- AbbVie's highly anticipated anti-inflammatory drug has notched yet another victory in the clinic, meeting all primary and secondary endpoints in a late-stage study evaluating it as a treatment for arthritis.
- Investigators tested two doses of upadacitinib during the Phase 3 SELECT-NEXT study, which enrolled patients with moderate to severe rheumatoid arthritis (RA) who hadn't previously responded to synthetic antirheumatic medications. Results showed 64% of patients on a 15 mg regimen and 66% of patients on a 30 mg regimen had at least 20% improvement in their disease symptoms, whereas 36% of participants in the placebo arm achieved such an improvement.
- The safety profile for upadacitinib was similar to that of previous Phase 2 testing. In a one Phase 2b study of RA patients, one participant developed a serious case of community-acquired pneumonia, while another mid-stage study showed no instances of serious infection. In SELECT-NEXT, 4% of patients in the 15 mg arm and 3% of patients in 30 mg arm reported serious adverse events (SAEs), while 2% receiving placebo had (SAEs).
AbbVie has come under investor pressure to diversify its portfolio, given that it is one of a small collection of big pharma players to see its bottom line driven by a single product. While Humira (adalimumab) has been a huge success for the North Chicago, IL-based drugmaker — raking in over $16 billion last year — the slow loss of patent protections and the entry of biosimilar competition have underscored the need for fresh products.
Upadacitinib can help achieve that for AbbVie. Like Humira, the candidate is under investigation for several indications, including ulcerative colitis and atopic dermatitis. And just last month, topline results revealed that it beat out placebo at improving symptoms for Crohn's disease patients Phase 2 study.
Should the drug gain approval in those indications, it could reach peak annual sales of $3.5 billion, according to a June 7 note from Jefferies. However, the investment bank said that estimate could be "too conservative," due in part to the Food and Drug Administration's recent dismissal of Eli Lilly and Incyte's JAK-1/2 inhibitor, baricitinib.
In a complete response letter, the agency said it needed additional data on the safety of baricitinib before it could give it the green light. While the drug is already approved in Europe, the stateside setback gives AbbVie and its medication a better chance to compete in the growing JAK inhibitor space.
To that end, the safety profile of upadacitinib during this most recent Phase 3 study is promising, according to Jefferies.
The drug isn't a slouch when it comes to efficacy, either. Secondary endpoints of 50% and 70% improvement in symptoms — known as ACR50 and ACR70, respectively, because they are based off criteria from the American College of Rheumatology — were also met. Roughly 40% of the patients in the treatment arms reached ACR50, as opposed to 15% in the placebo arm. Meanwhile, 21% of the 15 mg group, 27% of the 30 mg group and 6% of the placebo group achieved ACR70.
What's more, about half of the patients taking upadacitinib demonstrated low disease activity, versus 17% of those on placebo.
"We are especially encouraged by the results on the more stringent measures of efficacy, such as ACR70, low disease activity and clinical remission," AbbVie's Chief Scientific Officer Michael Severino said in the June 7 statement.
AbbVie will reveal more complete results from the trial at an upcoming medical meeting.