Dr. Menter described the efficacy data as “very compelling,” noting that at week 24 (8 weeks after the third injection), almost 50% of patients achieved a PASI 90.
As with the tumor necrosis factor blockers, the ustekinumab label includes warnings and precautions about the risk of serious infections and the possible increased risk of malignancies. Serious infections—including some that required hospitalization—have been reported in patients on ustekinumab. There has been one report of reversible posterior leukoencephalopathy syndrome (RPLS), a rare, potentially fatal neurologic disorder that is not caused by demyelination or a known infectious agent, according to the ustekinumab label. If RPLS is suspected, ustekinumab should be discontinued immediately and the patient should be treated.
Among the manufacturer's other postmarketing requirements is to enroll 4,000 ustekinumab-treated patients in the Psoriasis Longitudinal Assessment and Registry (PSOLAR), and follow them for 8 years for serious infections, tuberculosis, opportunistic infections, malignancy, hypersensitivity reactions, autoimmune diseases, and neurologic or demyelinating diseases.
Dr. Menter is cochair of PSOLAR.
Ustekinumab 'is the first drug that's based truly on a genetic defect recognized in psoriasis.'
Source DR. MENTER