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COSENTYX (sécukinumab) - Arthrite juvénile idiopathique (AJI)

Opinions on drugs - Posted on Dec 01 2022

Reason for request

New indication

Key points

Approval of reimbursement for the treatment of juvenile idiopathic arthritis (JIA) for the following indications:

  • active enthesitis-related juvenile arthritis for patients aged 6 years and over in the event of poor response or intolerance to conventional treatment, alone or in association with methotrexate (MTX).

active psoriatic juvenile arthritis for patients aged 6 years and over in the event of poor response or intolerance to conventional treatment, alone or in association with methotrexate (MTX).

Therapeutic improvement?

No therapeutic improvement in the care pathway of patients aged 6 years and over with active enthesitis-related juvenile arthritis, and patients aged 12 and over with active psoriatic juvenile arthritis.

Therapeutic improvement in the care pathway of patients aged 6 to 12 years with active psoriatic juvenile arthritis.

Role in therapeutic strategy?

The objective of JIA treatment is to control inflammation to relieve pain and stiffness, and also prevent and slow down joint lesions. Care is provided in specialist settings and involves fast-acting symptomatic treatments (NSAIDs, corticosteroids), as well as basic treatments, which may be conventional synthetic treatments (csDMARDs) such as methotrexate, which is the most commonly used, or leflunomide (off-label), biological treatments (bDMARDs), particularly anti-TNF alpha therapies depending on the form of JIA or targeted synthetic anti-JAK therapy (tsDMARD) with tofacitinib.

Enthesitis-related JIA

The biological therapies that have been granted a marketing authorisation and are covered for enthesitis-related JIA after failure to respond to csDMARDs are the following two anti-TNFα therapies administered by the SC route:

  • etanercept (ENBREL and its biosimilars) for adolescents from 12 years.
  • adalimumab (HUMIRA and its biosimilars) for children and adolescents from 6 years.

Role of COSENTYX (secukinumab) in the therapeutic strategy 

COSENTYX (secukinumab), anti-IL17 therapy, is a basic treatment of active enthesitis-related juvenile arthritis for patients aged 6 years and over, responding poorly to previous csDMARD treatment. It is a second-line treatment after failure to respond to csDMARD as an alternative to anti-TNF therapies, or a third-line treatment after failure to respond to an anti-TNF therapy, used alone or in association with methotrexate. Nevertheless, considering the lack of direct comparison versus anti-TNF therapies, though feasible, and the greater follow-up with this medicinal product class, the Committee deems that the use of an anti-TNF therapy as a second-line approach is preferable, where possible.

Psoriatic juvenile arthritis

The following targeted therapies have been granted a marketing authorisation for psoriatic juvenile arthritis after failure to respond to csDMARD treatment:

  • one anti-TNFα therapy administered by the SC route: etanercept (ENBREL and its biosimilars) for adolescents from 12 years.
  • one anti-JAK therapy administered orally: tofacitinib (XELJANZ) for children from 2 years. Note that its role in the therapeutic strategy has been reserved by the Committee for failure to respond to at least one biotherapy (namely as third-line and subsequent approach), and that it is not covered to date for this indication.

Role of COSENTYX (secukinumab) in the therapeutic strategy

COSENTYX (secukinumab), anti-IL17 therapy, is a basic treatment of active psoriatic juvenile arthritis for patients aged 6 years and over, responding poorly to previous csDMARD treatment. It is a second-line or subsequent treatment after failure to respond to csDMARD treatment, alone or in association with methotrexate.

For adolescents aged 12 years and over, it is an alternative to the only anti-TNF therapy available, etanercept. Nevertheless, considering the lack of direct comparison versus etanercept, though feasible, and the greater follow-up with the latter, the Committee deems that the use of etanercept as

a second-line approach is preferable where possible, except in the presence of psoriatic skin involvement, for which the data from adults have demonstrated the superiority of secukinumab versus etanercept, and those obtained in children aged 6 to 17 years, despite being exploratory, appear to support this superiority (80% PASI75 responders with secukinumab vs 66% with etanercept, and 71% PASI 90 responders vs 31% with etanercept).

For patients aged from 6 to 11 years, it is the only basic treatment available as a second-line approach. 


Clinical Benefit
Substantial

The Committee deems that the actual clinical benefit of COSENTYX (secukinumab) 75 mg in prefilled syringe and 150 mg in prefilled syringe and in prefilled pen is significant in the marketing authorisation indication. 

Clinical Added Value
minor

Considering:

  • the evidence of superiority in terms of time to onset of relapse, (clinically relevant primary outcome measure) of continued secukinumab treatment versus placebo, alone or in association with methotrexate, for children and adolescents aged from 6 years with active enthesitis-related JIA or active psoriatic JIA, failing to respond to csDMARD treatment and JIA ACR30 responders following the non-comparative treatment phase,
  • the safety data at week 104 which, though relating to a small number of patients, were similar to those known in adults,
  • and the unmet medical need among children aged 6 to 11 years after failure to respond to csDMARD treatment,

the Transparency Committee deems that COSENTYX (secukinumab) provides minor clinical added value (CAV IV) for the treatment of active psoriatic juvenile arthritis for patients aged 6 to 11 years in the event of poor response or intolerance to the conventional treatment.
no clinical added value

Considering:

  • the evidence of superiority in terms of time to onset of relapse, (clinically relevant primary outcome measure) of continued secukinumab treatment versus placebo, alone or in association with methotrexate, for children and adolescents aged from 6 years with active enthesitis-related JIA or active psoriatic JIA, failing to respond to csDMARD treatment and JIA ACR30 responders following the non-comparative treatment phase,
  • the safety data at week 104 which, though relating to a small number of patients, were similar to those known in adults,

But the lack of direct comparative data versus the other medicinal products available (adalimumab and etanercept), the Transparency Committee deems that COSENTYX (secukinumab) provides no clinical added value (CAV V) for the treatment of active enthesitis-related juvenile arthritis for patients aged 6 and over in the event of poor response or intolerance to the conventional treatment.

Considering:

  • the evidence of superiority in terms of time to onset of relapse, (clinically relevant primary outcome measure) of continued secukinumab treatment versus placebo, alone or in association with methotrexate, for children and adolescents aged from 6 years with active enthesitis-related JIA or active psoriatic JIA, failing to respond to csDMARD treatment and JIA ACR30 responders following the non-comparative treatment phase,
  • the safety data at week 104 which, though relating to a small number of patients, were similar to those known in adults,

But the lack of direct comparative data versus etanercept), the Transparency Committee deems that COSENTYX (secukinumab) provides no clinical added value (CAV V) for the treatment of active psoriatic juvenile arthritis for adolescents aged 12 and over in the event of poor response or intolerance to the conventional treatment.

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