Lilly and Incyte’s investigational baricitinib has outperformed AbbVie’s Humira in a phase III trial for rheumatoid arthritis.
The study, called RA-BEAM, met its primary objective of demonstrating superiority compared to placebo and also demonstrated superiority to Humira (adalimumab) on key secondary objectives.
After 24 weeks, baricitinib was also better than placebo in preventing progressive radiographic structural joint damage. This result was maintained at the 52-week mark.
David Ricks, senior VP and president of Lilly Biomedicines, said: “RA-BEAM is the first study to demonstrate that a once-daily oral treatment was superior in improving signs and symptoms of rheumatoid arthritis compared to the current injectable standard of care.”
RA-BEAM evaluated the safety and efficacy of baricitinib in over 1,300 patients who were randomised to receive 4mg baricitinib on background methotrexate, 40mg injectable every-other-week adalimumab on background methotrexate or placebo on background methotrexate.
Baricitinib is a once-daily, oral, selective JAK1 and JAK2 inhibitor. JAK-dependant cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that they may be useful for the treatment of a broad range of inflammatory conditions.
Lilly and Incyte had posted topline results in December last year and February this year in two trials known as RA-BEACON and RA-BUILD respectively.
AbbVie’s Humira achieved sales of $13bn in 2014 representing a growth of 17% from the year before, making it the largest selling pharmaceutical product across all disease areas.
The results from the new trial means that competition in the RA market is starting to heat up as in addition to baricitinib, Sanofi’s sarilumab is set to reach the market in 2016 and analysts have suggested it could bring in peak sales of $1bn.
RA is an autoimmune disease characterized by inflammation and progressive destruction of joints and affects over 23 million people worldwide.