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SPEVIGO (spesolimab) - Generalised pustular psoriasis (GPP)

Opinions on drugs - Posted on Apr 27 2023

Reason for request

Inclusion

First assessment.

 

Key points

Favourable opinion on reimbursement in " The treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy."

 

What therapeutic improvement?

Improvement in management strategy.

 

Role in the care pathway?

SPEVIGO (spesolimab) is the first medicinal produced indicated in the treatment of flares of generalised pustular psoriasis.

The clinical data dealing with the concomitant use of other treatments for GPP with spesolimab are limited. In compliance with the SmPC, spesolimab must not be used with other treatments for GPP, such as systemic immunosuppressants, to treat a flare.

If the symptoms of the flare persist, an additional dose of 900 mg may be administered one week after the first  dose.

The Committee considers that spesolimab (SPEVIGO) is a first-line treatment in the treatment of flares of generalised pustular psoriasis (GPP).


Clinical Benefit
Substantial

The clinical benefit provided by SPEVIGO 450 mg (spesolimab), concentrate for solution for infusion, is significant in the MA indication.

Clinical Added Value
minor

In view of:

  • an unmet medical need in the treatment of GPP flares,
  • the demonstration of the superiority of spesolimab 450 mg compared to placebo, with a significant effect, in adult patients with a moderate-to-severe flare of generalised pustular psoriasis in a randomised, double blind phase II, study, with regard to clinically relevant endpoints assessing the clearance of pustules at D8, the overall appraisal of disease severity by the doctor and disease severity according to the appearance and extent of the lesions,

but taking into account:

  • the impossibility of interpreting the results for the subjective hierarchical secondary endpoints of the disease (pain score, PSS score and FACIT-Fatigue score), in view of the large number of non-responders in the placebo group in week 4,

the Committee considers that SPEVIGO 450 mg (spesolimab), concentrate for solution for infusion provides minor clinical added value (CAV IV) in the management of  generalised pustular psoriasis flares in adults.

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