LEL Lilly(Eli)

 
TIDMLEL 
 
Media Contacts: 
 
Lilly: Sonja Popp-Stahly, +1 317-655-2993, spopp-stahly@lilly.com 
 
Incyte: Pam Murphy, +1 302-498-6944, pmurphy@incyte.com 
 
Lilly and Incyte's Oral JAK1 and JAK2 Inhibitor, Baricitinib, Showed Positive 
    Results in Phase IIb Study in Patients with Active Rheumatoid Arthritis 
 
              - Results presented as a late breaker at EULAR 2012 
 
BERLIN, Germany [June 8, 2012] - Eli Lilly and Company (NYSE: LLY) and Incyte 
Corporation (Nasdaq: INCY) announced the presentation of 12-week results from a 
Phase IIb study of baricitinib, formerly LY3009104 (INCB28050), an orally 
available janus kinase (JAK) inhibitor, in patients with active rheumatoid 
arthritis (RA). The results were presented as a late-breaking oral presentation 
at the European League Against Rheumatism's (EULAR) Annual European Congress of 
Rheumatology [EULAR abstract LB0005: 12-Week Results of a Phase IIb 
Dose-Ranging Study of LY3009104 (INCB028050), an Oral JAK1/JAK2 Inhibitor, in 
Combination with Traditional DMARDs in Patients with Rheumatoid Arthritis]. 
 
The Phase IIb randomized double-blind, placebo-controlled, dose-ranging study, 
known as JADA, involved a total of 301 patients with active RA on stable doses 
of methotrexate. Patients were randomized to receive either placebo or one of 
four once-daily doses of baricitinib (1 mg, 2 mg, 4 mg or 8 mg) for 12 weeks. 
 
Primary Endpoint Achieved 
 
The Phase IIb trial achieved the primary endpoint by demonstrating a 
statistically significant difference in the American College of Rheumatology 20 
(ACR20) response between the combined 4 mg and 8 mg baricitinib groups (76 
percent) compared with placebo (41 percent) after 12 weeks of treatment (p 
<0.001). Statistically significant improvement was observed at the first 
assessment point after two weeks of treatment and was sustained through week 
12. 
 
Summary of Secondary Endpoints 
 
A statistically significant difference in response for the ACR20, ACR50 and 
ACR70 secondary endpoints was observed with the 1 mg, 4 mg and 8 mg dose groups 
compared with placebo. 
 
ACR20 
 
  * 8 mg: 78 percent (p<0.001) 
 
  * 4 mg: 75 percent (p<0.001) 
 
  * 2 mg: 54 percent (not significant) 
 
  * 1 mg: 57 percent (p<0.05) 
 
  * Placebo: 41 percent 
 
ACR50 
 
  * 8 mg: 40 percent (p<0.001) 
 
  * 4 mg: 35 percent (p<0.001) 
 
  * 2 mg: 17 percent (not significant) 
 
  * 1 mg: 31 percent (p<0.05) 
 
  * Placebo: 10 percent 
 
ACR70 
 
  * 8 mg: 20 percent (p<0.001) 
 
  * 4 mg: 23 percent (p<0.001) 
 
  * 2 mg: 8 percent (not significant) 
 
  * 1 mg: 12 percent (p<0.05) 
 
  * Placebo: 2 percent 
 
Safety Results 
 
The most common treatment-emergent adverse event class was infections, with a 
similar rate observed among patients in the placebo group (12 percent) and 
patients receiving baricitinib (14 percent). One patient in the placebo group 
was diagnosed with an opportunistic infection of toxocariasis. No deaths or 
opportunistic infections occurred in the active treatment groups. 
 
There were seven serious adverse events reported in six patients (two events in 
the placebo group, four in the 2 mg group and one in the 8 mg group). 
Dose-dependent changes in laboratory tests (hemoglobin, neutrophil, serum 
creatinine, LDL and HDL) were observed, with greater changes being observed in 
the 8 mg baricitinib group. 
 
A copy of the EULAR oral presentation can be accessed at: Link to Presentation 
 
Trial Design and Status 
 
This Phase IIb trial consists of three parts: Part A, Part B and an open-label 
extension. Part A was randomized, double-blind and placebo-controlled. Patients 
randomized to baricitinib received one of four doses administered once daily 
for 12 weeks. 
 
In Part B, patients initially randomized to placebo or the 1 mg baricitinib 
dose were re-randomized to receive either 4 mg once daily or 2 mg twice daily 
for 12 weeks. Patients initially randomized to the 2 mg, 4 mg and 8 mg doses 
continued therapy for an additional 12 weeks. 
 
Patients completing Part B were eligible to continue in an open-label extension 
arm on either the 4 mg or 8 mg once daily doses of baricitinib for 52 
additional weeks. 
 
Part B of the study has completed and data analysis is underway. Patients are 
continuing to participate in the open-label long-term extension of the trial. 
 
About JAK Inhibition 
 
There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. These enzymes are 
critical components of signaling mechanisms utilized by a number of cytokines 
and growth factors, including those that are elevated in RA patients. Cytokines 
such as interleukin-6, 12, and 23 signal through the JAK pathway and have been 
clinically validated as therapeutic targets in inflammatory diseases. 
Additional JAK-dependent cytokines have also been implicated in a number of 
inflammatory and autoimmune diseases suggesting that JAK inhibitors may be 
useful for the treatment of a broad range of inflammatory conditions. 
 
About Baricitinib 
 
Baricitinib is an orally administered selective JAK1 and JAK2 inhibitor that is 
JAK3-sparing. Currently, baricitinib is in Phase II development as a treatment 
for rheumatoid arthritis and psoriasis. 
 
In December 2009, Lilly and Incyte announced an exclusive worldwide license and 
collaboration agreement for the development and commercialization of 
baricitinib and certain follow-on compounds for inflammatory and autoimmune 
diseases. 
 
About Rheumatoid Arthritis 
 
The disease is characterized by abnormal immune mechanisms that lead to joint 
inflammation and swelling with progressive destruction of joints. In addition 
to affecting the joints, RA can also affect connective tissue in the skin and 
organs of the body. 
 
Current treatment of RA includes the use of non-steroidal anti-inflammatory 
drugs, disease-modifying antirheumatic drugs such as methotrexate, and the 
newer injectable biological response modifiers that target tumor necrosis 
factor, a pro-inflammatory cytokine implicated in the pathogenesis of RA. 
 
About Eli Lilly and Company 
 
Lilly, a leading innovation-driven corporation, is developing a growing 
portfolio of pharmaceutical products by applying the latest research from its 
own worldwide laboratories and from collaborations with eminent scientific 
organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - 
through medicines and information - for some of the world's most urgent medical 
needs. Additional information about Lilly is available at www.lilly.com. 
 
About Incyte 
 
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company 
focused on the discovery, development and commercialization of proprietary 
small molecule drugs for oncology and inflammation. For additional information 
on Incyte, please visit the Company's website at www.incyte.com. 
 
P-LLY 
 
                                     # # # 
 
                                                                              3 
 
Arthritis Foundation, What is Rheumatoid Arthritis, http://www.arthritis.org/ 
types-what-is-rheumatoid-arthritis.php (Accessed: May 1, 2012). 
 
 
 
END 
 

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