J&J's next potential frontier for Stelara? Lupus, thanks to positive phase 2 data

Johnson & Johnson has been looking for ways to expand its blockbuster drug Stelara, now that a raft of new competitors have made things tougher in psoriasis. And the immunology med might just have a good prospect in lupus.

On Monday, the New Jersey drugmaker’s Janssen unit said the med had impressed in a phase 2 study. Sixty percent of patients receiving Stelara showed significant improvements in disease activity at week 24 of treatment, while just 31% of the placebo group did.

Based on those results, the pharma giant plans to take its star into the next stage of development, Newman Yeilding, Janssen’s head of immunology development, said in a statement, adding that they “provide strong rationale for moving into a phase 3 clinical development program.”

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Lupus, a chronic, inflammatory autoimmune disorder that can affect joints, the heart, lungs and various other areas of the body, afflicts at least 1.5 million U.S. patients, J&J figures, and about 5 million people worldwide. The FDA has approved just one new drug to treat the disease in the last half-century. That’s GlaxoSmithKline’s Benlysta, which last year posted “ongoing demand growth” of 18% in the U.S., bringing sales to £277 million.

Glaxo, for its part, has been working to keep Benlysta on that trajectory. Earlier this year, it teamed up with retired U.S. soccer star Shannon Boxx on an awareness campaign, and in July, it snagged an FDA go-ahead for a self-injectable version of the med, which initially existed in an IV formulation only.

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While it will still be awhile before J&J has a chance to challenge GSK in the field, the data does bode well for its effort to broaden Stelara’s reach. The med is up against a host of new rivals—J&J’s own Tremfya included—in psoriasis, and many of those psoriasis drugmakers are looking for an entry into the psoriatic arthritis market, too. Novartis’ Cosentyx, for one, is already there, while companies such as Eli Lilly and Pfizer are chasing their own nods for Taltz and Xeljanz, respectively.

So far, J&J has managed to land a Stelara approval in Crohn’s, though that’s also a crowded arena thanks to anti-TNF giants such as AbbVie’s Humira. More recently, it nabbed an OK in adolescent psoriasis.