Ustekinumab Vs Enbrel: J&J Unveils Drug Data

Ustekinumab, the experimental psoriasis drug developed by the American pharmaceutical major, Johnson & Johnson, is more effective and equally safe than the top-selling treatment Enbrel, results of the late stage study have showed.

Also, while Enbrel, the signature treatment jointly marketed by Wyeth and Amgen requires a series of 24 subcutaneous doses, the new drug on offer by J&J helped achieve significant skin clearance in 2 subcutaneous doses, the drug data touted.

Psoriasis is a chronic, immune-mediated, recurring skin disorder that is triggered by the overproduction of skin cells. Typically characterized by the appearance of red scaly patches that may itch and bleed, the condition is often painful.

The condition affects an estimated 7.5 million Americans and 10 million Europeans, of which nearly a quarter are ranked moderate to severe.

For the Phase 3 trials of the study 903 chronic patients, all with moderate to severe plaque psoriasis, were enrolled.

They were randomly assigned to receive either a twice-weekly 50 mg jab of Enbrel for 12 weeks or a 45 mg or 90 mg shot of Ustekinumab, one at the beginning of the trial and other four weeks later.

At 12 weeks follow-up, 74 percent of those receiving the 90 mg dose of Ustekinumab and 68 percent of those administered the 45 mg dose achieved at least a 75 percent reduction in severity of psoriasis symptoms compared to a relief rate of 57 percent in the Enbrel group.

Furthermore, while 14.7 percent of the patients treated with Enbrel reported adverse effects including injection site erythema, only 0.7 percent in the Ustekinumab group complained of the same.

"These findings reinforce the promise of Stelara (other name for Ustekinumab) as an infrequently administered and highly effective biologic therapy for the treatment of adults with moderate to severe psoriasis." Trial investigator Bruce Strober was quoted as saying while unveiling the results of the study at a medical meet in Paris.

Meanwhile, the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) unanimously recommended Ustekinumab for approval. If approved, the drug will directly challenge Enbrel which currently commands 75 percent of the U.S. psoriasis market.