Observational studyAdvances in therapy2017
The GENDER ATTENTION Observational Study: Gender and Hormonal Status Differences in the Incidence of Adverse Events During Cyclosporine Treatment in Psoriatic Patients.
Observational study in Advances in therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- A systematic review of sex and gender differences in treatment outcome of inflammatory skin diseases: Is it time for new guidelines?Journal of the European Academy of Dermatology and Venereology : JEADV · 2025Pooled it
- Sex-specific formulations of doxazosin mesylate via direct powder extrusion 3D printing.Drug delivery and translational research · 2025Article
- Targeting interleukin-2-inducible T cell kinase ameliorates immune-mediated aplastic anemia.Cancer immunology, immunotherapy : CII · 2025Article
- Oral Diseases During Systemic Psoriatic Drugs: A Review of the Literature and Case Series.Dermatology practical & conceptual · 2024Review
- Gender perspective in psoriasis: a scoping review and proposal of strategies for improved clinical practice by European dermatologists.International journal of women's dermatology · 2023Article
- The CHRONOS Real-World Evidence of Biologic Treatments in Psoriatic Arthritis in Italy: AWomen's health reports (New Rochelle, N.Y.) · 2022Article
- Long-term Safety of Oral Systemic Therapies for Psoriasis: A Comprehensive Review of the Literature.Dermatology and therapy · 2020Review
- Sex differences in pharmacokinetics predict adverse drug reactions in women.Biology of sex differences · 2020Article
- Sex and age as determinants for high blood pressure in pediatric renal transplant recipients: a longitudinal analysis of the CERTAIN Registry.Pediatric nephrology (Berlin, Germany) · 2020Article
- The SURF (Italian observational study for renal insufficiency evaluation in liver transplant recipients): a post-hoc between-sex analysis.BMC nephrology · 2019Observational
- Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies.Cells · 2019Review
- Psoriasis and sexual dysfunction: links, risks, and management challenges.Psoriasis (Auckland, N.Z.) · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFemale sex has been shown to be a risk factor for the development of adverse drug reactions; however, this has not been studied for cyclosporine (CsA). The aim of this study was to investigate, in Italian dermatological practice, the influence of gender and menopause and related hormones on the incidence of adverse events (AEs) during CsA treatment in psoriatic patients.
methodsMulticenter, prospective, observational study conducted from May 2011 to June 2013. Patients with plaque psoriasis, undergoing a new CsA administration course, or about to start it, were enrolled in the outpatient clinics of Italian dermatological centers. During the 2-6 months of study duration, patients had to note all AEs that occurred in a diary that was reviewed by the investigators at the follow-up visit. Sex hormone levels were measured within 7 days from the start date of a menstrual cycle.
resultsA total of 969 adult psoriatic patients were enrolled in the study, divided into four cohorts: fertile women and corresponding age-matched men; postmenopausal women and corresponding age-matched men. A significant difference in the percentage of patients with AEs was observed between fertile and postmenopausal women, but not between women and age-matched men. AE incidence rate was about 37% higher in fertile women than in age-matched men and about 18% higher in postmenopausal women than in age-matched men, but differences were not statistically significant. Incidence rate ratio of fertile vs. postmenopausal women was 0.67, reaching statistical significance. AEs were mild or moderate in severity in the great majority of patients of all cohorts and postmenopausal women had significantly less grade 1-2 AEs compared to fertile women, but more grade 3-4 AEs. FSH levels were significantly higher in postmenopausal women reporting no AEs, and DHEA sulfate levels were about 10% higher in men with no AEs, compared to those reporting at least one AE. Cortisol levels were slightly though significantly higher in postmenopausal women with no AE.
conclusionsA better understanding of sex- and hormone-related influences on drug responses may help to improve drug safety and efficacy, by permitting one to tailor pharmacological treatments to individual subjects or defined patient cohorts.
fundingNovartis Farma S.p.A., Italy.
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