Lilly and Incyte Announce Baricitinib Efficacy and Safety Data from the Open-Label, Long-Term Extension of the Phase 2b JADA

   Lilly and Incyte Announce Baricitinib Efficacy and Safety Data from the
 Open-Label, Long-Term Extension of the Phase 2b JADA Study in Patients with
                             Rheumatoid Arthritis

- Results from 52-week study presented at EULAR 2013 -

PR Newswire

MADRID, June 13, 2013

MADRID, June 13, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and
Incyte Corporation (Nasdaq: INCY) today announced 52-week efficacy and safety
data from the open-label, long-term extension of the Phase 2b JADA study of
baricitinib in patients with active rheumatoid arthritis (RA). Baricitinib,
formerly LY3009104 (INCB28050), is an orally available Janus kinase (JAK)
inhibitor being studied for use in the treatment of certain autoimmune
conditions, including RA. Among patients completing the open-label extension,
clinical improvements observed at week 24 were sustained at the end of
52weeks. The results were presented at the European League Against Rheumatism
(EULAR) Annual European Congress of Rheumatology in Madrid, Spain [EULAR
abstract OP0047: Baricitinib, an Oral Janus Kinase Inhibitor, in the Treatment
of Rheumatoid Arthritis: Safety and Efficacy in Open-Label, Long-Term
Extension Study].

The long-term extension of the JADA study evaluated the efficacy and safety of
baricitinib in 201 patients taking either 4 mg (n=108) or 8 mg (n=93) once
daily for up to 52 weeks. Doses could be escalated to 8 mg once daily at 28 or
32 weeks at the investigator's discretion when the patient presented more than
six tender and swollen joints.

As previously reported, in the initial 12-week portion of this study,
baricitinib was associated with statistically significant improvements in the
signs and symptoms of RA disease versus placebo[1] and these responses were
maintained or improved during an additional 12 weeks of blinded treatment.[2]

In the long-term extension, the clinical improvements observed at week 24 were
sustained through 52 weeks in RA patients. The following chart summarizes
selected efficacy results:

                  24-Week           52-Week
Improvement /     Responders/Total  Responders/Total
Activity Measure  Patients (Percent Patients (Percent
                  Responders)       Responders)
ACR20             149/201 (74%)     139/196 (71%)
ACR50             83/201 (41%)      96/197 (49%)
ACR70             43/201 (21%)      53/197 (27%)
CDAI Remission    34/200 (17%)      40/195 (21%)
SDAI Remission    30/195 (15%)      42/194 (22%)
DAS28 ESR <2.6    35/200 (18%)      47/195 (24%)
DAS28 ESR </= 3.2 55/200 (28%)      82/195 (42%)
DAS28 CRP <2.6    59/195 (30%)      80/194 (41%)
DAS28 CRP </= 3.2 93/195 (48%)      116/194 (60%)
Boolean Remission 19/195 (10%)      32/194 (16%)

Safety Results

Safety signals observed during the open-label extension were consistent with
previously reported results of baricitinib. Among patients who remained on the
4 mg dose, treatment-emergent adverse events (TEAEs) occurred in 57 (53
percent); serious adverse events (SAEs) in11 (10 percent); infections in 34
(31 percent); and serious infections in four (4 percent). Among patients who
received the 8 mg dose, TEAEs occurred in 59 (63 percent); SAEs in eight (9
percent); infections in 37 (40 percent); and serious infections in two (2
percent). No opportunistic infections or tuberculosis cases were observed.
There was one death in the 8 mg group due to a suspected myocardial

"In this clinical trial baricitinib showed statistically and clinically
significant improvements in the features of this condition, which were
maintained throughout a year of treatment. To date, baricitinib has
demonstrated an acceptable safety profile and side effects have generally been
straightforward to manage. These encouraging findings support further
investigation of this new drug in rheumatoid arthritis," said Peter Taylor,
M.A., Ph.D., F.R.C.P., Norman Collisson Chair of Musculoskeletal Sciences in
the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal
Sciences at the University of Oxford, and steering committee member for the

A copy of the EULAR oral presentation can be accessed at: 2013 EULAR - JADA
52-Week Presentation 

Trial Design

This randomized, open-label, long-term extension of Phase 2b JADA study
included 201 (95 percent) of the eligible 212 patients. Of the 201 patients,
184completed 52weeks of treatment, 15 discontinued treatment, and two
patients had not yet completed the full 52 weeks of treatment. Patients
received either 4 mg or 8 mg once-daily doses of baricitinib beginning at week
24 through week 52.

In the initial 12-week treatment duration, patients received one of four doses
of baricitinib (1 mg, 2 mg, 4 mg or 8 mg) or placebo, administered once daily.
In the 12- to 24-week portion of the study, 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 an additional 12 weeks; patients initially
randomized to the 2 mg, 4 mg and 8mg doses continued therapy with those

Patients who completed week 24 were eligible to receive either the 4- or 8-mg
once daily dose through week 52. The study is ongoing, with all patients who
are continuing in the study receiving baricitinib 4 mg once daily.

About JAK Inhibition

There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2.[3] These enzymes
are critical components of signaling mechanisms used by a number of cytokines
and growth factors, including several that are elevated in patients with RA.
Cytokines such as interleukin-6, -12 and -23 and both type 1 and type 2
interferons signal through these pathways. JAK-dependent cytokines have been
implicated in the pathogenesis of 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.
Baricitinib is in Phase III development as a potential treatment for
rheumatoid arthritis. It is in Phase II development as a potential treatment
for psoriasis and diabetic nephropathy.

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

About Rheumatoid Arthritis

Rheumatoid arthritis is an autoimmune disease that is characterized by
inflammation and progressive destruction of joints.[4] Current treatment of RA
includes the use of non-steroidal anti-inflammatory drugs, oral
disease-modifying antirheumatic drugs such as methotrexate, and injectable
biological response modifiers that target selected mediators implicated in the
pathogenesis of RA.[5]

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

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

This press release contains certain forward-looking statements about
baricitinib as a potential treatment for patients with rheumatoid arthritis
and reflects Lilly and Incyte's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and uncertainties in the
process of development and commercialization. There is no guarantee that
future study results and patient experience will be consistent with study
findings to date, that the product will receive regulatory approval, or, if
approved, that the product will be commercially successful. For further
discussion of these and other risks and uncertainties, see Lilly's and
Incyte's filings with the United States Securities and Exchange Commission.
Lilly and Incyte undertake no duty to update forward-looking statements.


[1] E. Keystone, P. Taylor, M. Genovese, D. Schlichting, S. Beattie, C. Gaich,
R. Fidelus Gort, M. Luchi, W.L. Macias. 12-week results of a phase 2b
dose-ranging study of LY3009104 (INCB028050), an oral JAK1/JAK2 inhibitor in
combination with traditional DMARDS in patients with rheumatoid arthritis.
Annals Rheumatic Disease. 2012; 71(Suppl3):152.

[2] M Genovese, E Keystone, P Taylor, P-Y Berclaz, C Lee, D Schlichting, S
Beattie, M Luchi, W Macias. 24-week results of a blinded phase 2b dose-ranging
study of baricitinib, an oral janus kinase 1/ janus kinase 2 inhibitor, in
combination with traditional disease modifying antirheumatic drugs in patients
with rheumatoid arthritis. Arthritis and Rheumatism. 2012; 64(10(supp)):S1049.

[3] S. Verstovsek. Therapeutic potential of JAK2 inhibitors. American Society
of Hematology. 2009: 636.

[4] Arthritis Foundation, What is Rheumatoid Arthritis, (Accessed:
May15, 2013).

[5] Arthritis Foundation, Medications for Rheumatoid Arthritis,
(Accessed: May 15, 2013).


Media: Sonja Popp-Stahly, +1 317-655-2993,
Investors: Phil Johnson, +1 317-655-6874,

Media and Investors: Pam Murphy, +1 302-498-6944,


SOURCE Eli Lilly and Company; Incyte Corporation
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