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TALTZ

Opinions on drugs - Posted on Oct 07 2020

Reason for request

New indications

Key points

Favourable opinion for reimbursement in the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis 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 five TNF inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab3) 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 TALTZ (ixekizumab) in the treatment of active non-radiographic axial spondyloarthritis and ankylosing spondylitis in patients who have responded inadequately to NSAIDs is as second-line therapy, following the failure of TNF inhibitors, given the absence of direct comparison of ixekizumab with TNF inhibitors enabling its role to be specified compared to the latter in first-line therapy (patients never having received a TNF inhibitor) and the need at this stage in the strategy.

The Committee highlights the fact that robust data are available for TALTZ (ixekizumab) specifically in patients with ankylosing spondylitis not having responded to TNF inhibitors (COAST-W study), in contrast with COSENTYX (secukinumab). In patients with non-radiographic axial spondyloarthritis, the available data do not enable a hierarchy between TALTZ (ixekizumab) and COSENTYX (secukinumab) to be determined.


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of TALTZ (ixekizumab) is moderate in the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults who have responded inadequately to NSAIDs.

 

Moderate

Clinical Added Value

no clinical added value

Considering :

  • the clinical benefit demonstrated versus placebo in the COAST-X, COAST-V and COAST-W studies in terms of ASAS40 responders (primary endpoint) and all the ranked secondary endpoints, in particular quality of life,

but,

  • the modest extent of this benefit in patients with non-radiographic axial spondyloarthritis and
  • the absence of comparison with TNF inhibitors in both indications, despite this being feasible,

the Transparency Committee considers that TALTZ (ixekizumab) 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) and in active ankylosing spondylitis in adults who have responded inadequately to NSAIDs, in the same way as COSENTYX (secukinumab).

 


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