AbbVie’s betting a large part of its post-Humira growth on two new immunology drugs. Now, one of those rising stars, Skyrizi, has delivered a clinical trial win that could further boost the Illinois pharma’s outlook.
Skyrizi beat placebo at improving psoriatic arthritis patients’ outcomes in two phase 3 clinical trials, AbbVie said Tuesday. The IL-23 inhibitor also hit several secondary endpoints such as skin clearance, physical function and minimal disease activity.
The trial win tees up a potential launch in 2022, BMO Capital Markets analyst Gary Nachman wrote in a note Tuesday. While psoriatic arthritis doesn't offer as much sales potential as its current approval in psoriasis, the new indication could still play a significant role in AbbVie’s broader market-expansion strategy, he said. Nachman currently pegs $350 million sales for the indication in 2025.
Specifically, in the Keepsake-1 and Keepsake-2 trials, 57% and 51% of patients on Skyrizi enjoyed at least a 20% reduction in a composite symptoms measure after six months of treatment. By contrast, only 34% and 27% patients on placebo achieved the so-called ACR20 response.
What’s more, 52% and 55% of Skyrizi patients in the two studies showed significant improvements in skin clearance as measured by at least a 90% improvement in Psoriasis Area Severity Index, or PASI 90, while only 10% of placebo patients in both trials could say the same.
The drug posted the results in patients who didn’t respond well to or couldn’t tolerate at least one existing therapy.
AbbVie has high hopes for Skyrizi and newly launched JAK inhibitor Rinvoq, counting on the pair to fill a revenue gap destined by the arrival of biosimilars to megablockbuster Humira.
Rinvoq has its own psoriatic arthritis application awaiting an FDA decision, and drug reviewers at the European Medicines Agency’s Committee for Medicinal Products for Human Use have already doled out a positive opinion. In its own trial, 71% and 79% of patients who got either a low or high dose of Rinvoq achieved ACR20 at week 12, versus 36% for placebo.
Confident in both drugs' potential, AbbVie management in December dialed up their forecast for the duo to $15 billion in 2025 sales on a risk-adjusted basis. Of the $15 billion, about $5.5 billion could come from Skyrizi’s sales in psoriatic arthritis and its currently approved indication of psoriasis.
To achieve that ambitious sales target, AbbVie plans to push for a large package of potential expansions for the two drugs. For Skyrizi, the company hopes the inflammatory bowel disease market could contribute $1.5 billion to its sales by 2025.
In Rinvoq’s case, the Illinois drugmaker has laid out a long list of programs on top of its leading rheumatoid arthritis indication. These include potentially $2 billion in 2025 sales generated by atopic dermatitis and $1 billion from IBD.
A month ago, data from a phase 3b study showed Rinvoq topped Sanofi and Regeneron’s blockbuster Dupixent in helping more patients achieving an eczema severity score. The drug also posted a recent phase 2b/3 win in previously untreated ulcerative colitis.
So far, the two drugs have wowed industry watchers with Street-beating sales quarter after quarter. In the third quarter, Skyrizi’s sales of $435 million came in 15% higher than consensus. AbbVie execs said the drug has snatched 33% of new and switching patient share with most switches from non-Humira drugs. Rinvoq’s $215 million tab also hit 21% above expectations.