STELARA

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.

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.