XELJANZ (tofacitinib) - Arthrite juvénile idiopathique polyarticulaire

Key points

Favourable opinion for reimbursement in the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs).

Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

The aim of JIA treatment is to combat inflammation, relieve pain and stiffness and to prevent or slow joint damage. Management is within a specialised setting and involves immediate-acting symptomatic treatments (NSAIDs, corticosteroids) as well as disease modifying antirheumatic drugs, which may be conventional (csDMARDs), such as methotrexate, which is the most widely used, or leflunomide (off-label), or biologic (bDMARDs), particularly TNF alpha inhibitors, depending on the form of JIA.

Polyarticular juvenile idiopathic arthritis with or without rheumatoid factor

The biologic therapies with an MA in pJIA following the failure of these csDMARDs are as follows:

• two TNF inhibitors, in IV form: ENBREL (etanercept) and HUMIRA (adalimumab)
•  an IL-6 inhibitor: ROACTEMRA (tocilizumab), SC and IV form.
• a T lymphocyte co-stimulation inhibitor, ORENCIA (abatacept), IV and SC form.

It should be noted that SIMPONI (golimumab) also has an MA but is not funded in France in this indication.

Juvenile oligoarthritis

Two biologic therapies have an MA in juvenile extended oligoarthritis from the age of 2 years in patients who have had an inadequate response to, or who have proved intolerant of, methotrexate: ENBREL (etanercept), TNF inhibitor, and ROACTEMRA (tocilizumab), an IL-6 inhibitor.

Juvenile psoriatic arthritis

ENBREL (etanercept) is the only biologic therapy with an MA in this indication when the response to a csDMARD has been inadequate, from the age of 12 years.

Role of XELJANZ (tofacitinib) in the therapeutic strategy:

XELJANZ (tofacitinib), a JAK 1 and 3 inhibitor, is a disease-modifying anti-rheumatic drug for polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs.

However, considering the lack of direct comparative data versus biologic therapy (in particular TNF inhibitors), despite this being feasible, and the greater experience with this class of medicinal products, the Committee considers that the role of XELJANZ (tofacitinib) is primarily following the failure of at least one biologic therapy, in particular a TNF inhibitor (i.e. in third and later-line treatment).

Special recommendations

Due to the risk of infections as a result of this treatment, the Committee recommends that patients ensure their vaccinations are up to date before the initiation of treatment, including human papillomavirus (HPV) vaccination where this is recommended.