Valeria Rios Rodriguez, Lidia Sánchez-Riera, Hildrun Haibel, Caroline Höppner, Murat Torgutalp, Fabian Proft, Judith Rademacher, Elke Binder, Annette Diehl, Ivana Vranic, Yuxi Zhao, Rajiv Mundayat, Arne Yndestad, Denis Poddubnyy
{"title":"Tofacitinib in early active axial spondyloarthritis: protocol of a randomized double-blind, placebo-controlled, multicenter phase IV study, FASTLANE.","authors":"Valeria Rios Rodriguez, Lidia Sánchez-Riera, Hildrun Haibel, Caroline Höppner, Murat Torgutalp, Fabian Proft, Judith Rademacher, Elke Binder, Annette Diehl, Ivana Vranic, Yuxi Zhao, Rajiv Mundayat, Arne Yndestad, Denis Poddubnyy","doi":"10.1177/1759720X251324429","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Early treatment initiation is one of the strongest predictors of good treatment response in axial spondyloarthritis (axSpA). Recently, the Assessment in SpondyloArthritis International Society (ASAS) defined early axSpA as a diagnosis of axSpA with a duration of axial symptoms equal to or less than 2 years. Tofacitinib is a Janus kinase (JAK) inhibitor for the treatment of ankylosing spondylitis.</p><p><strong>Objectives: </strong>Compare the efficacy and safety of tofacitinib versus placebo (both on non-steroidal anti-inflammatory drug (NSAID) background) in patients with active early axSpA and inadequate response to at least one NSAID.</p><p><strong>Design: </strong>This is a phase IV, randomized, double-blind, placebo-controlled, multicenter clinical trial.</p><p><strong>Methods and analysis: </strong>The study will recruit 104 patients aged ⩾18 and ⩽45 years with active early axSpA (chronic back pain ⩽2 years), inadequate response to at least one NSAID, and objective signs of active inflammation (on magnetic resonance imaging (MRI) of sacroiliac joints (SIJs) or elevated C-reactive protein). Patients will be randomized 1:1 to receive tofacitinib 5 mg twice daily or placebo, with background naproxen 500 mg twice daily for 16 weeks. Patients not meeting early treatment response criteria at week 4 will receive open-label tofacitinib until week 16. Primary and key secondary endpoints at week 16 will be the proportion of patients achieving disease remission (Axial Spondyloarthritis Disease Activity Score <1.3) and change from baseline in MRI SIJ Spondyloarthritis Research Consortium of Canada osteitis score, respectively. Safety will be monitored up to 4 weeks after the last study drug dose.</p><p><strong>Ethics: </strong>The study will be performed according to the ethical principles of the Declaration of Helsinki and will be approved by independent ethics committees of each center.</p><p><strong>Discussion: </strong>This is one of the first randomized clinical trials designed to evaluate the efficacy and safety of a JAK inhibitor in the recently ASAS-defined \"early\" axSpA population. <b><i>Trial registration</i>:</b> ClinicalTrials.gov: NCT06112665; CTIS: 2023-505050-18-00.</p>","PeriodicalId":23056,"journal":{"name":"Therapeutic Advances in Musculoskeletal Disease","volume":"17 ","pages":"1759720X251324429"},"PeriodicalIF":3.4000,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11898075/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Musculoskeletal Disease","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/1759720X251324429","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Early treatment initiation is one of the strongest predictors of good treatment response in axial spondyloarthritis (axSpA). Recently, the Assessment in SpondyloArthritis International Society (ASAS) defined early axSpA as a diagnosis of axSpA with a duration of axial symptoms equal to or less than 2 years. Tofacitinib is a Janus kinase (JAK) inhibitor for the treatment of ankylosing spondylitis.
Objectives: Compare the efficacy and safety of tofacitinib versus placebo (both on non-steroidal anti-inflammatory drug (NSAID) background) in patients with active early axSpA and inadequate response to at least one NSAID.
Design: This is a phase IV, randomized, double-blind, placebo-controlled, multicenter clinical trial.
Methods and analysis: The study will recruit 104 patients aged ⩾18 and ⩽45 years with active early axSpA (chronic back pain ⩽2 years), inadequate response to at least one NSAID, and objective signs of active inflammation (on magnetic resonance imaging (MRI) of sacroiliac joints (SIJs) or elevated C-reactive protein). Patients will be randomized 1:1 to receive tofacitinib 5 mg twice daily or placebo, with background naproxen 500 mg twice daily for 16 weeks. Patients not meeting early treatment response criteria at week 4 will receive open-label tofacitinib until week 16. Primary and key secondary endpoints at week 16 will be the proportion of patients achieving disease remission (Axial Spondyloarthritis Disease Activity Score <1.3) and change from baseline in MRI SIJ Spondyloarthritis Research Consortium of Canada osteitis score, respectively. Safety will be monitored up to 4 weeks after the last study drug dose.
Ethics: The study will be performed according to the ethical principles of the Declaration of Helsinki and will be approved by independent ethics committees of each center.
Discussion: This is one of the first randomized clinical trials designed to evaluate the efficacy and safety of a JAK inhibitor in the recently ASAS-defined "early" axSpA population. Trial registration: ClinicalTrials.gov: NCT06112665; CTIS: 2023-505050-18-00.
期刊介绍:
Therapeutic Advances in Musculoskeletal Disease delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of musculoskeletal disease.