Reason for request
Favourable opinion for reimbursement in the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs).
What therapeutic improvement ?
No therapeutic improvement compared to TNF inhibitors.
Role in the care pathway ?
The joint objectives of treatment in patients with axial spondyloarthritis (axSpA) are to control symptoms (inflammation, pain and spinal stiffness) and prevent structural damage in order to preserve or improve the functional capacities, autonomy, social participation and quality of life of patients and obtain clinical remission or, failing this, a low level of disease activity.
The first-line medicinal treatment of axSpA is based on the use of NSAIDs (prescription on demand, adapted to the patient and the evolution of symptoms, up to the maximum dose) as a symptomatic treatment. In the event of failure or an inadequate effect of an NSAID used at the maximum tolerated dose, a switch of NSAID can be performed.
Adjuvant therapies such as analgesics can be combined with the NSAIDs for residual pain but systemic or local corticosteroid therapy is not justified in axial forms. Conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (e.g., methotrexate, leflunomide, sulfasalazine) only appear to be effective in forms with peripheral joint involvement refractory to symptomatic treatment. Their efficacy in purely axial forms has not been demonstrated.
As second-line treatment, biologic therapies (bDMARDs) should be considered in patients with active disease despite NSAIDs. However, in the absence of inflammation demonstrated by laboratory tests or MRI, these biologic therapies are not indicated in nr-axSpA. A total of four TNF inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab) and two IL-17A inhibitors (ixekizumab, secukinumab) have an MA in active nr-axSpA in the event of failure, inadequate response, intolerance or contraindication to NSAIDs.
According to the guidelines published by the French Radiology Society (SFR), TNF inhibitors are preferred as first-line treatment given current experience; however the lack of direct comparative data between them means that it is not possible to determine a hierarchy. In the event of loss of response, primary inefficacy or intolerance to a first TNF inhibitor, a rotation to a second TNF inhibitor or a switch to an IL-17A inhibitor are alternatives deemed to be beneficial.
Role of the medicinal product in the care pathway
The role of COSENTYX (secukinumab) in the treatment of active non-radiographic axial spondyloarthritis in patients who have responded inadequately to NSAIDs is as second-line therapy, following the failure of TNF inhibitors. In these patients, the available data do not enable a hierarchy between COSENTYX (secukinumab) and TALTZ (ixekizumab) to be determined.
The Committee reiterates :
- that it is recommended to administer the first subcutaneous injection of this medicinal product in an appropriate healthcare setting given the rare but serious potential risk of systemic reactions to the injection, including anaphylactic reactions with subcutaneous secukinumab, as with other bDMARDs,
- and that it is important to manage cardiovascular risk factors given the increased cardiovascular risk in chronic inflammatory arthritis.
The Committee deems that the clinical benefit of COSENTYX (secukinumab) is moderate in the MA indication.
Clinical Added Value
|no clinical added value||
the Transparency Committee considers that the proprietary medicinal product COSENTYX (secukinumab) provides no clinical added value (CAV V) compared to TNF inhibitors in the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs).