Eli Lilly Says Long-Term Use of Taltz Shows Efficacy Improvements in PsA at ACR/ARHP

INDIANAPOLIS, Nov. 8, 2017 /PRNewswire/ -- Eli Lilly (NYSE: LLY) announced today patients with active psoriatic arthritis (PsA) treated with Taltz^® (ixekizumab), who were previously intolerant or had inadequate responses to TNF inhibitors, showed improvements in the signs and symptoms of PsA across treatment groups for up to 52 weeks. Interim results from the extension period of the Phase 3 SPIRIT-P2 study will be presented today in an oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego, Calif.

Over the 52-week extension period, the majority of patients treated with Taltz achieved at least a 20-percent improvement in disease activity, as defined by the American College of Rheumatology (ACR 20), the primary endpoint of the study extension.¹ Patients also maintained improvements in key secondary endpoints, including skin clearance and physical function, as measured by the Psoriasis Area Severity Index (PASI) and the Health Assessment Questionnaire Disability Index (HAQ-DI) respectively.

"These data are promising for the more than 37 million people worldwide who suffer from joint and skin symptoms of psoriatic arthritis," said Dr. Lotus Mallbris, vice president, immunology platform team leader, Lilly Bio-Medicines. "In addition to the efficacy of Taltz for people with skin symptoms, we are pleased to share new data suggesting that Taltz, if approved, may provide an option for those with joint symptoms of PsA."

Full SPIRIT-P2 Extension Results
During the extension period of the SPIRIT-P2 study, the majority of patients treated with Taltz showed improvements at 52 weeks in disease activity of PsA. Patients were required to have a diagnosis of PsA for at least six months, at least three tender and swollen joints and a previous intolerant or inadequate response to TNF inhibitors.

Patients who received treatment with Taltz during the initial double-blind treatment period of the SPIRIT-P2 study continued the same dosing regimen (either 80-mg of Taltz once every two weeks or 80-mg of Taltz once every four weeks) during the extension period. At 52 weeks, patients who continued treatment with Taltz achieved the following response rates:

• ACR 20: 68 percent of patients treated with Taltz every four weeks, 59 percent of patients treated with Taltz every two weeks.
• ACR 50: 46 percent of patients treated with Taltz every four weeks, 38 percent of patients treated with Taltz every two weeks.
• ACR 70: 29 percent of patients treated with Taltz every four weeks, 21 percent of patients treated with Taltz every two weeks.

Patients treated with placebo during the initial double-blind treatment period of the SPIRIT-P2 study were re-randomized during the extension period at week 16 or 24 to receive either 80-mg of Taltz once every two weeks or 80-mg of Taltz once every four weeks, following a 160-mg starting dose. At 52 weeks, patients re-randomized to Taltz achieving the following response rates:

• ACR 20: 61 percent of patients treated with Taltz every four weeks and 50 percent of patients treated with Taltz every two weeks.
• ACR 50: 44 percent of patients treated with Taltz every four weeks and 35 percent of patients treated with Taltz every two weeks.
• ACR 70: 24 percent of patients treated with Taltz every four weeks and 15 percent of patients treated with Taltz every two weeks.

"Many people living with PsA are seeking an effective treatment option that will address all of their symptoms including pain, swelling and stiffness of the joints, as well as painful skin plaques," said Mark C. Genovese, M.D., presenting author and professor and director of the Rheumatology Clinic in the Division of Immunology and Rheumatology, Stanford University. "This new data shows the potential impact ixekizumab, if approved, could have for PsA patients."

The observed safety profile was consistent with initial findings from the double-blind treatment period of the SPIRIT-P2 study. During the extension period, the majority of treatment-emergent adverse events were mild or moderate in severity, including injection site reaction, upper respiratory infection, nasopharyngitis and sinusitis. Serious adverse events occurred in 15 patients in the extension period, including one death.

Lilly has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Taltz as a treatment of adult patients with 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.

About the SPIRIT-P2 Extension
During the initial 24-week, double-blind treatment period of the SPIRIT-P2 study, patients were randomly assigned to placebo, 80-mg of Taltz once every two weeks or 80-mg of Taltz once every four weeks (both Taltz dosing groups following a 160-mg starting dose). Patients were required to have a diagnosis of PsA for at least six months, at least three tender and swollen joints and a previous intolerant or inadequate response to TNF inhibitors.

Following completion of the double-blind treatment period, patients who received treatment with Taltz continued the same dosing regimen during the extension period to evaluate response rates up to 156 weeks. Patients who received placebo during the double-blind treatment period were re-randomized at 16 or 24 weeks to receive 80-mg of Taltz every two weeks or four weeks (following a 160-mg starting dose).

During the extension period, the primary endpoint was the percentage of patients achieving at least a 20-percent improvement in a composite measure of disease activity, as defined by the ACR 20.¹ This study also evaluated secondary endpoints including ACR 50 and ACR 70, which represent 50-percent and 70-percent improvements in disease activity; improvement in physical function as assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI); and improved skin clearance as measured by the Psoriasis Area Severity Index (PASI).

Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations. See Important Safety Information below.

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

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.

Taltz is also in Phase 3 trials for the treatment of radiographic and non-radiographic axial spondyloarthritis.

About the SPIRIT-P2 Study
SPIRIT-P2 is a Phase 3, randomized, double-blind, placebo-controlled study examining the effect of Taltz compared with placebo in patients with PsA who were previously treated with TNF inhibitors and had an inadequate response to one or two TNF inhibitors or were intolerant to TNF inhibitors. The trial included 363 patients (randomized at a 1:1:1 ratio) with diagnosis of PsA for at least six months and who had at least three tender and three swollen joints. During the study, patients treated with Taltz received a starting dose of 160-mg administered subcutaneously (SC), as two 80-mg injections, followed by one of two dosing regimens: either 80-mg administered SC once every two weeks or 80-mg administered SC once every four weeks. The SPIRIT-P2 study will also evaluate the long-term efficacy and safety of Taltz in PsA for up to three years.

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.² It occurs when an overactive immune system sends out faulty signals that cause inflammation, leading to swollen and painful joints and tendons.³ 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).⁴ If left untreated, PsA can cause permanent joint damage.2 Additionally, up to 30 percent of people with psoriasis also develop PsA.2

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 newsroom.lilly.com/social-channels.

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 reflects Lilly's current belief. However, 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 Taltz will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly'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 undertakes no duty to update forward-looking statements to reflect events after the date of this release.

¹ A proposed revision to the ACR20: the hybrid measure of American College of Rheumatology response. Arthritis & Rheumatism. 2007;57:193-202. http://www.rheumatology.org/Portals/0/Files/A%20Proposed%20Revision%20to%20the%20ACR20.pdf. Accessed October 17, 2017.
² About psoriatic arthritis. National Psoriasis Foundation website. https://www.psoriasis.org/about-psoriatic-arthritis. Accessed October 17, 2017.
³ What is psoriatic arthritis? Arthritis Foundation website. http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php. Accessed October 17, 2017.
⁴ Classification of psoriatic arthritis. National Psoriasis Foundation website. https://www.psoriasis.org/psoriatic-arthritis/classification-of-psoriatic-arthritis. Accessed October 17, 2017.

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)

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