SAGE-PsA Study

image 158

Sex- And Gender-based analysis of the Effectiveness of advanced therapies in Psoriatic Arthritis (SAGE-PsA Study)

Brief description of the SAGE Study:

The expansion of advanced targeted therapies has changed the way patients with PsA are treated. However, despite the effectiveness of these therapies, many patients do not achieve optimal response to these therapies. Sex and gender are important factors that influence treatment response in PsA. Women with PsA are less likely to achieve remission, are more likely to experience side effects and tend to stop treatments earlier than men.

SAGE-PsA is an international, multicenter study supported by GRAPPA through multi-pharma supported grants. The aim of the study is to understand how sex and gender influence response to advanced therapies in PsA. The investigators hope to discover biological and socio-cultural mechanisms that explain the differences in treatment response between men and women with PsA. The results of this study will improve our understanding of the impact of sex and gender on PsA which will contribute to more personalized approach to care of people living with PsA.

Study Principal Investigators

lihi-eder

Study Steering Committee:

  • Philip Mease, University of Washington, USA
  • Vibeke Strand, Stanford University, USA
  • Alexis Ogdie, University of Pennsylvania, USA
  • Kristina Callis–Duffin, University of Utah, USA
  • Vinod Chandran, University of Toronto, Canada
  • Sibel Aydin, University of Ottawa, Canada
  • Katy Ying Ying Leung, Duke-NUS Medical School, Singapore
  • Laura Coates, Oxford University, UK
  • Ade Adebajo, University of Sheffield, UK
  • Anushka Soni, Oxford University, UK
  • Fabian Proft, University of Berlin, Germany
  • Paula Rochon, University of Toronto, Canada
  • Claudia Goldstein Schainberg, Brazil
  • Ennio Lubrano, University of Molise, Italy
  • Wendy Olsder - GRAPPA patient research partner
  • Jeffrey Chau – GRAPPA patient research partner

Primary Research Coordinator

fahmeen2

FAHMEEN AFGANI, MBBS, CCRP

Women's College Hospital

Canada

Study Aims

The overarching aim of this SAGE-PsA is to understand how sex and gender, and their intersection with age and ethnicity, influence response to advanced therapies in PsA. Through sex & gender based analytic type framework, the investigators aim to uncover biological and socio-cultural mechanisms that underlie treatment disparities in PsA. 

Specifically, the investigators aim to:

  • To determine the independent contribution of sex- (being male or female) and gender- (socio-cultural aspects of being men or women) related factors to the effectiveness of advanced therapies in PsA.
  • To establish whether pattern and magnitude of pain in patients with PsA are affected by biological and socio-cultural sex/gender-related constructs, and to assess whether they impact treatment effectiveness.
  • To determine the effect of intersectionality on drug effectiveness by studying whether the relationships between gender and treatment effectiveness in PsA are modified by age and ethnicity.

Study Population and procedures:

The study will prospectively enroll 540 men and women with active PsA from x countries across the world.

All participants will be starting treatment with 4 classes of targeted advanced therapies for peripheral musculoskeletal manifestations of PsA. Participants will be followed for a period of 1 year and will complete the following procedures:

  • Patient Questionnaire
  • Physical examination by a Physician
  • Laboratory tests
sage-study-img

Study Sites & Co-Investigators:

The SAGE-PsA study will involve approximately 40 research sites worldwide. We are currently in the process of finalizing all participating sites for this study. The primary coordinating center is Women’s College Hospital, in Toronto, Canada.

Study outcomes:

SAGE-PsA will provide novel information about the role of sex and gender in PsA which should inform the development of more specific approaches to optimize the use of advanced therapies in people living with PsA.

Canada

Women's College Hospital

Canda

Dr. Lihi Eder

Colorado

Swedish Medical Center

Canda

Philip Mease

Singapore

Singapore General Hospital

Singapore

Katy Leung

Canada

Ottawa Hospital Research Institute

Canda

Sibel Aydin & Alexis Ogdie-Beatty

Canada

Toronto Western Hospital

Canda

Vinod Chandran

Turkey

Hacettepe University, Ankara

Turkey

Umut Kalyoncu

Turkey

Namik Kemal University

Turkey

Dilek Solmaz

Brazil

University of São Paulo

Brazil

Claudia Schainberg

Italy

University of Molise

Italy

Ennio Lubrano

UK

University of Oxford

UK

Laura Coates

Germany

Charité – Universitätsmedizin Berlin

Germany

Proft, Fabian Nikolai

South Africa

Life Westville Hospital

South Africa

Ajesh Maharaj

Israel

Carmel Medical Center

Israel

Devy Zisman

Singapore

Sengkang General Hospital

Singapore

Stanley Angkodjojo

China

The Chinese University of Hong Kong

China

Lai Shan Tam & Isaac Cheng

India

Christian Medical College, Vellore

India

Ashish Mathew

Japan

Kyorin University School of medicine

Japan

Mitsumasa Kishimoto

Pakistan

Fatima Memorial Hospital & FMH College of Medicine and Dentistry

Pakistan

Muhammad Haroon

Israel

Tel Aviv Medical Center

Israel

Ori Elkayam, Arik Polachek

United Arab Emirates

Dr. Suliman Alhabib Hospital

United Arab Emirates

Ahmed Abogamal

Denmark

Parker Institute

Denmark

Lars Erik

France

Pitie Salpétriere hospital and Sorbonne Université

France

Laure Gossec

Italy

IRCCS Humanitas Research Hospital

Italy

Carlo Selmi

Italy

Università Cattolica del Sacro Cuore, Fondazione Policlinico Gemelli IRCSS

Italy

Maria Antonietta D'Agostino & Dr. Ortolan

Italy

University of Cagliari

Italy

Alberto Cauli

Denmark

Uppsala University Hospital

Sweden

Agnes Szentpetery

UK

Cambridge University Hospitals

UK

Deepak Jadon

Argentina

Hospital Italiano de Buenos Aires

Argentina

Maria Laura Acosta Felquer

Brazil

Hospital de Clinicas Universidade Federal de Uberlandia

Brazil

Roberto Ranza

Colombia

University Hospital Fundación Santa Fe de Bogotá

Colombia

Wilson Bautista-Molano

Minneapolis

St. Paul Rheumatology

USA

David Ridley

Utah

Salt Lake City VA and University of Utah

USA

Jessie Walsh

San Francisco

UCSF

USA

Lianne Gensler

Florida

University of Florida Division of Rheumatology

USA

Gurjit Kaeley

California

UNIVERSITY OF CALIFORNIA DAVIS

USA

SIBA Raychaudhuri

Oregon

University of Oregon

USA

Atul Deodhar

Germany

Rheumatology/Fraunhofer ITMP, University Hospital Frankfurt

Germany

Michaela Koehm

Study Timeline

FALL 2022

Secured funding

NOVEMBER 2022

REB approval at primary coordinating site (WCH, Toronto)

NOVEMBER 2022

Finalized 38 recruitment sites

CURRENT STAGE

Building REDCap database

CURRENT STAGE

Finalizing research contracts with sites

EXPECTED JANUARY 2023

Commencement of study recruitment

2023-2026

Data collection

EXPECTED 2026

Analysis and publication of results: anticipated 2026