- Johnson & Johnson, along with partner GlaxoSmithKline, aim to challenge AbbVie's blockbuster anti-inflammatory disease drug Humira (adalimumab) with their experimental drug sirukumab. Yet mixed results from a Phase 3 study of the IL-6 antibody suggest the comparison may not be a slam-dunk.
- Results from the study, presented at the annual meeting of the American College of Rheumatology over the weekend, showed a significantly greater improvement in blood markers for inflammation compared to Humira at 24 weeks.
- But sirukumb missed on its second co-primary endpoint, failing to separate from Humira in reducing signs and symptoms by 50% (so-called ACR50 response). While treatment with both doses of sirukumab led to clinically meaningful reductions, the difference compared to Humira was not statistically significant.
Humira has been one of the top-selling drugs worldwide over the past several years, pulling in roughly $14 billion last year for a number of autoimmune diseases including rheumatoid arthritis (RA).
The RA market alone is highly lucrative: Research and Markets forecasts total market value will hit $21.3 billion by 2020. Given the revenue at stake, a number of drugmakers are aiming to unseat currently dominant biologics like Humira.
Johnson & Johnson and GlaxoSmithKline's sirukumab, which blocks the cytokine IL-6, is potentially one of the frontrunners in this new wave of medications.
In the study, treatment with both the low and high doses of sirukumab led to mean declines of 2.58 and 2.96, respectively, on a commonly used nine-point scale to measure disease activity. This beat out Humira, which registered a decline of 2.19.
Yet the failure to separate from Humira on ACR50 muddies that success. Additionally, the rates of adverse events were higher among patients taking sirukumab than those on Humira.
Sirukumab was submitted for European and U.S. approval in September 2016, for adults with moderate or severe rheumatoid arthritis, as a monotherapy or combination therapy with methotrexate.The two companies have been working together since 2011 to develop sirukumab, with J&J retaining rights outside of the Americas.