Dive Brief:
- Eli Lilly's recently approved therapy Olumiant improved systemic lupus erythematosus (SLE) compared to placebo in a global Phase 2 study presented at the this year's Annual European Congress of Rheumatology, or EULAR, in the Netherlands.
- Study participants taking the higher 4 mg dose of Olumiant had significant resolution of arthritis or rash versus those in the control group, thereby meeting the primary endpoint.
- Patients on that higher dose also had greater scores in two measures of disease severity, the Systemic Lupus Erythematosus Responder Index and the Lupus Low Disease Activity State (LLDAS), as well as better flare reduction and lower tender joint counts.
Dive Insight:
SLE is the most common form of lupus. It typically affects women between 15 and 50, according to a statement from EULAR, with symptoms ranging from chronic skin rashes and arthritis to life-threatening organ damage.
A variety of treatments, including anti-inflammatories, antimalarials and immunosuppressants, are out there to treat the autoimmune disease. GlaxoSmithKline's Benlysta (belimumab), now available as a subcutaneous formulation, was the first lupus drug to gain approval since 1955, and is currently the only drug specifically approved by the Food and Drug Administration for the condition.
"Novel therapeutic strategies are needed for SLE, which causes significant morbidity and mortality, and so we are delighted to see the positive results from the Phase 2 trial of baricitinib," said Professor Thomas Dörner, chairperson of EULAR's Abstract Selection Committee.
There are a handful of companies developing drugs in SLE, but for some, success is elusive and failures have had dramatic impacts. Anthera Pharmaceuticals' blisimod knocked a third off the company's share price when it failed a Phase 3 trial in 2016. ImmuPharma also took a tumble in April, when shares fell by more than 75% after its drug Lupuzor (rigerimod) missed in a pivotal study of lupus patients.
Belgian biotech Ablynx, now owned by Sanofi, is developing a candidate called vobarilizumab for SLE. However, Ablynx's option agreement with AbbVie for the drug looked distinctly wobbly after vobarilizumab flunked the mid-stage STEADY trial. AbbVie is waiting until the complete STEADY data set is available before it decides whether to exercise its option.
Lilly's Olumiant (baricitinib), a once-daily oral janus kinase inhibitor, is part of the company's program to develop medicines for severe autoimmune diseases. Its lead indication is rheumatoid arthritis, for which it gained approval in the EU for second-line use in March.
The drug has faced problems in the U.S., however. Lilly and partner Incyte saw a delay to their original user fee action date, and then a no-go from the FDA due to safety concerns. Earlier this month, it narrowly snagged an OK from U.S. regulators, but only for the smaller 2 mg dose. Analysts expect the black box warning slapped on the drug's label will weigh down prescriber pickup as well.