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STELARA

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Opinions on drugs - Posted on Dec 16 2014

Reason for request

Extension of indication

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Actual benefit

Modéré

In view of:

  • the modest efficacy/adverse effects ratio,
  • the proof joint destruction in anti-TNFα naive patients on a secondary endpoint,
  • the absence of proof of its efficacy on joint destruction in the case of failure of one or several anti-TNFα agents,
  • the existence of alternatives with proven efficacy on joint destruction, and
  • the absence of comparative data enabling the therapeutic use of STELARA to be determined in relation to anti-TNFα agents,

the Committee considers that the actual benefit provided by STELARA is moderate in the treatment of active psoriatic arthritis in adults when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.


Improvement in actual benefit

V (absence)

In view of:

  • the absence of data comparing STELARA to anti-TNFα agents,

  • the proof on joint destruction in anti-TNFα naive patients on a secondary endpoint,

  • the absence of proof of its efficacy on joint destruction in the case of failure of one or several anti-TNFα agents, and

  • the existence of alternatives with proven efficacy on joint destruction,

STELARA, alone or combined with methotrexate, does not provide any improvement in the actual benefit (level V, non-existent) compared with anti‑TNFα agents in the treatment of active psoriatic arthritis in adults when response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.


Therapeutic use

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