As Stelara Sunset Begins, J&J Says Tremfya Will Step Up

Johnson & Johnson’s inflammatory disease blockbuster Stelara (ustekinumab) has begun its decline, as the first biosimilar versions of the IL-12/IL-23 inhibitor launched in Europe in the third quarter and are expected to launch in the US in early 2025. The company announced third quarter sales and earnings on 15 October showing sales of Stelara are down.

After more than a decade of solid growth, Stelara declined 6.6% to $2.68bn in the third quarter versus the prior-year period. Sales declined in both Europe and the US, with sales in Europe impacted by the availability of biosimilars but sales in the US also impacted by what J&J said was a change in patient mix that impacted payments. International sales of Stelara declined 4.8% and US sales declined 7.7%.

The decline in sales of Stelara and an 18% decline in sales of Simponi (golimumab) – a smaller immunology brand that generated $516m – have put J&J’s immunology franchise under pressure. Immunology sales declined 4.7% to $4.62bn in the third quarter.

Worldwide chairman-innovative medicines Jennifer Taubert said J&J’s newer IL-23 inhibitor Tremfya (guselkumab) is positioned to step into the spotlight.

“We’re really excited about Tremfya and what we see as the prospects ahead,” she said during the Q3 earnings call. “We think that Tremfya definitely is an asset that is of Stelara size or bigger and better.”

New Growth Ahead In IBD

Tremfya generated sales of $1bn in the third quarter, growth of 13% versus the prior-year period. Sales were driven by psoriasis and psoriatic arthritis, but the drug has new growth opportunities in irritable bowel disease (IBD) indications that should drive future growth.

“We believe we truly have a winning proposition for that asset in IBD,” Taubert said.

Tremfya, which was first approved by the US Food and Drug Administration in 2017 for the treatment of plaque psoriasis, was only approved in September for the treatment of ulcerative colitis, paving the way for its entry into gastrointestinal disease.

IBD has grown to become Stelara’s biggest market. The drug, like Tremfya, is approved for psoriasis and IBD indications, but IBD accounts for 75% of revenues, so J&J has high hopes for Tremfya in UC and Crohn’s disease. J&J filed an application with the FDA for Tremfya in Crohn’s disease in June, where an approval is anticipated.

“It’s off to a really nice start with really strong reception amongst the medical community,” Taubert said of the launch in UC. The area is competitive with Stelara and AbbVie’s IL-23 inhibitor Skyrizi (risankizumab), which is approved for both UC and Crohn’s disease, but J&J is trying to position Tremfya as differentiated because it is a dual-acting IL-23 inhibitor that blocks IL-23 and binds to CD64, a receptor expressed on cells that produce IL-23.

“It really sets what we believe is a new bar in terms of efficacy with the highest rate of endoscopic normalization,” Taubert said.

Management also highlighted a pipeline asset in immunology that is expected to be an important future growth driver, the oral IL-23 antagonist peptide JNJ-2113, which is in Phase III development for plaque psoriasis.

“We do think that being able to have that advanced efficacy and known safety profile in a simple oral tablet is not only going to be great for the existing biologics appropriate patients, but we think it gives us a great market expansion opportunity moving into earlier lines of therapy as well,” Taubert said.

J&J is studying JNJ-2113 in IBD indications as well, including in a Phase II study in UC.

“Given that the IL-23 pathway is well validated in inflammatory bowel disease, thanks to Stelara and Tremfya, we’re quite confident that those studies will come through for us,” exec VP-innovative medicines R&D John Reed said. Development in Crohn’s disease is also planned.

Overall, J&J’s innovative medicines business grew in the third quarter, with sales up 4.9% to $14.58bn, driven by Darzalex (daratumumab), Tremfya and other new brands like the cell therapy Carvykti (ciltacabtagene autoleucel) and depression drug Spravato (esketamine).