Dive Brief:
- AbbVie Inc. on Wednesday reported data from a study of one of its potential blockbusters, highlighting that both daily doses of its rheumatoid arthritis drug upadacitinib hit all primary and secondary endpoints in a Phase 3 trial.
- Both the 15mg and 30mg doses of the oral JAK-1 inhibitor showed statistically significant clearance of RA symptoms at 14 weeks in patients that don't respond well to methotrexate.
- AbbVie expects the compound to bring in annual sales of more than $4 billion. It will compete with the likes of older TNF blockers like AbbVie's own Humira, as well as newer oral compounds like Pfizer Inc.'s Xeljanz.
Dive Insight:
Even though Humira (adalimumab) remains the best-selling drug in the world and is expected to grow through 2020, AbbVie has built up an immunology pipeline behind its top franchise.
Upadacitinib will follow Humira in the rheumatoid arthritis space. Currently in testing across six arthritis studies collectively dubbed the SELECT program, the drug is in also development for other conditions such as Crohn's disease, ulcerative colitis, ankylosing spondylitis and atopic dermatitis.
Despite strong efficacy results in the study, AbbVie reported one patient taking the 15mg dose of the drug died during the study due to hemorrhagic stroke caused by a ruptured aneurysm. The company said the patient had "pre-existing cardiovascular risk factors." Another patient, also on the 15mg dose, suffered a pulmonary embolism. This patient also had pre-existing risk factors, according to the company.
While the safety issues take a bit of the shine off the performance of the drug, they are unlikely to stop its momentum.
Efficacy results showed that 68% of patients who received the 15mg dose of upadacitinib achieved an ACR20 score (a measure of RA severity) at 14 weeks, with 42% achieving ACR50 and 23% achieving ACR70. Twenty-three percent of patients achieved clinical remission.
Meanwhile, 71% of those patients given the 30mg dose achieved ACR20, compared with only 41% who remained on methotrexate. Forty-one percent of patients taking the 30mg dose achieved clinical remission at 14 weeks in the SELECT-monotherapy trial compared to only 8% in the methotrexate arm of the study.
Methotrexate is often given as a first-line therapy for rheumatoid arthritis patients, but many don't respond well.