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

  • STATUS
    Recruiting
  • End date
    Nov 4, 2023
  • participants needed
    300
  • sponsor
    Centre Hospitalier Universitaire de Saint Etienne
Updated on 4 August 2021
monoclonal antibodies
adalimumab
secukinumab
infliximab
steroidal anti-inflammatory drugs
tumor necrosis factor
NSAID
biological therapy
DMARD
anti-rheumatic drugs
enthesitis
golimumab
certolizumab pegol
rheumatoid arthritis
psoriatic arthritis
il-23
tnf blocker
fusion protein

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.

Details
Condition Axial Spondyloarthritis
Treatment Blood specimen, Secukinumab, TNF blocker
Clinical Study IdentifierNCT03445845
SponsorCentre Hospitalier Universitaire de Saint Etienne
Last Modified on4 August 2021

Eligibility

Yes No Not Sure

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
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