TREMFYA (guselkumab) - Rhumatisme psoriasique
Reason for request
Favourable opinion for reimbursement, in the treatment, alone or in combination with methotrexate (MTX), of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
What therapeutic improvement?
No clinical added value in the therapeutic strategy.
Role in the care pathway?
The objectives of treatment 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.
Nonsteroidal anti-inflammatories (NSAIDs) (up to the maximum authorised dose) are the reference first-line treatment. Analgesics can be used for residual pain, in conjunction with the other therapies. Local corticosteroid injections may be considered for joint pain and enthesitis.
As first-line therapy, conventional synthetic disease-modifying anti-rheumatic drugs or csDMARDs (methotrexate, leflunomide, sulfasalazine) should be considered in the event of peripheral arthritis refractory to symptomatic treatment. Conventional DMARDs have not demonstrated efficacy on isolated axial or enthesitic manifestations.
As second-line therapy, in the event of inadequate response, contraindication or intolerance to conventional disease-modifying anti-rheumatic drugs, biologic disease-modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic therapies (tsDMARDs) may be considered.
The biologic therapies currently available include TNF inhibitors (adalimumab, etanercept, infliximab and certolizumab pegol) and interleukin inhibitors (an IL12/23 inhibitor, ustekinumab and two IL17 inhibitors, secukinumab and ixekizumab). These treatments have identical MAs from the second line of treatment, but the Committee recommends that they be used preferentially in the event of failure of TNF inhibitors (i.e., as third and later-line treatment).
In addition, two JAK inhibitors (tsDMARD) are available - tofacitinib (XELJANZ) and since recently upadacitinib (RINVOQ) - that also have an MA in the event of failure of at least one conventional DMARD (i.e., from the second line). Given the absence of clinical studies having directly compared tofacitinib with TNFα antagonists, the absence of superiority of upadacitinib compared to adalimumab and the greater experience with TNFα antagonists, the latter should be favoured as second-line disease-modifying therapy. In the absence of data versus interleukin inhibitors, the role of JAK inhibitors cannot be specified compared to these medicinal products.
In patients with non-severe, not very active forms, having responded inadequately to at least one csDMARD and in whom neither bDMARDs nor JAK inhibitors are appropriate, apremilast (OTEZLA), a PDE4 inhibitor, may be considered.
Role of the medicinal product in the care pathway
TREMFYA (guselkumab), IL23 inhibitor, is a second or third-line disease-modifying treatment for active psoriatic arthritis in adults following the failure of first-line treatment with a conventional disease-modifying treatment.
As with the other interleukin inhibitors, considering:
- the absence of direct comparative data versus TNF inhibitors,
- experience of around 15 years with these medicinal products (marketing authorisation for etanercept dating back to 2003),
- demonstration of their efficacy on joint destruction,
the Committee considers that anti-TNF inhibitors should be favoured first. TREMFYA (guselkumab) primarily has a role following the failure of at least one TNF inhibitor (i.e., as third and later-line therapy).
Given the rare but serious potential risk of systemic reactions following injection, including anaphylactic reactions with subcutaneous guselkumab but also with other biologic disease-modifying drugs, the Transparency Committee recommends that the first subcutaneous injection of this drug be given in an appropriate care structure.
The Committee deems that the clinical benefit of TREMFYA 100 mg (guselkumab) solution for injection in pre-filled syringe and pen is moderate in the new MA indication.
Clinical Added Value
|no clinical added value||
the Transparency Committee considers that TREMFYA 100 mg (guselkumab) solution for injection in pre-filled syringe and pen provides no clinical added value (CAV V) in the care pathway for the treatment of active psoriatic arthritis in adults who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).