Latest news with #clinicalStudy
Medscape
03-07-2025
- Health
- Medscape
Pimecrolimus Repairs Steroid-Induced Skin Damage in AD
TOPLINE: Intermittent treatment with pimecrolimus 1% cream for 1 year was effective in reversing topical corticosteroid-induced skin damage in patients with atopic dermatitis. Pimecrolimus reduced skin damage by 30.5% on the face and by 38.6% on cubital areas, with skin thickness increases of 64.4% and 19.9%, respectively. METHODOLOGY: Researchers conducted a 12-month, single-group phase 4 study involving 41 adult patients with mild-to-moderate atopic dermatitis and clinically evident skin atrophy due to long-term corticosteroid use on the face and cubital areas. Participants received intermittent treatment with pimecrolimus 1% cream at the first signs of disease until lesions cleared, with prednicarbate 0.25% cream as a rescue medication for major flares. The mean duration of treatment was 201 ± 106 days. The primary endpoint was the decrease in the Dermatophot score from baseline to the end of the study as a measure of the reconstitution of corticosteroid-damaged skin being treated with pimecrolimus cream. TAKEAWAY: The Dermatophot score improved significantly from baseline — by 30.5% (95% CI, 20.8%-40.1%; P < .0001) on the face and 38.6% (95% CI, 28.2%-49.0%; P < .0001) on the cubital areas. Ultrasound measurements showed a 64.4% increase in facial skin thickness (P = .002) and a 19.9% increase in cubital area skin thickness (P < .02). At week 48, treatment success rates were 58.9% for facial lesions, 61.8% for cubital lesions, and 50.0% for whole-body lesions. Among subgroups defined by rescue medication use (> 33% vs ≤ 33% of the study period), those with lower exposure — using rescue medication for ≤ 33% of the study period — achieved numerically greater improvements in the Dermatophot score. Five patients experienced a total of six serious adverse events, none of which were considered related to the drug. IN PRACTICE: "In conclusion, this study demonstrated that long-term treatment with pimecrolimus 1% cream can lead to reconstitution of corticosteroid-damaged skin with favourable disease control," the authors wrote. SOURCE: The study was led by Diamant Thaçi, MD, Institute and Comprehensive Center for Inflammation Medicine, University of Luebeck, Luebeck, Germany. It was published online on June 20, 2025, in the Journal of Dermatological Treatment. LIMITATIONS: The study did not include a control group receiving standard therapy. The researchers noted that without a randomized double-blind design, they could not definitively determine whether disease control with pimecrolimus treatment enabled self-healing of skin atrophy through steroid reduction or whether pimecrolimus itself actively improved skin atrophy through pharmacologic effects. Patients with severe atrophy (Dermatophot score > 6) were not included as reconstitution of damaged skin was expected to be difficult in such cases. DISCLOSURES: The study was funded by Novartis Pharma Germany. One author reported being a former employee of Novartis Pharma Germany. Some authors reported receiving honoraria or grants, serving on advisory boards, or having other ties with various sources. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
25-06-2025
- Health
- Medscape
Stewardship Cuts IV Treatment for Paediatric Bone Infections
TOPLINE: A hospital-based antimicrobial stewardship program (ASP) using post-prescription review and feedback (PPRF) significantly decreased intravenous (IV) antibiotic duration, length of hospital stay, and reliance on third-generation cephalosporin in paediatric bone and joint infections over 5 years. METHODOLOGY: This single-centre, quasi-experimental study evaluated the effect of a PPRF-based multifaceted ASP on antibiotic use, treatment duration, and length of hospital stay in paediatric acute haematogenous bone and joint infections (AH-BJIs). This study included 285 children: 60 in the pre-ASP (2015-2016; mean age, 1.9 years; 50% boys) and 225 in the post-ASP (2017-2023; mean age, 2.9 years; 67.5% boys). Data on demographics, clinical features, microbiology, and treatment were collected from electronic medical records. Primary outcomes were parenteral/oral antibiotic duration, length of hospital stay, and clinical outcomes (sequelae, readmission, and mortality). TAKEAWAY: The median IV antibiotic duration and length of hospital stay in children with AH-BJIs were both significantly reduced after ASP implementation, dropping from 8.5 (interquartile range [IQR], 7.0-12.0) to 7 (IQR, 4.5-8.0) days and from 8.5 (IQR, 7.0-11.0) to 7 (IQR, 5.0-9.0) days, respectively (P < .001 for both). Post-2020, broad-spectrum antibiotic use significantly declined, with third-generation cephalosporin use fell from 81% to 10% in children aged 5 years or younger and cloxacillin use declined by 60.0% in children older than 5 years in favour of narrower spectrum cefazolin (P < .001 for both). Methicillin-susceptible Staphylococcus aureus was the most common pathogen (22.8%), followed by Kingella kingae (10.9%), which was found in only children younger than 4 years. Blood cultures were positive in 29.3% of cases. Among 52 children with soft-tissue/subperiosteal abscesses (46 occurring post-ASP), the median oral antibiotic duration was 41 days, with total treatment lasting 47 days; the ASP maintained safety, with no increase seen in sequelae (6.3% overall), readmissions (3.3% in the pre-ASP vs 3.6% in the post-ASP), and mortality (0%). IN PRACTICE: "After ASP implementation, the length of parenteral antibiotic treatment, length of hospital stay, and 3rd generation cephalosporin use in children with AH-BJI were reduced safely," the authors wrote. SOURCE: This study was led by Aina Font, Pharmacy Department, Consorci Hospitalari de Vic, Vic, Spain. It was published online on June 18, 2025, in the European Journal of Pediatrics. LIMITATIONS: This single-centre study had several limitations, such as the unbalanced sample size and inclusion of neonates, which may have affected generalisability; the findings based on local epidemiology may not apply to other settings. This study did not evaluate treatment days per 1000 admissions, cost-effectiveness, COVID-19 impact, diagnostic advances, and staff turnover effects, nor it systematically monitor prescriber adherence or satisfaction with the stewardship program. DISCLOSURES: No funding was secured for this study. The authors declared having no competing interests. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
11-06-2025
- Health
- Medscape
Peptide Predicts Cardiac Risk in Women With Unblocked Arteries
In women with angina pectoris but no obstructive coronary artery disease (ANOCA), a high concentration of pro-C-type natriuretic peptide (proCNP) is linked to a 73% increased risk for all-cause mortality. The substance also shows a positive association with atherosclerotic markers and a negative association with generalized inflammation. METHODOLOGY: The analysis focused on baseline associations between proCNP concentrations in plasma and clinical data in 1508 women with ANOCA, with exploratory analyses examining correlation patterns between proCNP and 185 cardiovascular plasma markers. Primary outcomes included all-cause death and a composite endpoint of cardiovascular events. Hazard ratios (HRs) were adjusted for age and creatine concentration, which have been linked to proCNP-derived peptides in plasma. TAKEAWAY: A high concentration of proCNP (≥ 53.4 pmol/L) was associated with a diagnosis of hypertension ( P = .001) and diabetes mellitus ( P < .001), postmenopausal status ( P < .001), but not age. = .001) and diabetes mellitus ( < .001), postmenopausal status ( < .001), but not age. The researchers identified 38 plasma markers significantly associated with proCNP, showing positive correlation with atherosclerotic markers and a negative correlation with pro-inflammatory markers. Women with high concentrations of proCNP were at increased risk for all-cause mortality (crude HR, 1.73; 95% CI, 1.10-2.73; P = .02) and adjusted HR, 1.57; 95% CI, 0.99-2.49; P = .06). = .02) and adjusted HR, 1.57; 95% CI, 0.99-2.49; = .06). No significant difference was found in rates of cardiovascular events between groups (crude HR, 1.08; 95% CI, 0.72-1.62; P = .71; and adjusted HR, 1.03; 95% CI, 0.68-1.56; P = .90). IN PRACTICE: 'The association between high proCNP concentrations and diabetes in women is notable as diabetes is associated with an excess risk of > 40% of fatal ischemic heart disease in women compared with men,' the researchers reported. 'Our findings thus raise the question whether increases in proCNP among elderly women are part of an adaptive vascular response to cardiovascular risk factors after menopause. Taken together, the baseline associations of the present study show high proCNP concentration in women with ANOCA is associated with a cardiovascular risk profile independent of NT-proBNP and low-grade inflammation.' SOURCE: This study was led by Peter D. Mark, MD, PhD, of the University of Copenhagen, in Copenhagen, Denmark. It appears online in the July 1 issue of JACC: ADVANCES . LIMITATIONS: As only women were examined in this study, it was impossible to evaluate whether the findings would be mirrored in men with ANOCA. Biomarkers, except for proCNP and high-sensitivity C-reactive protein, were quantified as relative plasma levels rather than absolute concentrations, limiting the interpretation of the statistical analyses. DISCLOSURES: This study received support through the Danish Biotek program via a grant from the Danish Health Ministry. The senior author, Jens P. Goetze, has served as a consultant for Novo Nordisk on biochemical method development.
Medscape
29-05-2025
- Health
- Medscape
Bariatric Surgery Linked With Psoriasis Improvement
Most patients with psoriasis experienced clinical improvement or remission after metabolic and bariatric surgery (MBS) in a systematic review. METHODOLOGY: Researchers conducted a systematic review of 14 studies that included 169 patients (mean age, 46.8 years; 74% women) with psoriasis who underwent MBS. Participants underwent various surgical procedures; gastric bypass was the most common (75.1%), followed by sleeve gastrectomy (17.8%), gastric banding (5.3%), and jejunoileal bypass (0.6%). Psoriasis treatments prior to surgery included topical treatments (46.2%), non-biologic systemic treatments (35.5%), and biologics (16.6%). At baseline, psoriasis severity was predominantly moderate (76.3%); 8.2% were severe and 15.6% were mild cases, based on psoriasis area and severity index and percent body surface area scores. TAKEAWAY: Average body mass index (BMI) decreased from 43.7 at baseline to 32.9after surgery, with BMI reduction ranging from 8 to 25 during follow-up periods of 4 months to 9 years. Psoriasis was either mild or had completely resolved in 97.2% of patients after bariatric surgery, whereas 2.4% experienced worsening of psoriasis. A total of 78.1% of patients continued psoriasis treatment post-surgery, but medications were downgraded to a lower category (such as systemic to topical treatments, or no treatment) in many patients. IN PRACTICE: 'MBS may improve psoriasis outcomes following surgery,' the study authors wrote. 'While initial findings are promising, further controlled trials are necessary to validate the long-term effects of MBS on psoriasis and explore its potential role as an adjunctive therapy.' SOURCE: The study was led by Miranda K. Branyiczky, BSc, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada, and was published online on May 24 in the Journal of the American Academy of Dermatology . LIMITATIONS: Limitations were reporting bias, variability in outcome measures, and the inclusion of case reports or series. DISCLOSURES: This study did not receive any funding. One author reported receiving grants, research support, speaker fees, and honoraria from multiple pharmaceutical companies including AbbVie, Alumis, Amgen, Arcutis Biotherapeutics, Bristol Myers Squibb, Eli Lilly and Company, Janssen Pharmaceuticals, Novartis, and Pfizer.
Medscape
26-05-2025
- Health
- Medscape
Gender Gaps Found in Timing of RA Treatment Initiation
Gender-based differences were identified in the clinical characteristics and time to initiation of the first biologic or targeted synthetic disease-modifying antirheumatic drug (b/ts DMARD) among patients with rheumatoid arthritis (RA), with women experiencing a longer disease duration before treatment initiation than men. METHODOLOGY: Researchers conducted a multicenter observational study using data from a Spanish registry to assess gender differences in clinical characteristics and in the timing of b/tsDMARD initiation in patients with RA. They included 3384 patients with RA (78.1% women) who started their first b/tsDMARD between January 2000 and October 2023. The main outcomes included the time from RA diagnosis to initiation of the first b/tsDMARD and disease activity at treatment initiation, which were compared by sex. The analysis stratified treatment initiation periods according to the emergence and marketing of different drugs during the study: Up to December 2006, January 2007-December 2016, and after January 2017. TAKEAWAY: Women had a lower mean age at treatment initiation than men (54.8 vs 57.0 years; P < .001) but a longer disease duration (mean, 7.3 vs 6.7 years; P = .031). < .001) but a longer disease duration (mean, 7.3 vs 6.7 years; = .031). Men had a higher body mass index and more comorbidities, whereas women were more likely to have Sjögren syndrome and osteoporosis. At treatment initiation, women had a higher Disease Activity Score 28–Erythrocyte Sedimentation Rate than men; however, no difference was observed in Disease Activity Score 28–C-reactive protein. Gender differences in disease duration before treatment initiation were especially notable in women from 2017 onward (hazard ratio, 0.9; P = .026). A longer RA duration before treatment was observed in women, older patients, and those on other conventional synthetic DMARDs (excluding methotrexate), whereas smokers, individuals with obesity, and those receiving methotrexate or glucocorticoids began treatment earlier. IN PRACTICE: "The delay in treatment initiation in women despite a higher activity rate merits reflection," the authors of the study wrote. SOURCE: This study was led by Paloma Vela-Casasempere, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, Spain. It was published online on May 14, 2025, in Arthritis Research & Therapy . LIMITATIONS: Only the covariates available in the registry were included in this study, potentially missing other confounding factors. Sex was recorded as a dichotomous variable (male/female), without accounting for self-identified gender. DISCLOSURES: The registry was supported by the Spanish Agency of Drugs and Medical Devices, Biogen, Bristol-Myers and Squibb, and others. Several authors reported receiving grants or contracts, consulting fees, honoraria, or travel support from various pharmaceutical companies, including Novartis and Pfizer.
