Lilly to Present New Data on Immunology Portfolio at ACR/ARHP Annual Meeting

Highlights include new data for baricitinib in rheumatoid arthritis and Taltz in plaque psoriasis and psoriatic arthritis

INDIANAPOLIS, Oct. 30, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced that it will present new data for baricitinib and Taltz® (ixekizumab) at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting taking place Nov. 3-8, 2017, in San Diego, Calif.

Lilly will feature new data for baricitinib in 17 abstracts, including six oral presentations on rheumatoid arthritis (RA) (Lilly and Incyte Corporation are partners on the development of baricitinib). Highlights include a new post-hoc analysis from RA-BEAM, a pivotal Phase 3 study, disclosing outcomes of patient-reported levels of pain control, as well as new findings from two safety analyses evaluating cardiovascular safety and long-term use of baricitinib in RA, respectively.

Additionally, Lilly will present eight abstracts featuring new data for Taltz, including two oral presentations. Highlights from the oral presentations include interim results from the extension period of the SPIRIT-P2 study evaluating the safety and efficacy of Taltz for the treatment of active psoriatic arthritis (PsA), in addition to a new analysis from the IXORA-S study comparing Taltz to Stelara®** (ustekinumab) for the treatment of nail lesions in patients with moderate-to-severe plaque psoriasis.

An additional eight abstracts will detail results from a selection of studies evaluating the impact of immune-mediated diseases.

"At Lilly, patients are at the heart of what we do every day," said Lotus Mallbris, M.D., vice president, immunology platform team leader, Lilly Bio-Medicines. "We are proud to present new data at ACR/ARHP from our continued research with the goal to help provide more treatment options for people living with autoimmune diseases."

Highlighted presentations and posters include: 

Baricitinib Data

Oral Presentations (All times PST)

Sunday, Nov. 5

Monday, Nov. 6

Tuesday, Nov. 7

Poster Presentations (All times PST)

Sunday, Nov. 5

Tuesday, Nov. 7

Taltz Data

Oral Presentations (All Times PST)

Monday, Nov. 6

Wednesday, Nov. 8

Poster Presentations (All Times PST)

Sunday, Nov. 5

Additional Data

Poster Presentations (All Times PST)

Monday, Nov. 6

Tuesday, Nov. 7

INDICATIONS AND USAGE FOR TALTZ

Taltz® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

IMPORTANT SAFETY INFORMATION FOR TALTZ

CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS
Infections
Taltz may increase the risk of infection. The Taltz group had a higher rate of infections than the placebo group (27% vs 23%). Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.

Hypersensitivity
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the TALTZ group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with TALTZ. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel Disease
Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease.

Immunizations
Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Live vaccines should not be given with Taltz.

ADVERSE REACTIONS
Most common adverse reactions ( > 1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.  

Please see accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

IX HCP ISI 18JUL2017

*The brand listed is a registered trademark owned or licensed by AbbVie, its subsidiaries or affiliates, and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Lilly or their products.

**The brand listed is a registered trademark owned or licensed by Janssen Pharmaceutical Companies of Johnson & Johnson, its subsidiaries or affiliates, and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Lilly or their products.

About Rheumatoid Arthritis
Rheumatoid arthritis is a systemic autoimmune disease characterized by inflammation and progressive destruction of joints.1,2 More than 23 million people worldwide suffer from RA.3 Approximately three times as many women as men have the disease. Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), such as methotrexate, and injectable, biological disease-modifying antirheumatic drugs (bDMARDs) that target selected mediators implicated in the pathogenesis of RA.4 Despite current treatment options, many patients do not reach their therapeutic goals or sustained remission.5,6 There remains an important need to provide additional treatments to improve overall patient care. 

About Baricitinib
Baricitinib is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. 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, including rheumatoid arthritis.

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 patients with inflammatory and autoimmune diseases. Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., the European Union and Japan in 2016. Baricitinib was approved in the EU in February 2017 and in Japan in July 2017. In April 2017, the U.S. Food and Drug Administration issued a Complete Response Letter on the New Drug Application for baricitinib. Baricitinib remains under review in other markets. It is also being studied for the treatment of atopic dermatitis and systemic lupus erythematosus. The Phase 3 program for psoriatic arthritis is expected to begin in 2018.

About Moderate-to-Severe Plaque Psoriasis
Psoriasis is a chronic, immune disease that affects the skin.7 It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis affects approximately 125 million people worldwide, approximately 20 percent of whom have moderate-to-severe plaque psoriasis.11,8 Psoriasis can occur on any part of the body and is associated with other serious health conditions, such as diabetes and heart disease.11 The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.11

About Active Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, progressive form of inflammatory arthritis that can cause swelling, stiffness and pain in and around the joints, nail changes and impaired physical function.9 It occurs when an overactive immune system sends out faulty signals that cause inflammation, leading to swollen and painful joints and tendons.10 Typically, psoriatic arthritis affects peripheral joints in the arms and legs (elbows, wrists, hands and feet), but can also affect joints in the axial skeleton (spine, hips and shoulders).11 If left untreated, PsA can cause permanent joint damage.14 Additionally, up to 30 percent of people with psoriasis also develop PsA.14

About Taltz®
Taltz® (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.

Lilly has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Taltz for the treatment of active PsA. Lilly also submitted Taltz to the European Medicines Agency (EMA) for the treatment for adult patients with active PsA. Taltz is approved for adult patients with active PsA in Japan. Submissions to other regulatory agencies around the world are expected later this year. Taltz is also in Phase 3 trials for the treatment of radiographic and non-radiographic axial spondyloarthritis.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels.

About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company's web site at www.incyte.com.        

Follow @Incyte on Twitter at https://twitter.com/Incyte.

P-LLY

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab) as a potential treatment for psoriatic arthritis and baricitinib as a potential treatment for patients with rheumatoid arthritis, and reflects Lilly's current belief. This press release also contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about baricitinib as a potential treatment for patients with rheumatoid arthritis, and reflects Lilly's and Incyte's current belief. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that Taltz or baricitinib will receive additional regulatory approvals, or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.


1 American College of Rheumatology, Rheumatoid Arthritis, http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp. Accessed October 23, 2017.
2 Hand Clinics, Advances in the Medical Treatment of Rheumatoid Arthritis, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf. Accessed October 23, 2017.
3 WHO Global Burden of Disease Report, (table 7, page 32) 2004, http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. Accessed October 23, 2017.
4 Arthritis Foundation, Medications for Rheumatoid Arthritis, http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php. Accessed October 23, 2017.
5 Rheumatoid arthritis, Lancet, https://www.ncbi.nlm.nih.gov/pubmed/27156434. Accessed October 23, 2017.
6 Sustained rheumatoid arthritis remission is uncommon in clinical practice, Arthritis Research & Therapy, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/. Accessed October 23, 2017.
7 Psoriasis media kit. National Psoriasis Foundation website. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed October 23, 2017.
8 Psoriasis. American Academy of Dermatology website. https://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis. Accessed October 23, 2017.
9 About psoriatic arthritis. National Psoriasis Foundation website. https://www.psoriasis.org/about-psoriatic-arthritis. Accessed October 23, 2017.
10 What is psoriatic arthritis? Arthritis Foundation website. http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php. Accessed October 23, 2017.
11 Classification of psoriatic arthritis. National Psoriasis Foundation website. https://www.psoriasis.org/psoriatic-arthritis/classification-of-psoriatic-arthritis. Accessed October 23, 2017.

Incyte logo. (PRNewsFoto/Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company)

 

Refer to:   

Danielle Neveles; danielle.neveles@lilly.com; 317-796-4564 (Lilly media) 


Phil Johnson; johnson_philip_l@lilly.com; 317-655-6874 (Lilly investors) 


Catalina Loveman; cloveman@incyte.com; 302-498-6171 (Incyte media) 


Michael Booth, DPhil; mbooth@incyte.com; 302-498-5914 (Incyte investors) 

SOURCE Lilly; Incyte Corporation

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