FDA Approves New Drug to Treat Psoriasis

The U.S. Food and Drug Administration approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis.

Ustekinumab is the first in a new class of biologics, for psoriasis. This new human interleukin-12 and -23 antagonist is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Ustekinumab treats psoriasis by blocking the action of two proteins that contribute to the overproduction of skin cells and inflammation.

Ustekinumab is administered subcutaneously as a weight-based dose. For patients weighing less than 100 kg (220 lbs), the recommended dose is 45 mg initially and four weeks later, followed by 45 mg every 12 weeks. For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. Nurses should use caution when drawing up and administering the drug to avoid dosing errors as it is available and packaged in two different dosage strengths: 45 mg/0.5 mL in a single-use glass vial and 90 mg/1 mL in a single-use glass vial.

The most common adverse reactions reported include nasopharyngitis, upper respiratory tract infection, headache, and fatigue. Adverse drug reactions may also occur at the site of administration including cellulitis, pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation.

Because ustekinumab reduces the immune system’s ability to fight infections, it poses a risk of infection. Serious infections have been reported with ustekinumab, some leading to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer, and ongoing studies are evaluating this risk. Before initiation of therapy, patients should be evaluated for tuberculosis and, if indicated, treated with antitubercular drug therapy before initiating ustekinumab therapy.

Ustekinumab therapy complicates vaccination administration. Non-live vaccines may be ineffective when administered during treatment. Patients receiving ustekinumab therapy must not, however, receive any live vaccines, nor should their household contacts because of the potential risk for shedding from the household contact and transmission to patient.