Your derm-data cheat sheet, with J&J's guselkumab, Lilly's Taltz, Sanofi's dupilumab and more

Eli Lilly
Eli Lilly is one of the companies looking to challenge Novartis' Cosentyx in the next-gen psoriasis market.

Dermatology has been a hot field for awhile, and with new meds and biosimilars pouring into the market, we’re looking at a shakeup ahead. Novartis has a biosim looking to beat Humira, Regeneron and Sanofi are revving up for their atopic dermatitis launch dupilumab and Johnson & Johnson’s guselkumab is aiming to challenge Novartis and Eli Lilly for the next-gen psoriasis crown, just to mention three.

That’s the reason for this roundup of data rolled out at the American Academy of Dermatology meeting over the weekend, your cheat sheet on the drugs and markets to keep an eye on.

Johnson & Johnson highlighted its drug guselkumab and its win over AbbVie giant Humira—and placebo—in a second pivotal study in severe plaque psoriasis. The J&J drug, an anti-IL-23 med, beat placebo at 84% to 8.5% of patients achieving cleared or minimal disease status. Compared with Humira, the score was 84.1% to 67.7% on the same measure. A larger proportion of guselkumab patients hit a psoriasis area severity index (PASI) score of 90 or above—70%—compared with 46.8% of Humira patients. The J&J could be approved later this year.

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

Regeneron and Sanofi unveiled detailed new data on Dupixent (dupilumab) in atopic dermatitis, a.k.a. eczema. At the one-year mark, improvement in symptoms according to one commonly used measure was 80% and 78% for patients in the dupilumab-plus-topical corticosteroids (TCS) arm, depending on dose. That compared with 46% for patients in the placebo-plus-TCS arm. The new drug also beat TCS alone in other measures of the disease. The two companies are hoping for an FDA nod any day now.

Eli Lilly rolled out head-to-head data for its psoriasis treatment Taltz against Johnson & Johnson’s more established med Stelara. According to Lilly, Taltz beat Stelara at improving patients’ scores on the psoriasis area severity index (PASI), with 83% of Taltz patients hitting 90 on that index, compared with 59% of Stelara patients. The Ixora-S study data is important, lead author Kristian Reich said, because it “demonstrates both high levels of skin improvement for patients treated with Taltz ... as well as higher response rates over Stelara, which is one of the most frequently used biologics in the treatment of moderate-to-severe plaque psoriasis.” 

Novartis, seeking to shore up its next-gen market leader Cosentyx as rivals like Taltz appear on the scene, unveiled a new analysis in patients with moderate-to-severe psoriasis who’ve relapsed after pausing treatment. The Novartis med helped patients regain clear or almost-clear skin within 16 weeks of retreatment with Cosentyx.

Novartis’ Sandoz unit presented data on its Humira biosimilar showing that the biosim had equivalent efficacy and safety to the AbbVie brand, in patients with moderate-to-severe plaque psoriasis. The phase 3 study showed that 67% of biosim patients hit 75 on the psoriasis area and severity index (PASI), compared with 65% of patients on the original brand.

Editor's note: The expected FDA decision timeframe for J&J's guselkumab approval was updated to later this year, rather than next month as originally stated.

Suggested Articles

Acadia's knew it had a winner in psychosis when it called off a trial for its Nuplazid. Now analysts are seeing a blockbuster in the making.

Sandoz would still consider acquisitions, as long as they fit the Novartis unit's focus on generics and biosimilars, CEO Richard Saynor said.

Novartis is planning 80 major drug submissions in key markets over the next three years, and 25 of those could be blockbuster opportunities.