- Associated Press - Wednesday, July 8, 2015

TRENTON, N.J. (AP) - A study funded by drugmaker Johnson & Johnson indicates its experimental psoriasis medicine works better than a rival drug that dominates the market for biologic drugs for immune disorders.

The J&J; drug, guselkumab, is now in its final stage of patient testing and in a couple of years likely will join other recent treatments that offer big improvements for the millions of patients with the common, painful skin disorder.

Its approval also would escalate the battle for tens of billions in annual sales among a half-dozen pharmaceutical and biotech companies that sell powerful injected drugs, produced inside living cells, to treat immune disorders including rheumatoid and juvenile arthritis, Crohn’s disease and colitis.

Johnson & Johnson, based in New Brunswick, New Jersey, already sells lucrative drugs in the category: Remicade, Stelara and Simponi.

Results of the midstage study, usually the next-to-last round before approval from regulators is sought, were published in Wednesday’s New England Journal of Medicine.

The study found that moderate-to-high doses of guselkumab cleared nearly all psoriasis plaques, or skin patches, on a higher percentage of patients than standard doses of AbbVie Inc.’s Humira. Humira, the best-selling psoriasis drug and the top-selling medicine worldwide, posted total global sales of $12.5 billion last year.

Dr. Mark Lebwohl, president of the American Academy of Dermatology and chairman of the dermatology department at the Icahn School of Medicine at Mount Sinai, said the higher guselkumab doses clearly were superior to Humira at clearing up 90 percent to 100 percent of psoriasis plaques. Previously, biologic drugs were considered good if they cleared up 75 percent of psoriasis patches.

“Patients who go from 75 percent to 90 percent, it’s life-changing for them,” said Lebwohl, who was not involved in the research.

Psoriasis, the most common inflammatory disease in this country, affects about 7.5 million Americans and nearly 120 million people in other countries.

Like other immune disorders, psoriasis occurs when certain parts of the immune system go into overdrive and attack the body. Psoriasis, which is not contagious, speeds up growth of skin cells. That causes symptoms including itching, burning or soreness; red skin patches covered with silvery scales, swollen and stiff joints, and dry, cracked skin that may bleed.

Current drugs for the condition, along with another experimental one in late-stage testing by Eli Lilly and Co., ixekizumab, fight psoriasis by tamping down different parts of the immune system that cause inflammation.

In the study, nearly 300 participants with moderate to severe psoriasis were divided into seven groups, with five getting different doses of guselkumab, one group getting dummy shots, and one getting shots of Humira. At what appears to be optimal doses, 62 percent of patients getting guselkumab had 90 percent of their psoriasis patches clear up, compared to 44 percent of those getting Humira; patches completely disappeared in about 30 percent of patients getting guselkumab, compared with 25 percent given Humira.

Side effects were similar between the two drugs, and weren’t a significant concern, Lebwohl said.


Follow Linda A. Johnson at https://twitter.com/lindaj_onpharma

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