The GENDER ATTENTION Observational Study: Gender and Hormonal Status Differences in the Incidence of Adverse Events During Cyclosporine Treatment in Psoriatic Patients

Delia Colombo, Giuseppe Banfi, Nicoletta Cassano, Alessandra Graziottin, Gino Antonio Vena, Giovanni Gualberto Fiori, Emanuela Zagni, Luca Stingeni, Sergio Chimenti, Enzo Berardesca, Giuseppe Micali, Giuseppe Albertini, Clara De Simone, Gilberto Bellia, Salvatore Amato, Fabio Ayala, Ferderico Bardazzi, Maria Grazia Bernengo, Maria Rita Bongiorno, Giovanni BorroniStefano Calvieri, Piergiacomo Calzavara Pinton, Calcedonio Cannarozzo, Serafinella Patrizia Cannavò, Angelo Cattaneo, Rossella Ceschini, Enrico Colombo, Maurizio Congedo, Francesco Cusano, Ornella De Pità, Sergio Di Nuzzo, Dario Donadio, Stefano Donelli, Raffaele Filotico, Maria Laura Flori, Maurizio Germino, Giampiero Girolomoni, Franco Kokelj, Anna Lanzoni, Giuseppe Lembo, Andrea Locatelli, Cristina Magnoni, Marco Marconi, Alberico Motolese, Manuela Papini, Aurora Parodi, Monica Pau, Ketty Peris, Stefano Piaserico, Giuseppe Ricotti, On behalf of the GENDER ATTENTION study group

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Introduction: Female 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. Methods: Multicenter, 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. Results: A 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. Conclusions: A 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. Funding: Novartis Farma S.p.A., Italy.

Original languageEnglish
Pages (from-to)1349-1363
Number of pages15
JournalAdvances in Therapy
Volume34
Issue number6
DOIs
Publication statusPublished - Jun 1 2017

Fingerprint

Cyclosporine
Observational Studies
Incidence
Therapeutics
Gonadal Steroid Hormones
Dehydroepiandrosterone Sulfate
Menstrual Cycle
Menopause
Ambulatory Care Facilities
Drug-Related Side Effects and Adverse Reactions
Psoriasis
Pharmaceutical Preparations
Italy
Hydrocortisone
Research Personnel
Hormones
Prospective Studies
Pharmacology
Safety

Keywords

  • Adverse drug reaction
  • Cyclosporine
  • Dermatology
  • Female
  • Gender
  • Psoriasis

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)

Cite this

The GENDER ATTENTION Observational Study : Gender and Hormonal Status Differences in the Incidence of Adverse Events During Cyclosporine Treatment in Psoriatic Patients. / Colombo, Delia; Banfi, Giuseppe; Cassano, Nicoletta; Graziottin, Alessandra; Vena, Gino Antonio; Fiori, Giovanni Gualberto; Zagni, Emanuela; Stingeni, Luca; Chimenti, Sergio; Berardesca, Enzo; Micali, Giuseppe; Albertini, Giuseppe; De Simone, Clara; Bellia, Gilberto; Amato, Salvatore; Ayala, Fabio; Bardazzi, Ferderico; Bernengo, Maria Grazia; Bongiorno, Maria Rita; Borroni, Giovanni; Calvieri, Stefano; Pinton, Piergiacomo Calzavara; Cannarozzo, Calcedonio; Cannavò, Serafinella Patrizia; Cattaneo, Angelo; Ceschini, Rossella; Colombo, Enrico; Congedo, Maurizio; Cusano, Francesco; De Pità, Ornella; Di Nuzzo, Sergio; Donadio, Dario; Donelli, Stefano; Filotico, Raffaele; Flori, Maria Laura; Germino, Maurizio; Girolomoni, Giampiero; Kokelj, Franco; Lanzoni, Anna; Lembo, Giuseppe; Locatelli, Andrea; Magnoni, Cristina; Marconi, Marco; Motolese, Alberico; Papini, Manuela; Parodi, Aurora; Pau, Monica; Peris, Ketty; Piaserico, Stefano; Ricotti, Giuseppe; On behalf of the GENDER ATTENTION study group.

In: Advances in Therapy, Vol. 34, No. 6, 01.06.2017, p. 1349-1363.

Research output: Contribution to journalArticle

Colombo, D, Banfi, G, Cassano, N, Graziottin, A, Vena, GA, Fiori, GG, Zagni, E, Stingeni, L, Chimenti, S, Berardesca, E, Micali, G, Albertini, G, De Simone, C, Bellia, G, Amato, S, Ayala, F, Bardazzi, F, Bernengo, MG, Bongiorno, MR, Borroni, G, Calvieri, S, Pinton, PC, Cannarozzo, C, Cannavò, SP, Cattaneo, A, Ceschini, R, Colombo, E, Congedo, M, Cusano, F, De Pità, O, Di Nuzzo, S, Donadio, D, Donelli, S, Filotico, R, Flori, ML, Germino, M, Girolomoni, G, Kokelj, F, Lanzoni, A, Lembo, G, Locatelli, A, Magnoni, C, Marconi, M, Motolese, A, Papini, M, Parodi, A, Pau, M, Peris, K, Piaserico, S, Ricotti, G & On behalf of the GENDER ATTENTION study group 2017, 'The GENDER ATTENTION Observational Study: Gender and Hormonal Status Differences in the Incidence of Adverse Events During Cyclosporine Treatment in Psoriatic Patients', Advances in Therapy, vol. 34, no. 6, pp. 1349-1363. https://doi.org/10.1007/s12325-017-0526-7
Colombo, Delia ; Banfi, Giuseppe ; Cassano, Nicoletta ; Graziottin, Alessandra ; Vena, Gino Antonio ; Fiori, Giovanni Gualberto ; Zagni, Emanuela ; Stingeni, Luca ; Chimenti, Sergio ; Berardesca, Enzo ; Micali, Giuseppe ; Albertini, Giuseppe ; De Simone, Clara ; Bellia, Gilberto ; Amato, Salvatore ; Ayala, Fabio ; Bardazzi, Ferderico ; Bernengo, Maria Grazia ; Bongiorno, Maria Rita ; Borroni, Giovanni ; Calvieri, Stefano ; Pinton, Piergiacomo Calzavara ; Cannarozzo, Calcedonio ; Cannavò, Serafinella Patrizia ; Cattaneo, Angelo ; Ceschini, Rossella ; Colombo, Enrico ; Congedo, Maurizio ; Cusano, Francesco ; De Pità, Ornella ; Di Nuzzo, Sergio ; Donadio, Dario ; Donelli, Stefano ; Filotico, Raffaele ; Flori, Maria Laura ; Germino, Maurizio ; Girolomoni, Giampiero ; Kokelj, Franco ; Lanzoni, Anna ; Lembo, Giuseppe ; Locatelli, Andrea ; Magnoni, Cristina ; Marconi, Marco ; Motolese, Alberico ; Papini, Manuela ; Parodi, Aurora ; Pau, Monica ; Peris, Ketty ; Piaserico, Stefano ; Ricotti, Giuseppe ; On behalf of the GENDER ATTENTION study group. / The GENDER ATTENTION Observational Study : Gender and Hormonal Status Differences in the Incidence of Adverse Events During Cyclosporine Treatment in Psoriatic Patients. In: Advances in Therapy. 2017 ; Vol. 34, No. 6. pp. 1349-1363.
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abstract = "Introduction: Female 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. Methods: Multicenter, 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. Results: A 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. Conclusions: A 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. Funding: Novartis Farma S.p.A., Italy.",
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TY - JOUR

T1 - The GENDER ATTENTION Observational Study

T2 - Gender and Hormonal Status Differences in the Incidence of Adverse Events During Cyclosporine Treatment in Psoriatic Patients

AU - Colombo, Delia

AU - Banfi, Giuseppe

AU - Cassano, Nicoletta

AU - Graziottin, Alessandra

AU - Vena, Gino Antonio

AU - Fiori, Giovanni Gualberto

AU - Zagni, Emanuela

AU - Stingeni, Luca

AU - Chimenti, Sergio

AU - Berardesca, Enzo

AU - Micali, Giuseppe

AU - Albertini, Giuseppe

AU - De Simone, Clara

AU - Bellia, Gilberto

AU - Amato, Salvatore

AU - Ayala, Fabio

AU - Bardazzi, Ferderico

AU - Bernengo, Maria Grazia

AU - Bongiorno, Maria Rita

AU - Borroni, Giovanni

AU - Calvieri, Stefano

AU - Pinton, Piergiacomo Calzavara

AU - Cannarozzo, Calcedonio

AU - Cannavò, Serafinella Patrizia

AU - Cattaneo, Angelo

AU - Ceschini, Rossella

AU - Colombo, Enrico

AU - Congedo, Maurizio

AU - Cusano, Francesco

AU - De Pità, Ornella

AU - Di Nuzzo, Sergio

AU - Donadio, Dario

AU - Donelli, Stefano

AU - Filotico, Raffaele

AU - Flori, Maria Laura

AU - Germino, Maurizio

AU - Girolomoni, Giampiero

AU - Kokelj, Franco

AU - Lanzoni, Anna

AU - Lembo, Giuseppe

AU - Locatelli, Andrea

AU - Magnoni, Cristina

AU - Marconi, Marco

AU - Motolese, Alberico

AU - Papini, Manuela

AU - Parodi, Aurora

AU - Pau, Monica

AU - Peris, Ketty

AU - Piaserico, Stefano

AU - Ricotti, Giuseppe

AU - On behalf of the GENDER ATTENTION study group

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Introduction: Female 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. Methods: Multicenter, 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. Results: A 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. Conclusions: A 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. Funding: Novartis Farma S.p.A., Italy.

AB - Introduction: Female 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. Methods: Multicenter, 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. Results: A 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. Conclusions: A 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. Funding: Novartis Farma S.p.A., Italy.

KW - Adverse drug reaction

KW - Cyclosporine

KW - Dermatology

KW - Female

KW - Gender

KW - Psoriasis

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