Revised SPC: Tremfya (guselkumab) solution for injection in pre-filled pen

SPC updated with licence extension for use in psoriatic arthritis in adults (in combination with methotrexate), in those that have not responded adequately to, or are intolerant of prior disease-modifying antirheumatic drug therapy.

SPS commentary:

In patients at high risk of joint damage, dose escalation to 100 mg every 4 weeks can be considered, which is in contrast to the use in psoriasis, where 100 mg every 8 weeks is the maximum dose.  The SPC states that in psoriatic arthritis studies, there was an increased incidence of liver enzyme elevations with 4 weekly treatment as compared to 8 weekly treatment or placebo.  Therefore when prescribing guselkumab as a 4 weekly regimen the manufacturers recommend baseline and ongoing liver testing, and if drug induced liver injury is suspected, guselkumab should be stopped.


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