Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis
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.
Timeline
- Start
- 2018-12-14
- Primary completion
- 2024-09-21
- Completion
- 2024-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Comparator | Certolizumab | Protein / enzyme biologic | 200 mg | Subcutaneous |
| Comparator | Certolizumab | Protein / enzyme biologic | 400 mg | Subcutaneous |
| Comparator | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |
| Comparator | Golimumab | Monoclonal antibody | 50 mg | Subcutaneous |
| Comparator | Golimumab | Monoclonal antibody | 100 mg | Subcutaneous |
| Comparator | Infliximab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Secukinumab | Monoclonal antibody | 150 mg | Subcutaneous |