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Exploring Sex-related Mechanisms of Psoriatic Arthritis response to advanced therapies (EXSEMP): Individual participant data (IPD) meta-analysis of randomized controlled trials of advanced therapies
Proposal
12489
Title of Proposed Research
Exploring Sex-related Mechanisms of Psoriatic Arthritis response to advanced therapies (EXSEMP): Individual participant data (IPD) meta-analysis of randomized controlled trials of advanced therapies
Lead Researcher
Lihi Eder
Affiliation
Women's College Hospital, University of Toronto
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
25 November 2024
Lay Summary
Psoriasis is a chronic skin and nail disease that can present as red, scaly rash and thick and pitted fingernails. Psoriatic arthritis is a chronic and potentially deforming type of arthritis that affects up to a third of people with psoriasis. Psoriatic arthritis causes pain, swelling and stiffness in the joints, tendons and spine which are associated with impaired function, reduced quality of life and can result joint damage and disability.Biologic therapies are treatments that specifically target proteins involved in the abnormal immune response that result in the skin and joint manifestations of psoriatic arthritis. Women living with psoriatic arthritis are less likely to respond to biologic therapies, which are effective, yet, expensive type of treatment for arthritis. Our study will explore the reasons for this finding by analyzing data from clinical trials that evaluated biologic therapies in psoriatic arthritis. We will investigate whether certain types of biologic treatments are more effective and safer in women living with psoriatic arthritis. Additionally, we will study whether selected factors, such as differences in the levels of inflammation, body weight, drug levels or differences in reporting of pain between males and females, could explain the lower response to treatment in women. The results of our study could contribute to the development of sex-specific recommendations for prescribing biologic treatment in psoriatic arthritis ultimately resulting in better patient care.
Study Data Provided
[{ "PostingID": 4183, "Title": "NOVARTIS-CAIN457F2306", "Description": "A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis" },{ "PostingID": 4184, "Title": "NOVARTIS-CAIN457F2312", "Description": "Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis (FUTURE 2)" },{ "PostingID": 19688, "Title": "NOVARTIS-CAIN457F2336", "Description": "A phase III, randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab (150 mg) in pre-filled syringe, with or without loading regimen, to demonstrate efficacy, safety and tolerability up to 2 years in patients with active psoriatic arthritis (FUTURE 4)" },{ "PostingID": 20877, "Title": "NOVARTIS-CAIN457F2366", "Description": "A randomized, double-blind, active control, multicenter study to evaluate the efficacy at week 52 of secukinumab monotherapy compared with adalimumab monotherapy in patients with active psoriatic arthritis" }]
Statistical Analysis Plan
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