, Vergani, D, Mieli-Vergani, G
Journal of pediatric gastroenterology and nutrition. 2018;(1):100-105
Abstract
OBJECTIVES Inflammatory bowel disease (IBD) and autoimmune liver disease (AILD) are closely associated, the former often dictating progression of the latter. Antibodies to tumor necrosis factor alpha (anti-TNFα) are effective in the management of IBD, but may cause liver injury. METHODS Retrospective review of medical records of patients with juvenile AILD who received anti-TNFα for IBD to evaluate the safety and efficacy of anti-TNFα. RESULTS Eleven patients (6 boys), ages 9 to 15 years (median 13 years) were identified. Ten had ulcerative colitis and 1 Crohn disease; 2 had autoimmune hepatitis type 1 and 9 autoimmune hepatitis-sclerosing cholangitis variant. All patients were started on infliximab (IFX, 5 mg/kg) and 2 required dose increase (10 mg/kg); 3 of 11 switched to adalimumab due to allergic reaction or nonresponse. Three received adalimumab after losing response or developing antibodies to IFX. Liver function tests (LFTs) improved in 5, 1 continued to have stably abnormal LFTs and 2 maintained normal LFTs. Patients on adalimumab showed stable or improved liver function compared to pretreatment status. Six of 8 treated with a full course of IFX maintained clinical remission of IBD for 6 months to 2.5 years; of the 6 patients treated with adalimumab, 1 sustained IBD clinical remission for 24 months, 2 achieved remission only after tacrolimus addition and 3 did not respond. CONCLUSIONS IBD in patients with AILD can be aggressive, requiring escalation to anti-TNFα or switching to other biologics. In this series, anti-TNFα did not impair liver function and improved gut disease in most of the patients, indicating that it can be beneficial and safe.
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Significant Decrease in Plasma Levels of D-Dimer, Interleukin-8, and Interleukin-12 After a 12-Month Treatment with Rosuvastatin in HIV-Infected Patients Under Antiretroviral Therapy.
Calza, L, Colangeli, V, Magistrelli, E, Contadini, I, Bon, I, Re, MC, Conti, M, Mancini, R, Viale, P
AIDS research and human retroviruses. 2017;(2):126-132
Abstract
OBJECTIVES Statins have shown anti-inflammatory and immune-modulatory properties in both general and HIV-infected population, but their effect on plasma D-dimer levels is controversial and it has not been investigated to date in HIV-positive patients. The aim of our study was to assess the effect of rosuvastatin on D-dimer and other serum inflammation markers among these subjects. METHODS Prospective, cohort study of HIV-1-infected adult patients receiving a stable combination antiretroviral therapy (cART), who started a lipid-lowering therapy with rosuvastatin (10 mg daily) and were followed up for at least 12 months. The primary endpoint was the change at month 12 in the median plasma concentration of D-dimer. The secondary endpoints included the variation in median plasma levels of these inflammatory biomarkers: interleukin-8 (IL-8), interleukin-10 (IL-10), and interleukin-12 (IL-12). RESULTS Sixty-two patients were enrolled in the study, and the endpoints were available for 54 subjects. After 12 months, a significant decrease in median plasma concentration of D-dimer was observed (-21.4%; interquartile range [IQR], -35.5; -4.2; p = .029). With regard to the inflammatory biomarkers, a significant decrease in median levels of IL-8 (-24.6%; IQR, -30.8; -1.8; p = .012) and IL-12 (-18.7%; IQR, -25.8; +2.5; p = .033) was also observed. Rosuvastatin led to a significant reduction in serum lipid values and showed a good tolerability profile. CONCLUSIONS Our findings show that a 12-month treatment with rosuvastatin associated with an effective cART can significantly decrease the plasma levels of D-dimer, IL-8, and IL-12, and suggest a potential role for this statin to reduce activated coagulation and systemic inflammation among HIV-infected persons.
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Percutaneous Epidural Adhesiolysis with Epidural Steroid Injection: A Non-inferiority Test of Non-particulate Steroids Versus Particulate Steroids.
Cho, S, Park, HS
Pain medicine (Malden, Mass.). 2016;(9):1612-9
Abstract
OBJECTIVES To evaluate the efficacy of dexamethasone sodium phosphate (DSP), a non-particulate steroid, during percutaneous epidural adhesiolysis (PEA), as compared with triamcinolone acetate (TA). DESIGN Retrospective observational study. SETTING Interventional pain management clinic in a tertiary care center. SUBJECTS Patients scheduled to receive PEA between March 2011 and January 2014. METHODS 47 patients underwent the procedure with TA (TA group), and 26 patients underwent the procedure with DSP (DSP group). At the end of the procedure, 20 ml of 0.18% ropivacaine containing 3000 units of hyaluronidase and 80 mg of TA or 10 mg of DSP was injected. Success rates and means of percent decreases in terms of verbal numerical rating scale (VNRS) of pain and Oswestry Disability Index (ODI) at follow-up visits 3 and 6 months after PEA were compared. Non-inferiority test was used for statistical analysis. RESULTS At 3 months, the success rate in VNRS of TA group and DSP group were 59.6% and 53.8%. The mean percent decreases of VNRS were 42.4% and 46.1% in TA group and DSP group, respectively. At this time point, non-inferiority was not demonstrated. In contrast at 6 months, the success rate in aspect of VNRS was 45.2% in TA group and 62.5% in DSP group. The mean of percent decreases in the VNRS was 34.9% in TA group and 52.8% in DSP group. The non-inferiority was met in two measurements. CONCLUSIONS DSP presents non-inferiority to TA in terms of success rate and percentage decrease of the VNRS 6 months after PEA.
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Preprocedural statin therapy, inflammation, and myocardial injury in low-risk stable coronary artery disease patients submitted to coronary stent implantation.
Greque, GV, Serrano, CV, Strunz, CM, Soeiro, A, Santos, M, Pivateli, F, Jacob, JL, Pesaro, AE, Nicolau, JC, Kalil-Filho, R
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2016;(2):222-9
Abstract
OBJECTIVE Evaluate if statin therapy prior to elective coronary stent implantation (CSI) reduces the plasma levels of markers of inflammation and of myocardial necrosis in low-risk stable coronary artery disease patients (CAD). BACKGROUND The elevation of markers of inflammation and of myocardial necrosis after percutaneous coronary intervention may interfere with clinical outcome. Among acute coronary syndrome patients, statins improve clinical outcomes when used before CSI-mostly due to reduction of CSI-related myocardial infarction. However, little is known concerning preprocedural statin therapy on the reduction of these markers in stable patients at low-risk. METHODS In this prospective, observational study, 100 patients (n = 50 on statin therapy vs. n = 50 not on statin) with stable coronary artery disease underwent elective CSI. Inflammatory (C-reactive protein [CRP], interleukin [IL]-6, tumor necrosis factor-α and matrix metalloproteinase-9) and myocardial necrosis markers (troponin I and CK-MB) were determined before and 24 hr after CSI. RESULTS All patients presented a significant increase of CRP and IL-6 after CSI. However, this increase was attenuated in patients on statin therapy prior to CSI than those without statin therapy: 75% vs. 150% (P < 0.001) and 192% vs. 300% (P < 0.01). The other pro-inflammatory markers were similar for both sets of patients. Troponin I and CK-MB did not change after CSI regardless of previous statin therapy or not. CONCLUSIONS Pretreatment with statin attenuates procedural inflammation, denoted by markedly lower increases of CRP and IL-6 levels, in elective CSI within low-risk stable CAD patients. Periprocedural myocardial injury was irrelevant and was not affected by preprocedural statin therapy in this population.