AbbVie‘s JAK inhibitor upadacitinib works better than its blockbuster Humira in keeping rheumatoid arthritis (RA) patients in clinical remission over almost a year of treatment.
New data from the SELECT-EARLY and SELECT-COMPARE trials show that over 48 weeks a significantly higher proportion of patients treated with upadacitinib monotherapy or as a duo with methotrexate stayed in clinical remission, compared to methotrexate alone or given with Humira (adalimumab).
The lead investigator in the SELECT-EARLY trial, Prof Ronald van Vollenhoven of the Amsterdam Rheumatology and Immunology Centre in the Netherlands, said that while remission is the primary treatment goal in RA, “a majority of patients do not achieve clinical remission today, despite currently available treatment options.”
The results – presented at the EULAR congress in Madrid this week – are another boost to AbbVie’s hopes of positive verdicts from the FDA and EMA when their reviews of the upadacitinib are completed later this year.
Upadacitinib and AbbVie’s recently-approved IL-23 inhibitor Skyrizi (risankizumab) for psoriasis are critical to AbbVie’s plans to defend its immunology franchise at a time when it is already seeing the rapid erosion of Humira in Europe due to biosimilar competition.
It’s a massive task, given that TNF inhibitor Humira brought in nearly $20bn in sales last year, but AbbVie’s president Mike Severino told the Goldman Sachs conference this week that with upadacitinib nearing approval decisions and Skyrizi already in launch mode, the future is looking bright for its immunology franchise.
Mike Severino
“It’s a large market, it’s a market that’s growing, it’s a market where we’ve been leaders, and so it allows us to maintain that position,” he said.
The goal with the new products has been to target the conditions where Humira is active and raise the therapeutic bar, added Severino, by improving response rates or providing options for patients who have failed current therapies.
AbbVie feels it has already achieved with Skyrizi in psoriasis and for upadacitinib in a broad range of RA patients, including those who are new to therapy and in the methotrexate inadequate-responder population.
Upadacitinib is “the only JAK inhibitor that shown the kind of head-to-head superiority against Humira that we’re talking about,” said Severino.
There’s no denying the scale of the task in hand, however, and even the most optimistic sales forecasts for Skyrizi and upadacitinib combined don’t come close to Humira’s level, in part because competition is now much more intense with several JAK, IL-23 and IL-17 inhibitors on or nearing the market.
AbbVie has previously forecast Skyrizi’s revenues to reach $5bn by 2023 – though analysts at Clarivate predict a much more modest $1.7bn by this date. Meanwhile, EvaluatePharma is modelling sales of $2.5bn for upadacitinib in 2024.