Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterized by inflammatory arthritis and enthesitis involving the spine. AxSpA prevalence is around 0.17% of the French population. Tumor necrosis factor (TNF) was the first target defined in axSpA. Since one third of axSpA patients failed to the first TNF blocker, many axSpA patients received a second biological Disease-Modifying AntiRheumatic Drugs (bDMARDs). Until few months, the only choice was to use a second TNF blocker.Since 2003, pharmaceutical companies investigated efficacy of TNF blockers already used in rheumatoid arthritis. Etanercept is a fusion protein with TNF receptor type II p75 and IgG1 Fc fragment, whereas adalimumab, infliximab, and golimumab are monoclonal antibodies. Certolizumab is a fusion between a fab fragment targeting TNF and a Peg fraction. All demonstrated efficacy versus placebo in a randomized double blinded study

In case of failure to the first TNF blockers, rheumatologists will follow the "Treat-to-Target" principle. This approach already demonstrated its benefit in rheumatoid arthritis or in psoriatic arthritis. This concept was also suggested for axSpA with low levels of evidence and recommendation. So rheumatologist will provide the best treatment in case of failure to the first TNF blockers, which is a daily clinical situation. Since few months, rheumatologists have the choice between targeting IL-23/17 axis compared to a second TNF blocker.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborator: Ministry of Health, France
• Treatments: Tumor Necrosis Factor Inhibitors

Criteria

Inclusion Criteria:

• Active axSPA with BASDAI>4 or ASDAS>3.5, who need change in TNF blocker treatment

• Aged over 18 years

• Inadequate response after at least 3 months to the 1st TNF blocker

• If non biologic DMARD treatment : stable dose for at least on month before inclusion

• If oral corticosteroids treatment : stable dose for at least on month before inclusion

• If NSAIDs treatment : stable dose for at least on month before inclusion

• Ability to complete questionnaires

• Social security affiliation

• Informed written consent given

Exclusion Criteria:

• Any contra-indication to TNF blocker and/or secukinumab

• Inflammatory bowel diseases

• Existing pregnancy, lactation, or intended pregnancy within the next 15 months Active tuberculosis or other severe infections such as sepsis or opportunistic infections

• Active infections, including chronic or localised infections.

• Moderate to severe heart failure (NYHA classes III/IV)

• Impossibility to give informed consent

• Impossibility to be followed for 12 months