Rotation or change of biotherapy after TNF blocker treatment failure for axial spondyloarthritis: the ROC-SpA study,...

Area of Science:

• Rheumatology and Immunology
• Clinical Trial Research
• Pharmacology

Background:

• Axial spondyloarthritis (axSpA) is a chronic inflammatory condition primarily causing low back pain.
• Non-steroidal anti-inflammatory drugs (NSAIDs) are first-line treatment; biological disease-modifying antirheumatic drugs (bDMARDs) are used for inadequate response.
• Recent guidelines suggest alternative bDMARDs after anti-TNF failure, with IL-17 inhibition showing promise.

Purpose of the Study:

• To compare the efficacy of an anti-interleukin-17 (IL-17) strategy versus a second anti-tumour necrosis factor (TNF) biologic in axSpA patients with prior anti-TNF treatment failure.
• To identify the more effective treatment option following inadequate response to a first anti-TNF therapy in axSpA.

Main Methods:

• The ROC-SpA study is a prospective, randomized, multicenter, superiority, open-label phase IV trial.
• It compares an anti-IL-17 strategy (secukinumab or ixekizumab) against a second TNF blocker in a 1:1 ratio.
• Inclusion criteria: active axSpA (BASDAI >4 or ASDAS >3.5) with inadequate 3-month response to a first anti-TNF, with stable concomitant therapies.

Main Results:

• The primary outcome is the Assessment of SpondyloArthritis International Society 40 (ASAS40) response at week 24.
• Secondary outcomes include ASAS40 at weeks 12 and 52, and other clinical scores (ASAS20, partial remission, ASDAS major improvement) at weeks 12, 24, and 52.
• Drug and anti-drug concentrations will be measured at baseline and at weeks 12, 24, and 52.

Conclusions:

• This trial aims to provide crucial data on optimal treatment sequencing for axSpA patients.
• Findings could influence international recommendations for managing axSpA after anti-TNF failure.
• The study is registered (NCT03445845, EudraCT2017-004700-22) and results will be disseminated widely.