The purpose of this study is to determine the feasibility of conducting a pragmatic trial of IL-17i versus JAKi in adults with axial spondyloarthritis (axSpA) who have failed at least one tumor necrosis factor-alpha inhibitor (TNFi), to estimate the effectiveness of IL-17i versus JAKi at 16 weeks and to determine additional effectiveness measures, safety, and treatment persistence of IL-17i versus JAKi
fulfill ASAS classification criteria for axSpA and/or modified New York classification criteria for AS
Active axSpA (ASDAS ≥ 2.1 and/or BASDAI ≥ 4)
Failure of or intolerance to ≥1 TNF
Participants of reproductive potential must agree to use any form of effective contraception during the study period, in accordance with standard clinical practice and FDA labeling for the assigned study medication
Previously received an IL-17i or JAKi
Active infection requiring antimicrobials
Inflammatory bowel disease (IBD)- Crohn's disease or Ulcerative Colitis
Active cancer or cancer remission within the past 3 years (apart from non-melanoma skin cancer (NMSC) and cervical intraepithelial neoplasia (CIN)
Parallel
Secukinumab (IL-17i )
DrugSecukinumab is a fully humanized monoclonal antibody targeting interleukin-17A. Secukinumab will be given as a prefilled syringe or autoinjector for subcutaneous administration. Dosing is 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4 followed by 150mg every 4 weeks thereafter for a total of 16 weeks.
Upadacitinib (JAKi)
DrugUpadacitinib is an oral selective inhibitor of janus kinase 1 (JAK1). Participants will take upadacitinib 15mg orally once daily for 16 weeks.
Feasibility as determined by enrollment of ≥60% of eligible patients
Feasibility as determined by ≥80% retention of randomized participants
Feasibility as determined by ≥90% completeness of primary clinical data
Change in the Ankylosing Spondylitis Disease Activity Score (ASDAS) reported as a mean (SD)
This is a 4 item questionnaire and one lab result (CRP). The first 4 questions are scored from 0-10. The result is a single numerical score, typically ranging from about 0 to 6, with higher scores indicating more active disease.
Number of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score
Percentage of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score
Number of participants in the different categories of disease activity as assessed by the ASDAS
The ASDAS categories are: Inactive disease (\<1.3) Low disease activity (1.3-\<2.1) High disease activity (2.1-3.5) Very high disease activity (\>3.5)
Percentage of participants in the different categories of disease activity as assessed by the ASDAS
The ASDAS categories are: Inactive disease (\<1.3) Low disease activity (1.3-\<2.1) High disease activity (2.1-3.5) Very high disease activity (\>3.5)
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