Lilly announces positive top-line results for Taltz® (ixekizumab) vs. Humira® (adalimumab) in a head-to-head superiority study (SPIRIT-H2H) in patients with active psoriatic arthritis

TORONTO, Dec. 17, 2018 /CNW/ - Eli Lilly and Company announced today Taltz^® (ixekizumab) met the primary and all major secondary endpoints in the Phase 3b/4 SPIRIT-H2H study, which evaluated the efficacy and safety of Taltz versus Humira^® (adalimumab) in patients with active psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drug (DMARD) naïve. The SPIRIT-H2H trial is the first large head-to-head (H2H) superiority study in active PsA to be completed. The open-label, randomized controlled trial is the first and only H2H study that uses on-label dosing for Taltz and Humira and also included conventional concomitant DMARDs.

At 24 weeks, patients treated with Taltz met the primary endpoint by demonstrating superiority in improving the signs and symptoms of active PsA compared to Humira, as measured by the proportion of patients simultaneously achieving at least a 50 per cent reduction in disease activity, as defined by the American College of Rheumatology (ACR50), as well as complete skin clearance as measured by the Psoriasis Area and Severity Index (PASI100). In addition, Taltz met the major secondary endpoints by demonstrating non-inferiority in ACR50 as a stand-alone endpoint, and superiority in PASI100 as a stand-alone endpoint, compared to Humira.

"We hear patient stories of treatment success every day, and the positive results from the SPIRIT-H2H trial only reinforce that Taltz effectively treats the debilitating joint signs and symptoms of active psoriatic arthritis, while also providing skin clearance," said Doron Sagman, Vice President, Medical Affairs, Lilly Canada. "These results are compelling, and we now have stronger evidence that Taltz is an important first-line biologic treatment for patients with active PsA."

566 patients with active PsA were enrolled in the study to evaluate the efficacy and safety of Taltz compared to Humira. Patients with active PsA were randomized to receive Taltz at the approved dose (160 mg by subcutaneous injection [two 80 mg injections] at Week 0 followed by 80 mg every 4 weeks) or Humira (40 mg every two weeks) for a total 52 weeks, with the primary analysis conducted at 24 weeks. Patients meeting the criteria for moderate-to-severe plaque psoriasis were randomized to receive the approved dose of Taltz (160 mg by subcutaneous injection [two 80 mg injections] at Week 0, followed by 80 mg [one injection] at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg [one injection] every 4 weeks) or Humira (80 mg administered subcutaneously [two 40 mg injections], followed by 40 mg subcutaneously given every other week starting one week after the initial dose] for a total of 52 weeks, with the primary analysis conducted at 24 weeks. 

"As a physician who sees and treats patients with active psoriatic arthritis, I can say the positive SPIRIT-H2H trial outcome is encouraging news for the entire arthritis community," says Dr. Dafna Gladman, Rheumatologist and Director of the Psoriatic Arthritis Program at the Toronto Western Hospital, and Senior Scientist at the Krembil Research Institute. "Patients with active disease will continue to benefit from a safe and highly effective treatment, and the medical community has strong research to support the use of Taltz as a first-line therapeutic agent in PsA."

Lilly plans to submit detailed data from the SPIRIT-H2H study for disclosure at scientific meetings and in peer-reviewed journals in 2019.

Lilly unites caring with discovery to create medicines that make life better for people living with immune-mediated diseases

About the SPIRIT-H2H Study
SPIRIT H2H study is a Phase 3b/4, multicentre, randomized, open-label, parallel-group study with blinded outcomes assessments evaluating the efficacy and safety of Taltz versus Humira in patients with PsA who are biologic DMARD naive during a 52-week treatment period. The primary endpoint of the study was the simultaneous achievement of ACR50 and PASI100 response at Week 24. This primary endpoint is an innovative approach that comprehensively measures clinically meaningful improvements across multiple domains of PsA. The major secondary endpoints were the demonstration of non-inferiority in ACR50 and superiority in PASI100 in Taltz compared to Humira. Patients with active PsA and plaque psoriasis with a body surface area involvement of at least three per cent, who had inadequate response to at least one conventional DMARD, were enrolled in the study. 

About Taltz^®
Taltz^® is an interleukin (IL) 17A inhibitor containing the active substance ixekizumab. This monoclonal antibody (protein) recognizes and binds specifically to certain proteins.ⁱ IL-17A is a protein that is found to be present in high levels in inflammatory diseases such as plaque psoriasis and psoriatic arthritis.^vii Taltz neutralizes IL-17A, thus reducing the signs and symptoms of psoriatic arthritis and plaque psoriasis, such as itching, pain, and scaling.^vii The full Canadian Product Monograph for Taltz (ixekizumab) is available here. The approval of Taltz for PsA is based on data from the double blind, multi-centre, randomized, placebo-controlled SPIRIT-P1 and SPIRIT-P2 clinical trials, which assessed the safety and efficacy of Taltz compared to placebo in 780 adults with active PsA.^vii

• SPIRIT-P1 evaluated the safety and efficacy of ixekizumab compared to placebo in patients with active PsA who had never been treated with a biologic disease-modifying antirheumatic drug.
• SPIRIT-P2 evaluated the safety and efficacy of ixekizumab compared to placebo in tumour necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors or were intolerant to a TNF inhibitor.
• In both studies, the primary efficacy endpoint was the proportion of patients who, at 24 weeks, had achieved ACR20 response, which represents at least a 20 per cent reduction in a composite measure of disease activity as defined by the American College of Rheumatology (ACR).
• Results from both studies demonstrated that more than half of patients treated with Taltz reached ACR20 by Week 24 and showed significant improvement in joint symptoms, compared to placebo:
  • SPIRIT-P1: 58 per cent of patients treated with Taltz reached ACR20 compared to 30 per cent on placebo.
  • SPIRIT-P2: 53 per cent of patients treated with Taltz reached ACR20 compared to 20 per cent on placebo.
• Additionally, both studies evaluated improvement in psoriasis plaques at 12 weeks, as measured by improvement in the Psoriasis Area Severity Index (PASI) of at least a 75 per cent. PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaling of skin lesions, weighted by the body surface area of involved skin.
• The following proportion of patients achieved PASI 75 responses:
• SPIRIT-P1: 75.3 per cent of patients treated with Taltz compared to placebo (7.5 per cent). In SPIRIT-P1, patients experienced improvement in itch severity, when compared to placebo at Week 12.
• SPIRIT-2: 57.4 per cent of patients treated with Taltz compared to placebo (10.4 per cent).^vii

About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, progressive form of inflammatory arthritis that can cause pain, swelling and stiffness in and around the joints, as well as impaired physical function.ⁱⁱ  It occurs when an overactive immune system sends out faulty signals that cause inflammation, leading to swollen and painful joints and tendons.ⁱⁱⁱ PsA can also cause inflammation with swelling and pain in areas where tendons and ligaments attach to bones, known as enthesitis, or with swelling of an entire finger or toe, which is usually painful and associated with reduced mobility, known as dactylitis.^iv  In some patients, the inflammation may involve joints of the spine and the sacroiliac joints that link the spine to the pelvis, and may cause back pain and stiffness.^v If left untreated, PsA can cause permanent joint damage.^vi

About Lilly Canada
Eli Lilly and Company 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 Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.

REFERENCES
i	Taltz^® Canadian Product Monograph, March 29, 2018.
ii	Ritchlin CT, Colbert RA, Gladman DD. Psoriatic Arthritis. N Engl J Med. 2017;376(10):957-970.
iii	Ritchlin CT, Colbert RA, Gladman DD. Psoriatic Arthritis. N Engl J Med. 2017;376(10):957-970.
iv	Gladman DD. Clinical Features and Diagnostic Considerations in Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41(4):569-79.
v	Gladman DD. Clinical Features and Diagnostic Considerations in Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41(4):569-79.
vi	Gladman DD. Clinical Features and Diagnostic Considerations in Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41(4):569-79.

SOURCE Eli Lilly Canada Inc.

566 patients with active PsA were enrolled in the study to evaluate the efficacy and safety of Taltz compared to Humira. Patients with active PsA were randomized to receive Taltz at the approved dose (160 mg by subcutaneous injection [two 80 mg injections] at Week 0 followed by 80 mg every 4 weeks) or Humira (40 mg every two weeks) for a total 52 weeks, with the primary analysis conducted at 24 weeks. Patients meeting the criteria for moderate-to-severe plaque psoriasis were randomized to receive the approved dose of Taltz (160 mg by subcutaneous injection [two 80 mg injections] at Week 0, followed by 80 mg [one injection] at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg [one injection] every 4 weeks) or Humira (80 mg administered subcutaneously [two 40 mg injections], followed by 40 mg subcutaneously given every other week starting one week after the initial dose] for a total of 52 weeks, with the primary analysis conducted at 24 weeks.

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