What type of study is this?

This is a Phase 2 study (also classified as: Placebo-Controlled, Observational).

September 10, 2025

Combination of leflunomide and hydroxychloroquine reduces disease activity in Sjögren’s disease

Key Points

Treatment led to a significant reduction in disease activity in Sjögren's disease patients at 24 weeks.
Results showed improvements in immunological markers alongside the reduction in disease activity.
The phase 2b trial was placebo-controlled, highlighting the validity of findings regarding therapy effectiveness.
This combination therapy addresses the unmet need for effective treatments for primary Sjögren's disease.

Abstract

Presented byDr Wing-Yi Wong , University Medical Center Utrecht, the NetherlandsConferenceEULAR 2025 Doihttps://doi.org/10.55788/97c306e6 At week 24, treatment with a combination of leflunomide and hydroxychloroquine resulted in a significant reduction in disease activity, as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), compared with placebo. The combination also led to significant improvements in several immunological markers. To date, an unmet need for effective treatments for primary Sjögren's disease remains 1. Following positive results in a previous study (EudraCt2014-003140-12), the combination of leflunomide and hydroxychloroquine was tested in the phase 2b, placebo-controlled RepurpSS-II trial (EudraCt: 2020- 001933-11). This 24-week trial was followed by a subsequent single-arm cross... Please login to read the full text of the article. If you have no account yet, please register now. Posted on 8 August 20258 August 2025 Previous Article « Guselkumab slows joint damage progression in PsA Next Article Patients with musculoskeletal pain and ACPA positivity: most progress to arthritis, but not always RA » Related Articles July 21, 2022 Alarmingly low activity in patients with non-inflammatory and inflammatory rheumatic disease August 8, 2025 Enpatoran shows encouraging signals in lupus, despite an unmet primary endpoint May 24, 2021 Patients with autoimmune disease may not be fully protected even after second COVID shot Register to view our latest news directly from the conference and receive news notifications in your field. Register Now Search for: site created by: © 2024 Medicom Medical Publishers. All rights reserved. Terms and Conditions | Privacy Policy HEAD OFFICE Laarderhoogtweg 25 1101 EB Amsterdam The Netherlands T: +31 85 4012 560 E: publishers@medicom-publishers.com

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