BENLYSTA

New indication.

Favourable opinion for reimbursement as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite standard therapy.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

The management of lupus patients requires the intervention of a multidisciplinary team.

The available treatments do not enable a cure to be envisaged for patients but are aimed at preserving vital functions during severe flare-ups of the disease, reducing inflammation, preventing complications and limiting the detrimental effects of medicinal products in the long term. Pharmacological treatments need to be accompanied by global management, with the implementation of patient education.

As in adults, the standard therapy for paediatric SLE is based firstly on synthetic anti-malarials, low-dose corticosteroid therapy (maintenance treatment) and nonsteroidal anti-inflammatories (NSAIDs).

In more severe or more active forms of the disease, inadequately controlled using synthetic anti-malarials and low-dose corticosteroid therapy (maintenance treatment), or in forms requiring the long-term use of corticosteroids, there may be recourse to immunosuppressant agents with an MA or temporary authorisation for use (RTU) (azathioprine, cyclophosphamide, thalidomide) and those used off-label (mycophenolate mofetil, tacrolimus, methotrexate and rituximab (last resort)). Their indications in children are the same as those in adults with, however, certain paediatric specificities concerning the MA, the adverse effects and the doses. The choice of treatment depends on the type of involvement and its severity.

Role of the medicinal product in the care pathway

In the treatment of SLE in children, BENLYSTA 120 mg and 400 mg (belimumab) plus standard of care should be reserved for children aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement)  following failure of or intolerance to well-managed treatment with synthetic anti-malarials, NSAIDs, corticosteroids and, potentially, immunosuppressant agents, depending on the specific organs involved. The Committee reiterates that treatment with BENLYSTA (belimumab) should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE.

Given the risk of severe or life-threatening hypersensitivity reactions and infusion reactions, BENLYSTA (belimumab) should be administered by a qualified healthcare professional trained to give infusion therapy in an environment where resources for managing such reactions are immediately available. Patients should remain under clinical supervision for a prolonged period of time (for several hours), following at least the first 2 infusions, taking into account the possibility of a late-onset reaction.