Guselkumab para psoriasis.

Dermatology > Psoriasis

FDA OKs Guselkumab for Plaque Psoriasis

First selective IL-23 blocker to reach market

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• by Alexandria Bachert MPH, Staff Writer, MedPage Today July 14, 2017 

The FDA has approved guselkumab (Tremfya) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, said drugmaker Janssen Biotech.

Administered as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4, the drug is the first and only biologic that selectively blocks interleukin-23, a cytokine that plays a key role in plaque psoriasis, Janssen said.

The approval is based on results from more than 2,000 patients in the phase III VOYAGE 1, VOYAGE 2 and NAVIGATE studies, which were presented at the 25th European Congress of Rheumatology and the 2017 American Academy of Dermatology Annual Meeting.

Clinical trials showed that seven out of ten guselkumab-treated patients achieved at least 90% clearer skin, and more than 80% demonstrated cleared or almost cleared skin at 16 weeks. Treatment with guselkumab also improved psoriasis of the scalp and symptoms such as itch, pain, stinging, burning, and skin tightness at week 16.

More than seven out of ten patients treated with guselkumab reported at least 90% clearer skin compared with more than four out of ten patients treated with adalimumab (Humira) at week 24.

Serious side effects may include upper respiratory infections, headache, injection site reactions, joint pain, diarrhea, stomach flu, fungal skin infections, and herpes simplex infections.

Janssen said it will work with payers and providers to ensure that guselkumab is accessible and affordable for patients, and will offer patient support programs such as a co-pay card for patients with commercial insurance to lower out-of-pocket cost for those eligible to $5 per dose.